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Masitinib in Refractory Active Rheumatoid Arthritis

NCT ID: NCT01410695

Last Updated: 2018-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis (RA)

Keywords

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Rheumatoid Arthritis RA masitinib DMARD methotrexate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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masitinib 3 mg

masitinib 3 mg/kg/day, tablets, orally, twice a day

Group Type EXPERIMENTAL

masitinib 3 mg

Intervention Type DRUG

Placebo (methotrexate)

Intervention Type DRUG

masitinib 6.0 mg

masitinib 6.0 mg/kg/day, tablets, orally, twice a day

Group Type EXPERIMENTAL

masitinib 6.0 mg

Intervention Type DRUG

Placebo (methotrexate)

Intervention Type DRUG

methotrexate

methotrexate at the dose of 15 or 20 mg per week

Group Type ACTIVE_COMPARATOR

methotrexate

Intervention Type DRUG

Placebo (masitinib)

Intervention Type DRUG

Interventions

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masitinib 3 mg

Intervention Type DRUG

masitinib 6.0 mg

Intervention Type DRUG

methotrexate

Intervention Type DRUG

Placebo (methotrexate)

Intervention Type DRUG

Placebo (masitinib)

Intervention Type DRUG

Other Intervention Names

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AB1010 AB1010

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AB Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques Tebib, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Lyon Sud, Pierre-Bénite, France

Locations

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ARTMEDI UPD s.r.o

Hostivice, , Czechia

Site Status

Countries

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France United States Czechia

Other Identifiers

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AB06012

Identifier Type: -

Identifier Source: org_study_id