A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial ofUstekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody,Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis andPreviously Treated with Biologic Anti-TNFa Agent(s)
- Conditions
- MedDRA version: 12.1Level: LLTClassification code 10037160Term: Psoriatic arthritis
- Registration Number
- EUCTR2009-012265-60-FR
- Lead Sponsor
- Centocor B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
• 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) = 0.6 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.
• Must have previously:
– received at least an 8-week dosage regimen of
etanercept, adalimumab, golimumab, or certolizumab pegol; or
– received at least a 14-week dosage regimen of
infliximab; or
– received less than an 8-week dosage regimen of etanercept, adalimumab,
golimumab, or certolizumab pegol or less than a 14-week dosage regimen of
infliximab as described above and have documented intolerance of anti-TNFa
therapy
• Women must be:
– surgically sterile
or
– abstinent, 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 pregnancy test at screening; and a negative urine pregnancy
test at Week 0.
• Men must agree to use a double barrier method of birth control 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 TB screening criteria:
– Have no history of latent or active TB prior to screening. An exception is
made for subjects with a history of latent TB and documentation of having
completed appropriate treatment for latent TB within
3 years prior to the first administration of study agent.
– 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.
• 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 currently not using
NSAIDs or other analgesics for PsA, must not have received NSAIDs or other
analgesics for PsA for at least 2 weeks prior to the first administration of the study
agent.
If using oral corticosteroids, the subject must be on a stable
• 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.
• Have received alpha-4 integrin antagonists 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 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,
dministered intramuscularly 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,
• 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 or active granulomatous infection
• Have had a Bacille Calmette-Guérin vaccination within 12 months of
screening.
• Have a chest radiograph within 3 months prior to the first administration of study
agent that shows an abnormality suggestive of a malignancy or current active
infection, including TB.
• Have or ever had a nontuberculous mycobacterial infection or opportunistic infection
• Have indeterminate initial and repeat QuantiFERON-TB Gold test results or a newly
positive QuantiFERON-TB Gold test and refuses TB prophylaxis
treatment.
• Have or have had a herpes zoster infection withi
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