Clinical trial 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
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Diseases
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Keywords: CT-P13
Inflectra
Remsima
Remicade
Infliximab
Observational
Follow-up
Safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2015-11-16
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)
timeFrame: During the observation period of 2 years
measure: Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study
timeFrame: At Day 1 of 2 year observation period
measure: Initial Dose of CT-P13 Infusion Administered to Participants
timeFrame: At Day 1 of 2 year observation period
measure: Number of Participants by Initial Frequency of CT-P13 Infusion Received
timeFrame: Baseline (Day 1) of 2 year observation period
measure: Total Dose of CT-P13 Infusion Received During Observation Period
timeFrame: During the observation period of 2 years
measure: Number of Participants With Change in CT-P13 Infusion Dose
timeFrame: During the observation period of 2 years
measure: Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)
timeFrame: During the observation period of 2 years
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
timeFrame: During the observation period of 2 years
Secondary outcomes:
measure: Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24
timeFrame: Baseline, Weeks 6, 12, 18 and 24
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24
timeFrame: Baseline, Weeks 6, 12, 18 and 24
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24
timeFrame: Baseline, Weeks 6, 12, 18 and 24
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Change From Baseline in European Quality of Life- 5 Dimensions 3 Level Version (EQ-5D-3L) Visual Analog Scale (VAS) Score at Months 6, 12, 18 and 24
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Change From Baseline in Physical Component Summary (PCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Change From Baseline in Mental Component Summary (MCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24
timeFrame: Baseline, Months 6, 12, 18 and 24
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: MHAT Trimontium OOD
city: Plovdiv
country: Bulgaria
facility: MHAT Kaspela EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center 17 Sofia EOOD
city: Edmonton
country: Canada
facility: Lucere Skin Dermatology & Laser Clinic
state: Alberta
city: St. John's
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: Sydney
country: Canada
facility: Dr. Juris Lazovskis Inc.
state: Nova Scotia
city: Barrie
country: Canada
facility: The Waterside Clinic
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health System
state: Ontario
city: Hamilton
country: Canada
facility: Adachi Medicine Professional Corporation
state: Ontario
city: Kitchener
country: Canada
facility: K-W Musculoskeletal Research Inc
state: Ontario
city: Milton
country: Canada
facility: Y. Liu Medicine Professional
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Imaging Associates
state: Ontario
city: Oakville
country: Canada
facility: Oakville Rheumatology & Osteoporosis
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Arthur Karasik Medicine Professional Corporation
state: Ontario
city: Windsor
country: Canada
facility: Dr. Sabeen Anwar Medicine Professional Corporation
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital
state: Quebec
city: Rimouski
country: Canada
facility: Centre Rhumatologie de l'Est
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre de Recherche Musculo-Squelettique
state: Quebec
city: Quebec
country: Canada
facility: Groupe de Recherche en Rhumatologie et Maladies Osseuses (GRMO)
city: Ostrava
country: Czechia
facility: Revmatolog Mudr. Sirova Klara s.r.o.
city: Praha 2
country: Czechia
facility: Revmatologický Ústav (RÚ)
city: Berlin
country: Germany
facility: Rheumapraxis Steglitz
city: Bernau
country: Germany
facility: Immanuel Diakonie GmbH
city: Dresden
country: Germany
facility: Rheumatologisches MVZ Dresden GmbH
city: Elmshorn
country: Germany
facility: Asklepios Gesundheitszentrum Elmshorn
city: Haldensleben
country: Germany
facility: Rheumatologische Praxis Dr. med. Kühne
city: Ludwigsfelde
country: Germany
facility: Dr. med. Jörg Kaufmann
city: Muenchen
country: Germany
facility: Praxis Dr. Herbert Kellner
city: Planegg
country: Germany
facility: MVZ für Rheumatologie Dr. Martin Welcker GmbH
city: Potsdam
country: Germany
facility: Berufsausübungsgemeinschaft Martin Bohl-Bühler & Dr. med. Sabine Reckert
city: Rendsburg
country: Germany
facility: Dr. med. Jochen Walter - FA für Innere Medizin Rheumatologe
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Crete
city: A Coruña A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: San Cristóbal de La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
city: Sailsbury
country: United Kingdom
facility: Salisbury NHS Foundation Trust - Salisbury District Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.