Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831922
• Other study ID #: AB04012
• Status: Completed
• Phase: Phase 2
• Start date: September 2004

Study information

• Verified date: December 2018
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• masitinib (AB1010)
3 mg/kg/day
• masitinib (AB1010)
6 mg/kg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

References & Publications (1)

Tebib J, Mariette X, Bourgeois P, Flipo RM, Gaudin P, Le Loët 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, pha — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of patients achieving ACR 20, 50, 70 and 90 at 12 weeks		12 weeks
Secondary	DAS (disease activity score) at 12 weeks		12 weeks
Secondary	ACRn at 12 weeks		12 weeks
Secondary	improvement of quality of life assessed by SF12 at 12 weeks		12 weeks

External Links

•   Publication on study results