NCT05777616

Brief Summary

The IFX adherence to CD in China was not high. Medicine concerns may be predictive factor of adherence. By enhancing knowledge and relieving medicine concerns, we may increase patients' adherence to IFX.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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 15, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

March 8, 2023

Last Update Submit

March 8, 2023

Conditions

Inflammatory Bowel Diseases

Keywords

Crohn's disease; adherence; medication concern; infliximab

Outcome Measures

Primary Outcomes (1)

  • Adherence

    Adherence was judged by comparing the theoretical infusion times with the actual infusion times in recent 1 year, which was referred to the definition of modified medication possession radio (mMPR)

    November 15 to December 28, 2021

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study was conducted at the Second Affiliated Hospital, Zhejiang University School of Medicine (SAHZU) from November 15 to December 28, 2021. All CD patients treated with infliximab were retrospectively identified in the electronic medical records (EMRs) from the SAHZU Crohn's and Colitis Center.

You may qualify if:

  • patients with a confirmed diagnosis of CD; were treated with infliximab for at least 12 weeks; were informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

Zhejiang, China

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn Disease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Yan Chen

    2nd Affiliated Hospital, School of Medicine, Zhejiang University,China

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 21, 2023

Study Start

November 15, 2021

Primary Completion

December 28, 2021

Study Completion

December 28, 2021

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations

CN(1)