An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT00207714|
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : August 7, 2012
Last Update Posted : October 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Golimumab Drug: MTX Drug: Placebo Drug: Infliximab||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||February 2005|
|Actual Study Completion Date :||February 2006|
|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
- Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 [ Time Frame: Week 16 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207714
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|