Masitinib in Refractory Active Rheumatoid Arthritis

Phase 2

Terminated

• Conditions: Rheumatoid Arthritis (RA)
• Interventions: Drug: masitinib 3 mg; Drug: masitinib 6.0 mg; Drug: methotrexate; Drug: Placebo (methotrexate); Drug: Placebo (masitinib)

• Registration Number: NCT01410695
• Lead Sponsor: AB Science

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-05
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2018-12
• Disposition First Submitted: 2018-12-12
• Disposition First Submitted QC: 2018-12-13
• Last Update Submitted: 2018-12-13
• Disposition First Posted: 2018-12-17
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 324

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
masitinib 6.0 mg	Placebo (methotrexate)	masitinib 6.0 mg/kg/day, tablets, orally, twice a day
masitinib 3 mg	masitinib 3 mg	masitinib 3 mg/kg/day, tablets, orally, twice a day
masitinib 3 mg	Placebo (methotrexate)	masitinib 3 mg/kg/day, tablets, orally, twice a day
masitinib 6.0 mg	masitinib 6.0 mg	masitinib 6.0 mg/kg/day, tablets, orally, twice a day
methotrexate	methotrexate	methotrexate at the dose of 15 or 20 mg per week
methotrexate	Placebo (masitinib)	methotrexate at the dose of 15 or 20 mg per week

Primary Outcome Measures

Name	Time	Method
ACR50	week 24

Secondary Outcome Measures

Name	Time	Method
ACR	week 12

Trial Locations

Locations (1)

ARTMEDI UPD s.r.o; 🇨🇿 Hostivice, Czechia