An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis

Study Overview
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Brief Summary
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An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis

Detailed Description
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The primary objective of this study is to assess the safety of Remsima™ in ankylosing spondylitis (AS) patients, in comparison with patients receiving other anti-TNF drugs, by evaluation of events of special interest (ESI) for up to 5 years from the first visit of each patient. In order to assess the primary study outcomes, the following ESI will be evaluated: Identified risks: Hepatitis B virus reactivation Congestive heart failure Opportunistic infections (excluding tuberculosis) Serious infections including sepsis (excluding opportunistic infection and tuberculosis) Tuberculosis Serum sickness (delayed hypersensitivity reactions ) Haematologic reactions Systemic lupus erythematosus/lupus-like syndrome Demyelinating disorders Lymphoma (not HSTCL) Hepatobiliary events Hepatosplenic T-cell Lymphoma (HSTCL) Serious infusion reaction during a re-induction following disease flare Sarcoidosis/sarcoid-like reactions Leukaemia Potential risks: Malignancy (excluding lymphoma) Skin cancer Pregnancy exposure† The secondary objectives of this study are to evaluate efficacy and additional safety of Remsima™ in AS patients, in comparison with patients receiving other TNF blockers.

Official Title
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An Observational, Prospective, Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis

Conditions
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Ankylosing Spondylitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients Patients with active AS 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: Patients with a history of hypersensitivity to infliximab Patients with a current or past history of chronic infection Patients with moderate or severe heart failure (NYHA class III/IV).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Remsima™<br>Patients who are taking Remsima™ for the treatment | |
| Other anti-TNF drugs<br>Patients who are taking other anti-TNF drugs such as infliximab (Remicade®), etanercept, adalimumab, etc. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |  | every 6 months, up to 5 years | 
| Bath Ankylosing Spondylitis Functional Index (BASFI) |  | every 6 months, up to 5 years | 
| Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS) Physician and Patient Global Assessment of Disease Status |  | every 6 months, up to 5 years |