Rheumatoid Arthritis Clinical Trial
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
Verified date | October 2012 |
Source | Centocor, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 172 |
Est. completion date | February 2006 |
Est. primary completion date | February 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening - Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria Exclusion Criteria: - Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease - Received disease-modifying antirheumatic drugs ([DMARDs] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin [IL]-1 receptor antagonist [anakinra], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Centocor, Inc. | Centocor BV |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at 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]). | Week 16 | No |
Secondary | Summary of ACR-N, Index of Improvement at 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. | Week 16 | No |
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