Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT02652494
Brief Summary:
This is a multicenter, prospective, non-interventional, observational single arm study.
Two-hundred patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the SPC of apremilast (Otezla®). Recruitment will continue until 200 patients have entered the study. Each patient will be followed for 12 months.
Detailed Description:
Baseline Demographics, disease characteristics and medication history prior to start of treatment with apremilast will be collected. Patients will be asked to complete baseline DLQI, SF36, EQ5D, TSQM,WPAI and PBI questionnaires. Photographs of the finger nails will be taken.
Follow-up visits Follow-up assessments will take place at the regularly scheduled outpatient visits at 6 and 12 months (+/- 1 month) after initiation of apremilast.
* Skin-specific disease measures (Psoriasis Activity and Severity Index (PASI), (static) Physician Global Assessment (sPGA), Body Surface Area (BSA))
* Patients will be asked to complete the following questionnaires:
* DLQI
* TSQM
* EQ5D
* SF36- Itch Visual Analog Scale (VAS)
* WPAI Work Productivity and Activity Index
* Patient Benefit Index PBI
End of treatment Upon discontinuation of treatment with apremilast, the date, the dose and reason for discontinuation will be documented.
AE monitoring All patients will be monitored for adverse events throughout the study.
From the time of the patient signing informed consent until treatment with apremilast is permanently abrogated, all non-serious adverse events that are considered related to apremilast and all Serious Adverse Events (SAEs) regardless of causality will be reported.
Study:
NCT02652494
Study Brief:
Protocol Section:
NCT02652494