Ankylosing Spondylitis Clinical Trial
Official title:
An Observational, Prospective, Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis
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.
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