Overview
An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis
Description
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.
Eligibility
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).