Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

NCT04333147 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 209564
• Study Type: interventional
• Target: 2,916
• Locations: 26 countries
• Sites: 366

Brief Summary

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X \[209564: NCT04333147\]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) \[csDMARD(s)\] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid arthritis; GSK3196165; Otilimab; Long-term safety; Long-term efficacy

Outcome Measures

Primary Outcomes (26)

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

  An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs were included.

  Up to approximately 145 Weeks

• Change From Baseline in Hematology Parameter of Platelet Count at Week 24

  Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

  Baseline (Day 01) and Week 24

• Change From Baseline in Hematology Parameter of Platelet Count at Week 48

  Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

  Baseline (Day 01) and Week 48

• Change From Baseline in Hematology Parameter of Platelet Count at Week 96

  Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

  Baseline (Day 01) and Week 96

• Change From Baseline in Hematology Parameter of Platelet Count at Week 144

  Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

  Baseline (Day 01) and Week 144

• Change From Baseline in Hematology Parameter of Hemoglobin at Week 24

  Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

  Baseline (Day 01) and Week 24

• Change From Baseline in Hematology Parameter of Hemoglobin at Week 48

  Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

  Baseline (Day 01) and Week 48

• Change From Baseline in Hematology Parameter of Hemoglobin at Week 96

  Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

  Baseline (Day 01) and Week 96

• Change From Baseline in Hematology Parameter of Hemoglobin at Week 144

  Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

  Baseline (Day 01) and Week 144

• Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24

  Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

  Baseline (Day 01) and Week 24

• Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48

  Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

  Baseline (Day 01) and Week 48

• Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96

  Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

  Baseline (Day 01) and Week 96

• Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144

  Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

  Baseline (Day 01) and Week 144

• Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24

  Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

  Baseline (Day 01) and Week 24

• Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48

  Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

  Baseline (Day 01) and Week 48

• Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96

  Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

  Baseline (Day 01) and Week 96

• Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144

  Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

  Baseline (Day 01) and Week 144

• Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24

  Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

  Baseline (Day 01) and Week 24

• Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48

  Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

  Baseline (Day 01) and Week 48

• Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96

  Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

  Baseline (Day 01) and Week 96

• Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144

  Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

  Baseline (Day 01) and Week 144

• Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities

  Number of participants with NCI-CTCAE \>=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case \>=Grade 3 shifts from Baseline.

  Up to approximately 145 Weeks

• Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24

  Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

  Baseline (Day 01) and Week 24

• Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48

  Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

  Baseline (Day 01) and Week 48

• Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96

  Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

  Baseline (Day 01) and Week 96

• Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144

  Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

  Baseline (Day 01) and Week 144

Secondary Outcomes (16)

• Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144

  Week 24, 48, 96 and 144

• Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144

  Week 24, 48, 96 and 144

• Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144

  Week 24, 48, 96 and 144

• Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132

  Week 24, 48, 96 and 132

• Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144

  Week 24, 48, 96 and 144

Study Arms (2)

Otilimab 90 mg

EXPERIMENTAL

Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.

Biological: Otilimab (GSK3196165); Drug: csDMARD(s)

Otilimab 150 mg

EXPERIMENTAL

Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.

Biological: Otilimab (GSK3196165); Drug: csDMARD(s)

Interventions

Otilimab (GSK3196165) BIOLOGICAL

GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

Otilimab 150 mg; Otilimab 90 mg

csDMARD(s) DRUG

Stable dose of csDMARD(s) as standard of care (SoC).

Otilimab 150 mg; Otilimab 90 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with rheumatoid arthritis who are aged \>=18 years at the time of signing informed consent, who have completed one of the qualifying GSK3196165 clinical studies and who, in the opinion of the investigator, may benefit from treatment with GSK3196165.
• Body weight \>=40 kilograms (kg).
• Male or female participants are eligible to participate as long as they meet the contraceptive eligibility criteria and agree to abide by the contraceptive requirements.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• For participants on methotrexate (MTX): must be willing to continue treatment with oral folic acid (at least 5 mg/week) or equivalent while receiving MTX (mandatory co-medication for MTX treatment).

