A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFalpha Monoclonal Antibody, Administered Intravenously, in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Patients eligible for this study must have active RA despite current methotrexate treatment.
Patients receiving current non steroidal anti inflammatory drugs (such as naproxen,
ibuprofen) or oral corticosteroids (such as prednisone) are allowed to enroll in this study.
Approximately 564 patients will be randomly assigned (like a flip of a coin) to 1 of 2
treatment groups in a 2:1 ratio. Group 1 (376 patients) will receive 2 mg/kg of golimumab
intravenously at Weeks 0, 4, and every 8 weeks thereafter (i.e. Weeks 12, 20, 28, 36, etc.).
Patients will be maintained on their current dose of MTX from their pharmacy (between 15-25
mg/week) throughout the study. Group 2 (188 patients) will receive saline (placebo)
intravenously at Weeks 0, 4, 12, 16 and 20 and will begin to receive golimumab 2 mg/kg
infusions beginning at Weeks 24, 28 and every 8 weeks thereafter in a pattern identical to
that of patients in Group 1. In addition, however, patients in Group 2 who demonstrate less
than 10% improvement in the number of tender and swollen joints when compared to the number
of involved joints when they entered the study will begin receiving golimumab 2 mg/kg
infusions at Weeks 16, 20, 28 and every 8 weeks subsequent to Week 100. Length of the trial
is 100 weeks of treatment and 12 weeks of follow up for side effects. All infusions in all
groups of patients will be completed over 20 to 40 minutes. At specific visits, patients
will have their joints examined, blood testing will be performed (to check for blood counts,
blood chemistry as safety checks, as well as tests to measure levels of golimumab in the
blood, inflammation markers in the blood and other evidence of improvement or worsening of
arthritis) and questionnaires will be given to patients and investigators to evaluate issues
such as whether symptoms are improving or not, and quality of life measurements are
improving or not. X-rays of the hands and feet will be performed at Weeks 0, 24, 52 and 100.
Patients and investigators will not know which study treatment was being given until the
last patient completes the Week 112 visit and the Week-112 information is completely
reviewed. Intravenous golimumab 2 mg/kg infusions over 20-40 minutes. Administered Week 0,
Week 4 and every 8 weeks thereafter to Week 100. Sterile normal saline, 100 cc, will be
administered over 25-35 minutes as the placebo.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
The primary endpoint is the proportion of patients with an American College of Rheumatology (ACR) 20 response at Week 14.
Centocor, Inc. Clinical Trial
United States: Food and Drug Administration
|Hinsdale, Illinois 60521|
|Miami, Florida 33176|
|Cleveland, Ohio 44195|
|Austin, Texas 78705|
|Omaha, Nebraska 68114|
|Baltimore, Maryland 21287|