Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)

Study Results

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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

4681 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2014-05-31

Brief Summary

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The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.

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Detailed Description

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This was a postmarketing observational study (PMOS) for participants with insufficiently controlled, moderate to severe, active AS who were eligible for adalimumab therapy. Participants started treatment with adalimumab under normal clinical settings in Germany. Enrolled participants were followed during adalimumab therapy . Participants were assessed during regular clinic visits for up to 24 months and 359 clinicians (rheumatologists/orthopedists/general practitioners/internist) participated in the study. Since this was an observational trial, not all doctors followed the stated age limitations and some participants under the age of 18 were enrolled.

Conditions

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Ankylosing Spondylitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ankylosing spondylitis

Participants with ankylosing spondylitis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Participants with active, AS for at least 4 weeks (BASDAI greater than or equal to 4).
2. Participants who failed treatment with two non-steroidal anti-inflammatory drugs (NSAIDs).
3. No contraindications for anti-tumor necrosis factors (TNF) therapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No