You may not qualify if:

• Had study intervention permanently discontinued at any time during a qualifying study except any participant with a new diagnosis of latent Mycobacterium tuberculosis (TB) at the end of study assessment in a qualifying study and currently undertaking or willing to complete at least 4 weeks of anti-TB treatment off study treatment, per world health organization (WHO) or national guidelines prior to re-commencing therapy and complete the remainder of anti-TB treatment while on study.
• Evidence of latent TB (as documented by a positive QuantiFERON-TB Gold plus test or T-SPOT.TB test, no findings on medical history or clinical examination consistent with active TB, and a normal chest radiograph) except for participants that
• Are currently undertaking or willing to complete at least 4 weeks of anti-TB therapy off study treatment, as per WHO or national guidelines prior to re- commencing study treatment and agree to complete the remainder of anti-TB treatment while in the study or
• Had documented evidence of satisfactory anti-TB treatment as per WHO or national guidelines following review by a physician specializing in TB on entry to a qualifying study.
• Current or previous active TB regardless of treatment.
• Were temporarily discontinued from study intervention at the time of the final study visit of a qualifying study and, in the opinion of the investigator, participation in the extension study poses an unacceptable risk for the participant's participation.
• A new cancer or malignancy except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured by the investigator.
• Have developed any lymphoproliferative disorder during a qualifying study, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, or signs and symptoms suggestive of current lymphatic disease.
• Have significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the participant's participation.
• Participants who are expected to be non-compliant with restrictions on medications and vaccinations prior to the study, during the study or during the 8-week safety follow-up of the study.
• Participants who are currently participating in any interventional clinical study other than a qualifying GSK3196165 clinical study.
• Abnormal chest radiograph within the last 12 weeks judged by the investigator as clinically-significant.
• Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
• History of sensitivity to any of the study treatments, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Iqvia Pty Ltd: collaborator

Study Sites (375)

GSK Investigational Site

Anniston, Alabama, 36207, United States

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GSK Investigational Site

Flagstaff, Arizona, 86001, United States

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GSK Investigational Site

Gilbert, Arizona, 85297, United States

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GSK Investigational Site

Glendale, Arizona, 85306, United States

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GSK Investigational Site

Mesa, Arizona, 85210, United States

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GSK Investigational Site

Phoenix, Arizona, 85032, United States

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GSK Investigational Site

Phoenix, Arizona, 85037, United States

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GSK Investigational Site

Tucson, Arizona, 85704, United States

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GSK Investigational Site

Covina, California, 91722, United States

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GSK Investigational Site

Poway, California, 92064, United States

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GSK Investigational Site

San Diego, California, 92108, United States

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GSK Investigational Site

San Diego, California, 92128, United States

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GSK Investigational Site

Upland, California, 91786, United States

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GSK Investigational Site

Van Nuys, California, 91405, United States

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GSK Investigational Site

Whittier, California, 90602, United States

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GSK Investigational Site

Denver, Colorado, 80230, United States

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GSK Investigational Site

Fort Collins, Colorado, 80528, United States

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GSK Investigational Site

Aventura, Florida, 33180, United States

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GSK Investigational Site

Brandon, Florida, 33511, United States

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Clearwater, Florida, 33765, United States

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Daytona Beach, Florida, 32117, United States

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Jacksonville, Florida, 32207, United States

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Miami, Florida, 33134, United States

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GSK Investigational Site

Miami, Florida, 33155, United States

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GSK Investigational Site

Miami, Florida, 33165, United States

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GSK Investigational Site

Miami, Florida, 33173, United States

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GSK Investigational Site

Miami Lakes, Florida, 33014, United States

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GSK Investigational Site

Miami Lakes, Florida, 33016, United States

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GSK Investigational Site

New Port Richey, Florida, 34652, United States

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GSK Investigational Site

Orlando, Florida, 32835, United States

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GSK Investigational Site

Palmetto Bay, Florida, 33157, United States

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GSK Investigational Site

Tamarac, Florida, 33321, United States

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GSK Investigational Site

Tampa, Florida, 33603, United States

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GSK Investigational Site

Tampa, Florida, 33614, United States

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Atlanta, Georgia, 30318, United States

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GSK Investigational Site

Marietta, Georgia, 30060, United States

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Idaho Falls, Idaho, 83404, United States

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Skokie, Illinois, 60076, United States

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Evansville, Indiana, 47715, United States

