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| Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade |
| 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) |
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
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| 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 years follow-up period. The study plans to enroll patients throughout Canada and Europe. |
| Observational |
Observational Model: Cohort
Time Perspective: Prospective |
| Not Provided |
| Not Provided |
| Non-Probability Sample |
| 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 |
- Rheumatoid Diseases
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Psoriatic Arthritis
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| Drug: CT-P13 biosimilar infliximab |
| CT-P13 biosimilar infliximab Intervention: Drug: CT-P13 |
| Not Provided |
|
| |
|
| Completed |
| 351 |
| 1500 |
| December 31, 2018 |
| December 31, 2018 (Final data collection date for primary outcome measure) |
Inclusion Criteria: - Patients aged ?18 years old at the time of enrollment
- 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: - Any reported contraindications for Inflectra according to the SmPC or Product Monograph
- Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrollment
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| Sexes Eligible for Study: | All |
|
| 18 Years and older (Adult, Older Adult) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Bulgaria, Canada, Czechia, Germany, Greece, Spain, United Kingdom |
| Czech Republic, France, Italy |
| |
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| NCT02605642 |
ZOBINF1505
C1231002 ( Other Identifier: Alias Study Number ) |
| No |
| 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 |
|
| 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/da.... |
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| Pfizer |
| Pfizer |
| Hospira, now a wholly owned subsidiary of Pfizer |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
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| Pfizer |
| March 2019 |
