Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel-Group, 12-Week Study to Assess the Clinically Effective Dose Range of Etoricoxib and to Assess Its Safety and Tolerability in Patients With Rheumatoid Arthritis
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the clinically active dose range of study medication in the treatment of patients with rheumatoid arthritis.
Status | Completed |
Enrollment | 761 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient with diagnosed rheumatoid arthritis (RA) for at least 6 months prior who is otherwise judged to be in general good health and who is currently taking nonsteroidal anti-inflammatory drugs (NSAIDS) to treat his/her RA symptoms - Patient will need to stop taking these medications in order to participate, but can continue taking his/her other anti-rheumatic medications as long as they have been stable for certain periods of time Exclusion Criteria: - Patients with a disease or medical condition(s) that could worsen or interfere with the evaluation of the effectiveness of study medication are not allowed to participate |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
Greenwald M, Peloso PM, Mandel D, Soto O, Mehta A, Frontera N, Boice JA, Zhan XJ, Curtis SP. Further assessment of the clinically effective dose range of etoricoxib: a randomized, double-blinded, placebo-controlled trial in rheumatoid arthritis. Curr Med — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients Who Met the ACR20 Responder Index Criteria | Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population) | 12 weeks | |
Secondary | Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | Time-weighted average change from baseline across Weeks 2, 7, and 12 | ||
Secondary | Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | Time-weighted average change from baseline across Weeks 2, 7, and 12 | ||
Secondary | Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | 0-mm indicates very well, 100-mm indicates very poor. | Time-weighted average change from baseline across Weeks 2, 7, and 12 | |
Secondary | Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | 0 indicates very well, 4 indicates very poor. | Time-weighted average change from baseline across Weeks 2, 7, and 12 | |
Secondary | Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | 0-mm indicates very well, 100-mm indicates very poor. | Time-weighted average change from baseline across Weeks 2, 7, and 12 |
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