An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
NCT ID: NCT02557308
Last Updated: 2024-12-09
Study Results
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View full resultsBasic Information
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TERMINATED
329 participants
OBSERVATIONAL
2015-05-26
2021-02-28
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 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 switched from Remsima to Remicade 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 were included in this analysis group.
No interventions assigned to this group
Other anti-TNF drugs
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
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 were included in this analysis group
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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).
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
Countries
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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 4.4
Identifier Type: -
Identifier Source: org_study_id