NCT02539368

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

POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,565 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows: * To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade * To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade * To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade

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 for the study will be entered into a web based electronic data capture (EDC) system at enrolment and then approximately every 3 months (at a minimum) thereafter up to 2 years. Adverse events will be encoded according to MedDRA 17.1 or later. The sample size will be approximately 2500 patients recruited over a 30 month period and followed up to 2 years. No inferential analyses are planned. Statistical analysis will be descriptive in nature.

Conditions

• Inflammatory Bowel Diseases
• Ulcerative Colitis
• Crohn's Disease

Interventions

Type	Name	Description
DRUG	CT-P13	biosimilar infliximab
DRUG	Remicade	infliximab

Timeline

• Start date: 2015-04-22
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2015-09-03
• Last updated: 2020-02-13
• Results posted: 2020-02-13

Locations

140 sites across 13 countries: Belgium, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Portugal, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study