Clinical trial NCT01474876: Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis
Official title: Multicountry Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis and Psoriatic Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Psoriatic Arthritis
Keywords: Post-marketing observational study (PMOS) Protocol
Effectiveness of Adalimumab (HUMIRA®)
Psoriatic Arthritis
Ankylosing Spondylitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a post-marketing observational study (PMOS) where adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. Study population will consist of adult aged (\>18 years) with Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) that can be administered adalimumab as per locally approved Summary of Product Characteristics (SmPC) and reimbursement criteria.

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. 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.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline
timeFrame: Baseline (Visit 0) to 12 months
measure: Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline
timeFrame: Baseline (Visit 0) to 12 months
measure: Percentage of Participants With Active Axial Symptoms in Remission
timeFrame: Baseline (Visit 0) to 12 months
measure: Percentage of Participants With Peripheral Symptoms in Remission
timeFrame: Baseline (Visit 0) to 12 months
Secondary outcomes:
measure: Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis
timeFrame: Baseline (Visit 0) to 12 months
measure: Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Baseline (Visit 0) to 12 months
measure: Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis
timeFrame: Baseline (Visit 0) to 12 months
measure: Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis
timeFrame: Baseline (Visit 0) to 12 months
measure: Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis
timeFrame: Baseline (Visit 0) to 12 months
measure: Mean Frequency of Extra-articular Manifestations (EAMs)
timeFrame: Baseline (Visit 0) to 12 months
measure: Duration of Treatment With Adalimumab
timeFrame: Baseline (Visit 0) to 12 months
measure: Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study
timeFrame: Baseline (Visit 0) to 12 months
measure: Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis
timeFrame: Baseline (Visit 0) to 12 months
measure: Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work
timeFrame: Baseline (Visit 0) to 12 months
measure: Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis
timeFrame: Baseline (Visit 0) to 12 months
measure: Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis
timeFrame: Baseline (Visit 0) to 12 months
measure: Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis
timeFrame: Baseline (Visit 0) to 12 months
measure: Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis
timeFrame: Baseline (Visit 0) to 12 months
measure: Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis
timeFrame: Baseline (Visit 0) to 12 months
measure: Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work
timeFrame: Baseline (Visit 0) to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Isidro Villanueva Torrecillas, MD
role: STUDY_DIRECTOR
References: