Clinical trial NCT01677598: A Study to Evaluate Ustekinumab in Patients With Plaque Psoriasis in Asia-Pacific Countries
Official title: A Study to Evaluate Ustekinumab in Clinical Practice in Patients With Plaque Psoriasis in Asia-Pacific Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: Plaque Psoriasis
Ustekinumab
CNTO 1275
Asia-Pacific
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-09-03
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at least 18 years of age with a diagnosis of plaque psoriasis, according to the dermatologists' clinical judgment

Brief summary: The purpose of this study is to determine how patients use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries.

Detailed description: This is an open-label (all people know the identity of the medication), multicenter, Phase 4, observational study (no study medication was administered during the study) designed to assess how patients will use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries. The study will consist of 4 study visits which will take place over the duration of 1 year. At the first visit (ie, Week 0), eligibility for the study will be determined (it will be screening and baseline visit). At each subsequent visit (Weeks 16, 28, and 52), exposure to ustekinumab will be recorded, questionnaires for efficacy will be completed, and information about adverse events and concomitant medications will be collected. As many patient reported outcome questionnaires as possible will be administered, depending on the availability of validated translations. Safety will be assessed by monitoring of adverse events, vital signs and physical examination.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of plaque psoriasis, according to the dermatologists' clinical judgment
* Agree to initiate treatment with ustekinumab on the same day as enrollment into the study
* Have not received anti-IL12/23 therapies within 6 months prior to enrollment into the study

Exclusion Criteria:

* Has difficulty understanding questions posed by any of the questionnaires
* Are currently participating in an investigational drug clinical study

Primary outcomes:
measure: Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval
timeFrame: up to 52 weeks
Secondary outcomes:
measure: Epidemiologic characteristics of the psoriasis population
timeFrame: Week 0
measure: Change from baseline (Week 0) in Psoriasis Area and Severity Index (PASI) score at Weeks 16, 28 and 52
timeFrame: Baseline (Week 0), Weeks 16, 28 and 52
measure: Change from baseline (Week 0) in Nail Psoriasis Severity Index (NAPSI) score at Weeks 16, 28, and 52
timeFrame: Baseline, Weeks 16, 28 and 52
measure: Change from baseline in EuroQol 5 Dimensional Questionnaire (EQ-5D) index score and EQ visual analog scale (VAS) at Weeks 16, 28, and 52
timeFrame: Baseline, Weeks 16, 28 and 52
measure: Change from baseline (Week 0) in Dermatology Life Quality Index (DLQI) score
timeFrame: Baseline, Weeks 16, 28 and 52
measure: Change from baseline (Week 0) in Patient Benefit Index (PBI) score at Weeks 16, 28, and 52
timeFrame: Baseline, Weeks 16, 28 and 52
measure: Number of patients achieving PASI 50, 75, and 90 response (ie, at least 50%, 75% and 90% improvement in PASI)
timeFrame: up to 52 weeks
measure: Number of patients achieving a DLQI improvement (reduction) of greater than or equal to 5 points
timeFrame: up to 52 weeks
measure: Number of patients achieving a score of 0 or 1 in DLQI
timeFrame: up to 52 weeks
measure: Number of patients achieving an improvement in PBI
timeFrame: up to 52 weeks
measure: Number of patients with comorbidities (obesity, hypertension, diabetes, dyslipidemia, and heart disease)
timeFrame: up to 52 weeks
measure: Health Economics/Medical Resource Utilization Questionnaire (HE/MRU)
timeFrame: up to 52 weeks
measure: Change from baseline in productivity VAS at Weeks 16, 28, and 52
timeFrame: Baseline, Weeks 16, 28 and 52
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
city: Incheon
country: Korea, Republic of
city: Seongnam-Si, Gyeonggi-Do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Johor Bahru
country: Malaysia
city: Pulau Pinang
country: Malaysia
city: Singapore
country: Singapore
city: Taipei
country: Taiwan
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: