Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis

A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00913432

Enrollment

Registered

2009-06-04

Start date

2007-03-31

Completion date

2010-09-30

Last updated

2018-12-13

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

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis, methotrexate, DMARD, c-kit inhibitor

Brief summary

A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments.

Interventions

DRUGmasitinib

3 mg/kg/day oral route

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA. 2. ACR functional class I-III 3. Have active RA 4. Failed (defined as active RA with stable dose during 3 months) i. methotrexate or ii. any DMARD including anti TNF alpha if patients previously failed methotrexate or iii. methotrexate in combination with any DMARD including anti TNF alpha

Exclusion criteria

1. Patient had a major surgery within 2 weeks prior to study entry. 2. Life expectancy \< 6 months.

Design outcomes

Primary

Measure	Time frame
American College of Rheumatology Score 50	week 12

Secondary

Measure	Time frame
DAS28	week 4, 8 and 12

Outcome results

None listed

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