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A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01008995
First received: November 5, 2009
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Psoriasis
 Drug: placebo
Drug: ustekinumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Chinese Subjects With Moderate to Severe Plaque-type Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
Drug Information available for: Ustekinumab
U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Scores could range from 0 (mild) to 72 (severe).


Secondary Outcome Measures:
  • The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Scores could range from 0 to 30. A lower DLQI score represents better quality of life.


Enrollment: 322
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
placebo Subcutaneous injection at Week 0 and 4,ustekinumab 45 mg subcutaneous injection at Week 12 and 16
 Drug: placebo
Subcutaneous injection at Week 0 and 4
Drug: ustekinumab
45 mg subcutaneous injection at Week 12 and 16
Experimental: 002
placebo Subcutaneous injection at Week 12,ustekinumab 45 mg subcutaneous injection at Week 0 4 and 16
 Drug: placebo
Subcutaneous injection at Week 12
Drug: ustekinumab
45 mg subcutaneous injection at Week 0, 4 and 16

Detailed Description:

In this study, 220 patients will be divided into two groups randomly (by chance), like flipping a coin. Each group will receive a different treatment. The results for each group are compared to each other. There are 2 treatment groups in this study, Group 1 and Group 2. Group 1 will receive placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. Group 2 will receive ustekinumab 45 mg at Weeks 0, 4, and 16 and placebo at Week 12. All patients in the study will eventually receive ustekinumab after Week 12. The patients will be in the study for about 36 weeks, with study visit approximately 10 times. Effectiveness evaluations will be conducted throughout the study and include the Psoriasis Area and Severity Index (PASI), Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI). Safety assessments will also be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure) and the occurrence and severity of adverse events. GROUP 1: Placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. GROUP 2: Ustekinumab 45 mg at Weeks 0, 4, and 16. Placebo at Week 12

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008995

Locations
China
Beijing, China
Chongqing, China
Dalian, China
Guangzhou, China
Hangzhou, China
Nanjing, China
Shanghai, China
Shenyang, China
Xi'An, China
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT01008995     History of Changes
Other Study ID Numbers: CR016318, C0743T23, CR016318
Study First Received: November 5, 2009
Results First Received: August 15, 2012
Last Updated: August 15, 2012
Health Authority: China: Ministry of Health
China: Food and Drug Administration

Keywords provided by Centocor, Inc.:
psoriasis
asian patients
Chinese
 ustekinumab
CNTO 1275
Stelara

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013