Psoriasis vulgaris
Conditions
Interventions
Patients with psoriasis vulgaris who wished to receive the addition of oral agent (apremilast) to the topical therapy will discontinue the biologics and administer the study drug (apremilast).
Sponsors
Ohtsuki Mamitaro
Miyachi Yoshiki
Non-Profit Organization Health Institute Research of Skin
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission maintenance period (the period from taking Apremilast until relapse) | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaire survey 1)Percentage of patients wishing to discontinue treatment with biological products (%) 2)Cross tabulation of the results of the questionnaire survey Remission maintenance therapy that adding study drug to topical therapy 1)The changes in the following index scores are evaluated by comparing the changes over time. (1) PASI (2) BSA (3) DLQI (4) ACR evaluation (TJC, SJC) *In the case of combined psoriatic arthritis (5) Enthesitis (6)HAQ-DI (7) PGA / sPGA (8) IGA (9) NAPSI (10) scPGA (11) PSSI 2) PASI score increase from baseline Compare and evaluate the rate of increase from baseline (PASI score before biologic administration) at weeks 4, 8, 12, 16, 20, and 24. 3) TSQM (treatment satisfaction survey) TSQM-9 Japanese version is used for evaluation. 4) Relationship between transition of serum LRG/CRP concentration and relapse Consider based on the relationship between serum LRG/CRP concentration and transition of symptoms. 5) Safety Confirm adverse events, diseases, etc. | — |
Contacts
Public ContactFumie Odagawa
EBC&M LLC.
Outcome results
None listed