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OpenTrials
Completed

NCT Number: NCT05135221

Combination Therapy With Two Biologicals

The efficacy and safety of dual biological therapy.

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Key information

Conditions

IBD

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heli Eronen

Lempäälä, 37500, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dual biological therapy

Biological

Simultaneous use of two biologicals.

Primary outcomes

  1. Clinical response

    Time frame: 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 outcomes

  1. Endoscopic response

    Time frame: 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.

  2. Haemoglobin level improvement

    Time frame: 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.

  3. Calprotectin level improvement

    Time frame: 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.

  4. C-reactive protein level improvement.

    Time frame: 18 months

    CRP < 10 mg/L. CRP levels were measured at baseline and 4, 12 and 18 months after initiation of treatment.

  5. Treatment related infections

    Time frame: 18 months

    Infection complications reported during treatment.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

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

Acronym: Combi

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Nov 26, 2021
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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