Status:
COMPLETED
A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis
Lead Sponsor:
Centocor Research & Development, Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.
Detailed Description
This is a randomized (patients are assigned to different treatments based on chance), double blind (neither the patient nor the physician knows whether medication or placebo \[an inactive substance th...
Eligibility Criteria
Inclusion
- Patients with plaque-type psoriasis diagnosed at least 6 months prior and covering at least 10% of total body surface areas
- Have psoriasis area-and-severity index score of \>=12
- Patients who are considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
- Have no history of latent or active TB
Exclusion
- Currently have nonplaque forms of psoriasis or drug-induced psoriasis
- Have any therapeutic agent targeted at reducing IL-12 or IL-23
- Have had a BCG vaccination within the previous 12 months
- Have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months
- Have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
- Patients known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C
- Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Patients with a malignancy or who have a history of malignancy (with the exception of certain skin cancers and pre-invasive cervical cancer)
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
766 Patients enrolled
Trial Details
Trial ID
NCT00267969
Start Date
December 1 2005
End Date
May 1 2011
Last Update
June 17 2013
Active Locations (42)
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1
Phoenix, Arizona, United States
2
Los Angeles, California, United States
3
Redwood City, California, United States
4
Santa Monica, California, United States