Study Stopped
Only Asia cohort is early terminated.Limited efficacy demonstrated in the contRAst program does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has decided not to progress with regulatory submissions.
Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)
contRAst 2
A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs
1 other identifier
interventional
1,764
17 countries
265
Brief Summary
This study \[contRAst 2 (201791: NCT03970837)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study \[contRAst X (209564: NCT04333147)\]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2019
Typical duration for phase_3
265 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedStudy Start
First participant enrolled
June 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2023
CompletedResults Posted
Study results publicly available
November 30, 2023
CompletedNovember 30, 2023
November 1, 2023
2.4 years
May 16, 2019
September 22, 2023
November 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo (Global Cohort)
ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) \[visual analogue scale (VAS) with values from 0=best to 100=worst\], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant \[high sensitivity C-reactive Protein milligram per liter (mg/L) (hsCRP)\]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Week 12
Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 (Asia Cohort)
ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) \[visual analogue scale (VAS) with values from 0=best to 100=worst\], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant \[high sensitivity C-reactive Protein milligram per liter (mg/L) (hsCRP)\]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.
Week 12
Secondary Outcomes (187)
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Less Than or Equal to (<=)10 [CDAI Low Disease Activity (LDA)] at Week 12 (Global Cohort)
Week 12
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Global Cohort)
Baseline (Day 1) and Week 12
Percentage of Participants Achieving 20% Improvement in ACR20 at Week 24: Non-inferiority Comparison With Tofacitinib (Global Cohort)
Week 24
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24 and Week 52
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24 and Week 52
- +182 more secondary outcomes
Study Arms (12)
GSK3196165 90mg + csDMARD (Global Cohort)
EXPERIMENTALParticipants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
GSK3196165 150mg + csDMARD (Global Cohort)
EXPERIMENTALParticipants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
Tofacitinib 5mg + csDMARD (Global Cohort)
ACTIVE COMPARATORParticipants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks.
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort)
PLACEBO COMPARATORParticipants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.
Placebo +csDMARD and GSK3196165 150mg +csDMARD (Global Cohort)
PLACEBO COMPARATORParticipants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.
Placebo +csDMARD and Tofacitinib 5mg +csDMARD (Global Cohort)
PLACEBO COMPARATORParticipants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
GSK3196165 90mg + csDMARD (Asia Cohort)
EXPERIMENTALParticipants in Asia Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
GSK3196165 150mg + csDMARD (Asia Cohort)
EXPERIMENTALParticipants in Asia Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
Tofacitinib 5mg + csDMARD (Asia Cohort)
ACTIVE COMPARATORParticipants in Asia Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks.
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort)
PLACEBO COMPARATORParticipants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort)
PLACEBO COMPARATORParticipants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort)
PLACEBO COMPARATORParticipants in Asia Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
Interventions
GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.
Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally.
Placebo matching GSK3196165 and Tofacitinib was administered.
Eligibility Criteria
You may qualify if:
- \>=18 years of age
- Has had RA for \>=6 months and was not diagnosed before 16 years of age
- Has active disease, as defined by having both\*
- \>=6/68 tender/painful joint count (TJC), and
- \>=6/66 swollen joint count (SJC)
- Has at least 1 bone erosion present on hand/wrist or foot radiographs
- Has had an inadequate response to one or two of the csDMARDs:
- methotrexate (MTX) 15-25 mg/week\*\* oral or injected
- hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day
- sulfasalazine up to 3000 mg/day
- leflunomide up to 20 mg/day\*\*\*
- bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement)
- iguratimod up to 50 mg/day
- If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.
- A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.
- +1 more criteria
You may not qualify if:
- History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjögren's syndrome secondary to RA, that may confound the evaluation of the effect of the study intervention.
- Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
- Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
- Iqvia Pty Ltdcollaborator
Study Sites (269)
GSK Investigational Site
Flagstaff, Arizona, 86001, United States
GSK Investigational Site
Glendale, Arizona, 85306, United States
GSK Investigational Site
Mesa, Arizona, 85210, United States
GSK Investigational Site
Tucson, Arizona, 85724, United States
GSK Investigational Site
Poway, California, 92064, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Roseville, California, 95661, United States
GSK Investigational Site
San Diego, California, 92108, United States
GSK Investigational Site
Tustin, California, 92780, United States
GSK Investigational Site
Van Nuys, California, 91405, United States
GSK Investigational Site
Denver, Colorado, 80230, United States
GSK Investigational Site
Fort Collins, Colorado, 80528, United States
GSK Investigational Site
Aventura, Florida, 33180, United States
GSK Investigational Site
Boca Raton, Florida, 33486, United States
GSK Investigational Site
Clearwater, Florida, 33765, United States
GSK Investigational Site
Daytona Beach, Florida, 32117, United States
GSK Investigational Site
Gainesville, Florida, 32607, United States
GSK Investigational Site
Hialeah, Florida, 33016, United States
GSK Investigational Site
Margate, Florida, 33063, United States
GSK Investigational Site
Miami, Florida, 33134, United States
GSK Investigational Site
Miami, Florida, 33155, United States
GSK Investigational Site
New Port Richey, Florida, 34652, United States
GSK Investigational Site
Palmetto Bay, Florida, 33157, United States
GSK Investigational Site
St. Petersburg, Florida, 33705, United States
GSK Investigational Site
Tamarac, Florida, 33321, United States
GSK Investigational Site
Tampa, Florida, 33606, United States
GSK Investigational Site
Marietta, Georgia, 30060, United States
GSK Investigational Site
Idaho Falls, Idaho, 83404, United States
GSK Investigational Site
Evansville, Indiana, 47715, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Bowling Green, Kentucky, 42101, United States
GSK Investigational Site
Lake Charles, Louisiana, 70601, United States
GSK Investigational Site
Monroe, Louisiana, 71203, United States
GSK Investigational Site
Hagerstown, Maryland, 21740, United States
GSK Investigational Site
Worcester, Massachusetts, 01605, United States
GSK Investigational Site
Grand Blanc, Michigan, 48439, United States
GSK Investigational Site
Lansing, Michigan, 48910, United States
GSK Investigational Site
Novi, Michigan, 48375, United States
GSK Investigational Site
Freehold, New Jersey, 07728, United States
GSK Investigational Site
Albuquerque, New Mexico, 87102, United States
GSK Investigational Site
Brooklyn, New York, 11201, United States
GSK Investigational Site
Greensboro, North Carolina, 27408, United States
GSK Investigational Site
Minot, North Dakota, 58701, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Yukon, Oklahoma, 73099, United States
GSK Investigational Site
Duncansville, Pennsylvania, 16635, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15224, United States
GSK Investigational Site
Wyomissing, Pennsylvania, 19610, United States
GSK Investigational Site
Columbia, South Carolina, 29204, United States
GSK Investigational Site
Myrtle Beach, South Carolina, 29572, United States
GSK Investigational Site
Summerville, South Carolina, 29486, United States
GSK Investigational Site
Knoxville, Tennessee, 37909-1907, United States
GSK Investigational Site
Amarillo, Texas, 79124, United States
GSK Investigational Site
Austin, Texas, 78745, United States
GSK Investigational Site
Colleyville, Texas, 76034, United States
GSK Investigational Site
Corpus Christi, Texas, 78404, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Houston, Texas, 77034, United States
GSK Investigational Site
Houston, Texas, 77065, United States
GSK Investigational Site
Houston, Texas, 77084, United States
GSK Investigational Site
