Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-12-31

Brief Summary

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Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur as a result of treatment with rituximab.

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Detailed Description

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Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur after treatment with rituximab.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ritxumab

all patients get treatment

Group Type EXPERIMENTAL

rituximab

Intervention Type DRUG

treatment with rituximab

Interventions

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rituximab

treatment with rituximab

Intervention Type DRUG

Other Intervention Names

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rituxan

Eligibility Criteria

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Inclusion Criteria

* Active rheumatoid arthritis
* Use of concomitant methotrexate

Exclusion Criteria

* Use of disease-modifying anti-rheumatic drugs (DMARDs)/biologics other than methotrexate
* Serious medical conditions that would preclude the use of the treating agent

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No