Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA)

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

Study Classification

INTERVENTIONAL

Study Completion Date

2003-11-30

Brief Summary

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The purpose of this study is to estimate the effect of anakinra, 100 mg once daily (QD), on the development of an anti-tetanus antibody response in subjects with RA after vaccination with a tetanus and diphtheria toxoids injection. In addition, this study will evaluate the general safety profile of therapy with anakinra, 100 mg QD, in subjects with RA after vaccination with a tetanus and diphtheria toxoids injection.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Anakinra (r-metHuIL-1ra)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Morning stiffness greater than or equal to 45 minutes;
* C-reactive protein (CRP) greater than or equal to 1.5 mg/dL;
* Erythrocyte sedimentation rate greater than or equal to 28 mm/hr;
* Stable methotrexate dose of less than or equal to 20 mg/week for 8 weeks prior to randomization;

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No