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GSK Investigational Site

Wichita, Kansas, 67207, United States

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GSK Investigational Site

Bowling Green, Kentucky, 42101, United States

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GSK Investigational Site

Lake Charles, Louisiana, 70601, United States

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GSK Investigational Site

Monroe, Louisiana, 71203, United States

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Wheaton, Maryland, 20902, United States

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GSK Investigational Site

Grand Blanc, Michigan, 48439, United States

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GSK Investigational Site

Lansing, Michigan, 48910, United States

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GSK Investigational Site

Novi, Michigan, 48375, United States

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GSK Investigational Site

St Louis, Missouri, 63141, United States

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GSK Investigational Site

Lincoln, Nebraska, 68516, United States

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Lebanon, New Hampshire, 03756, United States

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GSK Investigational Site

Freehold, New Jersey, 07728, United States

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Brooklyn, New York, 11201, United States

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Fayetteville, North Carolina, 30214, United States

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GSK Investigational Site

Greensboro, North Carolina, 27408, United States

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GSK Investigational Site

Minot, North Dakota, 58701, United States

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GSK Investigational Site

Cincinnati, Ohio, 45242, United States

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GSK Investigational Site

Vandalia, Ohio, 45377, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73103, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73104, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

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GSK Investigational Site

Yukon, Oklahoma, 73099, United States

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GSK Investigational Site

Greenville, South Carolina, 29601, United States

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GSK Investigational Site

Summerville, South Carolina, 29486, United States

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GSK Investigational Site

Amarillo, Texas, 79124, United States

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GSK Investigational Site

Austin, Texas, 78731, United States

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GSK Investigational Site

Austin, Texas, 78745, United States

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GSK Investigational Site

Baytown, Texas, 77521, United States

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GSK Investigational Site

Colleyville, Texas, 76034, United States

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GSK Investigational Site

Dallas, Texas, 75231, United States

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GSK Investigational Site

Houston, Texas, 77065, United States

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GSK Investigational Site

Houston, Texas, 77084, United States

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GSK Investigational Site

Houston, Texas, 77089, United States

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GSK Investigational Site

Houston, Texas, 77090, United States

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GSK Investigational Site

Lubbock, Texas, 79410, United States

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GSK Investigational Site

Plano, Texas, 75024, United States

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GSK Investigational Site

The Woodlands, Texas, 77382, United States

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GSK Investigational Site

Tomball, Texas, 77375, United States

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GSK Investigational Site

Waco, Texas, 76710, United States

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GSK Investigational Site

Glendale, Wisconsin, 53217, United States

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GSK Investigational Site

Ciudad Autonoma Buenos Aires, Buenos Aires, C1046AAQ, Argentina

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GSK Investigational Site

Ciudad Autonoma Buenos Aires, Buenos Aires, C1114ABH, Argentina

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GSK Investigational Site

Ciudad Autonoma Buenos Aires, Buenos Aires, C1417, Argentina

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GSK Investigational Site

Ciudad Autonoma Buenos Aires, Buenos Aires, C1430EGF, Argentina

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GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1426, Argentina

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GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF, Argentina

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GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO, Argentina

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GSK Investigational Site

La Palta, Buenos Aires, B1900AXI, Argentina

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GSK Investigational Site

Mar del Plata, Buenos Aires, B7600FYK, Argentina

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GSK Investigational Site

Quilmes, Buenos Aires, B1878GEG, Argentina

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GSK Investigational Site

San Isidro, Buenos Aires, 1643, Argentina

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GSK Investigational Site

San Nicolás de los Arroyos, Buenos Aires, B2900DMH, Argentina

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GSK Investigational Site

Córdoba, Córdoba Province, X5003DCE, Argentina

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Rosario, Santa Fe Province, S2000DSV, Argentina

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GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

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GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, T4000BRD, Argentina

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GSK Investigational Site

Buenos Aires, C1426BOR, Argentina

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GSK Investigational Site

Buenos Aires, C1430CKE, Argentina

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GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1015ABO, Argentina

