Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

NCT00831922 | Completed Phase 2

• 1 other identifier: AB04012
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; DMARD failure; ACR

Outcome Measures

Primary Outcomes (1)

• rate of patients achieving ACR 20, 50, 70 and 90 at 12 weeks

  12 weeks

Secondary Outcomes (3)

• DAS (disease activity score) at 12 weeks

  12 weeks

• ACRn at 12 weeks

  12 weeks

• improvement of quality of life assessed by SF12 at 12 weeks

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

masitinib (AB1010) 3 mg/kg/day

Drug: masitinib (AB1010)

2

EXPERIMENTAL

masitinib (AB1010) 6 mg/kg/day

Drug: masitinib (AB1010)

Interventions

masitinib (AB1010) DRUG

3 mg/kg/day

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AB Science: lead

Related Publications (1)

• 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.

  PMID: 19549290 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

masitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xavier Mariette, MD, PhD

  Hôpital Kremlin Bicêtre, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 29, 2009
• Study Start: September 1, 2004
• Primary Completion: October 1, 2006
• Last Updated: December 11, 2018

Record last verified: 2018-12