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The purpose of this observational study is to describe the effectiveness of deucravacitinib treatment and quality of life in adults with moderate-to-severe plaque psoriasis in routine clinical practice in Germany over a 5-year period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-to-severe plaque psoriasis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | Non-interventional observational study of patients receiving treatment with commercially available deucravacitinib 6 mg once daily according to the Summary of Product Characteristics |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 at Week 24 or nearest visit | Approximately 24 weeks after treatment initiation (data to be collected at visit nearest to this timepoint) |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of deucravacitinib treatment measured by the number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 and ≤ 6 | 5 years | |
| Effectiveness of deucravacitinib treatment measured by the number of participants who achieve Psoriasis Area Severity Index (PASI) 75/90/100 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with moderate-to-severe plaque psoriasis in Germany
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologische Spezial- und Schwerpunktpraxis Selters | Selters | Rhineland-Palatinate | Germany | |||
| Local Institution - 0001 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| 5 years |
| Effectiveness of deucravacitinib treatment measured by the number of participants who achieved static Physician's Global Assessment (sPGA) 0/1 and change in sPGA over time | 5 years |
| Effectiveness of deucravacitinib treatment measured by body surface area (BSA) affected by psoriasis and changes in BSA from baseline and over time | 5 years |
| Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the genital area | 5 years |
| Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the intertriginous areas | Including but not limited to axilla, popliteal fossa, inguinal, genital, submammary, anal region | 5 years |
| Effectiveness of deucravacitinib treatment in sensitive body areas measured by palmoplantar psoriasis Physician's Global Assessment (pp-PGA) for the palmoplantar area | 5 years |
| Effectiveness of deucravacitinib treatment in sensitive body areas measured by target Nail Psoriasis Severity Index (NAPSI) for the nails | 5 years |
| Effectiveness of deucravacitinib treatment in sensitive body areas measured by scalp-specific Physician's Global Assessment (ss-PGA) for the scalp | 5 years |
| Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)-9 | 5 years |
| Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the persistence of deucravacitinib therapy | Time from therapy initiation until discontinuation visualized using Kaplan-Meier methods | 5 years |
| Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by reasons for therapy discontinuation | Discontinuation of deucravacitinib defined as a treatment interruption of >90 days with or without resumption of deucravacitinib treatment, with or without start of a follow-up therapy | 5 years |
| Patient-reported outcomes measured by the Dermatology Life Quality Index (DLQI) | 5 years |
| Patient-reported outcomes evaluating pruritus measured by the Itch Numeric Rating Scale (NRS) | 5 years |
| Patient-reported outcomes measured by the Patient Benefit Index standard version (PBI-S) | 5 years |
| Selters |
| 56242 |
| Germany |