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...
Date First Received: August 22, 2007
Last Updated: July 2, 2008
Verified by: AstraZeneca, July 2008
Clinical Trial Phase: N/A | Start Date: August 2007
Overall Status: Recruiting
Estimated Enrollment: 360
Brief Summary
Official Title: “A Randomised, Double-Blind, Parallel-Group (Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months Rheumatoid Arthritis in Patients With Active Disease Receiving Background Methotrexate or Sulphasalazine”
Condition Keyword(s):
Intervention(s):
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
Study Type: Observational
Study Design: Prospective
Intervention(s) in this Clinical Trial
- Drug: AZD9056 OD
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated ESR or 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 (injection) methotrexate for at least 6 months prior to randomisation, or oral sulphasalazine for at least 16 weeks 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).
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Edward Keystone, MD, FRCPC Principal Investigator MOUNT SINAI HOSPITAL
Overall Contact: Omnicare Clinical, Research +49 2234 1852 0
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00520572
Study ID Number: D1520C00001
ClinicalTrials.gov Identifier: NCT00520572
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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