NCT01008995

Brief Summary

The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of ustekinumab in the treatment of patients with moderate to severe psoriasis in China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
322

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

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

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 14, 2012

Completed
Last Updated

November 11, 2013

Status Verified

October 1, 2013

Enrollment Period

1.7 years

First QC Date

November 5, 2009

Results QC Date

August 15, 2012

Last Update Submit

October 17, 2013

Conditions

Psoriasis

Keywords

psoriasisasian patientsChineseustekinumabCNTO 1275Stelara

Outcome Measures

Primary Outcomes (1)

  • The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12.

    Scores could range from 0 (mild) to 72 (severe).

    Baseline (Week 0) to Week 12

Secondary Outcomes (2)

  • The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12

    Week 12

  • The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12.

    Baseline (Week 0) to Week 12

Study Arms (2)

001

EXPERIMENTAL

placebo Subcutaneous injection at Week 0 and 4,ustekinumab 45 mg subcutaneous injection at Week 12 and 16

Drug: placeboDrug: ustekinumab

002

EXPERIMENTAL

placebo Subcutaneous injection at Week 12,ustekinumab 45 mg subcutaneous injection at Week 0 4 and 16

Drug: placeboDrug: ustekinumab

Interventions

placeboDRUG

Subcutaneous injection at Week 0 and 4

001
ustekinumabDRUG

45 mg subcutaneous injection at Week 12 and 16

001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be of Chinese ancestry
  • Have had a diagnosis of plaque-type psoriasis at least 6 months prior to study start
  • Have plaque-type psoriasis covering at least 10% of total BSA at screening and at the time of study start
  • Have a Psoriasis Area and Severity Index (PASI) score of 12 or greater at study start
  • Must be candidates for phototherapy or systemic treatment of psoriasis (either naive or history of previous treatment)

You may not qualify if:

  • Currently have nonplaque forms of psoriasis
  • Have current drug-induced psoriasis
  • Have used any investigational drug within the previous 4 weeks
  • Have used any biologic within the previous 3 months
  • Be known to be infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Beijing, China

Location

Unknown Facility

Chongqing, China

Location

Unknown Facility

Dalian, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Shenyang, China

Location

Unknown Facility

Xi'an, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Director, Clinical Research
Organization
Janssen R&D US
1 215-793-7646

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 6, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 11, 2013

Results First Posted

September 14, 2012

Record last verified: 2013-10

Locations

CN(9)