Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade

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NCT02605642

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Study Location
MHAT Trimontium OOD
Plovdiv, , 4000, Bulgaria
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Diseases, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Patients aged ≥18 years old at the time of enrollment

2. Patients who are prescribed CT-P13 or Remicade for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis prescribed according to the corresponding summary of product characteristics (SmPC and Product Monograph) as determined by the investigator

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Any reported contraindications for Inflectra according to the SmPC or Product
Monograph


2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its
excipients or other murine proteins, at the time of enrollment

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Rheumatoid Diseases, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic ArthritisPost-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade NCT02605642
  1. Plovdiv,
  2. Plovdiv,
  3. Sofia,
  4. Edmonton, Alberta
  5. St. John's, Newfoundland and Labrador
  6. Sydney, Nova Scotia
  7. Barrie, Ontario
  8. Brampton, Ontario
  9. Hamilton, Ontario
  10. Kitchener, Ontario
  11. Milton, Ontario
  12. Mississauga, Ontario
  13. Oakville, Ontario
  14. Ottawa, Ontario
  15. Toronto, Ontario
  16. Windsor, Ontario
  17. Montreal, Quebec
  18. Rimouski, Quebec
  19. Trois-Rivières, Quebec
  20. Quebec,
  21. Ostrava,
  22. Praha 2,
  23. Berlin,
  24. Bernau,
  25. Dresden,
  26. Elmshorn,
  27. Haldensleben,
  28. Ludwigsfelde,
  29. Muenchen,
  30. Planegg,
  31. Potsdam,
  32. Rendsburg,
  33. Heraklion, Crete
  34. A Coruña A Coruña,
  35. Barcelona,
  36. San Cristóbal de La Laguna,
  37. Portsmouth,
  38. Sailsbury,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade
Official Title PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)
Brief Summary

To assess persistence of CT-P13 in patients with Rheumatoid Diseases (Rheumatoid arthritis [RA], ankylosing spondylitis [AS], and psoriatic arthritis [PsA]) who are naïve to biologics or are switching from stable Remicade to CT-P13. The main objectives of the study are:

  • To evaluate real-life drug persistence in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
  • To characterise the patient populations and drug usage patterns of RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
  • To assess the safety of CT-P13 in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade for up to 2 years
Detailed Description The study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP), Good Epidemiological Practice (GEP), Good Practices for Outcomes Research, International Ethical Guidelines for Epidemiological Research, European Medicines Agency (EMA) European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology, and FDA Guidance for Industry. Data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. Data sources will be validated. The source data will consist of medical records, physician questionnaires, and patient questionnaires. Data for the study will be entered into an electronic data capture system. Questionnaires will be completed on electronic tablets. The study is a one year enrollment period with a two year follow-up period. The study plans to enroll patients throughout Canada and Europe.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The target study population will include biologic naïve rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patients starting biologic treatment with CT-P13 or those switched to CT-P13 from stable Remicade treatment
Condition
  • Rheumatoid Diseases
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
Intervention Drug: CT-P13
biosimilar infliximab
Other Names:
  • Inflectra
  • Remsima
Study Groups/Cohorts CT-P13
biosimilar infliximab
Intervention: Drug: CT-P13
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 12, 2017)		351
Original Estimated Enrollment
 (submitted: November 12, 2015)		1500
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients aged ?18 years old at the time of enrollment
  2. Patients who are prescribed CT-P13 or Remicade for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis prescribed according to the corresponding summary of product characteristics (SmPC and Product Monograph) as determined by the investigator

Exclusion Criteria:

  1. Any reported contraindications for Inflectra according to the SmPC or Product Monograph
  2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrollment
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Bulgaria,   Canada,   Czechia,   Germany,   Greece,   Spain,   United Kingdom
Removed Location Countries Czech Republic,   France,   Italy
 
Administrative Information
NCT Number NCT02605642
Other Study ID Numbers ZOBINF1505
C1231002 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2019