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Ulcerative ColitisNCT06269185

Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

An observational study of Ulcerative Colitis and Inflammatory Bowel Diseases, run by Vastra Gotaland Region at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Infliximab and Adalimumab
How many people
271 participants
Where
1 siteSweden
Study dates
6 Mar 2024to 18 Oct 2024
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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: We will perform a retrospective multicenter observational cohort study according to the Newcastle-Ottawa Scale (NOS) quality instrument. Bionaive patients (i.e. no prior anti-TNF or other biologic treatment) with active UC, who started treatment with IFX or ADA at four major out-patient IBD-units (Inflammatory Bowel Disease) in the region Västra Götaland in Sweden, will be included in the study. Data regarding exposure for the two compared drugs, baseline characteristics and outcomes after three months and one year will be recieved by a structured review of medical records.

Who may be able to join

  • Age 18-100 years.
  • Diagnosis of ulcerative colitis confirmed by endoscopy and histology.
  • Mild, moderate and severe disease activity.
  • Initiation of IFX or ADA-treatment at one of the centers of the study.

Who cannot join

  • Clinical remission.
  • Previous colonic surgery (resection of colonic segment or colectomy).
  • Primary indication for anti-TNF therapy by other disease than UC.
  • Prior use of any anti-TNF or other biologic or small molecule therapy.
  • Rescue therapy (i.e. infliximab used on hospitalized patients receiving intravenous corticosteroids).

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Västra Götalandsregionen

    Gothenburg

Other trials in Sweden

About this study

Official title: Comparison of Short and Long-term Efficacy Between Infliximab and Adalimumab on Patients With Ulcerative Colitis - a Retrospective Observational Multicenter Cohort Study

Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission. However, several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations.

The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (IFX) and adalimumab (ADA) in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment.

Being tested
Infliximab, Adalimumab
Keywords
infliximab, adalimumab, anti-TNF therapy
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InfliximabDrug

    Infliximab is an antiinflammatory drug (anti-TNF therapy) commonly used in treatment of ulcerative colitis

  • AdalimumabDrug

    Adalimumab is an antiinflammatory drug (anti-TNF therapy) commonly used in treatment of ulcerative colitis

Study groups in NCT06269185
Study groupRoleWhat they receive
InfliximabBio-naive patients with ulcerative colitis who starts treatment with infliximab
Receives: Drug: Infliximab
AdalimumabBio-naive patients with ulcerative colitis who starts treatment with adalimumab
Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients achieving steroid-free clinical remission

    Partial Mayo score ≤2 with no subscore >1 and no use of steroids between 6 and 12 months after start of anti-TNF therapy (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity).

    Measured: One year after start of anti-TNF therapy

Secondary outcomes (7)

  1. Percentage of patients achieving clinical response

    A decrease in the partial Mayo score from baseline of 2 or more points, along with either a rectal bleeding subscore of 0 or 1 or a decrease in the rectal bleeding subscore of 1 point or more (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity).

    Measured: Three months after start of anti-TNF therapy

  2. Percentage of patients achieving clinical remission

    Partial Mayo score ≤2 with no subscore >1 (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity).

    Measured: Three months after start of anti-TNF therapy

  3. Percentage of patients achieving biochemical remission

    Fecal Calprotectin <250 mg/kg

    Measured: Three months after start of anti-TNF therapy

  4. Percentage of patients achieving clinical remission

    Partial Mayo score ≤2 with no subscore >1 (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity).

    Measured: One year after start of anti-TNF therapy

  5. Percentage of patients achieving biochemical remission

    Fecal Calprotectin <250 mg/kg

    Measured: One year after start of anti-TNF therapy

  6. Percentage of patients achieving endoscopic response

    A decrease in endoscopic Mayo score of 1 or more points (Endoscopic Mayoscore, range 0-3, with higher value indicating more severe disease activity).

    Measured: 3-12 months after start of anti-TNF therapy

  7. Percentage of patients achieving endoscopic remission

    Endoscopic Mayo score 0-1 (Endoscopic Mayoscore, range 0-3, with higher value indicating more severe disease activity).

    Measured: 3-12 months after start of anti-TNF therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2024
  2. Study start6 Mar 2024
  3. Primary completion18 Oct 2024
  4. Study completion18 Oct 2024

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
271 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06269185
Sponsor's protocol ID
2024_IFXvsADAinUC
Status last verified
Mar 2024
First submitted
9 Feb 2024
Last updated
28 Oct 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bonovas S, Lytras T, Nikolopoulos G, Peyrin-Biroulet L, Danese S. Systematic review with network meta-analysis: comparative assessment of tofacitinib and biological therapies for moderate-to-severe ulcerative colitis. Aliment Pharmacol Ther. 2018 Feb;47(4):454-465. doi: 10.1111/apt.14449. Epub 2017 Dec 4.

    PubMed 29205421

  • Singh S, Murad MH, Fumery M, Dulai PS, Sandborn WJ. First- and Second-Line Pharmacotherapies for Patients With Moderate to Severely Active Ulcerative Colitis: An Updated Network Meta-Analysis. Clin Gastroenterol Hepatol. 2020 Sep;18(10):2179-2191.e6. doi: 10.1016/j.cgh.2020.01.008. Epub 2020 Jan 13.

    PubMed 31945470

  • Gies N, Kroeker KI, Wong K, Fedorak RN. Treatment of ulcerative colitis with adalimumab or infliximab: long-term follow-up of a single-centre cohort. Aliment Pharmacol Ther. 2010 Aug;32(4):522-8. doi: 10.1111/j.1365-2036.2010.04380.x. Epub 2010 May 25.

    PubMed 20500733

  • Sandborn WJ, Sakuraba A, Wang A, Macaulay D, Reichmann W, Wang S, Chao J, Skup M. Comparison of real-world outcomes of adalimumab and infliximab for patients with ulcerative colitis in the United States. Curr Med Res Opin. 2016 Jul;32(7):1233-41. doi: 10.1185/03007995.2016.1168290. Epub 2016 Mar 30.

    PubMed 26986449

  • Pouillon L, Baumann C, Rousseau H, Choukour M, Andrianjafy C, Danese S, Peyrin-Biroulet L. Treatment Persistence of Infliximab Versus Adalimumab in Ulcerative Colitis: A 16-Year Single-Center Experience. Inflamm Bowel Dis. 2019 Apr 11;25(5):945-954. doi: 10.1093/ibd/izy322.

    PubMed 30329067

  • Lee YI, Park Y, Park SJ, Kim TI, Kim WH, Cheon JH. Comparison of Long-Term Outcomes of Infliximab versus Adalimumab Treatment in Biologic-Naive Patients with Ulcerative Colitis. Gut Liver. 2021 Mar 15;15(2):232-242. doi: 10.5009/gnl19433.

    PubMed 32616683

  • Ma C, Huang V, Fedorak DK, Kroeker KI, Dieleman LA, Halloran BP, Fedorak RN. Outpatient Ulcerative Colitis Primary Anti-TNF Responders Receiving Adalimumab or Infliximab Maintenance Therapy Have Similar Rates of Secondary Loss of Response. J Clin Gastroenterol. 2015 Sep;49(8):675-82. doi: 10.1097/MCG.0000000000000265.

    PubMed 25389599

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis and Inflammatory Bowel Diseases, run by Vastra Gotaland Region at 1 site in Sweden.

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 4 inclusion and 5 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 28 Oct 2024. 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 Sweden. 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?

Percentage of patients achieving steroid-free clinical remission (time frame: One year after start of anti-TNF therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06269185, which also lists 7 linked publications.

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 28 Oct 2024.

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