A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis
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.
|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|
- 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: Baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]Scores could range from 0 (mild) to 72 (severe).
- 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: Baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]Scores could range from 0 to 30. A lower DLQI score represents better quality of life.
|Study Start Date:||October 2009|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
placebo Subcutaneous injection at Week 0 and 4,ustekinumab 45 mg subcutaneous injection at Week 12 and 16
Subcutaneous injection at Week 0 and 4Drug: ustekinumab
45 mg subcutaneous injection at Week 12 and 16
placebo Subcutaneous injection at Week 12,ustekinumab 45 mg subcutaneous injection at Week 0 4 and 16
Subcutaneous injection at Week 12Drug: ustekinumab
45 mg subcutaneous injection at Week 0, 4 and 16
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008995
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|