A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)

ConditionPsoriasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to assess the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age

Physician-reported diagnosis of moderate to severe plaque psoriasis

Be newly initiating deucravacitinib

Do not object to participate

Disqualifiers

Currently participating in or planning to participate in an interventional clinical trial

Previous treatment experience with deucravacitinib, including patients who received deucravacitinib as part of a blinded, randomized trial

Trial population

Adult patients who have been diagnosed with moderate-to-severe plaque psoriasis and who intend to start deucravacitinib treatment in France

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Deucravacitinib

    Drug

    As prescribed by treating clinician

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: Participants that have initiated deucravacitinib treatment1 intervention

Trial outcomes

Primary outcomes

1

Physician's Global Assessment (PGA) 0/1 response

Time frame
Baseline and at months 4, 12, 18 (optional), and 24
2

Dermatology Life Quality Index (DLQI) 0/1 response

Time frame
Baseline and at months 4, 12, 18 (optional), and 24
3

Time from date of treatment initiation to date of discontinuation

Time frame
Up to 24 months

Secondary outcomes

1

Change in percentage involved Body Surface Area (BSA) from start of deucravacitinib treatment

Time frame
Baseline and at months 4, 12, 18 (optional), and 24
2

Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS) - Itch

Time frame
Baseline and months 1, 4, 12, 18 (optional) and 24
3

Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS) - Skin pain

Time frame
Baseline and months 1, 4, 12, 18 (optional) and 24
4

Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS)] - Fatigue

Time frame
Baseline and months 1, 4, 12, 18 (optional) and 24

Other outcomes

Sponsors and contacts

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