A study of ARA 290 for treating rheumatoid arthritis.
- Conditions
- rheumatoid arthritisreumatoide artritisreuma
- Registration Number
- NL-OMON22511
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Brines M, Cerami A. Discovering erythropoietin's extra-hematopoietic functions: biology and clinical promise. Kidney Int 2006; 70(2):246-50.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
1. Diagnosis of RA, classified by ARA (American Rheumatism Association) 1987 revised criteria;
2. Active disease at screening and baseline: 6/68 tender and 6/66 swollen joints and either an erythrocyte sedimentation rate (ESR) of >=28 mm/hr or C-reactive protein (CRP)> 10 mg/l;
Exclusion Criteria
1. Current or previous treatment with biological agent;
2. Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings other than conditions related to rheumatoid arthritis (as judged by the investigator);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weekly measurements of:<br /><br>1. Disease activity, measured by the disease activity score: 'original DAS';<br /><br>2. Functionaly ability, measured by the Health Assessment Questionaire (HAQ) disability index;<br /><br>3. Systemic inflammation: ESR, CRP.
- Secondary Outcome Measures
Name Time Method Weekly assessment of:<br /><br>Tolerability, using blood investigation and physical examination.