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

  • STATUS
    Recruiting
  • End date
    Jun 22, 2026
  • participants needed
    1000
  • sponsor
    Celltrion
Updated on 22 January 2021

Summary

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.

Details
Condition Ankylosing spondylitis
Clinical Study IdentifierNCT02557308
SponsorCelltrion
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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