An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RA
NCT ID: NCT02557295
Last Updated: 2024-11-26
Study Results
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View full resultsBasic Information
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TERMINATED
248 participants
OBSERVATIONAL
2013-12-17
2020-03-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Remsima™
Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.
No interventions assigned to this group
Switch to Remsima I
Patients who switched from Remicade to Remsima were included in this analysis group.
No interventions assigned to this group
Switch to Remsima II
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.
No interventions assigned to this group
Remicade
Patients who have received only Remicade or switched from non-biologic treatment to Remsima were included in this analysis group.
No interventions assigned to this group
Switch to Remicade I
Patients who switched from Remsima to Remicade were included in this analysis group.
No interventions assigned to this group
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.
No interventions assigned to this group
Other Anti-TNF
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
No interventions assigned to this group
Switch to Other Anti-TNF
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group
No interventions assigned to this group
Biologic Naïve
Patients who received only non-biologic treatment will be included in this analysis group
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patients with active RA diagnosed according to the revised 1987 ACR or 2010 ACR/EULAR classification criteria
Exclusion Criteria
2. Patients with a current or past history of chronic infection
3. Patients with moderate or severe heart failure (NYHA class III/IV).
18 Years
ALL
No
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Principal Investigators
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Klara Sirova
Role: PRINCIPAL_INVESTIGATOR
Revmatologie MUDr. Klara Sirova s.r.o. Chelčického 616/12 , 702 00, Czech Republic
References
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Cheon JH, Nah S, Kang HW, Lim YJ, Lee SH, Lee SJ, Kim SH, Jung NH, Park JE, Lee YJ, Jeon DB, Lee YM, Kim JM, Park SH. Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness. Adv Ther. 2021 Aug;38(8):4366-4387. doi: 10.1007/s12325-021-01834-3. Epub 2021 Jul 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CT-P13 4.2
Identifier Type: -
Identifier Source: org_study_id
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