A Belgian Registry of HUMIRA® (Adalimumab) in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis ( ProAct )

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

Total Enrollment

5940 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-13

Study Completion Date

2018-01-11

Brief Summary

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This is a five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA (adalimumab).

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Detailed Description

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Conditions

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Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with rheumatic disease

Patients suffering from rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with ongoing HUMIRA (adalimumab) treatment who have been prescribed HUMIRA (adalimumab) within local reimbursement guidelines.
* Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Exclusion Criteria

* Contraindications according to the summary of product characteristics.
* Patients who are actually followed in the ReAlise registry (M03-634 NCT00234884).

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No