Status:
COMPLETED
A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis
Lead Sponsor:
Centocor, Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psorias...
Detailed Description
This is a randomized (the study medication is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel-group, multicenter study to dete...
Eligibility Criteria
Inclusion
- Have had a diagnosis of plaque-type psoriasis at least 6 months
- Plaque-type psoriasis covering at least 10% of total body surface areas
- Psoriasis area-and-severity index score of 12 or greater
- Considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
- Women of childbearing potential and all men must agree to use adequate birth control measures
- Have no history of latent or active tuberculosis
Exclusion
- Currently have nonplaque forms of psoriasis or drug-induced psoriasis
- Women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study
- Patients who 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
- Patients who 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
- Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence)
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00320216
Start Date
November 1 2003
End Date
March 1 2005
Last Update
April 20 2015
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