EUCTR2016-001224-63-EE进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects with Active Psoriatic Arthritis - Discover 2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 684
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Be a man or a woman at least 18 years of age
- •2. Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet ClASsification criteria for Psoriatic ARthritis (CASPAR) at screening
- •3. Have active PsA as defined by:
- •a. At least 5 swollen joints and at least 5 tender joints at screening and at baseline
- •b. CRP =0.6 mg/dL at screening from the central laboratory.
- •4. Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
- •5. Have active plaque psoriasis, with at least one psoriatic plaque of =2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis.
- •6. Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.
- •- Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance.
- •- Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance.
- •- NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance.
- •7. If currently using non-biologic DMARDs , subjects should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before first administration of study agent and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using MTX, SSZ, or HCQ, must not have received for at least 4 weeks before first administration of study agent. If currently not using LEF, must not have received for at least 12 weeks before first administration of study agent.
- •a. If using MTX, the route of administration and dose must be stable and the dose must be =25 mg/week.
- •b. If receiving SSZ, the dose must be = 3g/day.
- •c. If receiving HCQ, the dose must be =400 mg/day.
- •d. If receiving LEF, the dose must be =20 mg/day.
- •8. If currently using NSAIDs or other analgesics for PsA, subjects must be on a stable dose for at least 2 weeks before 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 within 2 weeks before first administration of study agent.
- •9. If currently using oral corticosteroids for PsA, subjects must be on a stable dose equivalent to =10 mg of prednisone/day for at least 2 weeks before first administration of study agent. If currently not using oral corticosteroids, the subject must not have received oral corticosteroids within 2 weeks before first administration of study agent.
- •For additional inclusion criteria please refer to protocol section 4.1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 547
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 137
排除标准
- •1. Has other inflammatory diseases that might confound the evaluations or benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis , systemic lupus erythematosus, or Lyme disease.
- •2. Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab (AIN457), anti-TNFa agents (such as adalimumab, etanercept, infliximab, golimumab SC or intravenous [IV], certolizumab pegol, or their respective biosimilars), tildrakizumab (MK3222), ixekizumab (LY2439821), brodalumab (AMG827), risankizumab (BI-655066), or other investigative biologic treatment for PsA or psoriasis.
- •3. Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor.
- •4. Has received any systemic immunosuppressants within 4 weeks of the first administration of study agent.
- •5. Is currently receiving 2 or more non-biologic DMARDs specified in Table 4.
- •6. Has received non-biologic DMARDs (other than MTX, SSZ, HCQ, LEF) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent.
- •7. Has received apremilast within 4 weeks prior to the first administration of study agent.
- •8. Has received phototherapy or any systemic medications/treatments that could affect psoriasis evaluations (including, but not limited to, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, fumaric acid derivatives, with the exception of those in Table 4) within 4 weeks of the first administration of study agent.
- •9. Has used topical medications/treatments that could affect psoriasis evaluations within 2 weeks of the first administration of any study agent.
- •10. Has received epidural, intra-articular, intramuscular, or IV corticosteroids, including adrenocorticotropic hormone during the 4 weeks before first administration of study agent.
- •13. Has unstable suicidal ideation or suicidal behavior in the last 6 months, that may be defined as an eC-SSRS rating at screening of
- •? - Ideation level 4: Some intent to act (4”), no plan; OR
- •? - Ideation level 5: Specific plan and intent (5”), OR
- •? - Any of the following suicidal behaviors:
- •– actual suicide attempts
- •– interrupted attempts
- •– aborted attempts
- •– preparatory actions
- •AND is confirmed to be at risk by the investigator based on an evaluation by a mental health professional. The final decision on excluding a subject will be made at the judgment of the investigator.
- •35. Is seropositive for antibodies to hepatitis C virus (HCV) at screening, unless the subject had 2 negative HCV ribonucleic acid (RNA) test results at least 6 months apart prior to screening and have a third negative HCV RNA test result at screening.
- •For additional exclusion criteria please refer to protocol section 4.2.
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