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

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

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: etoricoxib
* Drug: etoricoxib
* Drug: etoricoxib
* Drug: etoricoxib
* Drug: Comparator: placebo
* Drug: etoricoxib
* Drug: Comparator: diclofenac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period I: 1<br>etoricoxib | Drug: etoricoxib<br>* Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.<br>|
| Experimental: Period I: 2<br>etoricoxib | Drug: etoricoxib<br>* Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.<br>|
| Experimental: Period I: 3<br>etoricoxib | Drug: etoricoxib<br>* Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.<br>|
| Experimental: Period I: 4<br>etoricoxib | Drug: etoricoxib<br>* Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.<br>|
| Placebo Comparator: Period I: 5<br>Placebo | Drug: Comparator: placebo<br>* Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.<br>|
| Experimental: Period II: 1<br>etoricoxib | Drug: etoricoxib<br>* Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.<br>|
| Active Comparator: Period II: 2<br>diclofenac | Drug: Comparator: diclofenac<br>* Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arcoxia