Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02605642
Study type	Observational
Source	Pfizer
Contact
Status	Completed
Phase
Start date	September 10, 2015
Completion date	December 31, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04226131` - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics	N/A
Completed	`NCT04171414` - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis	Phase 3
Completed	`NCT02833350` - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)	Phase 2
Completed	`NCT04255134` - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)	Phase 4
Recruiting	`NCT05615246` - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed	`NCT03248518` - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases	N/A
Completed	`NCT03514355` - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms	N/A
Recruiting	`NCT06005220` - SBD121, a Synbiotic Medical Food for RA Management	N/A
Recruiting	`NCT05451615` - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis	Phase 3
Completed	`NCT05054920` - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis	N/A
Completed	`NCT02037737` - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting	N/A
Recruiting	`NCT04079374` - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel	Phase 3
Completed	`NCT02504268` - Effects of Abatacept in Patients With Early Rheumatoid Arthritis	Phase 3
Recruiting	`NCT05496855` - Remote Care in People With Rheumatoid Arthritis	N/A
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting	`NCT06031415` - Study of GS-0272 in Participants With Rheumatoid Arthritis	Phase 1
Recruiting	`NCT06103773` - A Study of Single and Multiple Oral Doses of TollB-001	Phase 1
Completed	`NCT05999266` - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting	`NCT05302934` - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting	`NCT04169100` - Novel Form of Acquired Long QT Syndrome	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms