A Study to Observe the Safety and Efficacy of Vedolizumab in Biologically Naive Participants With Ulcerative Colitis (UC) or Crohn´s Disease (CD)

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

CHRONOS - A Multicenter, Non - Interventional Study to Observe the Safety and Efficacy of Vedolizumab (Entyvio) in Patients With Ulcerative Colitis or Crohn´s Disease That Are Biologic naïve, Observed in Daily Practice in Austria

ClinicalTrials.gov ID

NCT02986724

Acronym / sponsor ID

CHRONOS / Vedolizumab-4017

Conditions

Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases

Keywords

Drug therapy

Study type

Observational

Recruitment status

Completed

Enrolment

60 participants (actual)

Lead sponsor

TakedaIndustry (pharma, biotech, devices)

Study start

4 Jan 2017 (actual)

Primary completion

31 Aug 2020 (actual)

Study completion

31 Aug 2020 (actual)

First posted

8 Dec 2016 (estimated)

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.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Biologically naïve participants with UC or CD undergoing treatment with Vedolizumab (Entyvio) will be evaluated for safety and efficacy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Percentage of Participants With UC Achieving Clinical Response Based on Partial Mayo Score

   Time frame: Baseline up to 52 Weeks

   Clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and >=25% from baseline, with an accompanying decrease in rectal bleeding subscore of >=1 point from baseline or absolute rectal bleeding subscore of <=1 point. Mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. Outcome measure is planned to be assessed in bio-naive participants who receive vedolizumab treatment.

2. Percentage of Participants With CD Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI)

   Time frame: Baseline up to 52 Weeks

   Clinical response is defined as a decrease in HBI score of >=3 points from baseline. HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower well being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease.

3. Number of Bio-naïve Participants Reporting One or More Treatment-emergent Adverse Events

   Time frame: Baseline up to 52 Weeks

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 25 Sep 2020.
• Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Related trials for Crohn Disease

• Not yet recruitingPhase 1

  An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates

  Ulcerative Colitis, Crohn's Disease

• RecruitingObservational study

  Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease

  Inflammatory Bowel Disease, Crohn's Disease

• RecruitingObservational study

  Ibd CAncer and seRious Infections in France (I-CARE 2)

  IBD, Ulcerative Colitis

• RecruitingObservational study

  Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study

  Crohn Disease (CD), Colitis Ulcerative

• Enrolling by invitationPhase 4

  MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease

  Inflammatory Bowel Diseases, Crohn Disease

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.

1 site in 1 country: see every site and its status.