Masitinib in Refractory Active Rheumatoid Arthritis

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

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01410695

Enrollment

324

Registered

2011-08-05

Start date

2011-07-31

Completion date

2015-10-31

Last updated

2018-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid Arthritis, RA, masitinib, DMARD, methotrexate

Brief 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.

Interventions

DRUGmasitinib 3 mg

DRUGmasitinib 6.0 mg

DRUGmethotrexate

DRUGPlacebo (methotrexate)

DRUGPlacebo (masitinib)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
ACR50	week 24

Secondary

Measure	Time frame
ACR	week 12

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026