UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057308 |
|---|---|
| Receipt number | R000065511 |
| Scientific Title | 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) |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2025/03/17 10:21:47 |
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Basic information
Public title
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)
Acronym
MEGA-J study
Scientific Title
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)
Scientific Title:Acronym
MEGA-J study
Region
| Japan |
Condition
Condition
Inflammatory bowel disease (Crohn's disease and ulcerative colitis) and rheumatoid arthritis
Classification by specialty
| Gastroenterology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to assess the safety of Remsima (biosimilar infliximab [CTH] or CT-P13 IV) in patients with rheumatoid arthritis (RA) and/or inflammatory bowel disease (IBD) who were stable on reference infliximab and have already switched or have chosen to switch their treatment from reference infliximab to Remsima (biosimilar infliximab [CTH] or CT-P13 IV).
The secondary objectives of this study are to evaluate the overall clinical effectiveness and drug retention of Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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).
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Nishimata |
Organization
Junaikai Medical Corporation Sameshima Hospital
Division name
Department of Gastroenterology
Zip code
892-0846
Address
9-8 Kajiya-cho, Kagoshima City, 892-0846, Japan
TEL
81-99-224-2277
nnissy1022@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Soyeon |
| Middle name | |
| Last name | Park |
Organization
Celltrion, Inc.
Division name
Deparment of Global Medical Affairs
Zip code
22006
Address
22nd Fl. IBS Tower, 263 Central-ro, Yeonsu-gu, Incheon, Republic of Korea
TEL
82-32-850-6928
Homepage URL
https://www.celltrion.com/en-us
soyeon.park2@celltrion.com
Sponsor or person
Institute
Celltrion, Inc. (formerly Celltrion Healthcare Co. Ltd.)
Institute
Department
Personal name
Funding Source
Organization
Celltrion, Inc. (formerly Celltrion Healthcare Co. Ltd.)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoyukai RiverSide Clinic
Address
2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel
011-521-2321
rinrishinsa@riversideclinic.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
220
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational, prospective cohort study to assess the safety, clinical effectiveness, and drug retention of Remsima (biosimilar infliximab [CTH] or CT-P13 IV) treatment in patients with RA, and/or IBD (UC or CD) who switch from reference infliximab treatment to Remsima (biosimilar infliximab [CTH] or CT-P13 IV), in routine clinical practice.
Study participants will be prospectively followed for a 5-year period following initiation of Remsima (biosimilar infliximab [CTH] or CT-P13 IV).
Baseline clinical characteristics, reference infliximab treatment effectiveness assessments and history of treatment with reference infliximab will be collected retrospectively from medical records.
Management information
Registered date
| 2025 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065511
