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Rheumatoid Arthritis (RA)

Masitinib in Refractory Active Rheumatoid Arthritis

Sponsored by AB Science

About this trial

Last updated 6 years ago

Study ID

AB06012

Status

Terminated

Type

Interventional

Phase

Phase 2/Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 10 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status