Phase
Condition
Arthritis And Arthritic Pain
Joint Injuries
Psoriasis And Psoriatic Disorders
Treatment
Tofacitinib 5Mg Tab,Oral
HS-10374-matched placebo tablets
HS-10374
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subjects between the ages of 18-75 years.
Has a history of psoriatic arthritis (PsA) for at least 6 months, and meets theClassification Criteria for Psoriatic Arthritis (CASPAR) at screening.
Active arthritis as shown ≥ 3 swollen joints (66 joints) and ≥ 3 tender joints (68joints) at both screening and baseline.
Active plague psoriatic skin lesion or documented history of plague psoriatic atscreening.
hs-CRP ≥ 3mg/L at screening.
Subjects either (i) do not have prior exposure to biologics (biologic-naïve) or (ii)have failed or been intolerant to 1 TNF-inhibitor (TNFi-experienced).
Exclusion
Exclusion Criteria:
Non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-inducedpsoriasis), with the exception of nail psoriasis, which is allowed.
Other autoimmune or autoinflammatory condition ( ie, rheumatoid arthritis, systemiclupus erythematous, gout), with the exception of inflammatory bowel disease and/orautoimmune uveitis being inactive at least 12 months before the screening, asassessed by the investigator.
Active fibromyalgia syndrome
Recent history of active infection, chronic infection history or risk of seriousinfection.
Study Design
Connect with a study center
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai 200040
ChinaActive - Recruiting
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