Evaluation of Efficacy and Safety of subcutaneous Remsima injection in Subjetcs with Active Ankylosing Spondylitis

CHONNAM NATIONAL UNIVERSITY BITGOEUL HOSPITA0 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年9月18日

适应症

试验速览

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•individuals aged 19 and above, male, or non-pregnant and non-lactating females, who are participants in the trial:
•Participants satisfying Modified NY criteria,
•Baseline BASDAI = 4 indicating active axial SpA,
•Total back pain measured with VAS = 40 mm (0-100 mm) at baseline,
•Participants must have had inadequate response or intolerance to at least two NSAIDs of approved dosages for a minimum of 4 weeks each, prior to assignment.

•1. Evidence of ongoing infectious or malignant processes within the chest, as assessed by a qualified physician, acquired within the last 3 months prior to enrollment through chest X-ray or MRI.
•2. Conditions that cause or require immune suppression and/or immune-modulating therapy for the trial participant, constituting a risk.
•3. Active systemic infection within the past 2 weeks prior to randomization (except for colds) or any recurring infections.
•4. History of lymphoproliferative disorder regardless of evidence of local recurrence or metastasis, known malignancy, or history of untreated or treated malignancy within the last 5 years

发起方

CHONNAM NATIONAL UNIVERSITY BITGOEUL HOSPITA