(OSKIRA-X): A LONG-TERM EXTENSION STUDY TO ASSESS THE SAFETY AND EFFICACY OF FOSTAMATINIB DISODIUM IN THE TREATMENT OF RHEUMATOID ARTHRITIS
- Conditions
- -M05M05
- Registration Number
- PER-091-10
- Lead Sponsor
- AstraZeneca AB,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 144
• Provide informed consent, before any specific study procedure.
• Men or women 18 years of age or older with a diagnosis of RA after 16 years of age, according to the modified criteria (1987) of the North American College of Rheumatology.
• AR active
• Documented history of positive rheumatoid factor
• Current presence of rheumatoid factor
• Radiographic erosion in the 12 months prior to enrollment
• Presence of cyclic citrullinated anti-peptide (anti-CCP) antibodies in serum.
• Treatment with oral, subcutaneous or intramuscular methotrexate for at least 6 months before randomization. The dose and route of administration of methotrexate should have been stable between 7.5 mg and 25 mg per week for at least 6 weeks before randomization. Patients receiving lower doses of methotrexate (7.5 mg and 10 mg) should receive them as a result of a documented history of intolerance at higher doses of methotrexate.
• Females who are pregnant or breast feeding
• Poorly controlled hypertension
• Liver disease or significant liver function test abnormalities
• Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
• Recent or significant cardiovascular disease
• Significant active or recent infection including tuberculosis
• Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment with other biological agent
• Severe renal impairment
• Neutropenia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method