A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor

Sponsor
Hoffmann-La Roche
Study ID
NCT02079532
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Key Dates

Start date
Nov 30, 2006
Status verified
Jun 2016
Primary completion
Nov 30, 2010
Completion
Nov 30, 2010

Study Design

Enrollment
302 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MabThera (Rituximab)

Primary Outcome Measure

Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28) [ Time Frame: Week 24 ]

Related Studies