N/A
N=2,543
Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease
Inflammatory Bowel Diseases · Ulcerative Colitis · Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02539368 ↗Enrolled (actual)
2,543
Serious AEs
15.0%
Results posted
Feb 2020
Primary outcome: Primary: Disease Characteristics of Participants: Disease Duration — 63.0; 112.5; 120.0; 86.0 months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CT-P13 (Drug); Remicade (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Characteristics of Participants: Disease Duration |
63.0; 112.5; 120.0; 86.0; 101.0 | — |
| PRIMARY Number of Participants Who Switched Treatment |
237; 47; 72; 121; 20; 30 | — |
| PRIMARY Reasons for Switching Treatment by Participants |
— | — |
| PRIMARY Total Dose of Infusion Received |
NA; NA; NA; NA; NA | — |
| PRIMARY Number of Participants by Frequency of Infusion Received |
5; 0; 0; 0; 0; 140 | — |
| PRIMARY Number of Participants Who Had Change in Infusion Dose |
479; 110; 89; 28; 31 | — |
| PRIMARY Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change |
213; 61; 31; 26; 16; 5 | — |
| PRIMARY Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC) |
1025; 262; 187; 39; 67 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs) |
621; 133; 130; 15; 30; 256 | — |
| SECONDARY Number of Participants Remaining in Clinical Remission or Relapse |
870; 312; 261; 51; 70; 166 | — |
| SECONDARY Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission |
606; 246; 150; 29; 49; 485 | — |
| SECONDARY Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index According to Disease Activity |
137; 45; 24; 10; 7; 91 | — |
| SECONDARY Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission |
169; 83; 55; 9; 13; 117 | — |
| SECONDARY Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity |
157; 30; 28; 4; 9; 76 | — |
| SECONDARY Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis |
61; 33; 21; 4; 6; 553 | — |
| SECONDARY Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location |
257; 62; 34; 6; 11; 135 | — |
| SECONDARY Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity |
324; 92; 66; 9; 17; 165 | — |
| SECONDARY Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent |
41; 10; 5; 0; 2; 151 | — |
| SECONDARY Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity |
80; 46; 24; 6; 6; 75 | — |
| SECONDARY Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index |
64; 30; 14; 3; 6; 90 | — |
| SECONDARY Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24 |
13.70; 10.23; 8.79; 7.70; 12.18; -1.09 | — |
| SECONDARY Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24 |
1066.31; 556.88; 362.48; 616.03; 537.58; -283.21 | — |
| SECONDARY Number of Participants With Imaging Test Results |
516; 134; 106; 28; 50 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02539368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.