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Córdoba, 5000, Argentina

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GSK Investigational Site

Nueva Cordoba, X5000AVE, Argentina

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Salta, A4400ANW, Argentina

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GSK Investigational Site

San Juan, 5400, Argentina

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GSK Investigational Site

Gold Coast, Queensland, 4222, Australia

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GSK Investigational Site

Woodville, South Australia, 5011, Australia

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GSK Investigational Site

Mons, 7000, Belgium

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GSK Investigational Site

Blagoevgrad, 2700, Bulgaria

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GSK Investigational Site

Pleven, 5800, Bulgaria

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Plovdiv, 4000, Bulgaria

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GSK Investigational Site

Rousse, 7000, Bulgaria

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GSK Investigational Site

Sevlievo, 5400, Bulgaria

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GSK Investigational Site

Sofia, 1431, Bulgaria

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GSK Investigational Site

Sofia, 1606, Bulgaria

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GSK Investigational Site

Sofia, 1612, Bulgaria

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Sofia, 1784, Bulgaria

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GSK Investigational Site

Vidin, 3700, Bulgaria

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GSK Investigational Site

Brampton, Ontario, L6T 0G1, Canada

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GSK Investigational Site

Trois-Rivières, Quebec, G8Z 1Y2, Canada

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GSK Investigational Site

Bengbu, Anhui, 233004, China

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GSK Investigational Site

Guilin, Guangxi, 541001, China

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GSK Investigational Site

Shijiazhuang, Hebei, 050051, China

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GSK Investigational Site

Wuhan, Hubei, 430030, China

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Changsha, Hunan, 410013, China

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GSK Investigational Site

Zhuzhou, Hunan, 412007, China

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GSK Investigational Site

Baotou, Inner Mongolia, 014010, China

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GSK Investigational Site

Tongliao, Inner Mongolia, 10050, China

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GSK Investigational Site

Taizhou, Jiangsu, 225300, China

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GSK Investigational Site

Xuzhou, Jiangsu, 221009, China

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GSK Investigational Site

Nanchang, Jiangxi, 330006, China

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GSK Investigational Site

Pingxiang, Jiangxi, 337055, China

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GSK Investigational Site

Changchun, Jilin, 130021, China

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Jinzhou, Liaoning, 121000, China

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Chengdu, Sichuan, 610041, China

