Combination Therapy With Two Biologicals

Completed

• Conditions: IBD

• Registration Number: NCT05135221
• Lead Sponsor: Tampere University Hospital

Brief Summary

The efficacy and safety of 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 Timeline

• Study Start: 2015-01-01
• Primary Completion: 2019-12-30
• Study Completion: 2021-10-01
• Study First Submitted: 2021-10-13
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-19
• Last Update Submitted: 2021-11-19
• Study First Posted: 2021-11-26
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical response	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Endoscopic response	18 months	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.
Haemoglobin level improvement	18 months	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.
Treatment related infections	18 months	Infection complications reported during treatment.
Calprotectin level improvement	18 months	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.
C-reactive protein level improvement.	18 months	CRP \< 10 mg/L. CRP levels were measured at baseline and 4, 12 and 18 months after initiation of treatment.

Trial Locations

Locations (1)

Heli Eronen; 🇫🇮 Lempäälä, Finland