N/A
Completed N=183
The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Source: ClinicalTrials.gov NCT02570750 ↗Enrolled (actual)
183
Serious AEs
3.1%
Results posted
Dec 2018
Primary outcomePrimary: Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 — 23.1; 23.4; 16.5; 17.1 units on a scale
Summary
The main purpose of this study is to assess the effect of smoking status on the success of Etanercept therapy in patients with moderate-to-severe psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 |
23.1; 23.4; 16.5; 17.1 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) |
22.0; 21.7; 12.3; 12.8; 16.4; 16.8 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 |
9.3; 4.4; 45.8; 44.1 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24 |
77.0; 82.3; 97.9; 98.5 | — |
| SECONDARY Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12 |
12.6; 12.8 | — |
| SECONDARY Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants |
24.2; 23.9; 12.2; 12.1; 17.1; 16.8 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients aged ≥18 years at the time of screening
- Clinical diagnosis of chronic plaque type psoriasis for at least 6 months as determined by the subjects medical history, and confirmation of the diagnosis through physical examination by the investigator
- Patients who are scheduled by their dermatologist to initiate treatment with Etanercept prescribed independently by the investigator as per local clinical practice guideline
- Stable plaque psoriasis for at least 2 months prior to Baseline
- Diagnosis of severe psoriasis defined as PASI > 10
- Eligible for Etanercept treatment according to Summary of Product Characteristics (SmPC)
- Smokers with smoking >10 cigarettes daily for smokers group (Group 1) or non-smokers for non-smoking group (Group 2)
- Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study
Exclusion Criteria
- Previous or current treatment with antipsoriatic biologic drugs, such as Etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab.
- Exclusion Criteria according to the Enbrel® SmPC, with particular attention to: hypersensitivity to the active substance (etanercept) or to any of the excipients; sepsis or risk of sepsis, active infections, including chronic or localised infections.
- Positive pregnancy test, breast feeding or considering becoming pregnant during the study
- Clinically significant drug or alcohol abuse
Data sourced from ClinicalTrials.gov (NCT02570750). 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.