CompletedPhase 2

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

20 participantsStarted 2007-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

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

What they're measuring

American College of Rheumatology Score 50

Timeframe: week 12

Trial details

NCT IDNCT00913432

SponsorAB Science

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-06

View on ClinicalTrials.gov More Rheumatoid Arthritis trials