Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo. (NCT04711902) | Clinical Trial Compass
CompletedPhase 3
Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo.
China41 participantsStarted 2021-06-24
Plain-language summary
The purpose of this study was to assess the efficacy and safety of secukinumab in Chinese participants with active Psoriatic arthritis (PsA ) compared to placebo.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* Participant must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
* Chinese male or non-pregnant, non-lactating Chinese female participants at least 18 years of age.
* Diagnosis of PsA classified by Classification of Psoriatic Arthritis (CASPAR) criteria and with symptoms for at least 6 months with moderate to severe Psoriatic arthritis (PsA).
* Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
* Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis.
* Participants on Methotrexate (MTX) must be on folic acid supplementation at randomization.
* Participants who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine washout has been performed.
Exclusion Criteria:
* Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
* Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine).
* Previous exposure to secukinumab or other biologic drug directly targeting interleukin- 17 (IL-17) or IL…