Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis (OSKIRA-Asia-1)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of the study is to evaluate the effectiveness of four dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 12 weeks.
Full description
(OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients with Active Rheumatoid Arthritis who are Inadequate Responders to Methotrexate Therapy
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Male or female aged 18 and over
- Active rheumatoid arthritis (RA) diagnosed after the age of 16
- 6 or more swollen joints and 6 or more tender/painful joints from certain joints in the hands, wrists, arms and knees
- At least one of: positive result for rheumatoid factor test, either in the past or currently (blood test); x-ray showing bone erosion within the last 12 months; presence of certain antibodies in the blood (blood test)
- Currently taking methotrexate for at least 4 months (and on a stable dose for at least 6 weeks)
Exclusion criteria
- Females who are pregnant or breast feeding
- Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders.
- Previously taken, but not responded to, certain biological treatments for rheumatoid arthritis
- High blood pressure that is not controlled by medication
- Low levels of neutrophils in the blood (blood test).
Trial design
Primary purpose
Allocation
Interventional model
Masking
163 participants in 5 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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