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GSK Investigational Site

Huzhou, Zhejiang, 313000, China

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GSK Investigational Site

Beijing, 100015, China

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GSK Investigational Site

Beijing, 100144, China

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GSK Investigational Site

Guangzhou, 510080, China

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GSK Investigational Site

Hangzhou, 310005, China

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GSK Investigational Site

Nanjing, 210008, China

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GSK Investigational Site

Shanghai, 200040, China

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GSK Investigational Site

Tianjin, 300052, China

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GSK Investigational Site

Yangzhou, 225000, China

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GSK Investigational Site

Yanji, 133000, China

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GSK Investigational Site

Barranquilla, 110221, Colombia

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GSK Investigational Site

Barranquilla, 80020, Colombia

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GSK Investigational Site

Bogotá, 110221, Colombia

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GSK Investigational Site

Bucaramanga, 680003, Colombia

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GSK Investigational Site

Brno, 638 00, Czechia

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GSK Investigational Site

Brno, 65691, Czechia

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GSK Investigational Site

Ostrava, 70200, Czechia

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GSK Investigational Site

Prague, 10000, Czechia

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GSK Investigational Site

Prague, 12850, Czechia

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GSK Investigational Site

Prague, 140 00, Czechia

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GSK Investigational Site

Prague, 148 00, Czechia

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GSK Investigational Site

Prague, 150 06, Czechia

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GSK Investigational Site

Praha 4 Nusle, 140 00, Czechia

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GSK Investigational Site

Uherské Hradiště, 686 01, Czechia

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GSK Investigational Site

Zlín, 760 01, Czechia

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GSK Investigational Site

Pärnu, 80010, Estonia

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GSK Investigational Site

Tallinn, 10117, Estonia

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GSK Investigational Site

Tallinn, 10128, Estonia

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GSK Investigational Site

Tallinn, 13419, Estonia

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GSK Investigational Site

Tartu, 50106, Estonia

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GSK Investigational Site

Tartu, 50708, Estonia

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GSK Investigational Site

Dresden, Saxony, 01307, Germany

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GSK Investigational Site

Rendsburg, Schleswig-Holstein, 24768, Germany

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GSK Investigational Site

Hamburg, 20095, Germany

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GSK Investigational Site

Magdeburg, 39120, Germany

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GSK Investigational Site

Baja, 6500, Hungary

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GSK Investigational Site

Balatonfüred, 8230, Hungary

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GSK Investigational Site

Budapest, 1023, Hungary

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GSK Investigational Site

Budapest, 1036, Hungary

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GSK Investigational Site

Szentes, 6600, Hungary

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GSK Investigational Site

Székesfehérvár, 8000, Hungary

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GSK Investigational Site

Veszprém, 8200, Hungary

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GSK Investigational Site

Ahmedabad, 380005, India

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GSK Investigational Site

Ahmedabad, 380016, India

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GSK Investigational Site

Belagavi, 590010, India

