None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : At baseline, eligible participants who meet the criteria for final inclusion/exclusion are randomly assigned to either the treatment group (Remicade administratio
Sponsors
CHONNAM NATIONAL UNIVERSITY BITGOEUL HOSPITAL
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of spondyloarthritis international society 20 response(ASAS 20) | — |
Secondary
| Measure | Time frame |
|---|---|
| MRI SIJ Spondyloarthritis Research Consortium Canada (SPARCC) score;Ankylosing Spondylitis Disease Activity Score- C reactive protein(ASDASCRP);Bath Ankylosing Spondylitis Disease Activity Index;Assessment of spondyloarthritis international society Health Index;Bath Ankylosing Spondylitis Metrology Index (BASMI);Maastricht Ankylosing Spondylitis Enthesitis Score (MASES);44-swelling and tender joints;Bath ankylosing spondylitis functional index(BASFI);adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactTae-Jong Kim
CHONNAM NATIONAL UNIVERSITY BITGOEUL HOSPITAL
Outcome results
None listed