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

Celltrion Healthcare

Status: Terminated

Conditions: Ankylosing Spondylitis

Study type: Observational

Funder types: Industry

Identifiers

NCT02557308

CT-P13 4.4

Details and patient eligibility

About

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

Full description

This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with AS in comparison with patients receiving other TNF blockers. For the RemsimaTM cohort data will be collected for patients who commence treatment with RemsimaTM in accordance with the product label at the time of enrolment. Patients who have been treated with Remicade® prior to enrolment, their dosing schedule will be continued appropriately. This observational study allows drug switching between anti-TNF drugs. If switched to RemsimaTM, data will be collected until the end of study for each patient. If switched to other anti-TNF drugs (infliximab (Remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier. For switched patients, their assessment schedule will be re-started from the day of switch. Patients will undergo safety and efficacy assessments in accordance with routine medical practice. The decision to treat with RemsimaTM will be independent of the decision to enroll the patient in this registry.

Enrollment: 329 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients

• Patients with active AS

• Patients who meet the following conditions can be enrolled:

  i) The RemsimaTM cohort will include all patients who will start RemsimaTM at the time of enrolment in accordance to the approved product label ii) Patients who have started to be treated with an established anti -TNF such as Infliximab (Remicade®), Etanercept, Adalimumab and etc. within 6 months

• Female patients of childbearing potential who agree to use of adequate contraception to prevent pregnancy and continuation of contraceptive use for at least 6 months after their final dose of RemsimaTM.

• 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
• Current diagnosis of TB or severe or chronic infections (e.g. sepsis, abscess or opportunistic infections or invasive fungal infections), or a past diagnosis of TB or severe or chronic infection, without sufficient documentation of complete resolution following treatment.
• Recent exposure to persons with active TB, or a positive test result for latent TB (defined as a positive interferon-γ release assay [IGRA] with a negative examination of chest X-ray) at Screening.
• Patients with moderate or severe heart failure (NYHA class III/IV).

Trial design

329 participants in 8 patient groups

Remsima™

Description:

Patients who have received only Remsima were included in this analysis group

Switch to Remsima I

Description:

Patients who switched from Remicade to Remsima were included in this analysis group.

Switch to Remsima II

Description:

Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group

Remicade

Description:

Patients who switched from Remsima to Remicade were included in this analysis group.

Switch to Remicade I

Description:

Patients who switched from Remsima to Remicade were included in this analysis group.

Switch to Remicade II

Description:

Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group.

Other anti-TNF drugs

Description:

Following patients were included in other anti-TNF group. * Patients who have received only anti-TNF other than Remsima or Remicade * Patients who switched from biologic treatment other than anti-TNF before study enrollment to anti-TNF other than Remsima or Remicade

Switch to Other Anti-TNF

Description:

Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group