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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00975130
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SC golimumab — BIOLOGICAL
    Subcutaneous golimumab at a dose of 50 mg administered once monthly.
  • 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.

Study Details

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.

Key Dates

First listed
Sep 11, 2009
Start date
Sep 30, 2009
Status verified
Mar 2017
Primary completion
Aug 31, 2011
Completion
Feb 29, 2012

Study Design

Enrollment
3,366 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SC-GLM50
    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.
  • Experimental: IV GLM 2 mg/kg + GLM50-SC
    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.
  • Experimental: GLM50-SC
    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.

Primary Outcome Measure

Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6 [ Time Frame: Month 6 ]

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