Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade
NCT02605642
Last updated date
ABOUT THIS STUDY
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
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
- Plovdiv,
- Plovdiv,
- Sofia,
- Edmonton, Alberta
- St. John's, Newfoundland and Labrador
- Sydney, Nova Scotia
- Barrie, Ontario
- Brampton, Ontario
- Hamilton, Ontario
- Kitchener, Ontario
- Milton, Ontario
- Mississauga, Ontario
- Oakville, Ontario
- Ottawa, Ontario
- Toronto, Ontario
- Windsor, Ontario
- Montreal, Quebec
- Rimouski, Quebec
- Trois-Rivières, Quebec
- Quebec,
- Ostrava,
- Praha 2,
- Berlin,
- Bernau,
- Dresden,
- Elmshorn,
- Haldensleben,
- Ludwigsfelde,
- Muenchen,
- Planegg,
- Potsdam,
- Rendsburg,
- Heraklion, Crete
- A Coruña A Coruña,
- Barcelona,
- San Cristóbal de La Laguna,
- Portsmouth,
- 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:
| ||||||
| 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 |
| ||||||
| Intervention | Drug: CT-P13
biosimilar infliximab Other Names:
| ||||||
| 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 | 351 | ||||||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor | Pfizer | ||||||
| Collaborators | Hospira, now a wholly owned subsidiary of Pfizer | ||||||
| Investigators |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | December 2019 | ||||||