CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 118 enrolled
Drug / intervention
Inflectradrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03801928
NCT03801928N/ACompleted
CompareCT.gov

OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA

Pfizer·observational·Posted Jan 14, 2019·Updated Mar 2, 2021

In Brief

An observational study evaluating Inflectra for Inflammatory Bowel Disease (IBD) and 2 related conditions. Completed, enrolled 118 participants across 15 sites in 2 countries.

Detailed Summary

This is a prospective, observational, multicenter study conducted in adult patients with ulcerative colitis (UC) or Crohn's disease (CD). The study plans to recruit 300 subjects in the United States and Canada in which the participating physician has decided to treat with INFLECTRA. The study will evaluate treatment patterns, adherence, disease activity, remission status, relapse status, treatment satisfaction, and healthcare resource utilization. Patient outcomes will be assessed at four time points (quarterly) for approximately 52 weeks after the decision to initiate treatment with INFLECTRA.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInflammatory Bowel Disease (IBD), Crohn's Disease (CD), Ulcerative Colitis (UC)
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 14, 2019
Enrollment StartFeb 23, 2018
Primary CompletionFeb 7, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.5 years ago

Interventions

Inflectradrug

The study plans to recruit 300 subjects in the United States and Canada initiating or switching to treatment with INFLECTRA over an 8 month period. The decision to start INFLECTRA will be entirely a clinical decision made by the participating physician irrespective of this study.