Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease
NCT03801928 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 118
Last updated 2021-03-02
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.
Conditions
- Inflammatory Bowel Disease (IBD)
- Crohn's Disease (CD)
- Ulcerative Colitis (UC)
Interventions
- DRUG
-
Inflectra
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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-23
- Primary Completion
- 2020-02-07
- Completion
- 2020-02-07
Countries
- United States
- Canada
Study Locations
More Related Trials
-
A Phase 1b Study to Assess the Safety and Anti-inflammatory Effects of Two Different Doses of SRT2104 in Patients With Ulcerative Colitis
NCT01453491 ·Status: COMPLETED ·Phase: PHASE1
-
"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"
NCT02452151 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
NCT02165215 ·Status: COMPLETED ·Phase: PHASE3
-
Synergistic Effect of Vedolizumab and Pentoxifylline
NCT02953275 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease
NCT00207662 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn's Disease
NCT00102921 ·Status: COMPLETED ·Phase: PHASE2
-
Immune Regulation in Ulcerative Colitis or Crohn s Disease
NCT00001184 ·Status: RECRUITING
-
An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)
NCT00988832 ·Status: COMPLETED
-
EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis
NCT03679546 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease
NCT02425111 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis
NCT01612039 ·Status: COMPLETED ·Phase: PHASE2
-
Synbiotic Treatment in Crohn's Disease Patients
NCT00305409 ·Status: COMPLETED ·Phase: NA
-
A Prospective Study on the Incidence and Risk Factors Related to Infection in Patients With Inflammatory Bowel Disease
NCT02904590 ·Status: COMPLETED
-
A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease
NCT00207766 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis
NCT03849599 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease
NCT07113522 ·Status: RECRUITING ·Phase: PHASE2
-
A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
NCT03251118 ·Status: ACTIVE_NOT_RECRUITING
-
Anti-TNF Therapy for Refractory Colitis in Hospitalized Children
NCT02799615 ·Status: COMPLETED
-
Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease
NCT01442025 ·Status: COMPLETED ·Phase: PHASE4
-
Biomarkers of Anti-TNF Treatment in Inflammatory Bowel Disease (IBD)
NCT01971970 ·Status: COMPLETED
-
Phase 2 Dose-finding IMU-838 for Ulcerative Colitis
NCT03341962 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
NCT01203631 ·Status: COMPLETED ·Phase: PHASE2
-
Characterization of the Intestinal Microbiota in Patients With Inflammatory Bowel Disease and/or Spondyloarthritis and Study of the Impact of an Anti-TNF Alpha Therapy
NCT03359642 ·Status: COMPLETED ·Phase: NA
-
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
NCT00032799 ·Status: COMPLETED ·Phase: PHASE3
-
Improving Outcomes Among Urgent Care Clinic Patients With Inflammatory Bowel Disease
NCT03239704 ·Status: UNKNOWN ·Phase: NA