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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT00520572

Run by

AstraZeneca

People needed

385

Starts

2007-08-01

Expected to finish

2009-03-01

Last updated by the study team

2013-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Research Site — Orlando, Florida, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Petoskey, Michigan, United States
• Research Site — Syracuse, New York, United States
• Research Site — Portland, Oregon, United States
• Research Site — Olympia, Washington, United States
• Research Site — Rosario, Santa Fe Province, Argentina
• Research Site — Buenos Aires, Argentina
• Research Site — Córdoba, Argentina
• Research Site — Planta Baja San Juan, Argentina
• Research Site — San Miguel de Tucumán, Argentina
• Research Site — Woolloongabba, Queensland, Australia
• Research Site — Woodsville, South Australia, Australia
• Research Site — Victoria Park, Western Australia, Australia
• Research Site — George Town, Australia
• Research Site — Hasselt, Belgium
• Research Site — Winnipeg, Manitoba, Canada
• Research Site — St. John's, Newfoundland and Labrador, Canada
• Research Site — Prague, Czechia
• Research Site — Uherské Hradiště, Czechia
• Research Site — Zlín, Czechia
• Research Site — Bobigny, France
• Research Site — Bordeaux, France
• Research Site — Aventura, Florida, United States

Full record on ClinicalTrials.gov

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