Combination Therapy With Two Biologicals (Combi)

Combining Biological Therapies in Patients With Inflammatory Bowel Disease: a Finnish Multi-centre Study.

The efficacy and safety of dual biological therapy.

Study Overview

• Status: Completed
• Conditions: IBD
• Intervention / Treatment: Biological: dual biological therapy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Finland
  • Lempäälä, Finland, 37500
    • Heli Eronen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

IBD patients treated in Finnish tertiary centers.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic response	Endoscopic response was assessed by Mayo endoscopic score for UC, simple endoscopic score for CD based on endoscopic characteristics (MAYO ≤ 1 and SES-CD < 3 as cut off values for endoscopic remission). Endoscopy was performed at baseline and 4, 12 or 18 months after initiation of treatment.	18 months
Haemoglobin level improvement	Blood haemoglobin ≥117 g/L for females and ≥134 g/L for males. Measured at baseline and 4, 12 and 18 months after initiation of treatment.	18 months
Calprotectin level improvement	Change in fecal Calprotectin level measured from baseline and 4, 12 and 18 months of treatment. Feacal calprotectin level ≤ 250 µg/g as cut-off value for remission.	18 months
C-reactive protein level improvement.	CRP < 10 mg/L. CRP levels were measured at baseline and 4, 12 and 18 months after initiation of treatment.	18 months
Treatment related infections	Infection complications reported during treatment.	18 months

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Principal Investigator: Heli Eronen, Kanta-Häme Central Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): December 30, 2019
• Study Completion (ACTUAL): October 1, 2021

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (ACTUAL): November 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: combination therapy; adalimumab; golimumab; ustekinumab; vedolizumab; biological
• Other Study ID Numbers: CBT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No