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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02539368
Date of registration: 22/07/2015
Prospective Registration: Yes
Primary sponsor: Pfizer
Public title: Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease CONNECT-IBD
Scientific title: POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)
Date of first enrolment: April 22, 2015
Target sample size: 2565
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02539368
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Belgium Czech Republic Czechia Finland France Germany Greece Hungary
Ireland Italy Netherlands Portugal Slovakia Spain United Kingdom
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Inflammatory Bowel Diseases
Ulcerative Colitis
Intervention(s)
Drug: CT-P13
Drug: Remicade
Primary Outcome(s)
Disease Characteristics of Participants: Disease Duration [Time Frame: Baseline (Day 1)]
Number of Participants by Frequency of Infusion Received [Time Frame: Baseline (Day 1)]
Number of Participants Who Had Change in Infusion Dose [Time Frame: From baseline to follow-up period (up to a maximum duration of 2 years)]
Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change [Time Frame: From baseline to follow-up period (up to a maximum duration of 2 years)]
Number of Participants Who Switched Treatment [Time Frame: From baseline to follow-up period (up to a maximum duration of 2 years)]
Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC) [Time Frame: From baseline to follow-up period (up to a maximum duration of 2 years)]
Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs) [Time Frame: From baseline to follow-up period (up to a maximum duration of 2 years)]
Reasons for Switching Treatment by Participants [Time Frame: From baseline to follow-up period (up to a maximum duration of 2 years)]
Total Dose of Infusion Received [Time Frame: From baseline to follow-up period (up to a maximum duration of 2 years)]
Secondary Outcome(s)
Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index [Time Frame: Baseline, Months 6, 12, 18 and 24]
Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis [Time Frame: At Baseline]
Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity [Time Frame: Baseline, Months 6, 12, 18 and 24]
Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location [Time Frame: Baseline, Months 6, 12, 18 and 24]
Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission [Time Frame: Baseline, Months 6, 12, 18 and 24]
Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index According to Disease Activity [Time Frame: Baseline, Months 6, 12, 18 and 24]
Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24 [Time Frame: Baseline, Months 6, 12, 18 and 24]
Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24 [Time Frame: Baseline, Months 6, 12, 18, and 24]
Number of Participants Remaining in Clinical Remission or Relapse [Time Frame: Months 6, 12, 18 and 24]
Number of Participants With Imaging Test Results [Time Frame: From baseline up to follow-up period (a maximum of 2 years)]
Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent [Time Frame: Baseline, Months 6, 12, 18 and 24]
Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity [Time Frame: Baseline, Months 6, 12, 18 and 24]
Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission [Time Frame: Baseline, Months 6, 12, 18 and 24]
Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity [Time Frame: Baseline, Months 6, 12, 18 and 24]
Secondary ID(s)
C1231001
ZOB INF 1402
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Hospira, now a wholly owned subsidiary of Pfizer
Ethics review
Results
Results available: Yes
Date Posted: 13/02/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02539368
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