None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Subjects who met the final selection/exclusion criteria from the Baseline were randomly assigned to the test group (Eucept-administered group) or the control grou
Sponsors
CHONNAM NATIONAL UNIVERSITY BITGOEUL HOSPITAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects greater than 18 years of age 2. Patients fulfilling the ASAS classification criteria for axial SpA including both non radiographic axial spondyloarthritis (nr-Ax SpA) and ankylosing spondylitis(AS) 3. Evidence of bone marrow edema on SI joint MRI or elevation of hsCRP 4. BASDAI =4 5. Total back pain VAS = 40 mm (0-100 mm) 6. Patients with axSpA underwent a trial of at least 2 course of NSAIDs with optimum doses for at least 1 month without response or with partial response
Exclusion criteria
Exclusion criteria: 1. Chest x-ray or MRI with evidence of an ongoing infectious or malignant process acquired within 3 months prior to enrollment and evaluated by a qualified physician 2. A condition that causes an immunosuppressive state in the subject and/or is at risk if immunomodulatory therapy is administered 3. Active systemic infection (except cold) or any recurrent infections in the past 2 weeks prior to randomization 4. History of lymphoproliferative disease or known malignancy, with or without evidence of local recurrence or metastasis, or a history of untreated or untreated malignancies within the past 5 years. 5. Pregnant or breast feeding females of child-bearing potential not using highly effective contraception
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;Number of adverse events ;Bath ankylosing spondylitis functional index(BASFI) | — |
Countries
Korea, Republic of
Contacts
Public ContactTae-Jong Kim
CHONNAM NATIONAL UNIVERSITY BITGOEUL HOSPITAL
Outcome results
None listed