Clinical trial NCT00831922: Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis
Official title: A Multicenter, Open Label, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis With Inadequate Response to at Least One Disease Modifying Anti Rheumatic Drugs (DMARD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
DMARD failure
ACR
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2009-01-29
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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


Eligibility 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

Primary outcomes:
measure: rate of patients achieving ACR 20, 50, 70 and 90 at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: DAS (disease activity score) at 12 weeks
timeFrame: 12 weeks
measure: ACRn at 12 weeks
timeFrame: 12 weeks
measure: improvement of quality of life assessed by SF12 at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Kremlin Bicêtre, France
name: Xavier Mariette, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tebib J, Mariette X, Bourgeois P, Flipo RM, Gaudin P, Le Loet X, Gineste P, Guy L, Mansfield CD, Moussy A, Dubreuil P, Hermine O, Sibilia J. Masitinib in the treatment of active rheumatoid arthritis: results of a multicentre, open-label, dose-ranging, phase 2a study. Arthritis Res Ther. 2009;11(3):R95. doi: 10.1186/ar2740. Epub 2009 Jun 23.