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.
Conditions
Interventions
Trade Name: Remsima
Product Name: Remsima
Product Code: CT-P13
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN
Sponsors
Marta Maia Boscá Watts
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate the efficacy (clinical and radiological remission in week 24) of the injection guided by ultrasound of anti-TNF in the treatment of the PD. Combined remission in week 24 (clinical and radiological) is considered the clinical observation of the closure of all external orifices that drained at baseline (clinical remission is defined as the closure of all external fistulous orifices that drained in the basal study when compressed with the fingers) and the absence of collections greater than 2 cm in the treated fistulous trajectories confirmed by Magnetic Resonance (MR). - To improve the local anti-TNF injection technique by using endoanal ultrasound and performing the procedure on an outpatient basis, in the endoscopy unit, with sedation. ; Secondary Objective: -To evaluate the clinical response (defined as the closure of at least 50% of all external orifices that drained in the baseline study) in week 24. -To quantify (in week 24) the improvement in the PDAI, CDAI and IBDQ. -Time (in weeks) when combined remission is achieved -Time (in weeks) when a relapse occurs. -To observed side effects, related to the drug or related to the procedure. -To evaluate the number of surgical interventions. ;Primary end point(s): The primary endpoints are those related to the clinical activity of the PD (PDAI, including whether it drains spontaneously or at gentle pressure) and the morphological description of the PD (collections and trajectory: its presence, inflammatory signs and its size / length, both resonance as by endoanal ultrasound). Combined remission in week 24 (clinical and radiological) is considered to be the clinical observation of the closure of all external orifices that drained at baseline and the absence of collections greater than 2 cm in treated fistulous tracts confirmed by magnetic resonance.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Personal and diagnostic history, clinical assesment, current treatment, inflammatory activity assesment.; Timepoint(s) of evaluation of this end point: Personal and diagnostic history, clinical assesment: at screening visit. Current treatment, inflammatory activity assesment: in all visits (screening, week 4, 8, 12, 16, 20 and 24). | — |
Countries
Spain
Contacts
Public ContactMarta Maia Boscá Watts
Marta Maia Boscá Watts
Outcome results
None listed