N/A
Completed N=789
EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries
Ankylosing Spondylitis (AS) · Psoriatic Arthritis (PsA · Rheumatoid Arthritis (RA
Source: ClinicalTrials.gov NCT01078402 ↗
Enrolled (actual)
789
Serious AEs
3.4%
Results posted
Feb 2013
Primary outcomePrimary: Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA — 56; 251; 78 participants
Summary
This is a non-interventional, post-marketing, observational study (PMOS) in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exists to characterize patient populations being prescribed Humira in Eastern Europe. Further, it is important to establish the clinical outcome and tolerability of Humira in Eastern European patients, as well as their compliance with Humira treatment, in particular the acceptability of self-injection, which may influence all of the above in routine clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA |
56; 251; 78 | — |
| PRIMARY Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS |
2; 12; 24; 138; 26; 66 | — |
| SECONDARY Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy |
1.8; 1.5; 1.3; 1.6; 1.3; 0.8 | — |
| SECONDARY Participant Acceptability of Self-injection at Month 13 (End of Study) |
86.2; 95.9; 92.3; 89.5; 7.2; 0.8 | — |
| SECONDARY Compliance With the Humira Administration Schedule at Month 13 (End of Study) |
403; 109; 210; 722; 11; 5 | — |
| SECONDARY Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy |
28.6; 29.7; 29.9; 29.2 | — |
| SECONDARY Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
78; 30; 36; 144; 18; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients with active RA, PsA or AS for whom Humira therapy is indicated according to the local product label and who meet the following criteria:
- Are newly prescribed Humira therapy (no prior history of treatment with Humira), including patients with infliximab or etanercept treatment history OR
- Completed Abbott sponsored interventional clinical trials and are continuing treatment with commercial Humira thereafter.
Exclusion Criteria
- Patients who are being treated or will be treated with drugs at risk of interactions with Humira (see Humira Summary of Product Characteristics)
- Patients currently participating in another clinical trial
- Patients with diagnosis of active tuberculosis
Data sourced from ClinicalTrials.gov (NCT01078402). 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.