Clinical trial NCT03378388: 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
Official title: Effectiveness and Safety of Treatment With Vedolizumab in Adult Patients With Ulcerative Colitis or Crohn's Disease in Real Life
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-12-19
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Detailed description: This is a prospective, non-interventional and pharmaco-epidemiological study of participants with IBD. The study will provide the real-life data of treatment effectiveness and safety of vedolizumab in adult participants with UC or CD.

The study will enroll approximately 300 participants. All participants will be enrolled in one observational group:

Vedolizumab

Data will be collected and observed for 24 months in the participants who will be freely chosen by physicians to prescribe vedolizumab at the end of consultation in the recruitment period.

This multi-center trial will be conducted in France. The overall time to participate in this study is 36 months, including participant's recruitment period of 12 months and treatment period of 24 months. Participants will make a minimum of 4 follow-up visits to the clinic in treatment period at Month 6, 12, 18, and 24.

Eligibility criteria: Inclusion Criteria:

1. Suffering from active disease of UC or CD according to the investigator's judgment.
2. 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.
3. Meeting the same criteria as those described at the pre-screening.
4. Prescription of vedolizumab during consultation.
5. Able to be followed a priori over a period of 24 months.

Exclusion Criteria:

1. With exclusion criteria for vedolizumab and any contra-indication to vedolizumab: hypersensitivity to the active substance or to any of its excipients, active severe infections, such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy (PML).
2. Participation in an interventional study (but not in another non-interventional study).
3. Unclassified colitis.
4. Stomy.

Primary outcomes:
measure: Number of Participants With Complete Steroid-free Clinical Remission at Month 24
timeFrame: Month 24
Secondary outcomes:
measure: Number of Participants with Complete Steroid-free Remission at Month 6, 12 and 18
timeFrame: Months 6, 12, and 18
measure: Duration of Treatment in Participants Treated with Vedolizumab
timeFrame: Baseline up to Month 24
measure: Number of Participants who had Treatment Failure When Treated With Vedolizumab
timeFrame: Baseline up to Month 24
measure: Number of Treatment Lines in Participants Treated with Vedolizumab
timeFrame: Baseline up to Month 24
measure: Number of Naïve Participants Ineligible to Anti TNF Alpha
timeFrame: Baseline up to Month 24
measure: Number of Non-naïve Participants Ineligible to Anti TNF Alpha
timeFrame: Baseline up to Month 24
measure: Number of Participants who Experience at Least one Treatment-emergent Adverse Event (TEAE)
timeFrame: Baseline up to Month 24
measure: Number of Participants with Non-serious Adverse Drug Reactions (ADRs)
timeFrame: Baseline up to Month 24
measure: Number of Participants with Special Situation Report (SSR)
timeFrame: Baseline up to Month 24
measure: Number of Participants with Product Quality Issues
timeFrame: Baseline up to Month 24
measure: Number of Participants with Markedly Abnormal Laboratory Values
timeFrame: Baseline up to Month 24
measure: Patient Reported Outcomes (PRO) 1: Quality of Life
timeFrame: Months 6, 12, 18 and 24
measure: PRO 2: Number of Participants who met Item 1 and 2 on the Partial Mayo Score and Item 2 and 3 on the HBI
timeFrame: Months 6, 12, 18 and 24
measure: Number of Participants With Concordance Between PRO-2 and Physicians Answers
timeFrame: Baseline up to 24 Months
measure: Number of Participants who had Relapses
timeFrame: Baseline up to Month 24
measure: Number of Participants who had Surgery
timeFrame: Baseline up to Month 24
measure: Number of Participants who had Complications due to Adverse Events (AEs)
timeFrame: Baseline up to Month 24
measure: Number of Participants who had Hospitalizations
timeFrame: Baseline up to Month 24
measure: Number of Participants who had Absenteeism
timeFrame: Baseline up to Month 24
measure: Number of Participants with Vedolizumab Effectiveness on Extra-intestinal Manifestations or Fistula
timeFrame: Baseline up to Month 24
measure: Number of Participants with Mucosal Healing Having Undergone Endoscopy
timeFrame: Months 6, 12, 18 and 24
measure: Percentage of Physicians Following the French National Consensus for the Management of IBD into Clinical Practice
timeFrame: Baseline up to Month 24
measure: Number of Participants with Comorbodities, Previous Line of Therapy and Concomitant Treatments
timeFrame: Baseline up to Month 24
Other outcomes:
Locations:
city: BAYONNE Cedex
country: France
facility: Centre Hospitalier Cote Basque
city: Blois Cedex
country: France
facility: Ch de Blois
city: Grasse
country: France
facility: Clinique du palais
city: Jossigny
country: France
facility: Ghef Ch Marne La Vallee
city: Lyon Cedex 03
country: France
facility: Hopital Edouard Herriot
city: Lyon Cedex 07
country: France
facility: Ctre Hosp St Joseph Et St Luc
city: Montpellier Cedex 5
country: France
facility: Hopital Saint Eloi-Chru Montpellier
city: Pierre Benite Cedex
country: France
facility: Ch Lyon Sud
city: St Jean de Luz Cedex
country: France
facility: Polyclinique Cote Basque Sud
city: St Priest En Jarez Cedex
country: France
facility: HOPITAL NORD-CHU de SAINT-ETIENNE
city: Toulouse
country: France
facility: Clinique Ambroise Pare
city: Vandoeuvre Les Nancy Cedex
country: France
facility: HOPITAUX DE BRABOIS-CHRU de NANCY
city: Venissieux Cedex
country: France
facility: Gh mutualiste les portes du sud
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: