Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03839680
Other study ID # P/2019/412
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date April 15, 2019

Study information

Verified date January 2019
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab (VDZ) who achieve mucosal healing at week 54 of treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 15, 2019
Est. primary completion date April 15, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age over 18 years,

- established diagnosis of ulcerative colitis for at least 3 months

- moderate to severe active ulcerative colitis with a Mayo endoscopic sub-score = 1 before vedolizumab introduction

- patients receiving vedolizumab according to French drug labelling (previous exposure to anti-TNF, contraindicated or intolerant to anti-TNF),

- possibility of concomitant therapy including corticosteroids and immunosuppressors,

- patients naive to anti-integrin,

- no contraindication to proctosigmoidoscopy

Exclusion Criteria:

- age under 18 years

- ulcerative colitis not proven, Crohn's disease, or inderterminate colitis

- personal history of high-grade dysplasia or colorectal cancer

- surgery with ileo-anal anastomosis

- patients' refusal to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Endoscopy
The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body.

Locations

Country Name City State
France CHU de Besançon Besançon
France CHU de Montpellier Montpellier
France CHU de Nantes Nantes
France CHI de Haute-Saône Vesoul

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Risk factors of mucosal healing Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis:
Demographic data: age, gender, smoking habit
Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS)
Treatments:
Previous therapy used including number of TNF ? antagonist and reason for failure
Concomitant drugs: corticosteroids, immunosuppressors
Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy.
14 weeks
Other Risk factors of mucosal healing Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis:
Demographic data: age, gender, smoking habit
Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS)
Treatments:
Previous therapy used including number of TNF ? antagonist and reason for failure
Concomitant drugs: corticosteroids, immunosuppressors
Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy.
30 weeks
Other Risk factors of mucosal healing Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis:
Demographic data: age, gender, smoking habit
Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS)
Treatments:
Previous therapy used including number of TNF ? antagonist and reason for failure
Concomitant drugs: corticosteroids, immunosuppressors
Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy.
54 weeks
Other Endoscopic response defined by a decrease in Mayo endoscopic sub-score =1 or decrease in UCEIS = 2 points 14 weeks
Other Endoscopic response defined by a decrease in Mayo endoscopic sub-score =1 or decrease in UCEIS = 2 points 30 weeks
Other Endoscopic response defined by a decrease in Mayo endoscopic sub-score =1 or decrease in UCEIS = 2 points 54 weeks
Other Clinical response defined by a decrease in the total Mayo score = 3 points and = 30 %, with a decrease in the sub score for rectal bleeding = 1 or an absolute rectal-bleeding sub-score = 1 14 weeks
Other Clinical response defined by a decrease in the total Mayo score = 3 points and = 30 %, with a decrease in the sub score for rectal bleeding = 1 or an absolute rectal-bleeding sub-score = 1 30 weeks
Other Clinical response defined by a decrease in the total Mayo score = 3 points and = 30 %, with a decrease in the sub score for rectal bleeding = 1 or an absolute rectal-bleeding sub-score = 1 54 weeks
Other Clinical remission defined by a total Mayo score = 2 with no sub-score > 1 14 weeks
Other Clinical remission defined by a total Mayo score = 2 with no sub-score > 1 30 weeks
Other Clinical remission defined by a total Mayo score = 2 with no sub-score > 1 54 weeks
Other Histologic remission defined by a Nancy index score at 0 or 1 14 weeks
Other Histologic remission defined by a Nancy index score at 0 or 1 30 weeks
Other Histologic remission defined by a Nancy index score at 0 or 1 54 weeks
Primary Mucosal healing at defined by Mayo endoscopic sub-score = 1 or UCEIS = 1 54 weeks
Secondary Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0 14 weeks
Secondary Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0 30 weeks
Secondary Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0 54 weeks
Secondary Endoscopic pattern of mucosal healing 54 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05702879 - Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
Not yet recruiting NCT05953402 - A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Recruiting NCT03950232 - An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT03124121 - Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels Phase 4
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Withdrawn NCT04209556 - A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis Phase 2
Terminated NCT00061282 - Clotrimazole Enemas for Pouchitis in Children and Adults Phase 1/Phase 2
Recruiting NCT04398550 - SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis N/A
Recruiting NCT04314375 - Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis Phase 4
Active, not recruiting NCT04857112 - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis Phase 2
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Active, not recruiting NCT04033445 - A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2/Phase 3
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Active, not recruiting NCT06221995 - Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Recruiting NCT04767984 - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis Phase 2
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Recruiting NCT06071312 - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach Phase 1/Phase 2
Completed NCT03760003 - Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis Phase 2
Not yet recruiting NCT05539625 - Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis Phase 2