Lubbock, Texas, 79410, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Tomball, Texas, 77375, United States
GSK Investigational Site
Glendale, Wisconsin, 53217, United States
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Buenos Aires, C1114ABH, Argentina
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Buenos Aires, C1430EGF, Argentina
GSK Investigational Site
Quilmes, Buenos Aires, B1878GEG, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, X5003DCE, Argentina
GSK Investigational Site
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
GSK Investigational Site
San Miguel de Tucumán, Tucumán Province, T4000BRD, Argentina
GSK Investigational Site
Buenos Aires, C1128AAF, Argentina
GSK Investigational Site
Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
GSK Investigational Site
Córdoba, 5000, Argentina
GSK Investigational Site
San Juan, 5400, Argentina
GSK Investigational Site
Westmead, New South Wales, 2145, Australia
GSK Investigational Site
Gold Coast, Queensland, 4222, Australia
GSK Investigational Site
Woodville, South Australia, 5011, Australia
GSK Investigational Site
Hobart, Tasmania, 7000, Australia
GSK Investigational Site
Box Hill, Victoria, 3128, Australia
GSK Investigational Site
Heidelberg West, Victoria, 3081, Australia
GSK Investigational Site
Blagoevgrad, 2700, Bulgaria
GSK Investigational Site
Pleven, 5800, Bulgaria
GSK Investigational Site
Plovdiv, 4000, Bulgaria
GSK Investigational Site
Rousse, 7000, Bulgaria
GSK Investigational Site
Rousse, 7002, Bulgaria
GSK Investigational Site
Sevlievo, 5400, Bulgaria
GSK Investigational Site
Sofia, 1000, Bulgaria
GSK Investigational Site
Sofia, 1431, Bulgaria
GSK Investigational Site
Sofia, 1606, Bulgaria
GSK Investigational Site
Sofia, 1612, Bulgaria
GSK Investigational Site
Sofia, 1784, Bulgaria
GSK Investigational Site
Stara Zagora, 6000, Bulgaria
GSK Investigational Site
Vidin, 3700, Bulgaria
GSK Investigational Site
Bengbu, Anhui, 233004, China
GSK Investigational Site
Guilin, Guangxi, 541001, China
GSK Investigational Site
Shijiazhuang, Hebei, 050051, China
GSK Investigational Site
Wuhan, Hubei, 430030, China
GSK Investigational Site
Changsha, Hunan, 410013, China
GSK Investigational Site
Zhuzhou, Hunan, 412007, China
GSK Investigational Site
Baotou, Inner Mongolia, 014010, China
GSK Investigational Site
Tongliao, Inner Mongolia, 10050, China
GSK Investigational Site
Nanjing, Jiangsu, 210009, China
GSK Investigational Site
Taizhou, Jiangsu, 225300, China
GSK Investigational Site
Xuzhou, Jiangsu, 221009, China
GSK Investigational Site
Yancheng, Jiangsu, 224001, China
GSK Investigational Site
Jiujiang, Jiangxi, 332000, China
GSK Investigational Site
Nanchang, Jiangxi, 330006, China
GSK Investigational Site
Changchun, Jilin, 130021, China
GSK Investigational Site
Jinzhou, Liaoning, 121000, China
GSK Investigational Site
Huzhou, Zhejiang, 313000, China
GSK Investigational Site
Beijing, 100032, China
GSK Investigational Site
Beijing, 100144, China
GSK Investigational Site
Changchun, 130012, China
GSK Investigational Site
Changzhou, 213003, China
GSK Investigational Site
Chengdu, 610041, China
GSK Investigational Site
Guangzhou, 510080, China
GSK Investigational Site
Guangzhou, 510630, China
GSK Investigational Site
Hangzhou, 310005, China
GSK Investigational Site
Nanjing, 210008, China
GSK Investigational Site
Shanghai, 200040, China
GSK Investigational Site
Tianjin, 300052, China
GSK Investigational Site
Xi'an, 710061, China
GSK Investigational Site
Yangzhou, 225000, China
GSK Investigational Site
Yanji, 133000, China
GSK Investigational Site
Barranquilla, 80020, Colombia
GSK Investigational Site
Bogotá, 110221, Colombia
GSK Investigational Site
Bucaramanga, 680003, Colombia
GSK Investigational Site
Medellín, 50015, Colombia
GSK Investigational Site
Pärnu, 80010, Estonia
GSK Investigational Site
Tallinn, 10117, Estonia
GSK Investigational Site
Tallinn, 10128, Estonia
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tartu, 50106, Estonia
GSK Investigational Site
