EUCTR2016-001163-37-PL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 including those Previously Treated with Biologic Anti-TNFa Agent(s) - Discover-1
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
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 at screening
- •3. Have active PsA as defined by:
- •a. At least 3 swollen joints and at least 3 tender joints at screening and at baseline
- •b. C-reactive protein (CRP) =0.3 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. Subjects may have been previously treated with up to 2 anti-TNFa agents , and must document the reason for discontinuation
- •a. Lack of benefit to an anti-TNFa therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy and/or at least a 14 week dosage regimen of infliximab. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity.
- •b. Intolerance to an anti-TNFa biologic therapy, as assessed by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab.
- •c. If no intolerance or lack of benefit, the reason for discontinuation must be documented.
- •8. 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 a MTX, SSZ, or HCQ, must have not 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.
- •9. 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.
- •10. 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 firs
排除标准
- •1. Has other inflammatory diseases that might confound the evaluations
- •of benefit of guselkumab therapy, including but not limited to RA, axial
- •spondyloarthritis, systemic lupus erythematosus, or
- •Lyme disease.
- •2. Has ever received more than 2 anti-TNFa agents.
- •3. Has received an anti-TNF agent within the following timeframes:
- •a. Has received infliximab or golimumab within 8 weeks before the first
- •administration of study agent.
- •b. Has received golimumab SC, adalimumab or certolizumab pegol within
- •XML File Identifier: GPZHHfOYPZqlcwVnuSZZzjoDz+k=
- •6 weeks before the first administration of study agent.
- •c. Has received etanercept within 4 weeks before the first administration
- •of study agent.
- •4. Has previously been treated with guselkumab.
- •5. Has previously received any biologic treatment, including, but not
- •limited to ustekinumab, abatacept, secukinumab, tildrakizumab,
- •ixekizumab, brodalumab, risankizumab, or other investigative biologic
- •6. Has previously received tofacitinib, baricitinib, filgotinib, peficitinib,
- •decernotinib, or any other Janus kinase inhibitor.
- •7. Has previously received any systemic immunosuppressants within the
- •4 weeks of the first administration of study agent
- •8. Has received non-biologic DMARDs including, but not limited to
- •chloroquine, gold preparations, and penicillamine within 4 weeks before
- •the first administration of study agent.
- •9. Is currently receiving 2 or more non-biologic DMARDs at baseline.
- •10. Has received apremilast within 4 weeks prior to the first
- •administration of study agent.
- •16. Has unstable suicidal ideation or suicidal behavior in the last 6
- •months, that may be defined as an electronic Columbia-Suicide Severity
- •Rating Scale (eC-SSRS) rating at screening of:
- •- ideation level 4: some intent to act no plan, or:
- •- ideation level 5: specific plan and intent, OR
- •- any of the following suicidal behaviors:
- •* actual suicide attempts
- •* interrupted attempts
- •* aborted attempts
- •* prepartory 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
- •38. 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 a complete overview of the inclusion criteria please refer to protocol
- •section 4.2. (pages 60-64)
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