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

Last updated on December 15, 2017

About this Study

This is a post-marketing observational study of patients with Inflammatory Bowel Disease
(specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed Inflectra
(infliximab) or Remicade (infliximab) for treatment. Inflectra 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
Inflectra for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard
of care Remicade

- To assess the safety of Inflectra up to a 2-year follow-up period in the treatment of
patients with CD or UC in the context of standard of care Remicade

- To assess the effectiveness of Inflectra in the treatment of patients with CD or UC in
the context of standard of care Remicade

- To evaluate the immunogenicity profile of Inflectra in the treatment of patients with CD
or UC

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

FOR MORE INFORMATION
Study Location
UZ Leuven Campus Gasthuisberg
Leuven, Vlaams Brabant, 3000 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 Inflectra 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Any reported contraindications for Inflectra 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 Inflectra.

NCT02539368
Pfizer
Recruiting
Post-Marketing Use Of Inflectra (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

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Post-Marketing Use Of Inflectra (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease
Post Approval Safety Study (Pass): Post-marketing Observational Cohort Study Of Patients With Inflammatory Bowel Disease (Ibd) Treated With Inflectra (Infliximab) 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 Inflectra (infliximab) or Remicade (infliximab) for treatment. Inflectra 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 Inflectra for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade
  • To assess the safety of Inflectra up to a 2-year follow-up period in the treatment of patients with CD or UC in the context of standard of care Remicade
  • To assess the effectiveness of Inflectra in the treatment of patients with CD or UC in the context of standard of care Remicade
  • To evaluate the immunogenicity profile of Inflectra in the treatment of patients with CD or UC
  • To evaluate patient-reported outcomes (PRO) including quality of life (QoL), work productivity and healthcare resource utilization (HRU) in patients treated with Inflectra for CD or UC
The study will be conducted according to good clinical practice (GCP) guidelines and data source will be validated. The source data 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 thereafter up to 2 years. Adverse events will be encoded according to MedDRA 17.1 or later. The sample size will be of 3300 patients recruited over 2 years. No inferential analyses are planned. Statistical analysis will be descriptive in nature.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The target study population will include patients with CD or UC, who are being treated, or initiating treatment, with Inflectra or Remicade at the time of study enrolment. This would include the following treatment subgroups:

  • Biologic-naïve patients initiating Inflectra (or Remicade);
  • Patients currently being treated with Inflectra (or Remicade);
  • Patients who are considered stable by the Investigator under Remicade therapy for CD or UC, who switch to Inflectra;
  • Patients switching to Inflectra or Remicade from an alternative biologic therapy (e.g. adalimumab) due to non-responsiveness to or intolerance;
  • Patients re-initiating Inflectra 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: Inflectra (infliximab)
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3300
June 30, 2019
January 31, 2019   (Final data collection date for primary outcome measure)

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 Inflectra 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 Inflectra 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 Inflectra.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Belgium,   Czechia,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Portugal,   Slovakia,   Spain,   United Kingdom
Czech Republic,   Ireland
 
NCT02539368
ZOB INF 1402
C1231001 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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