Rheumatoid Arthritis Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Verified date | August 2013 |
Source | Centocor, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.
Status | Completed |
Enrollment | 264 |
Est. completion date | July 2012 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of rheumatoid arthritis for at least 6 months - Be on a stable dose of methotrexate for 4 weeks - Have at least 4 swollen and 4 tender joints Exclusion Criteria: - Prior exposure to biologic anti-TNFalpha agents - Inflammatory diseases other than rheumatoid arthritis - Treatment with Disease Modifying Anti-rheumatic drug (DMARDs)/systemic immunosuppressives other than methotrexate during the 4 weeks prior to the first administration of study agent - History of, or ongoing, chronic or recurrent infectious disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centocor, Inc. | Schering-Plough |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14 | ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity. | Week 14 | No |
Secondary | Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein) | DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessments of disease activity. A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A DAS28 (using CRP) responder is defined as a participant with a DAS28 response of "Good" or "Moderate" at Week 14. A "Good" response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A "Moderate" response was defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >0.6 to >1.2 The table below shows the number of participants in each treatment group who were DAS28 responders at Week 14. | Week 14 | No |
Secondary | American College of Rheumatology 20 Response, Using CRP, at Week 24 | ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity. | Week 24 | No |
Secondary | HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline | The HAQ assesses the degree of difficulty a person has in accomplishing tasks in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). The full range of the HAQ scale is 0-24 with 0 being the best possible outcome. The HAQ score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3 with 0 being the best possible outcome (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, or 3=unable to do). The mean change from baseline at Week 24 in HAQ score is provided below for each treatment group. A negative change from baseline is indicative of a lesser degree of difficulty in accomplishing tasks assessed in the HAQ. | Baseline to Week 24 | No |
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