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

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ClinicalTrials.gov Identifier: NCT02539368
Recruitment Status : Completed
First Posted : September 3, 2015
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Brief 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
  • To evaluate patient-reported outcomes (PRO) including quality of life (QoL), work productivity and healthcare resource utilization (HRU) in patients treated with CT-P13 for CD or UC

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Ulcerative Colitis Crohn's Disease Drug: CT-P13 Drug: 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 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.

Study Type : Observational
Actual Enrollment : 2565 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Observational Cohort Study Of Patients With Inflammatory Bowel Disease (Ibd) Treated With Ct-p13 In Usual Clinical Practice (Connect-ibd)
Actual Study Start Date : April 22, 2015
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab

Group/Cohort Intervention/treatment
CT-P13
biosimilar infliximab
Drug: CT-P13
biosimilar infliximab
Other Names:
  • Inflectra
  • Remsima

Remicade
infliximab
Drug: Remicade
infliximab




Primary Outcome Measures :
  1. Patients' demographic characteristics [ Time Frame: Once at enrolment ]
  2. Clinical and diagnostic characteristics [ Time Frame: Once at enrolment ]
    Relevant medical history for Crohn's Disease (CD) or Ulcerative Colitis (UC) including prior treatments

  3. Number of subjects who discontinue treatment for any reason [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice ]
  4. Number of subjects who switch treatment for any reason [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice ]
  5. Change from baseline in infliximab therapy for any reason [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice ]
  6. Change from baseline in steroid use for the management of Crohns Disease (CD) or Ulcerative colitis (UC) for any reason [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]
  7. Number of patients who switched co-therapy (steroid) use in the management of CD or UC [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]
  8. Number of patients with serious adverse events (SAEs) and adverse events of special interest (AESIs) [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years. ]

Secondary Outcome Measures :
  1. Data relating to Harvey Bradshaw Index (HBI) for patients with CD [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]
  2. Data relating to Partial Mayo Scoring System for Assessment of UC Activity, (abbreviated version without the endoscopy sub-score) [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]
  3. Data relating to the Montreal classification index for CD [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]
  4. Data relating to the Montreal classification index for UC: classification by extent [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]
  5. Data relating to the Montreal classification index for UC: classification by severity [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]
  6. Data relating to the fistula drainage assessment index for CD [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.

Exclusion Criteria:

  1. Any reported contraindications for CT-P13 or Remicade, according to the SmPC.
  2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.
  3. Prior history of failure to respond to Remicade or CT-P13.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539368


  Show 140 Study Locations
Sponsors and Collaborators
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02539368     History of Changes
Other Study ID Numbers: ZOB INF 1402
C1231001 ( Other Identifier: Alias Study Number )
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018

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

Keywords provided by Pfizer:
CT-P13
Inflectra
Remicade
Infliximab
Observational
Follow-up
Safety
Effectiveness

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents