Status:
COMPLETED
Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis
Lead Sponsor:
AB Science
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the activity of 2 oral doses of AB1010 in subjects suffering from active RA who have shown an inadequate response to one DMARD including MTX or anti-TNF, aft...
Eligibility Criteria
Inclusion
- Meet American College of Rheumatology (ACR) criteria for RA
- Have active RA
- ACR functional class I-III
- Disease onset at \> 16 years of age
- Disease duration of at least 6 months
- Failure to one DMARD including methotrexate and anti-TNF alpha
Exclusion
- Pregnant or breastfeeding women
- Inadequate bone marrow function
- Current use of a DMARD within 4 weeks (or 5 half-lives, whichever is longer) of screening except for leflunomide which requires a specific wash-out
- Any previous use of recombinant IL1-Ra
- Current use of more than 1 non steroidal anti-inflammatory drug (NSAID) or change of dose of the NSAID within 4 weeks of baseline or NSAID use greater than the maximum recommended dose
- Within 4 weeks before baseline, use of more than 10 mg/day of prednisone or equivalent or change in the dose of prednisone or equivalent, or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids (\>20 mg prednisone or equivalent
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00831922
Start Date
September 1 2004
Last Update
December 11 2018
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