NCT02605642

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 351 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Diseases
• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	CT-P13	biosimilar infliximab

Timeline

• Start date: 2015-09-10
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2015-11-16
• Last updated: 2020-01-13
• Results posted: 2020-01-13

Locations

38 sites across 7 countries: Bulgaria, Canada, Czechia, Germany, Greece, Spain, United Kingdom

Regulatory

• FDA-regulated drug study