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

Sponsor
Centocor, Inc.
Study ID
NCT01008995
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 31, 2009
Status verified
Oct 2013
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

Enrollment
322 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 001
    placebo Subcutaneous injection at Week 0 and 4,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

Primary Outcome Measure

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 ]

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