NCT03248024

Brief Summary

The objective of this study is to analyze the factors influencing the medical and non-medical direct costs of patients treated with biotherapy during the last twelve months (infliximab or adalimumab), including biosimilars (infliximab biosimilars: Inflectra ™ and Remsima ™) for treating Crohn's desease or ulcerative colitis

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
Last Updated

August 14, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

August 9, 2017

Last Update Submit

August 9, 2017

Conditions

Keywords

Chronic DiseaseUlcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Retrospective health care consumption

    Desease treatment cost individual level data

    one year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received biotherapy during the last 12 months preceeding consultation for treatment of crohn's disease or ulcerative colitis.

You may qualify if:

  • Patients over 18 of age the day of consultation
  • Patients with crohn's disease or ulcerative colitis.
  • Patients accepting to respond to the questionnary

You may not qualify if:

  • Age under 18 years , the day of consultation
  • Patient that not accept or unable to complete the retrospective questionnary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammatory Bowel DiseasesChronic DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsColitisColonic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 14, 2017

Study Start

November 28, 2016

Primary Completion

February 7, 2017

Study Completion

February 7, 2017

Last Updated

August 14, 2017

Record last verified: 2017-07