Tartu, 50406, Estonia
GSK Investigational Site
Cahors, 46000, France
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Rendsburg, Schleswig-Holstein, 24768, Germany
GSK Investigational Site
Berlin, 10117, Germany
GSK Investigational Site
Hamburg, 20095, Germany
GSK Investigational Site
Magdeburg, 39120, Germany
GSK Investigational Site
Budapest, 1023, Hungary
GSK Investigational Site
Budapest, 1036, Hungary
GSK Investigational Site
Szentes, 6600, Hungary
GSK Investigational Site
Székesfehérvár, 8000, Hungary
GSK Investigational Site
Aichi, 455-8530, Japan
GSK Investigational Site
Aichi, 457-8511, Japan
GSK Investigational Site
Aichi, 466-8560, Japan
GSK Investigational Site
Chiba, 260-8712, Japan
GSK Investigational Site
Chiba, 284-0003, Japan
GSK Investigational Site
Fukuoka, 804-0025, Japan
GSK Investigational Site
Fukuoka, 807-8555, Japan
GSK Investigational Site
Fukuoka, 814-0180, Japan
GSK Investigational Site
Fukuoka, 820-8505, Japan
GSK Investigational Site
Hiroshima, 734-8551, Japan
GSK Investigational Site
Hokkaido, 053-8567, Japan
GSK Investigational Site
Hokkaido, 060-0001, Japan
GSK Investigational Site
Hokkaido, 060-8604, Japan
GSK Investigational Site
Hokkaido, 060-8648, Japan
GSK Investigational Site
Hokkaido, 063-0811, Japan
GSK Investigational Site
Hokkaido, 085-0032, Japan
GSK Investigational Site
Hyōgo, 673-1462, Japan
GSK Investigational Site
Hyōgo, 675-1392, Japan
GSK Investigational Site
Ibaraki, 312-0057, Japan
GSK Investigational Site
Kagawa, 761-0793, Japan
GSK Investigational Site
Kagoshima, 891-0133, Japan
GSK Investigational Site
Kanagawa, 222-0036, Japan
GSK Investigational Site
Kanagawa, 231-8682, Japan
GSK Investigational Site
Kanagawa, 232-0024, Japan
GSK Investigational Site
Kanagawa, 236-0004, Japan
GSK Investigational Site
Kanagawa, 245-8575, Japan
GSK Investigational Site
Kanagawa, 252-0392, Japan
GSK Investigational Site
Kochi, 780-8522, Japan
GSK Investigational Site
Kochi, 781-0112, Japan
GSK Investigational Site
Kumamoto, 862-0976, Japan
GSK Investigational Site
Miyagi, 980-8574, Japan
GSK Investigational Site
Miyagi, 983-8512, Japan
GSK Investigational Site
Nagano, 380-8582, Japan
GSK Investigational Site
Nagasaki, 850-0832, Japan
GSK Investigational Site
Nagasaki, 852-8501, Japan
GSK Investigational Site
Nagasaki, 857-1195, Japan
GSK Investigational Site
Niigata, 940-2085, Japan
GSK Investigational Site
Niigata, 957-0054, Japan
GSK Investigational Site
Okayama, 700-0013, Japan
GSK Investigational Site
Okayama, 700-8557, Japan
GSK Investigational Site
Okayama, 700-8607, Japan
GSK Investigational Site
Saga, 843-0393, Japan
GSK Investigational Site
Saitama, 359-1111, Japan
GSK Investigational Site
Shizuoka, 430-8558, Japan
GSK Investigational Site
Tokyo, 104-8560, Japan
GSK Investigational Site
Tokyo, 113-8431, Japan
GSK Investigational Site
Tokyo, 113-8519, Japan
GSK Investigational Site
Tokyo, 142-0054, Japan
GSK Investigational Site
Tokyo, 142-8666, Japan
GSK Investigational Site
Tokyo, 153-8515, Japan
GSK Investigational Site
Tokyo, 198-0042, Japan
GSK Investigational Site
Tokyo, 204-8585, Japan
GSK Investigational Site
Tottori, 683-8504, Japan
GSK Investigational Site
Wakayama, 649-2211, Japan
GSK Investigational Site
Yamaguchi, 750-8520, Japan
GSK Investigational Site
Mexico City, Durango, 06700, Mexico
GSK Investigational Site
Guadalajara, Jalisco, 44650, Mexico
GSK Investigational Site
Mérida, Yucatán, 97070, Mexico
GSK Investigational Site
San Luis Potosí City, 78213, Mexico
GSK Investigational Site
Bialystok, 15-879, Poland
GSK Investigational Site
Bydgoszcz, 85-065, Poland
GSK Investigational Site
Częstochowa, 42202, Poland
GSK Investigational Site
Elblag, 82-300, Poland
GSK Investigational Site
Gdansk, 80-382, Poland
GSK Investigational Site
Gdynia, 81-537, Poland
GSK Investigational Site
Grodzisk Mazowiecki, 05-825, Poland
GSK Investigational Site
Katowice, 40-040, Poland
GSK Investigational Site
Katowice, 40-282, Poland
GSK Investigational Site
Krakow, 30-033, Poland
