N/A
Completed N=103
A Study of Effectiveness and Safety of Tumor Necrosis Factor (TNF) Inhibitors in Patients With Moderate to Severe Psoriasis
Source: ClinicalTrials.gov NCT01126619 ↗Enrolled (actual)
103
Serious AEs
2.9%
Results posted
Oct 2012
Primary outcomePrimary: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score — 48.65; 75.70; 87.85; 90.29 Percent change
Summary
In recent years, biologics have changed the treatment of psoriasis, giving us additional therapeutic options that are potentially less toxic to the liver, kidneys, and bone marrow and are not teratogenic. Nevertheless, traditional systemic therapies continue to play an important role in the treatment of psoriasis in Turkey, even in patients who are requiring biologic treatments according to national recommendations. This study is designated to observe the effectiveness and safety of tumor necrosis factor inhibitors in patients with moderate to severe psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score |
48.65; 75.70; 87.85; 90.29 | — |
| PRIMARY Percentage of Participants With 75% Reduction in PASI Score |
31.4; 51.2; 67.4; 70.9 | — |
| SECONDARY Dynamic Physician Global Assessment (PGA) of Change in Psoriasis |
1.51 | — |
| SECONDARY Dynamic Patient Global Assessment (PGA) of Change in Psoriasis |
1.51 | — |
| SECONDARY Static Physician Global Assessment (PGA) of Psoriasis |
0; 14; 0; 38; 0; 19 | — |
| SECONDARY Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score |
53.13; 66.40; 73.98; 65.72 | — |
| SECONDARY Percent Change From Baseline in Work Productivity and Activity Impairment |
96; 72; 75; 72 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
28; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients ≥18 years old with moderate-to-severe psoriasis.
- Patients for whom the physician has decided to initiate psoriasis treatment with anti-TNFs in accordance with Turkish Ministry of Health regulations and reimbursements.
- Patients who are able to understand and answer a self administered questionnaire.
- Patients signed an informed consent form stating that they agreed to have their photographs taken, analyzed, and included in a scientific publication.
Exclusion Criteria
- Patients who do not consent to being photographed during the study.
- Females who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study.
- Patients with untreated tuberculosis.
Data sourced from ClinicalTrials.gov (NCT01126619). 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.