Trial · NCT04340076
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Non-inferiority of the incidence proportion of persistent flares (Psoriasis Area and Severity Index (PASI) >5 for ≥ 3 months). | 18 months | |
| Secondary | Whether participants will have successful DR after 12 and 18 months, defined as using a lower dose than the normal dose and PASI ≤ 5. | 18 months | Definition of successful dose reduction: lower dose than the normal dose and PASI≤ 5. |
| Secondary | Psoriasis disease activity, measured with the Psoriasis Area and Severity Index (PASI) at each 3-monthly study visit. | 18 months | |
| Secondary | Dermatology-related quality of life as measured with the Dermatology Life Quality Index (DLQI) at each 3-montly study visit. | 18 months | |
| Secondary | Whether participants will have short disease flares throughout the study period (18 months), defined as a PASI > 5 at one time point. | 18 months | |
| Secondary | Whether other anti-psoriatic medication will be initiated in participants during the study period (18 months). | 18 months | |
| Secondary | Whether participants will have serious adverse events (SAE) and adverse events of special interest (AEoSI) during the study period. | 18 months | AEoSI include, but are not limited to, infections, malignancies, and joint complaints or new-onset psoriatic arthritis. |
| Secondary | Drug trough levels of each included drug, measured in blood serum samples which will be collected from participants at each 3-montly time point. | 18 months | |
| Secondary | Anti-drug antibody levels of each included drug, measured in blood serum samples which will be collected from participants at each 3-montly time point. | 18 months | |
| Secondary | Utilities, derived from EuroQoL 5 Dimensions (EQ-5D-5L) questionnaires, which will be measured at each 3-montly time point. | 18 months | Utility scores will be used to calculate quality adjusted life years (QALYs) which are used to determine cost-effectiveness of DR. |
| Secondary | Health status of participants, assessed by using the Short Form 36 (SF-36) version 2 questionnaire at every 3-monthly time point. | 18 months | |
| Secondary | Volumes of care, as measured with the iMTA Medical Consumption Questionnaire (MCQ) at each 3-monthly time point. Scores will be used to calculate direct medicals costs and non-medical costs. | 18 months | |
| Secondary | Loss of productivity and presenteeism of participants, as measured with the iMTA Productivity Cost Questionnaire (PCQ) at each 3-monthly time point. Scores will be used to calculate direct medicals costs and non-medical costs. | 18 months |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04340076/registered