NCT03189888

Brief Summary

BACKGROUND: Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative colitis, although is limited by costs and variability of results.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

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

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

June 13, 2017

Last Update Submit

June 14, 2017

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • steroid-free clinical remission

    3 months

Study Arms (1)

apheresis

OTHER

leukapheresis in ulcerative colitis

Device: apheresis

Interventions

apheresisDEVICE
apheresis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • moderate UC with steroid-dependence and azathioprine intolerance or resistance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Imperiali G, Amato A, Terpin MM, Beverina I, Bortoli A, Devani M, Vigano C; Study Group on IBD (GSMII). Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Resistant Moderate Ulcerative Colitis: A Prospective Multicenter Study. Gastroenterol Res Pract. 2017;2017:9728324. doi: 10.1155/2017/9728324. Epub 2017 Dec 21.

    PMID: 29403531DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Blood Component Removal

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 16, 2017

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 16, 2017

Record last verified: 2017-06