NCT00913432

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_2 rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

2.3 years

First QC Date

June 3, 2009

Last Update Submit

December 12, 2018

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritismethotrexateDMARDc-kit inhibitor

Outcome Measures

Primary Outcomes (1)

  • American College of Rheumatology Score 50

    week 12

Secondary Outcomes (1)

  • DAS28

    week 4, 8 and 12

Study Arms (2)

masitinib 3 mg

EXPERIMENTAL

masitinib 3 mg/kg/day

Drug: masitinib

masitinib 6 mg

EXPERIMENTAL

masitinib 6 mg/kg/day

Drug: masitinib

Interventions

masitinibDRUG

3 mg/kg/day oral route

Also known as: AB1010
masitinib 3 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA.
  • ACR functional class I-III
  • Have active RA
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

masitinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jacques Tebib, MD, PhD

    CHU de Lyon Sud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 4, 2009

Study Start

March 1, 2007

Primary Completion

June 1, 2009

Study Completion

September 1, 2010

Last Updated

December 13, 2018

Record last verified: 2018-12