Registry of Psoriasis Health Outcomes: A Longitudinal Real-world Collaboration (RePhlect) - A Real-World, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan
| Registry | NCT06382987, acronym RePhlect |
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 600 (Estimated) |
| Sponsor | Bristol-Myers Squibb (Industry) |
| Conditions | Plaque Psoriasis |
| Interventions | Deucravacitinib, Apremilast (Drug) |
| Dates | start 2024-01-22, primary completion 2029-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2024-04-25, last updated 2024-04-25 |
| Locations | 2 sites in Japan |
Related Papers Related Patents Related Grants Related Experts
All trials for Plaque Psoriasis All trials of Deucravacitinib All trials of Apremilast
-Summary
This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Participants that have initiated deucravacitinib treatment | | Drug: Deucravacitinib | |
| Participants that have initiated apremilast treatment | | Drug: Apremilast | |
- Deucravacitinib (Drug): According to the product label
- Apremilast (Drug): According to the product label
+Outcome measures
Primary outcomes
- Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib. [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) [1 month, 3 months, 6 months and every 6 months up to 5 years]
Secondary outcomes
- Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
- Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up [1 month, 3 months, 6 months and every 6 months up to 5 years]
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Japanese adult participants aged 18 years old or older
* Physician-reported diagnosis of plaque psoriasis
* Newly initiating deucravacitinib or apremilast according to the label
* Participants who have signed informed consent
Exclusion Criteria:
* Participants currently participating in or planning to participate in an interventional clinical trial
* Patients enrolled in deucravacitinib post-marketing surveillance study (ClinicalTrial.gov ID: NCT05633264)
* Previous treatment experience with the treatment of interest (e.g. patients who have history of apremilast will not be eligible to be enrolled in apremilast arm of the study and similar for deucravacitinib)
+Locations (2)
| Facility | City | Country | Status |
|---|
| Mebix. Inc. | Minato-ku, Tokyo | Japan | Recruiting |
| Fukuoka University Hospital | Fukuoka | Japan | Recruiting |
+Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb