Examination of the usefulness of apremilast

Not Applicable

• Conditions: Psoriasis vulgaris

• Registration Number: JPRN-jRCTs031200238
• Lead Sponsor: Ohtsuki Mamitaro

Brief Summary

Overall patient satisfaction with biological agents in the treatment of psoriasis was high, but dissatisfaction and concern existed regarding the cost of treatment, prolonged treatment period, and the limited number of medical institutions where treatment could be received. The 24-week remission maintenance rate was 63.6%, and the remission maintenance period was 20.97 + - 1.05 weeks when patients in remission maintenance with biological agents were switched to treatment with apremilast.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-11
• Study Completion: 2022-12-23
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

Questionnaire survey
1) Patients with psoriasis vulgaris who have been in remission for more than 6 months with biologics
*Remission : Patients with PASI<2, BSA<2, and DLQI = 0 or 1
*In the case of complication of the psoriatic arthritis, patients with SJC = 0, TJC = 0, and HAQ-DI less than or equal 0.5
2) Those who are 20 years of age or older at the time of registration
3) Those who gave consent to participate in the survey after explaining the content of this research

Remission maintenance therapy that adding study drug to topical therapy
1)Those who responded to the questionnaire survey and requested oral treatment to discontinue the biologics and add the study drug to the topical therapy as treatment during the remission maintenance period
2)Those who obtained written informed consent to participate in remission maintenance therapy after explaining the content of this study

Exclusion Criteria

Questionnaire survey
1) Those who have participated in other clinical research, clinical trials, etc. within the past 3 months
2)Others, which the investigator judges to be ineligible as a research subject

Remission maintenance therapy that adding study drug to topical therapy
1)Those with hypersensitivity to the ingredients of the drug under study (corresponding to contraindications for Otezura tablets)
2)Pregnant women or women who may be pregnant, women who wish to become pregnant during the study period
3)Lactating women
4)In addition, what the investigator determines to be ineligible as a research subject (eg, depression/suicidal thoughts Person)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission maintenance period (the period from taking Apremilast until relapse)