A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2
- Conditions
- Rheumatoid ArthritisMedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
- Registration Number
- EUCTR2010-020744-35-PT
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
1.Male or female aged 18 and over
2. A diagnosis of RA after the age of 16
3. Currently taking 1 of the following traditional DMARDs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Females who are pregnant/lactating
2.Any systemic inflammatory conditions(other than RA), connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data
3. Poorly controlled blood pressure
4.History of liver function abnormality requiring investigation, drug induced liver injury, chronic liver disease, excessive alcohol consumption/chronic alcohol induced disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method