Psoriatric arthritis MedDRA version: 12.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis
Conditions
Interventions
Trade Name: Stelara
Product Name: ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Solution for injection
Current Sponsor code: ustekinumab
Other descriptive name: Human Anti-IL-12 Antibody
Con
Sponsors
Janssen Biologics B.V.
Eligibility
Sex/Gender
All
Inclusion 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 baseline -AND- – 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-TNF alpha agent, must have: - 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-TNF alpha 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 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 TB screening criteria: - Have no history of latent or active TB prior to screening. An exception is made for subjects with prior use of anti-TNFa agent(s) with a history of latent TB and documentation of having completed appropriate treatment for latent TB (see Section 9.1.2) within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.– 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 stab
Exclusion criteria
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. • 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 (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, administered 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 TB or a history of or clinically active granulomatous infection, including TB, histoplasmosis or coccidioidomycosis, prior to screening. • 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 a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to evaluate the efficacy of ustekinumab in subjects with active PsA including those previously treated with biologic anti- TNF? agent(s) by assessing the reduction in signs and symptoms of PsA and to evaluate the safety of ustekinumab in this population.;Secondary Objective: The secondary objectives of this study are to evaluate the efficacy of ustekinumab in: 1. Improving physical function; 2. Improving psoriatic skin lesions; and 3. Inhibiting the progression of structural damage.;Primary end point(s): The primary endpoint is the proportion of subjects achieving an ACR 20 response at Week 24. | — |
Countries
Austria, France, Germany, Hungary, Poland, Sweden, United Kingdom
Outcome results
None listed