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OpenTrials
Completed

NCT Number: NCT00831922

Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

masitinib (AB1010)

Drug

3 mg/kg/day

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. DAS (disease activity score) at 12 weeks

    Time frame: 12 weeks

  2. ACRn at 12 weeks

    Time frame: 12 weeks

  3. improvement of quality of life assessed by SF12 at 12 weeks

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

AB Science

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2006
First posted
Jan 29, 2009
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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