NCT01677598

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Geographic Reach
5 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2013

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

August 30, 2012

Last Update Submit

October 24, 2024

Conditions

Plaque Psoriasis

Keywords

Plaque PsoriasisUstekinumabCNTO 1275Asia-Pacific

Outcome Measures

Primary Outcomes (1)

  • Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval

    Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval will be assessed at Weeks 0, 16, 28, 52.

    up to 52 weeks

Secondary Outcomes (13)

  • Epidemiologic characteristics of the psoriasis population

    Week 0

  • Change from baseline (Week 0) in Psoriasis Area and Severity Index (PASI) score at Weeks 16, 28 and 52

    Baseline (Week 0), Weeks 16, 28 and 52

  • Change from baseline (Week 0) in Nail Psoriasis Severity Index (NAPSI) score at Weeks 16, 28, and 52

    Baseline, Weeks 16, 28 and 52

  • Change from baseline in EuroQol 5 Dimensional Questionnaire (EQ-5D) index score and EQ visual analog scale (VAS) at Weeks 16, 28, and 52

    Baseline, Weeks 16, 28 and 52

  • Change from baseline (Week 0) in Dermatology Life Quality Index (DLQI) score

    Baseline, Weeks 16, 28 and 52

  • +8 more secondary outcomes

Study Arms (1)

Patients with plaque psoriasis

Patients with plaque psoriasis using ustekinumab in Asia-Pacific countries.

Drug: No intervention

Interventions

No interventionDRUG

No intervention will be administered during study. This will be an observational study in patients using ustekinumab as label-recommended or other/missed dose interval in Asia-Pacific countries

Also known as: CNTO 1275
Patients with plaque psoriasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at least 18 years of age with a diagnosis of plaque psoriasis, according to the dermatologists' clinical judgment

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Jakarta Pusat, Indonesia

Location

Unknown Facility

Johor Bahru, Malaysia

Location

Unknown Facility

Pulau Pinang, Malaysia

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Seongnam-Si, Gyeonggi-Do, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Suwon, South Korea

Location

Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 3, 2012

Study Start

December 2, 2011

Primary Completion

November 30, 2013

Study Completion

November 30, 2013

Last Updated

October 28, 2024

Record last verified: 2024-10

Locations

MY(2)KR(4)SG(1)ID(1)TW(1)