Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy

NCT04362735 | Unknown FDA Drug

• 1 other identifier: IISR-2020-103104
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

INTRODUCTION: Vedolizumab is a gut selective anti-integrin agent which binds to the alfa4beta7 integrin, preventing its coupling to the endothelial MadCAM-1. It reduces leucocyte trafficking from the endothelium consequently reducing intestinal tissue inflammation. There is scarce evidence on the use of vedolizumab in CD in Brazil, mostly in patients with no previous biological therapy, where the drug seems to have a more adequate therapeutic potential. Tha primary aim of the study is to analyze clinical remission rates at weeks 12, 26 and 52, and at last follow-up on naive CD patients submitted to vedolizumab therapy. Secondary outcomes will be clinical response rates at weeks 12, 26 and 52, and at last follow-up; endoscopic remission rates in colonoscopies performed; persistence of drug therapy over time; adverse events during treatment with vedolizumab and rates of abdominal surgery during therapy. METHODS: A retrospective, longitudinal, observational study will be performed with patients with CD who used Vedolizumab at any time of their treatment as the first biologic option, after failure of conventional therapy. Following the induction dose of 300 mg at weeks 0, 2 and 6, and maintenance of 300 mg every 8 weeks, patients will be followed up to 52 weeks (1 year) or more (last follow-up captured). Records of the clinical evaluations at week 12, 26 and 52, and last follow-up, will be checked according to the HBI and PGA to define clinical response or clinical remission. Colonoscopies will also be checked to evaluate mucosal healing. Electronic charts will be reviewed also to analyze adverse events and surgery during therapy.

Conditions

Crohn Disease

Keywords

vedolizumab

Outcome Measures

Primary Outcomes (3)

• Clinical remission

  HBI index ≤ 4

  12 weeks

• Clinical remission

  HBI index ≤ 4

  26 weeks

• Clinical remission

  HBI index ≤ 4

  52 weeks

Secondary Outcomes (5)

• Clinical response

  12 weeks

• Clinical response

  26 weeks

• Clinical response

  52 weeks

• Mucosal healing

  through study completion, an average of 52 weeks

• Need for major surgery during treatment

  through study completion, an average of 52 weeks

Study Arms (1)

Study group

All patients using vedolizumab for Crohn's disease as first biologic agent (all patients naive to previous biological therapy)

Drug: Vedolizumab

Interventions

Vedolizumab DRUG

Vedolizumab 300 mg at weeks 0, 2 and 6 as induction. Maintenance every 4 or 8 weeks, as on-label recommendations.

Study group

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

All patients using vedolizumab as first option of biological therapy for CD of any location.

You may qualify if:

• \- Patients with CD (any location)who used vedolizumab as the first biological agent during medical treatment, after failure of conventional therapy (5-ASA, steroids and/or immunomodulators such as azathioprine and methotrexate).

You may not qualify if:

• Patients with UC
• Patients with other causes of intestinal inflammation (ischemic or infectious colitis, for example) non-IBD related
• Patients with IBD-undetermined not defined as CD or UC
• Patients with vedolizumab who had previous exposure to anti-TNF agents
• Pregnant patients
• Pediatric patients (less than 18 years old)

Sponsors & Collaborators

• Pontifícia Universidade Católica do Paraná: lead
• Takeda: collaborator

Related Publications (3)

• Perin RL, Damiao AOMC, Flores C, Ludvig JC, Magro DO, Miranda EF, Moraes AC, Nones RB, Teixeira FV, Zeroncio M, Kotze PG. VEDOLIZUMAB IN THE MANAGEMENT OF INFLAMMATORY BOWEL DISEASES: A BRAZILIAN OBSERVATIONAL MULTICENTRIC STUDY. Arq Gastroenterol. 2019 Sep 30;56(3):312-317. doi: 10.1590/S0004-2803.201900000-58. eCollection 2019.

  PMID: 31633731 RESULT

• Kopylov U, Verstockt B, Biedermann L, Sebastian S, Pugliese D, Sonnenberg E, Steinhagen P, Arebi N, Ron Y, Kucharzik T, Roblin X, Ungar B, Shitrit AB, Ardizzone S, Molander P, Coletta M, Peyrin-Biroulet L, Bossuyt P, Avni-Biron I, Tsoukali E, Allocca M, Katsanos K, Raine T, Sipponen T, Fiorino G, Ben-Horin S, Eliakim R, Armuzzi A, Siegmund B, Baumgart DC, Kamperidis N, Maharshak N, Maaser C, Mantzaris G, Yanai H, Christodoulou DK, Dotan I, Ferrante M. Effectiveness and Safety of Vedolizumab in Anti-TNF-Naive Patients With Inflammatory Bowel Disease-A Multicenter Retrospective European Study. Inflamm Bowel Dis. 2018 Oct 12;24(11):2442-2451. doi: 10.1093/ibd/izy155.

  PMID: 29788318 RESULT

• Schreiber S, Dignass A, Peyrin-Biroulet L, Hather G, Demuth D, Mosli M, Curtis R, Khalid JM, Loftus EV Jr. Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease. J Gastroenterol. 2018 Sep;53(9):1048-1064. doi: 10.1007/s00535-018-1480-0. Epub 2018 Jun 4.

  PMID: 29869016 RESULT

MeSH Terms

Conditions

Crohn Disease

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Paulo Kotze, phd

  Professor of postgraduate program

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulo Kotze, phd

CONTACT

+5541996648989; pgkotze@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 27, 2020
• Study Start: August 1, 2020
• Primary Completion: January 20, 2021
• Study Completion: April 1, 2021
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share