Masitinib in Refractory Active Rheumatoid Arthritis

December 13, 2018 updated by: AB Science

A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs

The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

324

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Hostivice, Czechia, 25301
        • ARTMEDI UPD s.r.o

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. Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months
  2. Patient with ACR functional class I-III
  3. Patient who have active RA
  4. Patient who failed (defined as active RA with stable dose during 3 months) methotrexate or any DMARD including biologics drugs if patients previously failed methotrexate or methotrexate in combination with any DMARD including biologics drugs
  5. Patient with a disease onset at > 16 years of age

Exclusion Criteria:

  1. Patient for whom the use of methotrexate is contraindicated as per its SPC
  2. Patient with documented fibromyalgia
  3. Patient with lactose intolerance
  4. Patient presenting with cardiac disorders

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: masitinib 3 mg
masitinib 3 mg/kg/day, tablets, orally, twice a day
Drug: masitinib 3 mg
Other Names:
  • AB1010
Drug: Placebo (methotrexate)
Experimental: masitinib 6.0 mg
masitinib 6.0 mg/kg/day, tablets, orally, twice a day
Drug: Placebo (methotrexate)
Drug: masitinib 6.0 mg
Other Names:
  • AB1010
Active Comparator: methotrexate
methotrexate at the dose of 15 or 20 mg per week
Drug: methotrexate
Drug: Placebo (masitinib)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ACR50
Time Frame: week 24
week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
ACR
Time Frame: week 12
week 12

Collaborators and Investigators

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

Sponsor

AB Science

Investigators

  • Principal Investigator: Jacques Tebib, MD, Centre Hospitalier Lyon Sud, Pierre-Bénite, France

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

July 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Actual)

December 17, 2018

Last Update Submitted That Met QC Criteria

December 13, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB06012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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