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GSK Investigational Site

Hubli, 580021, India

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GSK Investigational Site

Hyderabad, 500018, India

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GSK Investigational Site

Jaipur, 302001, India

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GSK Investigational Site

Jaipur, 302006, India

Location

GSK Investigational Site

Kolkata, 700020, India

Location

GSK Investigational Site

Nagpur, 440009, India

Location

GSK Investigational Site

Nagpur, 440012, India

Location

GSK Investigational Site

New Delhi, 110026, India

Location

GSK Investigational Site

Pune, 411004, India

Location

GSK Investigational Site

Surat, 395002, India

Location

GSK Investigational Site

Aichi, 455-8530, Japan

Location

GSK Investigational Site

Aichi, 457-8511, Japan

Location

GSK Investigational Site

Aichi, 466-8560, Japan

Location

GSK Investigational Site

Chiba, 260-8712, Japan

Location

GSK Investigational Site

Chiba, 270-2296, Japan

Location

GSK Investigational Site

Chiba, 284-0003, Japan

Location

GSK Investigational Site

Fukuoka, 804-0025, Japan

Location

GSK Investigational Site

Fukuoka, 807-8555, Japan

Location

GSK Investigational Site

Fukuoka, 814-0180, Japan

Location

GSK Investigational Site

Fukuoka, 820-8505, Japan

Location

GSK Investigational Site

Hiroshima, 734-8551, Japan

Location

GSK Investigational Site

Hokkaido, 053-8567, Japan

Location

GSK Investigational Site

Hokkaido, 060-0001, Japan

Location

GSK Investigational Site

Hokkaido, 060-8648, Japan

Location

GSK Investigational Site

Hokkaido, 063-0811, Japan

Location

GSK Investigational Site

Hokkaido, 085-0032, Japan

Location

GSK Investigational Site

Hyōgo, 673-1462, Japan

Location

GSK Investigational Site

Hyōgo, 675-1392, Japan

Location

GSK Investigational Site

Ibaraki, 312-0057, Japan

Location

GSK Investigational Site

Kagawa, 761-0793, Japan

Location

GSK Investigational Site

Kagoshima, 891-0133, Japan

Location

GSK Investigational Site

Kanagawa, 231-8682, Japan

Location

GSK Investigational Site

Kanagawa, 232-0024, Japan

Location

GSK Investigational Site

Kanagawa, 245-8575, Japan

Location

GSK Investigational Site

Kanagawa, 252-0392, Japan

Location

GSK Investigational Site

Kochi, 780-8522, Japan

Location

GSK Investigational Site

Kochi, 781-0112, Japan

Location

GSK Investigational Site

Kumamoto, 862-0975, Japan

Location

GSK Investigational Site

Miyagi, 980-8574, Japan

Location

GSK Investigational Site

Miyagi, 983-8512, Japan

Location

GSK Investigational Site

Nagano, 380-8582, Japan

Location

GSK Investigational Site

Nagasaki, 850-0832, Japan

Location

GSK Investigational Site

Nagasaki, 852-8501, Japan

Location

GSK Investigational Site

Nagasaki, 857-1195, Japan

Location

GSK Investigational Site

Niigata, 940-2085, Japan

Location

GSK Investigational Site

Niigata, 957-0054, Japan

Location

GSK Investigational Site

Okayama, 700-0013, Japan

Location

GSK Investigational Site

Okayama, 700-8557, Japan

Location

GSK Investigational Site

Okayama, 700-8607, Japan

Location

GSK Investigational Site

Saitama, 359-1111, Japan

Location

GSK Investigational Site

Tokyo, 104-8560, Japan

Location

GSK Investigational Site

Tokyo, 113-8431, Japan

Location

GSK Investigational Site

Tokyo, 113-8519, Japan

Location

GSK Investigational Site

Tokyo, 142-8666, Japan

Location

GSK Investigational Site

Tokyo, 153-8515, Japan

Location

GSK Investigational Site

Tokyo, 198-0042, Japan

Location

GSK Investigational Site

Wakayama, 649-2211, Japan

Location

GSK Investigational Site

Yamaguchi, 750-8520, Japan

Location

GSK Investigational Site

Ādaži, LV2164, Latvia

Location

GSK Investigational Site

Liepāja, LV-3401, Latvia

Location

GSK Investigational Site

Kaunas, LT-45130, Lithuania

Location

GSK Investigational Site

Kaunas, LT-50128, Lithuania

Location

GSK Investigational Site

Klaipėda, LT-92288, Lithuania

Location

GSK Investigational Site

Šiauliai, 76231, Lithuania

Location

GSK Investigational Site

Vilnius, LT-01117, Lithuania

Location

GSK Investigational Site

Klang, 41200, Malaysia

Location

GSK Investigational Site

Kuala Lumpur, 59100, Malaysia

Location

GSK Investigational Site

Seremban, Negeri Sembilan, 70300, Malaysia

Location

GSK Investigational Site

Sibu, 96000, Malaysia

Location

GSK Investigational Site

Mexicali, Baja California Sur, 21100, Mexico

Location

GSK Investigational Site

Mexico City, Durango, 06700, Mexico

Location

GSK Investigational Site

León, Guanajuato, 37000, Mexico

Location

GSK Investigational Site

Guadalajara, Jalisco, 44130, Mexico

Location

GSK Investigational Site

