NCT05135221

Brief Summary

The efficacy and safety of dual biological therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 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

January 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

5 years

First QC Date

October 13, 2021

Last Update Submit

November 19, 2021

Conditions

IBD

Keywords

biologicalcombination therapyadalimumabustekinumabvedolizumabgolimumab

Outcome Measures

Primary Outcomes (1)

  • Clinical response

    In CD, clinical response was assessed using a modified Harvey-Bradshaw index (HBI, omitting abdominal palpation) and clinical remission was defined as HBI\<5. In UC, partial MAYO score \<3 was cut the off value for clinical remission. Patients symptoms were assessed at baseline, 4, 12 and 18 months after initiation of treatment.

    18 months

Secondary Outcomes (5)

  • Endoscopic response

    18 months

  • Haemoglobin level improvement

    18 months

  • Calprotectin level improvement

    18 months

  • C-reactive protein level improvement.

    18 months

  • Treatment related infections

    18 months

Interventions

dual biological therapyBIOLOGICAL

Simultaneous use of two biologicals.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

IBD patients treated in Finnish tertiary centers.

You may qualify if:

  • Simultaneous use of two different biological treatments for IBD.
  • Treatment duration with combination therapy for at least for induction period.

You may not qualify if:

  • Age under 16 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heli Eronen

Lempäälä, 37500, Finland

Location

Study Officials

  • Heli Eronen

    Kanta-Häme Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 13, 2021

First Posted

November 26, 2021

Study Start

January 1, 2015

Primary Completion

December 30, 2019

Study Completion

October 1, 2021

Last Updated

November 26, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)