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

NCT ID: NCT00576433

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

As prescribed

rituximab [MabThera/Rituxan]

Intervention Type DRUG

1000mg iv on days 1 and 15

Interventions

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Methotrexate

As prescribed

Intervention Type DRUG

rituximab [MabThera/Rituxan]

1000mg iv on days 1 and 15

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Chelyabinsk, , Russia

Site Status

Irkutsk, , Russia

Site Status

Kazan', , Russia

Site Status

Khabarovsk, , Russia

Site Status

Khanty-Mansiysk, , Russia

Site Status

Kursk, , Russia

Site Status

Moscow, , Russia

Site Status

Nizhny Novgorod, , Russia

Site Status

Novosibirsk, , Russia

Site Status

Novosibirsk, , Russia

Site Status

Ryazan, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Tyumen, , Russia

Site Status

Ufa, , Russia

Site Status

Vladivostok, , Russia

Site Status

Voronezh, , Russia

Site Status

Yaroslavl, , Russia

Site Status

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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ML21271

Identifier Type: -

Identifier Source: org_study_id