Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)

NCT00975130 | Completed Phase 3 Results

• 3 other identifiers: P061292009-011137-26CTRI/2009/091/000883
• Study Type: interventional
• Target: 3,366
• Locations: 0 countries
• Sites: N/A

Brief Summary

Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antirheumatic drug (DMARD) regimens used in daily rheumatology practice. Subsequently, Part 2 will study if a strategy of intravenous (IV) golimumab to induce remission followed by SC golimumab to retain remission is superior to continuing a SC regimen.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (2)

• Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6

  EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease \>1.2 units and a final DAS28-ESR \< 3.2 units, while a moderate response was defined as a decrease \> 1.2 units and final DAS28-ESR \>= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR \<= 5.1 units

  Month 6

• Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12

  The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6.

  Start of Month 11, End of Month 12

Secondary Outcomes (172)

• Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6

  Baseline, Month 2, Month 4, Month 6

• Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6

  Baseline, Month 2, Month 4, Month 6

• Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6

  Baseline, Month 2, Month 4, Month 6

• Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6

  Baseline, Month 2, Month 4, Month 6

• Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6

  Baseline, Month 2, Month 4, Month 6

Study Arms (3)

SC-GLM50

EXPERIMENTAL

In Part 1 of the study, participants received subcutaneous golimumab treatment at a dose of 50 mg once monthly for 6 months in combination with background DMARD treatment.

Biological: SC golimumab

IV GLM 2 mg/kg + GLM50-SC

EXPERIMENTAL

After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive intravenous (IV) golimumab at a dose of 2 mg/kg once monthly for a period of 6 months or until remission is achieved. Participants will receive IV GLM at a dose of 2 mg/kg at the start of Month 7, and then at the start of Month 8 and Month 10 if the subject has not achieved remission at any of these IV administration visits. If remission is achieved, participants were switched to subcutaneous golimumab at a dose of 50 mg once monthly until study end, in combination with background DMARD treatment.

Biological: SC golimumab; Biological: IV golimumab

GLM50-SC

EXPERIMENTAL

After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months, in combination with background DMARD treatment.

Biological: SC golimumab

Interventions

SC golimumab BIOLOGICAL

Subcutaneous golimumab at a dose of 50 mg administered once monthly.

Also known as: SCH 900259, subcutaneous

GLM50-SC; IV GLM 2 mg/kg + GLM50-SC; SC-GLM50

IV golimumab BIOLOGICAL

Intravenous golimumab administered up to 3 times (month 7, 8, 10) during a period of 6 months at a dose of 2 mg/kg of body weight.

Also known as: SCH 900259, intravenous

IV GLM 2 mg/kg + GLM50-SC

Eligibility Criteria

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

You may qualify if:

• For Part 1:
• Age \>=18 years, either sex, any race.
• Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria.
• Active disease despite DMARD treatment
• Subject must be taking at least one of the allowed DMARDs, and must be able to continue with it during the trial.
• Eligibility for anti tumor necrosis factor (TNF) use according to the following criteria:
• Participant must have failed conventional treatment according to the investigator's opinion OR local guidelines.
• Local guidelines regarding safety screening of anti TNF candidates (ie, tuberculosis \[TB\] screening and other safety screening such as vaccination, if applicable) must be met. Chest X-ray and either a PPD skin test or QuantiFERON®-TB Gold test are also required.
• Anamnesis and physical examination must make the participant eligible for anti TNF use and trial participation according to the investigator's judgment.
• For Part 2:
• Participant must have completed Part 1 of this trial.
• Participant must have:
• good or moderate response to SC golimumab at the end of Month 6 compared to Baseline, AND.
• no DAS28 ESR remission.
• Both the investigator and the subject must agree to switch the participant's treatment to IV administration as may be required in Part 2 of this trial.

You may not qualify if:

• History of biologic drug use for RA.
• Evidence of active TB. or latent TB that is untreated.
• Moderate to severe heart failure
• Certain inflammatory rheumatic disease other than RA or certain systemic inflammatory condition
• Allergy to latex

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (4)

• Combe B, Dasgupta B, Louw I, Pal S, Wollenhaupt J, Zerbini CA, Beaulieu AD, Schulze-Koops H, Durez P, Yao R, Vastesaeger N, Weng HH; GO-MORE Investigators. Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs: results of the GO-MORE study. Ann Rheum Dis. 2014 Aug;73(8):1477-86. doi: 10.1136/annrheumdis-2013-203229. Epub 2013 Jun 5.

  PMID: 23740226 RESULT

• Durez P, Vanthuyne M, Soyfoo MS, Hoffman I, Malaise M, Geusens P. Efficacy of golimumab in Belgian patients with active rheumatoid arthritis despite treatment with non-biologic disease-modifying anti-rheumatic drugs: sub-analysis of the GO-MORE study. Acta Clin Belg. 2017 Dec;72(6):424-428. doi: 10.1080/17843286.2017.1314079. Epub 2017 Apr 21.

  PMID: 28431485 DERIVED

• Schulze-Koops H, Giacomelli R, Samborski W, Rednic S, Herold M, Yao R, Govoni M, Vastesaeger N, Weng HH. Factors influencing the patient evaluation of injection experience with the SmartJect autoinjector in rheumatoid arthritis. Clin Exp Rheumatol. 2015 Mar-Apr;33(2):201-8. Epub 2015 Jan 29.

  PMID: 25664404 DERIVED

• Dasgupta B, Combe B, Louw I, Wollenhaupt J, Zerbini CA, Beaulieu A, Schulze-Koops H, Durez P, Wolff V, Yao R, Weng HH, Govoni M, Vastesaeger N. Patient and physician expectations of add-on treatment with golimumab for rheumatoid arthritis: relationships between expectations and clinical and quality of life outcomes. Arthritis Care Res (Hoboken). 2014 Dec;66(12):1799-807. doi: 10.1002/acr.22371.

  PMID: 24839031 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Injections, Subcutaneous; golimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: September 11, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: February 1, 2012
• Last Updated: April 13, 2017
• Results First Posted: December 7, 2012

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share