A Study to Assess the Effectiveness and Safety of Treatment With Vedolizumab in Adult Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real Life

NCT03378388 | Terminated

• 2 other identifiers: Vedolizumab-5039U1111-1203-0268
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Steroid-free Clinical Remission at Month 24

  Clinical remission is defined as Harvey Bradshaw-index (HBI) score less than or equal to (\<=) 4 and partial mayo clinic score \<=3. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0-4), abdominal pain (0-3), number of liquid stools per day, abdominal mass (0-3), and complications (score 1 per item). Total score is sum of individual parameters. Score ranges from minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores means more severe disease. Mayo score is an instrument designed to measure disease activity of UC and consists of 3 sub scores: 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 means more severe disease.

  Month 24

Secondary Outcomes (23)

• Number of Participants with Complete Steroid-free Remission at Month 6, 12 and 18

  Months 6, 12, and 18

• Duration of Treatment in Participants Treated with Vedolizumab

  Baseline up to Month 24

• Number of Participants who had Treatment Failure When Treated With Vedolizumab

  Baseline up to Month 24

• Number of Treatment Lines in Participants Treated with Vedolizumab

  Baseline up to Month 24

• Number of Naïve Participants Ineligible to Anti TNF Alpha

  Baseline up to Month 24

Study Arms (1)

Vedolizumab

Participants diagnosed with UC or CD, who fail or are intolerant to a previous biologic treatment or with contra-indication to anti-tumor necrosis factor alpha (TNF alpha) after failure of conventional treatments without exclusion except participant refusal, and were potentially eligible for a treatment with vedolizumab will be observed from the first prescription during consultation over a period of 24 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who are biologically naive and are diagnosed with active disease of UC or CD according to investigator's judgement.

You may qualify if:

• Suffering from active disease of UC or CD according to the investigator's judgment.
• In failure or intolerant to a previous biologic treatment, or with contra-indication to anti-TNFalpha after failure of conventional treatments, regardless of the line of treatment.
• Meeting the same criteria as those described at the pre-screening.
• Prescription of vedolizumab during consultation.
• Able to be followed a priori over a period of 24 months.

You may not qualify if:

• Participation in an interventional study (but not in another non-interventional study).
• Unclassified colitis.
• Stomy.

Sponsors & Collaborators

• Takeda: lead

Study Sites (13)

Centre Hospitalier Cote Basque

Bayonne, France

Location

Ch de Blois

Blois, France

Location

Clinique du palais

Grasse, France

Location

Ghef Ch Marne La Vallee

Jossigny, France

Location

Ctre Hosp St Joseph Et St Luc

Lyon, France

Location

Hopital Edouard Herriot

Lyon, France

Location

Hopital Saint Eloi-Chru Montpellier

Montpellier, France

Location

Ch Lyon Sud

Pierre-Bénite, France

Location

Polyclinique Cote Basque Sud

Saint-Jean-de-Luz, France

Location

HOPITAL NORD-CHU de SAINT-ETIENNE

Saint-Priest-en-Jarez, France

Location

Clinique Ambroise Pare

Toulouse, France

Location

HOPITAUX DE BRABOIS-CHRU de NANCY

Vandœuvre-lès-Nancy, France

Location

Gh mutualiste les portes du sud

Vénissieux, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 19, 2017
• Study Start: February 13, 2018
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

FR (13)