Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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, after 3 months (12 weeks) of treatment.

The safety and efficacy will be evaluated on:

Rate of patients achieving ACR 20, 50, 70 and 90 DAS (disease activity score) after 3 months treatment ACRn after 3 months treatment Therapeutic maintenance of AB1010 at 3 months Quality of Life assessed by SF12 Health Assessment Questionnaire (HAQ) Clinical and biological safety Pharmacokinetic profile of AB1010

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Science
• Treatments: Antirheumatic Agents

Criteria

Inclusion Criteria:

1. Meet American College of Rheumatology (ACR) criteria for RA

2. Have active RA

3. ACR functional class I-III

4. Disease onset at > 16 years of age

5. Disease duration of at least 6 months

6. Failure to one DMARD including methotrexate and anti-TNF alpha

Exclusion Criteria:

1. Pregnant or breastfeeding women

2. Inadequate bone marrow function

3. 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

4. Any previous use of recombinant IL1-Ra

5. 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

6. 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