Phase 2
Completed N=761
Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)
Source: ClinicalTrials.gov NCT00264147 ↗Enrolled (actual)
761
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Proportion of Patients Who Met the ACR20 Responder Index Criteria — 28.57; 35.06; 37.75; 38.57 Proportion of Patients — p=<0.001
Summary
To assess the clinically active dose range of study medication in the treatment of patients with rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Met the ACR20 Responder Index Criteria |
28.57; 35.06; 37.75; 38.57; 47.10 | <0.001 sig |
| 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) |
-8.13; -11.01; -10.96; -9.56; -12.06 | 0.002 sig |
| 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) |
-5.39; -6.58; -6.91; -6.25; -7.77 | 0.001 sig |
| 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) |
-12.32; -19.90; -21.12; -21.49; -25.75 | <0.001 sig |
| 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) |
-0.68; -0.93; -1.09; -1.01; -1.24 | <0.001 sig |
| 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) |
-17.44; -21.95; -22.75; -22.25; -31.07 | <0.001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00264147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.