IBDCombiNCT05135221
Combination Therapy With Two Biologicals
An observational study of IBD, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The efficacy and safety of dual biological therapy. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBD
- What is being tested?
- dual biological therapy
- How many people
- 16 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2015to 1 Oct 2021
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: IBD patients treated in Finnish tertiary centers.
Who may be able to join
- Simultaneous use of two different biological treatments for IBD.
- Treatment duration with combination therapy for at least for induction period.
Who cannot join
- -Age under 16 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combining Biological Therapies in Patients With Inflammatory Bowel Disease: a Finnish Multi-centre Study.
The efficacy and safety of dual biological therapy.
Read the 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.
- Conditions
- IBD
- Being tested
- dual biological therapy
- Keywords
- biological, combination therapy, adalimumab, ustekinumab, vedolizumab, golimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual biological therapyBiological
Simultaneous use of two biologicals.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Treatment related infections
Infection complications reported during treatment.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Jan 2015
- Primary completion30 Dec 2019
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 16 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heli T Eronen, Tampere University Hospital
- Investigators
- Heli Eronen, Principal investigator, Kanta-Häme Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135221
- Sponsor's protocol ID
- CBT
- Acronym
- Combi
- Status last verified
- Nov 2021
- First submitted
- 13 Oct 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Biological Therapies in Patients With Inflammatory Bowel Disease: a Finnish Multi-centre Study.
- ClinicalTrials.gov ID
- NCT05135221
- Acronym / sponsor ID
- Combi / CBT
- Conditions
- IBD
- Keywords
- biological, combination therapy, adalimumab, ustekinumab, vedolizumab, golimumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- IBD patients treated in Finnish tertiary centers.
Key inclusion criteria (2 listed)
- Simultaneous use of two different biological treatments for IBD.
- Treatment duration with combination therapy for at least for induction period.
Key exclusion criteria (1 listed)
- -Age under 16 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual biological therapySimultaneous use of two biologicals. | Biological | – |
Primary outcome
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.
5 secondary outcomes
Endoscopic response
Time frame: 18 months
Haemoglobin level improvement
Time frame: 18 months
Calprotectin level improvement
Time frame: 18 months
C-reactive protein level improvement.
Time frame: 18 months
Treatment related infections
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heli Eronen principal investigator
Kanta-Häme Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.