Vedolizumab Induction May Prevent Celiac Enteritis

Status Terminated

Clinical Trial Summary

Celiac disease (CD) is characterized as an autoimmune disorder whereby gluten (a protein found in wheat, barley, rye, malt) induces an immunological response in genetically susceptible individuals. The prevalence of CD has been estimated to affect 0.5-1% of the population worldwide. Long term sequelae are numerous and include risk of lymphoma, malabsorption leading to weight loss, anemia, multiple vitamin deficiencies, osteoporosis/osteopenia, secondary autoimmunity, etc. (1)

Clinical Trial Description

Adult subjects with CD will be recruited through our clinic. All patients enrolled will have established CD diagnosed > 6 months. All patients will have history of abnormal MARSH score on initial duodenal biopsy at diagnosis and MARSH 0 on repeat biopsy following a gluten free diet (GFD). All patients will also have positive celiac serologies (anti-TTG, anti-gliadin, etc.) at diagnosis, as well as, positive HLA DQ2/DQ8 genetic profile. At enrollment, all patients will have negative celiac serologies, indicative of serologic remission on a gluten free diet. Female subjects of childbearing potential (does not include those with history of tubal ligation/surgical sterilization, hysterectomy and/or oophorectomy) who are sexually active with a non-sterilized male partners agree to routinely use adequate contraception from signing informed consent, during study process and for an additional 18 weeks after the last dose of vedolizumab. A male subject who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing informed consent throughout the duration of the study and for 18 weeks after the last dose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02929316
Study type	Interventional
Source	AGA Clinical Research Associates, LLC
Contact
Status	Terminated
Phase	Phase 2
Start date	June 25, 2018
Completion date	October 5, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04349904` - Near-Focus NBI Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation
Recruiting	`NCT05581628` - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Completed	`NCT04593251` - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis	Phase 1
Completed	`NCT05810441` - Intestinal Transglutaminase Antibodies in Celiac Disease Diagnosis
Recruiting	`NCT05555446` - Bovine Colostrum to Prevent Absorption of Gluten	Early Phase 1
Completed	`NCT02754609` - Hookworm Therapy for Coeliac Disease	Phase 1
Terminated	`NCT01902368` - Celiac Disease Screening	N/A
Completed	`NCT02472704` - Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo	N/A
Completed	`NCT02312349` - Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
Completed	`NCT01172665` - Celiac Disease Database
Completed	`NCT01100099` - HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease	Phase 2/Phase 3
Completed	`NCT00639444` - Risk of Celiac Disease and Age at Gluten Introduction	N/A
Active, not recruiting	`NCT05425446` - Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients	Phase 1
Enrolling by invitation	`NCT02202681` - Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule	N/A
Completed	`NCT00362856` - Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects	Phase 2
Terminated	`NCT03866538` - Budesonide in Patients With Immune Mediated Enteropathies	Phase 4
Recruiting	`NCT05135923` - Glutenfree, Gut Microbiota and Metabolic Regulation	N/A
Completed	`NCT05052164` - Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women	N/A
Completed	`NCT03775499` - Probiotic BL NCC 2705 and Gluten Sensitivity	N/A
Completed	`NCT03707730` - A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease	Phase 2