A Study of Re-Treatment With 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
NCT00502840
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 \>2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to 3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Key Dates

Start date
Jul 23, 2007
Status verified
Jul 2017
Primary completion
Sep 20, 2011
Completion
Sep 20, 2011

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Change From Baseline in DAS28 Score at Week 24 [ Time Frame: Week 24 ]

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