GSK Investigational Site
Krakow, 30510, Poland
GSK Investigational Site
Lodz, 90-127, Poland
GSK Investigational Site
Lodz, 90-644, Poland
GSK Investigational Site
Lublin, 20-582, Poland
GSK Investigational Site
Nowy Targ, 34-400, Poland
GSK Investigational Site
Olsztyn, 10-117, Poland
GSK Investigational Site
Poznan, 60-702, Poland
GSK Investigational Site
Poznan, 61-113, Poland
GSK Investigational Site
Siedlce, 08-110, Poland
GSK Investigational Site
Sochaczew, 96-500, Poland
GSK Investigational Site
Warsaw, 01-192, Poland
GSK Investigational Site
Warsaw, 02-793, Poland
GSK Investigational Site
Wroclaw, 50-088, Poland
GSK Investigational Site
Wroclaw, 52-416, Poland
GSK Investigational Site
Kemerovo, 650066, Russia
GSK Investigational Site
Kemerovo, 650070, Russia
GSK Investigational Site
Korolyov, 141060, Russia
GSK Investigational Site
Krasnoyarsk, 660123, Russia
GSK Investigational Site
Moscow, 111539, Russia
GSK Investigational Site
Moscow, 115404, Russia
GSK Investigational Site
Moscow, 115522, Russia
GSK Investigational Site
Moscow, 129110, Russia
GSK Investigational Site
Novosibirsk, 630091, Russia
GSK Investigational Site
Novosibirsk, 630099, Russia
GSK Investigational Site
Omsk, 644024, Russia
GSK Investigational Site
Saint Petersburg, 190068, Russia
GSK Investigational Site
Tomsk, 634050, Russia
GSK Investigational Site
Ulyanovsk, 432063, Russia
GSK Investigational Site
Yaroslavl, 150007, Russia
GSK Investigational Site
Yaroslavl, 150030, Russia
GSK Investigational Site
Yaroslavl, 150062, Russia
GSK Investigational Site
Yekaterinburg, 620102, Russia
GSK Investigational Site
Anyang-Si, Gyeonggi-do, 14068, South Korea
GSK Investigational Site
Cheonan-si, 330-721, South Korea
GSK Investigational Site
Daegu, 41944, South Korea
GSK Investigational Site
Daegu, 42601, South Korea
GSK Investigational Site
Gwangju, 61469, South Korea
GSK Investigational Site
Incheon, 400-711, South Korea
GSK Investigational Site
Seongnam-si, 13620, South Korea
GSK Investigational Site
Seoul, 04763, South Korea
GSK Investigational Site
Seoul, 05505, South Korea
GSK Investigational Site
Seoul, 06591, South Korea
GSK Investigational Site
Seoul, 120-752, South Korea
GSK Investigational Site
Seoul, 134-727, South Korea
GSK Investigational Site
Seoul, 3080, South Korea
GSK Investigational Site
Suwon, 16499, South Korea
GSK Investigational Site
Barcelona, 08003, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Santander, 39008, Spain
GSK Investigational Site
Seville, 41009, Spain
GSK Investigational Site
Bangkok, 10400, Thailand
GSK Investigational Site
Muang, 40002, Thailand
GSK Investigational Site
Rajathevee, 10400, Thailand
GSK Investigational Site
Romford, Essex, RM1 3PJ, United Kingdom
GSK Investigational Site
Northwood, Middlesex, HA6 2RN, United Kingdom
GSK Investigational Site
Kenilworth, Warwickshire, CV8 1JD, United Kingdom
Related Publications (1)
Fleischmann RM, van der Heijde D, Strand V, Atsumi T, McInnes IB, Takeuchi T, Taylor PC, Bracher M, Brooks D, Davies J, Goode C, Gupta A, Mukherjee S, O'Shea C, Saurigny D, Schifano LA, Shelton C, Smith JE, Wang M, Wang R, Watts S, Weinblatt ME. Anti-GM-CSF otilimab versus tofacitinib or placebo in patients with active rheumatoid arthritis and an inadequate response to conventional or biologic DMARDs: two phase 3 randomised trials (contRAst 1 and contRAst 2). Ann Rheum Dis. 2023 Dec;82(12):1516-1526. doi: 10.1136/ard-2023-224482. Epub 2023 Sep 12.
PMID: 37699654DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
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
- Double blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2019
First Posted
June 3, 2019
Study Start
June 5, 2019
Primary Completion
October 29, 2021
Study Completion
January 18, 2023
Last Updated
November 30, 2023
Results First Posted
November 30, 2023
Record last verified: 2023-11
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.
IPD for this study will be made available via the Clinical Study Data Request site.