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CompletedNCT00913432Updated Dec 13, 2018

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

A Phase 2 interventional study of masitinib and masitinib in Rheumatoid Arthritis, sponsored by AB Science. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-13.

Sponsored by AB Science · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • rheumatoid arthritis
  • methotrexate
  • DMARD
  • c-kit inhibitor
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 20 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

AB Science is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Patient had a major surgery within 2 weeks prior to study entry.
  2. Life expectancy \< 6 months.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    masitinib 3 mg

    masitinib 3 mg/kg/day

    Drug: masitinib

  • Experimental
    masitinib 6 mg

    masitinib 6 mg/kg/day

    Drug: masitinib

Interventions

  • Drugmasitinib

    3 mg/kg/day oral route

    Also known as: AB1010

  • Drugmasitinib

    masitinib 6 mg/kg/day oral route

    Also known as: AB1010

06

What researchers measure

Primary outcomes

  1. American College of Rheumatology Score 50

    Time frame: week 12

Secondary outcomes

  1. DAS28

    Time frame: week 4, 8 and 12

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00913432
Lead sponsor
AB Science
Responsible party
Sponsor
First posted
Jun 4, 2009
Start date
Mar 2007
Primary completion
Jun 2009
Completion
Sep 2010
Last update
Dec 13, 2018

Study contacts

Jacques Tebib, MD, PhD
principal investigator · CHU de Lyon Sud

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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