N/A
N=4,635
Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis in Normal Medical Practice
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01111240 ↗Enrolled (actual)
4,635
Serious AEs
3.1%
Results posted
Dec 2014
Primary outcome: Primary: Mean Change From Baseline in Disease Activity Score (DAS)28 — -1.7; -1.9; -1.9; -2.0 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Disease Activity Score (DAS)28 |
-1.7; -1.9; -1.9; -2.0; -2.0; -2.1 | — |
| PRIMARY Mean Tender Joint Count (TJC) Over Time |
15.0; 7.5; 6.1; 5.5; 5.2; 5.2 | — |
| PRIMARY Mean Swollen Joint Count (SJC) Over Time |
8.3; 3.0; 2.4; 2.0; 1.9; 1.8 | — |
| PRIMARY Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time |
8.9; 6.4; 5.1; 4.6; 4.2; 4.1 | — |
| PRIMARY Mean Target Lesion Score (TLS) Over Time |
6.1; 3.2; 2.7; 2.4; 2.3; 2.2 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) |
877; 143 | — |
| SECONDARY Number of Participants by Severity of Enthesitis Over Time |
422; 407; 119; 286; 130; 31 | — |
| SECONDARY Number of Participants by Severity of Dactylitis Over Time |
452; 765; 352; 420; 228; 42 | — |
| SECONDARY Number of Participants by Severity of Nail Psoriasis Levels Over Time |
843; 771; 305; 996; 446; 99 | — |
| SECONDARY Mean Erythrocyte Sedimentation Rate (ESR) Over Time |
23.3; 14.3; 14.2; 14.3; 14.5; 14.5 | — |
| SECONDARY Mean C-Reactive Protein (CRP) Levels Over Time |
12.8; 6.2; 5.9; 5.6; 6.0; 5.4 | — |
| SECONDARY Patients Global Assessment of Disease Activity Over Time |
6.8; 3.9; 3.4; 3.2; 3.1; 3.1 | — |
| SECONDARY Participants Assessment of Fatigue Over Time |
5.5; 4.1; 3.9; 3.7; 3.6; 3.6 | — |
| SECONDARY Participants Assessment of Pain Over Time |
6.1; 4.0; 3.7; 3.6; 3.5; 3.5 | — |
| SECONDARY Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time |
69.6; 76.3; 77.3; 78.3; 78.7; 79.1 | — |
| SECONDARY Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit |
29.3; 28.2; 21.7; 20.9; 49.0; 28.4 | — |
| SECONDARY Mean Number of Days Missed From Work Due to Psoriatic Arthritis |
22.6; 5.1; 3.8; 3.0; 2.5; 3.4 | — |
| SECONDARY Percentage of Participants With In-Patient Hospitalization |
17.7; 12.0; 9.1; 7.0; 4.8; 3.8 | — |
| SECONDARY Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication |
43.7; 43.2; 42.7; 2.4; 1.4; 0.9 | — |
Summary
This study is a documentation of effectiveness and safety of Humira in patients with psoriatic arthritis.
Eligibility Criteria
Inclusion:
- 18 years of age or older (younger patients may be enrolled at the discretion of physician)
- Diagnosis of Psoriatic Arthritis (or any indication at the discretion of physician) and initiating adalimumab therapy
- Signed/dated Informed Consent
Exclusion:
-None
Data sourced from ClinicalTrials.gov (NCT01111240). 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.