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

AbbVie

Status: Completed

Conditions: Psoriatic Arthritis; Ankylosing Spondylitis

Study type: Observational

Funder types: Industry

Identifiers

NCT01474876

P12-768

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 566 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

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)

Trial design

566 participants in 2 patient groups

Ankylosing Spondylitis

Description:

Participants with a diagnosis of ankylosing spondylitis

Psoriatic Arthritis

Description:

Participants with a diagnosis of psoriatic arthritis