Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis

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

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis

Detailed Description

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Conditions

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Rheumatoid Arthritis

Interventions

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adalimumab

40 mg adalimumab every other week

Intervention Type BIOLOGICAL

Other Intervention Names

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ABT-D2E7 Humira

Eligibility Criteria

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Inclusion Criteria

* Eighteen years or older
* Females - post-menopausal for at least 1 year, surgically sterile or practicing an acceptable method of birth control
* Females - negative pregnancy test at screening
* Confirmed diagnosis of active RA \>= 6 swollen joints and \>= 9 tender joints
* Met ACR criteria for diagnosis of RA for at least 3 months
* Active RA defined by a DAS \>= 3.2 at study entry

Exclusion Criteria

* Subject had prior treatment with cyclophosphamide or chlorambucil
* Subjects previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in CD4 lymphopenia
* Prior treatment with intravenous immunoglobulin or investigational agent in with 30 days or 5 half-lives of adalimumab
* Subject with history of cancer within the past 10 years other than resected basal cell or squamous cell carcinoma of the skin

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Abbott

Other Identifiers

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M03-583

Identifier Type: -

Identifier Source: org_study_id