TREATMENT OF PERIANAL DISEASE WITH LOCAL INJECTION OF REMSIMA GUIDED BY ULTRASOUND

Phase 1

• Conditions: Perianal disease (PD): alteration associated with inflammatory bowel disease (IBD) that includes fissures, ulcers, fistulas or abscesses, and is one of the most difficult aspects of treating IBD. Both by direct affectation of the sphincters and by the repeated surgeries that may be necessary to avoid septic conditions, there may be pain and incontinence to gases and feces, which supposes an important reduction of the quality of life of the patients.; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-000668-27-ES
• Lead Sponsor: Marta Maia Boscá Watts

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

-Patients diagnosed with Crohn's disease with complex PD.
-Older than 18 years-old.
-EPA with no response, or partial response at the discretion of the clinician, to usual medical treatment and / or drainage of abscesses, treatment of fistulas and / or placement of perianal setons.
-PD with less than two internal holes and three external holes.
-PDAI> 4.
- Absence of rectal involvement or mild endoscopic activity (SES-CD <5).
- Willing to enter the study and sign the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients with PD not associated with IBD.
-Patients with moderate or severe allergic reactions due to anti-TNF.
-PD with more than two internal holes or three external holes.
-Rectovaginal fistulas.
-Moderate or severe proctitis.
-Anal or rectal stenosis that prevents an endoscopic ultrasound.
-Patients with more than two fistulous trajectories.
-Patients with perianal abscesses not drained of more than 2 cm.
-PDAI <4.
-Patients receiving specific local treatments for perianal disease such as stem cell injection. It must have been more than a year since the patient was treated with stem cells to be included in this study.
-Definitive ileostomy carrier.
-Pregnancy or breastfeeding, or desire for it during next year.
-Recent surgical treatment with advancement sleeve flaps or others that were not drainage and / or seton placement.
-Any other condition that in the opinion of the investigator prevents the patient from completing the study.
-Any other condition that reduces the life expectancy to less than 1 year, including knowledge of cancer.
-Patients who do not accept their participation in the study and / or do not sign the informed consent document.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified