A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Etanercept

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).