A Phase 2a, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab and Golimumab Combination Therapy in Participants with Active Psoriatic Arthritis - AFFINITY

Janssen-Cilag International NV0 个研究点目标入组 90 人开始时间: 2021年8月5日最近更新: 2021年10月18日

研究概览

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•- Be =18 to =65 years of age, inclusive.
•- Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator.
•- Have a diagnosis of PsA for =6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis criteria at screening.
•- Have active PsA as defined by: At least 3 swollen joints and at least 3 tender joints at screening and at baseline and, hsCRP =0.3 mg/dL at screening from the central laboratory
•- 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.
•For the complete overview of the inclusion criteria, please refer to section 5.1 of the protocol
•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 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 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, psychiatric, genitourinary, or metabolic disturbances.
•- Has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months prior to screening or a cardiac hospitalization within the last 3 months prior to screening.
•- Has a history of, or concurrent, congestive heart failure, including medically controlled, asymptomatic congestive heart failure.
•- Has a history of a demyelinating disorder such as multiple sclerosis or optic neuritis.
•- Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab and/or golimumab therapy, including but not limited to RA, AS, nr-AxSpA, systemic lupus erythematosus, or lyme disease.
•For the complete overview of the exclusion criteria, please refer to
•section 5.2 of the protocol

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