NCT00462345View on ClinicalTrials.gov

A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.

PHASE4CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions
Rheumatoid Arthritis
Interventions
DRUG

rituximab

1000 mg i.v. on Days 1 and 15

DRUG

Methotrexate

10 to 25 mg/week p.o. or parenteral from Day 1 through Week 24

DRUG

Corticosteroid or NSAID

≤10 mg/day prednisone p.o., or equivalent corticosteroid, or NSAIDs p.o. from Day 1 through Week 24

DIETARY_SUPPLEMENT

Folate

≥5 mg/week, once daily or b.i.d. from Day 1 through Week 24

Trial Locations (4)

137701

Seoul

110-744

Seoul

133-792

Seoul

138-736

Seoul

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT00462345 - A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies. | Biotech Hunter | Biotech Hunter