KCT0008747
Recruiting
未知
Evaluation of Efficacy and Safety of subcutaneous Remsima injection in Subjetcs with Active Ankylosing Spondylitis
CHONNAM NATIONAL UNIVERSITY BITGOEUL HOSPITA0 sites60 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Sponsor
- CHONNAM NATIONAL UNIVERSITY BITGOEUL HOSPITA
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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