Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

NCT ID: NCT00963703

Last Updated: 2012-03-20

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

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells.

This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

Rituximab 1000 mg Intravenously day 1 and day 15

Interventions

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Rituximab

Rituximab 1000 mg Intravenously day 1 and day 15

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with documented rheumatoid arthritis by ACR criteria
* Disease duration \< 5 years
* May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination
* Tender joint count \>= 6, swollen joint count \>= 6, and one must be a knee
* Corticosteroids \<= 10 mg per day permitted on stable doses for at least 4 weeks
* Patients must consent to 2 arthroscopic synovial biopsy procedures

Exclusion Criteria

* History of severe allergic or anaphylactic reactions to monoclonal antibodies
* Previous treatment with Rituximab
* Previous treatment with Arava
* Injected with steroids within 4 weeks of day 1 of study
* Treatment with any investigational agent within 4 weeks of day of study
* Any severe or significant medical condition or disease or known active infection
* Pregnancy or nursing at present
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Arthritis Centre, Unversity of Manitoba

Locations

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Arthritis Centre, University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2007:160

Identifier Type: -

Identifier Source: org_study_id

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