Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

December 8, 2018 updated by: AB Science

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
masitinib (AB1010) 3 mg/kg/day
Drug: masitinib (AB1010)
3 mg/kg/day
Drug: masitinib (AB1010)
6 mg/kg/day
EXPERIMENTAL: 2
masitinib (AB1010) 6 mg/kg/day
Drug: masitinib (AB1010)
3 mg/kg/day
Drug: masitinib (AB1010)
6 mg/kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of patients achieving ACR 20, 50, 70 and 90 at 12 weeks
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
DAS (disease activity score) at 12 weeks
Time Frame: 12 weeks
12 weeks
ACRn at 12 weeks
Time Frame: 12 weeks
12 weeks
improvement of quality of life assessed by SF12 at 12 weeks
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AB Science

Investigators

  • Principal Investigator: Xavier Mariette, MD, PhD, Hôpital Kremlin Bicêtre, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 28, 2009

First Posted (ESTIMATE)

January 29, 2009

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 8, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB04012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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