EUCTR2009-012265-60-HU
Active, not recruiting
Not Applicable
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis Including Those Previously Treated with Biologic Anti-TNFa Agent(s) - PSUMMIT II
Centocor B.V.0 sites300 target enrollmentDecember 21, 2010
DrugsStelara
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Centocor B.V.
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men or women between 18 and 99 years of age, inclusive.
- •Have had PsA at least 6 months prior to the first administration of study agent.
- •Have a diagnosis of active PsA as defined by:
- •– 5 or more swollen joints and 5 or more tender joints at screening and at
- •– C\-reactive protein (CRP) \= 0\.3 mg/dL at screening.
- •Have at least 1 of the PsA subsets:
- •Have active plaque psoriasis or a documented history of plaque psoriasis.
- •Have active PsA despite current or previous DMARD and/or NSAID therapy.
- •Subjects previously treated with a biologic anti\- TNFa agent, must have:
- •– received at least an 8\-week dosage regimen of
Exclusion Criteria
- •Have other inflammatory diseases that might confound the evaluations of benefit of
- •ustekinumab therapy,
- •Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in
- •the study or within 15 weeks after receiving the last administration of study agent.
- •Have used any therapeutic agent targeted at reducing IL\-12 or IL\-23
- •Have used any investigational drug within the previous 4 weeks or 5 times the t1/2 of the investigational agent, whichever is longer.
- •Have received infliximab, golimumab, or certolizumab pegol within 12 weeks prior
- •to the first administration of the study agent.
- •Have received adalimumab or etanercept within 8 weeks prior to the first
- •administration of the study agent.
Outcomes
Primary Outcomes
Not specified
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