Guadalajara, Jalisco, 44650, Mexico

Location

GSK Investigational Site

Mérida, Yucatán, 97070, Mexico

Location

GSK Investigational Site

Durango, 34270, Mexico

Location

GSK Investigational Site

México, 6700, Mexico

Location

GSK Investigational Site

San Luis Potosí City, 78213, Mexico

Location

GSK Investigational Site

Bialystok, 15-351, Poland

Location

GSK Investigational Site

Bialystok, 15-879, Poland

Location

GSK Investigational Site

Bydgoszcz, 85-065, Poland

Location

GSK Investigational Site

Bydgoszcz, 85-168, Poland

Location

GSK Investigational Site

Częstochowa, 42202, Poland

Location

GSK Investigational Site

Elblag, 82-300, Poland

Location

GSK Investigational Site

Gdansk, 80-382, Poland

Location

GSK Investigational Site

Gdynia, 81-338, Poland

Location

GSK Investigational Site

Gdynia, 81-537, Poland

Location

GSK Investigational Site

Grodzisk Mazowiecki, 05-825, Poland

Location

GSK Investigational Site

Katowice, 40-040, Poland

Location

GSK Investigational Site

Katowice, 40-282, Poland

Location

GSK Investigational Site

Krakow, 30-033, Poland

Location

GSK Investigational Site

Krakow, 30-363, Poland

Location

GSK Investigational Site

Krakow, 30-510, Poland

Location

GSK Investigational Site

Lodz, 90-127, Poland

Location

GSK Investigational Site

Lodz, 90-644, Poland

Location

GSK Investigational Site

Lublin, 20-362, Poland

Location

GSK Investigational Site

Lublin, 20-582, Poland

Location

GSK Investigational Site

Nowa Sól, 67-100, Poland

Location

GSK Investigational Site

Olsztyn, 10-117, Poland

Location

GSK Investigational Site

Poznan, 60-529, Poland

Location

GSK Investigational Site

Poznan, 60-702, Poland

Location

GSK Investigational Site

Poznan, 60-773, Poland

Location

GSK Investigational Site

Poznan, 61-113, Poland

Location

GSK Investigational Site

Siedlce, 08-110, Poland

Location

GSK Investigational Site

Sochaczew, 96-500, Poland

Location

GSK Investigational Site

Staszów, 28-200, Poland

Location

GSK Investigational Site

Torun, 87-100, Poland

Location

GSK Investigational Site

Warsaw, 00-465, Poland

Location

GSK Investigational Site

Warsaw, 00-874, Poland

Location

GSK Investigational Site

Warsaw, 01-192, Poland

Location

GSK Investigational Site

Warsaw, 02-118, Poland

Location

GSK Investigational Site

Warsaw, 02-673, Poland

Location

GSK Investigational Site

Warsaw, 02-793, Poland

Location

GSK Investigational Site

Wroclaw, 50-381, Poland

Location

GSK Investigational Site

Wroclaw, 52-416, Poland

Location

GSK Investigational Site

Zamość, 22-400, Poland

Location

GSK Investigational Site

Kemerovo, 650066, Russia

Location

GSK Investigational Site

Kemerovo, 650070, Russia

Location

GSK Investigational Site

Korolyov, 141060, Russia

Location

GSK Investigational Site

Krasnoyarsk, 660022, Russia

Location

GSK Investigational Site

Moscow, 115404, Russia

Location

GSK Investigational Site

Moscow, 115522, Russia

Location

GSK Investigational Site

Moscow, 129110, Russia

Location

GSK Investigational Site

Novosibirsk, 630091, Russia

Location

GSK Investigational Site

Novosibirsk, 630099, Russia

Location

GSK Investigational Site

Omsk, 644024, Russia

Location

GSK Investigational Site

Saint Petersburg, 190068, Russia

Location

GSK Investigational Site

Saint Petersburg, 197022, Russia

Location

GSK Investigational Site

Saratov, 410012, Russia

Location

GSK Investigational Site

Smolensk, 214025, Russia

Location

GSK Investigational Site

Tomsk, 634061, Russia

Location

GSK Investigational Site

Tver', 170036, Russia

Location

GSK Investigational Site

Ulyanovsk, 432063, Russia

Location

GSK Investigational Site

Yaroslavl, 150003, Russia

Location

GSK Investigational Site

Yaroslavl, 150007, Russia

Location

GSK Investigational Site

Yaroslavl, 150062, Russia

Location

GSK Investigational Site

Yekaterinburg, 620043, Russia

Location

GSK Investigational Site

Yekaterinburg, 620102, Russia

Location

GSK Investigational Site

Belgrade, 11000, Serbia

Location

GSK Investigational Site

Pretoria, Gauteng, 184, South Africa

Location

GSK Investigational Site

Durban, KwaZulu-Natal, 4319, South Africa

Location

GSK Investigational Site

Bellville, 7530, South Africa

Location

GSK Investigational Site

Bloemfontein, 9301, South Africa

Location

GSK Investigational Site

Cape Town, 7405, South Africa

Location

GSK Investigational Site

Cape Town, 7500, South Africa

Location

GSK Investigational Site

Johannesburg, 2113, South Africa

Location

GSK Investigational Site

Johannesburg, 2193, South Africa

Location

GSK Investigational Site

Kempton Park, 1619, South Africa

Location

GSK Investigational Site

Pretoria, 0002, South Africa

Location

