Ankylosing Spondylitis Clinical Trial
Official title:
An Observational, Prospective, Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
NCT number | NCT02557308 |
Other study ID # | CT-P13 4.4 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 2014 |
Est. completion date | June 2026 |
An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | June 2026 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult patients 2. Patients with active AS 3. Patients (or legal guardian, if applicable) who are willing to give informed consent for long term follow-up including access to all medical records Exclusion Criteria: 1. Patients with a history of hypersensitivity to infliximab 2. Patients with a current or past history of chronic infection 3. Patients with moderate or severe heart failure (NYHA class III/IV). |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | TaeHwan Kim | Seoul |
Lead Sponsor | Collaborator |
---|---|
Celltrion |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection of events of special interest in AS patients | Patients will be observed for the events of special interest listed in protocol | every visit, up to 5 years | |
Secondary | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | every 6 months, up to 5 years | ||
Secondary | Bath Ankylosing Spondylitis Functional Index (BASFI) | every 6 months, up to 5 years | ||
Secondary | Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS) Physician and Patient Global Assessment of Disease Status | every 6 months, up to 5 years |
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