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

NCT ID: NCT00913432

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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rheumatoid arthritis methotrexate DMARD c-kit inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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masitinib 3 mg

masitinib 3 mg/kg/day

Group Type EXPERIMENTAL

masitinib

Intervention Type DRUG

3 mg/kg/day oral route

masitinib 6 mg

masitinib 6 mg/kg/day

Group Type EXPERIMENTAL

masitinib

Intervention Type DRUG

masitinib 6 mg/kg/day oral route

Interventions

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masitinib

3 mg/kg/day oral route

Intervention Type DRUG

masitinib

masitinib 6 mg/kg/day oral route

Intervention Type DRUG

Other Intervention Names

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AB1010 AB1010

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AB Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques Tebib, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Lyon Sud

Other Identifiers

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AB06010

Identifier Type: -

Identifier Source: org_study_id