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Combination Therapy With Two Biologicals

NCT ID: NCT05135221

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2021-10-01

Brief Summary

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The efficacy and safety of dual biological therapy.

Detailed Description

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Data of all patients treated with the combination of two biologicals in four Finnish tertiary centres were collected and analysed. Inclusion criteria were simultaneous use of two biological treatments (infliximab, adalimumab, golimumab, vedolizumab or ustekinumab), age 16 years or over and follow-up for at least induction period after introduction of second biological therapy. The primary outcome was effectiveness, defined as remission assessed by physician after at least four months of DBT. The secondary outcome was safety defined by any adverse events or infection complications during DBT.

Conditions

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IBD

Keywords

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biological combination therapy adalimumab ustekinumab vedolizumab golimumab

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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dual biological therapy

Simultaneous use of two biologicals.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-Age under 16 years.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Heli T Eronen

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heli Eronen

Role: PRINCIPAL_INVESTIGATOR

Kanta-Häme Central Hospital

Locations

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Heli Eronen

Lempäälä, , Finland

Site Status

Countries

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Finland

Other Identifiers

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CBT

Identifier Type: -

Identifier Source: org_study_id