Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

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

566 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-05-31

Brief Summary

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This 12-month postmarketing observational study (PMOS) was a prospective, single-arm, multicenter, multi-country study, with follow-up visits at 3, 6, 9, and 12 months after the initial baseline visit. The study was conducted to determine the long-term effectiveness of treatment with adalimumab in routine clinical use in participants with Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries.

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Detailed Description

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Additional study objectives were to evaluate AS and PsA with regard to extra-articular manifestations (EAMs), functional status, the use of concomitant nonsteroidal anti-inflammatory medication, and work productivity impairment. In addition, the Ankylosing Spondylitis Disease Activity Score (ASDAS), a new disease activity index in AS, was measured in parallel with the standard Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to assess the effectiveness of adalimumab in treating axial symptoms.

Conditions

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Ankylosing Spondylitis Psoriatic Arthritis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Ankylosing Spondylitis

Participants with a diagnosis of ankylosing spondylitis

No interventions assigned to this group

Psoriatic Arthritis

Participants with a diagnosis of psoriatic arthritis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Patients will be enrolled in this Postmarketing observational study PMOS if they fulfill all of the below criteria:

1. Adult patients with diagnosis of Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA).
2. Eligible for adalimumab therapy according to the local product label and prescription/reimbursement guidelines.
3. Have been prescribed adalimumab within a maximum of one (1) month prior to the study enrolment.
4. Have negative result of Tuberculosis (TB) screening test or TB prophylaxis as per local guidelines.
5. Are willing to provide Authorization to the investigator to use and/or disclose personal and/or health data, or to provide Informed Consent if requested by the Local Regulations, before entry into the study.