An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis
Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate|
- Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).
- Summary of ACR-N, Index of Improvement at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient's assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient's global assessment of disease activity (VAS 0-10); c. Physician's global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement.
|Study Start Date:||November 2003|
|Study Completion Date:||February 2006|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
|Experimental: Golimumab (CNTO 148) with Methotrexate (MTX)||
Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.Drug: MTX
Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous
|Experimental: Infliximab with MTX||
Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneousDrug: Infliximab
Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous
|Placebo Comparator: Placebo with MTX||
Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneousDrug: Placebo
Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous
This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.
Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks