N/A
Completed N=555
Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis
Source: ClinicalTrials.gov NCT01474876 ↗Enrolled (actual)
555
Serious AEs
4.7%
Results posted
Jul 2015
Primary outcomePrimary: Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline — 76.5; 73.1 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline |
76.5; 73.1 | — |
| PRIMARY Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline |
83.3; 83.6 | — |
| PRIMARY Percentage of Participants With Active Axial Symptoms in Remission |
34.3; 28.8 | — |
| PRIMARY Percentage of Participants With Peripheral Symptoms in Remission |
11.1; 14.8 | — |
| SECONDARY 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 |
-4.6; -1.9 | — |
| SECONDARY Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) |
-2.6; -1.9; -2.3; -1.9 | — |
| SECONDARY Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis |
0.62; 0.71 | — |
| SECONDARY Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis |
0.98; 2.47; 1.18; 0.96; 0.57; 1.77 | 0.0164 sig |
| SECONDARY 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 |
-0.9; -4.1 | — |
| SECONDARY Mean Frequency of Extra-articular Manifestations (EAMs) |
0.5; 1.1; 0.2; 0.6; 0.1; 0.5 | — |
| SECONDARY Duration of Treatment With Adalimumab |
11.8; 11.6; 4.8; 5.0 | — |
| SECONDARY Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study |
96.6; 94.9 | — |
| SECONDARY Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis |
-9.7; -37.3; -38.6; -36.5 | — |
| SECONDARY Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work |
56.6; 56.1 | — |
| SECONDARY 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 |
-4.2; -2.4 | — |
| SECONDARY Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis |
0.75; 0.84 | — |
| SECONDARY Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis |
0.23; 1.35; 0.21; 0.87 | 0.0576 |
| SECONDARY 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 |
-0.7; -3.8 | — |
| SECONDARY Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis |
-6.0; -32.8; -33.6; -34.7 | — |
| SECONDARY Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work |
55.6; 54.3 | — |
Eligibility Criteria
Inclusion Criteria
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 Criteria
Patients fulfilling below exclusion criteria will not be eligible for this Postmarketing study (PMOS):
- Meet contraindications for treatment with adalimumab as outlined in the latest version of the local Summary of Product Characteristics (SmPC)
Data sourced from ClinicalTrials.gov (NCT01474876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.