A Phase 2a Multicenter Randomized Double blind Study Evaluating the Efficacy and Safety of Subcutaneously Administered combination therapy in Improving the Signs and Symptoms in Participants with Active Psoriatic Arthritis.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Psoriatic And Enteropathic Arthropathies
  • Age: Between 18 - 65 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Medically stable on the basis of physical examination, medical history, and vital signs performed at screening
    2. Have a diagnosis of Psoriatic ARthritis (PsA) for =6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening
    3. Have active Psoriatic ARthritis (PsA)
    4. Have at least 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
    5. Have active plaque psoriasis, with at least one psoriatic plaque of =2 cm diameter or nail changes consistent with psoriasis
    6. Have inadequate response (IR)to a prior anti-tumor necrosis factor a (TNFa)therapy

You may not be eligible for this study if the following are true:

    1. Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal insufficiency, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
    2. Has unstable cardiovascular disease
    3. Has a history of, or concurrent, congestive heart failure, including medically controlled, asymptomatic congestive heart failure
    4. Has a history of a demyelinating disorder
    5. Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab and/or golimumab therapy
    6. Has the arthritis mutilans subset of PsA
    7. Has a nonplaque form of psoriasis
    8. Has current drug-induced psoriasis
    9. Has a history of an infected joint prosthesis or has ever received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced
    10. Currently has a malignancy or a history of malignancy within 5 years before screening
    11. Has or has had a herpes zoster infection within 2 months before screening
    12. Has a history of lymphoproliferative disease
    13. Has a transplanted organ
    14. Has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, mAbs, or antibody fragments
    15. Has unstable suicidal ideation or suicidal behavior in the last 6 month
    16. Has had major surgery within 8 weeks prior to screening, or will not have fully recovered from such surgery, or has such surgery planned during the time the participant is expected to participate in the study
    17. Has a history of chronic or recurrent infectious disease
    18. Has or has had a serious infection or has been hospitalized or received IV antibiotics for an infection within 2 months prior to screening
    19. Has a history of active granulomatous infection, including histoplasmosis, or coccidioidomycosis, before screening
    20. Has ever had a nontuberculous mycobacterial infection or opportunistic infection
    21. Has persistently indeterminate (indeterminate on repeat sampling) QuantiFERON-TB test results



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