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

NCT ID: NCT02605642

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 351 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-10
• Study Completion Date: 2018-12-31

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.

Conditions

Rheumatoid Diseases; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CT-P13

biosimilar infliximab

CT-P13

Intervention Type: DRUG

biosimilar infliximab

Interventions

CT-P13

biosimilar infliximab

Intervention Type: DRUG

Other Intervention Names

Inflectra; Remsima

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

MHAT Trimontium OOD

Plovdiv, , Bulgaria

MHAT Kaspela EOOD

Plovdiv, , Bulgaria

Diagnostic Consultative Center 17 Sofia EOOD

Sofia, , Bulgaria

Lucere Skin Dermatology & Laser Clinic

Edmonton, Alberta, Canada

Nexus Clinical Research

St. John's, Newfoundland and Labrador, Canada

Dr. Juris Lazovskis Inc.

Sydney, Nova Scotia, Canada

The Waterside Clinic

Barrie, Ontario, Canada

William Osler Health System

Brampton, Ontario, Canada

Adachi Medicine Professional Corporation

Hamilton, Ontario, Canada

K-W Musculoskeletal Research Inc

Kitchener, Ontario, Canada

Y. Liu Medicine Professional

Milton, Ontario, Canada

Credit Valley Imaging Associates

Mississauga, Ontario, Canada

Oakville Rheumatology & Osteoporosis

Oakville, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Arthur Karasik Medicine Professional Corporation

Toronto, Ontario, Canada

Dr. Sabeen Anwar Medicine Professional Corporation

Windsor, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital

Montreal, Quebec, Canada

Groupe de Recherche en Rhumatologie et Maladies Osseuses (GRMO)

Québec, Quebec, Canada

Centre Rhumatologie de l'Est

Rimouski, Quebec, Canada

Centre de Recherche Musculo-Squelettique

Trois-Rivières, Quebec, Canada

Revmatolog Mudr. Sirova Klara s.r.o.

Ostrava, , Czechia

Revmatologický Ústav (RÚ)

Prague, , Czechia

Rheumapraxis Steglitz

Berlin, , Germany

Immanuel Diakonie GmbH

Bernau, , Germany

Rheumatologisches MVZ Dresden GmbH

Dresden, , Germany

Asklepios Gesundheitszentrum Elmshorn

Elmshorn, , Germany

Rheumatologische Praxis Dr. med. Kühne

Haldensleben I, , Germany

Dr. med. Jörg Kaufmann

Ludwigsfelde, , Germany

Praxis Dr. Herbert Kellner

München, , Germany

MVZ für Rheumatologie Dr. Martin Welcker GmbH

Planegg, , Germany

Berufsausübungsgemeinschaft Martin Bohl-Bühler & Dr. med. Sabine Reckert

Potsdam, , Germany

Dr. med. Jochen Walter - FA für Innere Medizin Rheumatologe

Rendsburg, , Germany

University General Hospital of Heraklion

Heraklion, Crete, Greece

Complexo Hospitalario Universitario A Coruña

A Coruña A Coruña, , Spain

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, , Spain

Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

Portsmouth, , United Kingdom

Salisbury NHS Foundation Trust - Salisbury District Hospital

Sailsbury, , United Kingdom

Countries

Bulgaria; Canada; Czechia; Germany; Greece; Spain; United Kingdom

References

Taylor PC, Christensen R, Moosavi S, Selema P, Guilatco R, Fowler H, Mueller M, Liau KF, Haraoui B. Real-life drug persistence in patients with rheumatic diseases treated with CT-P13: a prospective observational cohort study (PERSIST). Rheumatol Adv Pract. 2021 Apr 23;5(2):rkab026. doi: 10.1093/rap/rkab026. eCollection 2021.

Reference Type: DERIVED

PMID: 34377890 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

C1231002

Identifier Type: OTHER

Identifier Source: secondary_id

ZOBINF1505

Identifier Type: -

Identifier Source: org_study_id