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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
385
American College of Rheumatology 20 Response (ACR20) at 6 Months
The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment
Time frame: 6 months
American College of Rheumatology 50 Response (ACR50) at 6 Months
The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment.
Time frame: 6 months
American College of Rheumatology 70 Response (ACR70) at 6 Months
The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment
Time frame: 6 months
Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.
Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of disease activity; and ESR) after 6 months' treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. (The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms).
Time frame: Baseline to 6 months
Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.
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Research Site
Aventura, Florida, United States
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
...and 41 more locations
Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months' treatment, calculated as score at 6 months minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. (The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability).
Time frame: Baseline to 6 months