A Real World, Observational, Prospective Cohort Study to Evaluate Safety and Effectiveness of Remsima in Patients with Rheumatoid Arthritis (RA) and/or Inflammatory Bowel Disease (IBD)

A Real World, Observational, Prospective Cohort Study to Evaluate Safety and Effectiveness of Remsima in Patients with Rheumatoid Arthritis (RA) and/or Inflammatory Bowel Disease (IBD) - MEGA-J study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057308

Enrollment

2000

Registered

2025-03-17

Start date

2018-12-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease (Crohn&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with a confirmed diagnosis of RA (aged 20 years and above) and/or IBD (ulcerative colitis [UC] or Crohn's disease [CD]) (aged 6 years and above). 2. Patients with RA and/or IBD who were stable on reference infliximab treatment and have already switched or have chosen to switch their treatment from reference infliximab to Remsima (biosimilar infliximab [CTH] or CT-P13 IV). 3. Patients with medical history and reference infliximab data available. 4. Patients (or legal guardian, if applicable) who provide signed and dated written informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Patients whose medical records are unavailable. 2. Patients who previously participated in Remsima (biosimilar infliximab [CTH] or CT-P13 IV) clinical studies, including post-marketing studies.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is to evaluate the incidence of uncommon ADRs including TB and serious infections in patients who were stable on reference infliximab and have already switched to Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment during routine clinical practice or have chosen to switch to Remsima (biosimilar infliximab [CTH] or CT-P13 IV).	—

Secondary

Measure	Time frame
The secondary endpoints of this study are - To describe the baseline demographics and clinical characteristics of patients switching to Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment. - To describe the history of treatment with reference infliximab. - To describe history of TB in patients before initiation of Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment. - To describe the dosage and duration of Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment (treatment persistence/drug retention). - To describe baseline co-morbidities. - To describe the proportion of patients undergoing anti-infliximab antibody measurements and tuberculosis tests. - To describe the dosage and duration of treatment for the following concomitant drugs: azathioprine, sulfasalazine, methotrexate and mercaptopurine. - To describe the safety profile (AE/ SAE) of Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment. - To describe the incidence of TB and other serious infections during Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment. - To describe the grade 3 and 4 AEs including infusion related reactions following Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment. - To describe the long-term disease response assessment scores (including remission status of patients with IBD) following Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment.	—

Measure

Time frame

The secondary endpoints of this study are - To describe the baseline demographics and clinical characteristics of patients switching to Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment. - To describe the history of treatment with reference infliximab. - To describe history of TB in patients before initiation of Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment. - To describe the dosage and duration of Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment (treatment persistence/drug retention). - To describe baseline co-morbidities. - To describe the proportion of patients undergoing anti-infliximab antibody measurements and tuberculosis tests. - To describe the dosage and duration of treatment for the following concomitant drugs: azathioprine, sulfasalazine, methotrexate and mercaptopurine. - To describe the safety profile (AE/ SAE) of Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment. - To describe the incidence of TB and other serious infections during Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment. - To describe the grade 3 and 4 AEs including infusion related reactions following Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment. - To describe the long-term disease response assessment scores (including remission status of patients with IBD) following Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment.

—

Countries

Japan

Contacts

Public ContactSoyeon Park

Celltrion, Inc. Deparment of Global Medical Affairs

soyeon.park2@celltrion.com82-32-850-6928

Outcome results