Status:
COMPLETED
A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis
Lead Sponsor:
AstraZeneca
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 etane...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT00713544
Start Date
July 1 2008
End Date
April 1 2009
Last Update
October 3 2011
Active Locations (49)
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1
Research Site
Blagoevgrad, Bulgaria
2
Research Site
Plovdiv, Bulgaria
3
Research Site
Sofia, Bulgaria
4
Research Site
Medellín, Colombia, Colombia