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

An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00576433

Enrollment

Registered

2007-12-19

Start date

2007-12-31

Completion date

2010-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Interventions

DRUGMethotrexate

As prescribed

DRUGrituximab [MabThera/Rituxan]

1000mg iv on days 1 and 15

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* adult patients, 18-80 years of age; * moderate to severe active rheumatoid arthritis; * inadequate response to previous or current treatment with 1 anti-TNF agent; * receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for \>=4 weeks.

Exclusion criteria

* previous treatment with MabThera; * use of an anti-TNF alpha agent within 8 weeks of study start; * concurrent treatment with any DMARD other than methotrexate; * active infection, or history of serious recurrent or chronic infection.

Design outcomes

Primary

Measure	Time frame
AEs, including infusion-related adverse events	For 48 weeks after initial treatment

Secondary

Measure	Time frame
Safety of re-treatment (AEs)	For 24 weeks after re-treatment.
Laboratory parameters, vital signs.	Throughout study
ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT.	For 48 weeks after initial treatment.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026