|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)|
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
|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 an 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.|
|Observational Model: Cohort|
Time Perspective: Prospective
The target study population will include patients with CD or UC, who are being treated, or initiating treatment, with CT-P13 or Remicade at the time of study enrolment. This would include the following treatment subgroups:
- Biologic-naïve patients initiating CT-P13 (or Remicade);
- Patients currently being treated with CT-P13 (or Remicade);
- Patients who are considered stable by the Investigator under Remicade therapy for CD or UC, who switch to CT-P13;
- Patients switching to CT-P13 or Remicade from an alternative biologic therapy (e.g. adalimumab) due to non-responsiveness to or intolerance;
- Patients re-initiating CT-P13 or Remicade after having successfully completed and exited a previous course of infliximab therapy in the past.
- Patients with fistulating disease or stomas and those receiving combination therapy will be included.
- Inflammatory Bowel Diseases
- Ulcerative Colitis
- Crohn's Disease
- Drug: CT-P13
- Drug: Remicade
|October 31, 2018|
|October 31, 2018 (Final data collection date for primary outcome measure)|
- At least 12 years of age at the time of initial confirmed diagnosis of CD or UC and at least 18 years of age at the time of enrolment to the study.
- Patients who are prescribed CT-P13 or Remicade for the treatment of CD or UC prescribed according to the corresponding summary of product characteristics (SmPC) as determined by the Investigator. Patients with stomas or surgery/pouch will be included.
- Any reported contraindications for CT-P13 or Remicade, according to the SmPC.
- Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.
- Prior history of failure to respond to Remicade or CT-P13.
|Sexes Eligible for Study:||All|
|18 Years and older (Adult, Older Adult)|
|Contact information is only displayed when the study is recruiting subjects|
|Belgium, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Portugal, Slovakia, Spain, United Kingdom|
|Czech Republic, Ireland|
|ZOB INF 1402|
C1231001 ( Other Identifier: Alias Study Number )
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
|Plan to Share IPD:||No|
|Plan Description:||Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....|
|Hospira, now a wholly owned subsidiary of Pfizer|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|