A Phase 3 Multicenter, Randomized, Double-blind, Placebo controlled trial ofUstekinumab, a Fully Human anti-IL 12/23p40 Monoclonal Antibody, AdministeredSubcutaneously, in Subjects with Active Psoriatic Arthritis. - PSUMMIT I
- Conditions
- Psoriatic ArthritisMedDRA version: 12.0Level: LLTClassification code 10037160Term: Psoriatic arthritis
- Registration Number
- EUCTR2009-012264-14-LV
- Lead Sponsor
- Janssen Biologics B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• 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 baseline
-AND- C-reactive protein (CRP) = 0.3 mg/dL at screening.
• Have at least 1 of the PsA subsets: DIP joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
• Have active plaque psoriasis or a documented history of plaque psoriasis.
• Have active PsA despite current or previous DMARD and/or NSAID therapy.
DMARD therapy is defined as taking a DMARD for at least 3 months, or evidence of
DMARD intolerance. NSAID therapy is defined as taking an NSAID for at least 4
weeks or evidence of NSAID intolerance.
• Women must be:
– surgically sterile, or
– abstinent (at the discretion of the investigator/per local regulations), or
– if sexually active, be practicing a highly effective method of birth control as local
regulations permit, before entry, and must agree to continue to use the same
method of contraception throughout the study.
• Women of childbearing potential must have a negative serum ß-human chorionic
gonadotropin (ß-hCG) pregnancy test at screening; and a negative urine pregnancy
test at Week 0.
• Men capable of fathering children must agree to use a double barrier method of birth control (or must have been surgically sterilized) and to not donate
sperm during the study and for 15 weeks after receiving the last dose of study drug.
• Are considered eligible according to the following tuberculosis (TB) screening
criteria:
– Have no history of latent or active TB prior to screening.
– Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination.
– Have had no recent close contact with a person with active TB or, if there has
been such contact, will be referred to a physician specializing in TB to undergo
additional evaluation and, if warranted, receive appropriate treatment for latent
TB prior to or simultaneously with the first administration of study agent.
– Within 6 weeks prior to the first administration of study agent, have a negative
QuantiFERON-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent.
– Have a chest radiograph taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB
• If using MTX, subjects should have started treatment at a dose not to exceed
25 mg/week at least 3 months prior to the first administration of study agent and
should have no serious toxic side effects attributable to MTX. MTX route of
administration and doses should be stable for at least 4 weeks prior to the first administration of study agent. If currently not using MTX, must have not received MTX for at least 4 weeks prior to the first administration of the study agent.
• If using NSAIDs or other analgesics for PsA, must be on a stable dose for at least 2
weeks prior to the first administration of study agent. If c
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 used any biologic agents that are targeted for reducing TNFa, including but not limited to infliximab, etanercept, adalimumab, golimumab, and certolizumab pegol.
• Have received natalizumab, efalizumab, or agents that deplete B or T cells within 12 months of screening, or, if after receiving these agents, evidence is available at screening of persistent depletion of the targeted lymphocyte population.
• Have used alefacept within 3 months prior to the first administration of study agent.
• Have received abatacept.
• Known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients.
• Have received DMARDs other than MTX or anakinra within 4 weeks prior to the first administration of the study agent.
• Have received leflunomide within 4 weeks prior to the first administration of study
agent or have received leflunomide from 4 to 12 weeks prior to the first administration of study agent and have not undergone a drug elimination procedure.
• Have received any systemic medications/treatments that could affect psoriasis or
PASI evaluation within 4 weeks of the first administration of study agent.
• Have used topical medications/treatments that could affect psoriasis or PASI
evaluation (including, but not limited to corticosteroids (with the exception of low potency corticosteroids used on the palms, soles, face and/or intertriginous areas), anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens) within 2 weeks of the first administration of study agent.
• Have received any systemic immunosuppressives within 4 weeks of the first administration of the study agent.
• Have received intra-articular, IM, or IV corticosteroids during the 4 weeks prior to the first administration of the study agent.
• Are currently receiving lithium or have received lithium within 4 weeks of the first
administration of the study agent.
• Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months prior to the first administration of study agent, during the
study, or within 12 months after the last administration of study agent.
• Have a history of chronic or recurrent infectious disease, including but not limited to
chronic renal infection, chronic chest infection recurrent urinary tract infection, or open, draining, or infected skin wounds or ulcers.
• Have a history of an infected joint prosthesis, or have received antibiotics for a
suspected infection of a joint prosthesis, if that prosthesis has not been removed or
replaced.
• Have had or have a serious infection, or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening.
• Have a history of latent TB or a history of or clinically active granulomatous infection, including TB, histoplasmosis or coccidioidomycosis, prior to screening.
• Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of
screening.
• Have a chest radiograph within 3 months prior to t
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method