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Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

masitinib (AB1010)

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, DMARD failure, ACR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

masitinib (AB1010) 3 mg/kg/day

masitinib (AB1010) 6 mg/kg/day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

DAS (disease activity score) at 12 weeks

ACRn at 12 weeks

improvement of quality of life assessed by SF12 at 12 weeks

Full Information

NCT ID

NCT00831922

First Posted

January 28, 2009

Last Updated

December 8, 2018

Sponsor

AB Science

1. Study Identification

Unique Protocol Identification Number

NCT00831922

Brief Title

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AB Science

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, DMARD failure, ACR

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

masitinib (AB1010) 3 mg/kg/day

Arm Title

Arm Type

Experimental

Arm Description

masitinib (AB1010) 6 mg/kg/day

Intervention Type

Drug

Intervention Name(s)

masitinib (AB1010)

Intervention Description

3 mg/kg/day

Intervention Type

Drug

Intervention Name(s)

masitinib (AB1010)

Intervention Description

6 mg/kg/day

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

DAS (disease activity score) at 12 weeks

Time Frame

12 weeks

Title

ACRn at 12 weeks

Time Frame

12 weeks

Title

improvement of quality of life assessed by SF12 at 12 weeks

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xavier Mariette, MD, PhD

Organizational Affiliation

Hôpital Kremlin Bicêtre, France

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

19549290

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.

Results Reference

result

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Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

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