Status:
COMPLETED
Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Ankylosing Spondylitis
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- Patients will be enrolled in this Postmarketing observational study PMOS if they fulfill all of the below criteria:
- Adult patients with diagnosis of Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA).
- Eligible for adalimumab therapy according to the local product label and prescription/reimbursement guidelines.
- Have been prescribed adalimumab within a maximum of one (1) month prior to the study enrolment.
- Have negative result of Tuberculosis (TB) screening test or TB prophylaxis as per local guidelines.
- 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.
Exclusion
- Patients fulfilling below exclusion criteria will not be eligible for this Postmarketing study (PMOS):
- 1\. Meet contraindications for treatment with adalimumab as outlined in the latest version of the local Summary of Product Characteristics (SmPC)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT01474876
Start Date
November 1 2011
End Date
May 1 2014
Last Update
July 8 2015
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