Phase 2
Completed N=373
A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00713544 ↗Enrolled (actual)
373
Serious AEs
1.6%
Results posted
Oct 2011
Primary outcomePrimary: American College of Rheumatology 20 Response (ACR20) — 20; 15; 17; 34 Participants
Summary
This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when added to treatment with methotrexate. The purpose of this study is also to find out which dose of AZD5672 is the most effective at treating RA and to find out how well the body tolerates AZD5672 when taken for up to 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American College of Rheumatology 20 Response (ACR20) |
20; 15; 17; 34; 25; 58 | — |
| SECONDARY American College of Rheumatology 50 Response (ACR50) |
10; 5; 6; 11; 6; 35 | — |
| SECONDARY American College of Rheumatology 70 Response (ACR70) |
3; 2; 3; 2; 3; 12 | — |
| SECONDARY Disease Activity Score (Based on 28 Joint Count) (DAS28) |
-1.3; -1.1; -1.3; -1.3; -1.1; -2.6 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) |
-0.3; -0.2; -0.2; -0.3; -0.3; -0.5 | — |
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 of positive rheumatoid factor (blood test), current presence of positive rheumatoid factor (blood test), baseline radiographic erosion, presence of serum anti-cyclic citrullinated peptide antibodies (bloo
- Be receiving either: Oral (tablets) or subcutaneous (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, etc).
- Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes.
Data sourced from ClinicalTrials.gov (NCT00713544). 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.