N/A
N=500
Greek Study of the Quality of Life in Patients With Psoriasis Treated With Adalimumab
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01077128 ↗Enrolled (actual)
500
Serious AEs
2.2%
Results posted
Feb 2014
Primary outcome: Primary: Mean Change of Dermatology Life Quality Index (DLQI) Scores — 4.9; 9.3; 11.3; 12.1 units 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
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change of Dermatology Life Quality Index (DLQI) Scores |
4.9; 9.3; 11.3; 12.1 | — |
| SECONDARY Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores |
66.2; 95.1; 97.5; 97.9 | — |
| SECONDARY Mean Change in the Dermatology Life Quality Index (DLQI) Score by Physician's Global Assessment of Disease Severity (PGA) Response Groups and by Geographical Region |
6.3; 9.6; 11.5; 12.3; 12.9; 14.9 | — |
| SECONDARY Percentage of Patients Reporting "No Problem" on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) |
74.6; 66.2; 90.2; 91.5; 90.8; 81.2 | — |
| SECONDARY Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores |
12.5; 25.9; 31.8; 35.9 | — |
| SECONDARY Assessment of Long Term Use and Safety of Adalimumab as Prescribed by the Dermatologist in a Normal Clinical Setting and in Accordance With the Terms of the European Marketing Authorization |
500 | — |
Summary
Primary objective
* To evaluate the quality of life of Adalimumab treated patients over a period of 12 months
Secondary objectives
* To evaluate the long-term efficacy of Adalimumab in patients with moderate to severe chronic plaque psoriasis as prescribed by the dermatologists in day-to-day clinical practice and in accordance with the terms of the European marketing authorization.
* To evaluate changes in patients quality of life according to treatment response over a 12-month period
* To observe and assess the long term use and safety of Adalimumab as prescribed by the dermatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization.
Eligibility Criteria
Inclusion Criteria
- Patients with moderate to severe chronic plaque psoriasis who are newly prescribed Humira (adalimumab) therapy (have never been treated with adalimumab before) and for whom the treating physician has made the decision that they are eligible for treatment with adalimumab in accordance with the terms of the local marketing authorization
- Patients with moderate to severe chronic plaque psoriasis for whom Adalimumab is indicated and has been prescribed according to the current approved local SPC as long as the first administration of adalimumab is not older than two months and they have not had dose interruptions since the initiation of adalimumab, and the Investigator can provide all the needed source documentation including a completed DLQI questionnaire at the start of Adalimumab treatment.
- Patient age ≥ 18
- Patient is willing to consent to data being collected and provided to Abbott
Exclusion Criteria
- Patients who meet contraindications as outlined in the latest version of the local approved SPC
- Patients who participate in another clinical/observational study
- Patients who are not willing to sign an Informed Consent Form
Data sourced from ClinicalTrials.gov (NCT01077128). 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.