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Masitinib in Refractory Active Rheumatoid Arthritis

NCT01410695 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2018-12-17

No results posted yet for this study

Summary

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.

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

masitinib 3 mg

DRUG

masitinib 6.0 mg

DRUG

methotrexate

DRUG

Placebo (methotrexate)

DRUG

Placebo (masitinib)

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Principal Investigators

  • Jacques Tebib, MD · Centre Hospitalier Lyon Sud, Pierre-Bénite, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-10-31
Completion
2015-10-31
FDA Drug
Yes

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01410695 on ClinicalTrials.gov