(OSKIRA-X): A LONG-TERM EXTENSION STUDY TO ASSESS THE SAFETY AND EFFICACY OF FOSTAMATINIB DISODIUM IN THE TREATMENT OF RHEUMATOID ARTHRITIS

AstraZeneca AB,0 个研究点目标入组 144 人开始时间: 2010年12月13日最近更新: 2023年9月4日

试验速览

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•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

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