Masitinib in Refractory Active Rheumatoid Arthritis

Rheumatoid Arthritis (RA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01410695
• Other study ID #: AB06012
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: July 2011
• Est. completion date: October 2015

Study information

• Verified date: December 2018
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 324
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Drug:
• masitinib 3 mg

• masitinib 6.0 mg

• methotrexate

• Placebo (methotrexate)

• Placebo (masitinib)

Locations

Country	Name	City	State
Czechia	ARTMEDI UPD s.r.o	Hostivice

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR50		week 24
Secondary	ACR		week 12