Combination Therapy With Two Biologicals

IBD Clinical Trial

— Combi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05135221
• Other study ID #: CBT
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2021
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The efficacy and safety of dual biological therapy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 1, 2021
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• IBD

Intervention

Biological:
• dual biological therapy
Simultaneous use of two biologicals.

Locations

Country	Name	City	State
Finland	Heli Eronen	Lempäälä

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Treatment related infections	Infection complications reported during treatment.	18 months