GSK Investigational Site

Somerset West, 7130, South Africa

Location

GSK Investigational Site

Stellenbosch, 7600, South Africa

Location

GSK Investigational Site

Anyang-si, 431-070, South Korea

Location

GSK Investigational Site

Cheonan-si, 31151, South Korea

Location

GSK Investigational Site

Daegu, 41944, South Korea

Location

GSK Investigational Site

Gwangju, 61469, South Korea

Location

GSK Investigational Site

Incheon, 22332, South Korea

Location

GSK Investigational Site

Seongnam-si, 13620, South Korea

Location

GSK Investigational Site

Seoul, 03722, South Korea

Location

GSK Investigational Site

Seoul, 05505, South Korea

Location

GSK Investigational Site

Seoul, 06591, South Korea

Location

GSK Investigational Site

Seoul, 3080, South Korea

Location

GSK Investigational Site

Suwon-si, Gyeonggi-do, 16499, South Korea

Location

GSK Investigational Site

A Coruña, 15006, Spain

Location

GSK Investigational Site

Barcelona, 08003, Spain

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Córdoba, 140044, Spain

Location

GSK Investigational Site

Elche, ?03203, Spain

Location

GSK Investigational Site

Santander, 39008, Spain

Location

GSK Investigational Site

Santiago de Compostela. La Coruña., 15706, Spain

Location

GSK Investigational Site

Seville, 41009, Spain

Location

GSK Investigational Site

Valencia, 46010, Spain

Location

GSK Investigational Site

Bangkok, 10400, Thailand

Location

GSK Investigational Site

Rajathevee, 10400, Thailand

Location

GSK Investigational Site

Cherkasy, 18009, Ukraine

Location

GSK Investigational Site

Ivano-Frankivsk, 76008, Ukraine

Location

GSK Investigational Site

Kharkiv, 61039, Ukraine

Location

GSK Investigational Site

Kharkiv, 61124, Ukraine

Location

GSK Investigational Site

Kharkiv, 61176, Ukraine

Location

GSK Investigational Site

Kyiv, 02125, Ukraine

Location

GSK Investigational Site

Kyiv, 03037, Ukraine

Location

GSK Investigational Site

Kyiv, 03049, Ukraine

Location

GSK Investigational Site

Kyiv, 04054, Ukraine

Location

GSK Investigational Site

Kyiv, 1023, Ukraine

Location

GSK Investigational Site

Kyiv, 2002, Ukraine

Location

GSK Investigational Site

Lutsk, 43005, Ukraine

Location

GSK Investigational Site

Lutsk, 43024, Ukraine

Location

GSK Investigational Site

Odesa, 65025, Ukraine

Location

GSK Investigational Site

Poltava, 36011, Ukraine

Location

GSK Investigational Site

Vinnytsia, 21001, Ukraine

Location

GSK Investigational Site

Vinnytsia, 21018, Ukraine

Location

GSK Investigational Site

Vinnytsia, 21029, Ukraine

Location

GSK Investigational Site

Vinnytsia, 21050, Ukraine

Location

GSK Investigational Site

Zaporizhzhia, 69014, Ukraine

Location

GSK Investigational Site

Zaporizhzia, 69065, Ukraine

Location

GSK Investigational Site

Zhytomyr, 10002, Ukraine

Location

GSK Investigational Site

Orpington, Kent, BR5 3QG, United Kingdom

Location

GSK Investigational Site

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

GSK Investigational Site

Coventry, CV3 4FJ, United Kingdom

Location

Related Publications (1)

• Weinblatt ME, Taylor PC, McInnes IB, Atsumi T, Strand V, Takeuchi T, Bracher M, Brooks D, Curtis P, Gupta A, Nijhawan R, O'Shea C, Rayner K, Saurigny D, Shelton C, Wang M, Wang R, Fleischmann RM. Long-term safety and efficacy of anti-GM-CSF otilimab in patients with rheumatoid arthritis: long-term extension of three phase 3 randomised trials (contRAst X). BMJ Open. 2025 Mar 5;15(3):e088869. doi: 10.1136/bmjopen-2024-088869.

  PMID: 40044198 DERIVED

Related Links

• 201790 contRAst 1 NCT03980483
• 201791 contRAst 2 NCT03970837
• 202018 contRAst 3 NCT04134728

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Otilimab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a parallel group treatment study with two arms that are initially participant and investigator blinded. A participant's treatment allocation will remain blinded at least until their qualifying study has been reported.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants who received GSK3196165 in their qualifying study will continue in this study on the same dose. Participants who received a comparator (tofacitinib or sarilumab) in their qualifying study will be centrally randomized using interactive response technology (IRT) in a ratio of 1:1 to either GSK3196165 90 mg or 150 mg.

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 3, 2020
• Study Start: May 12, 2020
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

LA (2); IN (13); ES (6); TH (2); PL (38); AR (23); BU (10); CA (2); LI (5); JP (48); CN (25); MY (4); DE (4); HU (7); ME (9); RU (22); SE (1); US (79); CO (4); ZA (12); BE (1); CZ (11); KR (11); AU (2); UA (22); GB (3)