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

Celltrion Healthcare

Status: Terminated

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02557295

CT-P13 4.2

Details and patient eligibility

About

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis.

Full description

This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with RA in comparison with patients receiving non-biologic treatmentsor other anti-TNF drugs. 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 (3 mg/kg of RemsimaTM by IV infusion at weeks 0, 2, 6 (±3 days) and every 8 weeks (±14 days) thereafter). For 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.

Enrollment: 248 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients
2. Patients with active RA diagnosed according to the revised 1987 ACR or 2010 ACR/EULAR classification criteria

Exclusion criteria

1. Patients with a history of hypersensitivity to murine, chimeric, human, or humanized proteins.
2. Patients with a current or past history of chronic infection
3. Patients with moderate or severe heart failure (NYHA class III/IV).

Trial design

248 participants in 9 patient groups

Remsima™

Description:

Patients who have received only Remsima or switched from non-biologic treatment to 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 have received only Remicade or switched from non-biologic treatment to Remsima 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 will be included in this analysis group.

Other Anti-TNF

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 non-biologic treatment to anti-TNF other than Remsima or Remicade * Patients who switched from biologic treatment other than anti-TNF before study enrolment 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 will be included in this analysis group

Biologic Naïve

Description:

Patients who received only non-biologic treatment will be included in this analysis group