Phase 2
Completed N=385
A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT00520572 ↗Enrolled (actual)
385
Serious AEs
1.8%
Results posted
Oct 2010
Primary outcomePrimary: American College of Rheumatology 20 Response (ACR20) at 6 Months — 23; 26; 23; 21 Participants
Summary
The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid arthritis with regard to signs and symptoms and to determine what dose is favourable over a 6-month treatment period. Patients will receive background treatment with either Methotrexate or Sulphasalazine
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American College of Rheumatology 20 Response (ACR20) at 6 Months |
23; 26; 23; 21; 21; 42 | — |
| SECONDARY American College of Rheumatology 50 Response (ACR50) at 6 Months |
13; 8; 9; 13; 11; 30 | — |
| SECONDARY American College of Rheumatology 70 Response (ACR70) at 6 Months |
6; 7; 5; 5; 3; 15 | — |
| SECONDARY Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months. |
-1.2; -1.4; -1.1; -1.4; -1; -2.3 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months. |
-0.3; -0.3; -0.2; -0.3; -0.3; -0.6 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). At least one of the following: documented history and current presence of positive rheumatoid factor (blood test), baseline radiographic erosion.
Be receiving either oral (tablets) or subcutaneous/intramuscular (injection) methotrexate for at least 6 months prior to randomisation.
Exclusion Criteria
- Any other inflammatory disease in addition to RA that may interfere with the study (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, e t c). Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes. Persistently abnormal liver function enzymes (blood test).
Data sourced from ClinicalTrials.gov (NCT00520572). 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.