Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: etoricoxib

• Registration Number: NCT00264147
• Lead Sponsor: Organon and Co

Brief Summary

To assess the clinically active dose range of study medication in the treatment of patients with rheumatoid arthritis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-12-09
• Study First Submitted QC: 2005-12-09
• Study First Posted: 2005-12-12
• Study Start: 2006-01
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2009-03-19
• Results First Submitted QC: 2009-05-22
• Results First Posted: 2009-07-07
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 761

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Period I: 1	etoricoxib	etoricoxib
Period I: 3	etoricoxib	etoricoxib
Period I: 2	etoricoxib	etoricoxib
Period II: 1	etoricoxib	etoricoxib
Period I: 4	etoricoxib	etoricoxib

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Who Met the ACR20 Responder Index Criteria	12 weeks	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)

Secondary Outcome Measures

Name	Time	Method
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
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)	Time-weighted average change from baseline across Weeks 2, 7, and 12	0 indicates very well, 4 indicates very poor.
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
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)	Time-weighted average change from baseline across Weeks 2, 7, and 12	0-mm indicates very well, 100-mm indicates very poor.
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)	Time-weighted average change from baseline across Weeks 2, 7, and 12	0-mm indicates very well, 100-mm indicates very poor.