Ankylosing Spondylitis
Conditions
Brief summary
This study is the trial to demonstrate how our product is similar to remicade by comparing the results of blood samples in active Ankylosing Spondylitis patients.
Interventions
DRUGInfliximab
Infliximab 5mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed with active ankylosing spondylitis * BASDAI score ≥ 4 and visual analogue scale(VAS) score of spinal pain ≥ 4
Exclusion criteria
* have total ankylosing of spine * have allergies to infliximab * serious infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK equivalence to remicade | PK sampling at week 22 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria | at week 14, 30 and 54 |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline | at week 14, 30 and 54 |
| Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline | at week 14, 30 and 54 |
| Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 20% criteria | at week 14, 30 and 54 |
| Chest expansion at Weeks 14, 30 and 54 compared with Baseline | at weeks 14, 30 and 54 |
| Quality of life questionnaire (SF-36) | at week 14, 30 and 54 |
| Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline | at weeks 14, 30 and 54 |
Countries
South Korea
Outcome results
None listed