Can FITC-Adalimumab predict the efficacy of Adalimumab in patients with colitis ulcerosa, when it is applied to the intestinal mucosa during an endoscopic examination? Is FITC-Adalimumab safe and tolerable in this setting? Open-label, one-arm clinical trial in one study site

Phase 1

• Conditions: lcerative colitis; MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-001594-14-DE
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-22
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

?Able to give informed consent
?Insufficient response or contra-indications to systemic treatment with glucocorticoids or immunosuppressive agents or glucocorticoid dependency
?If concomitant medication,
•Systemic glucocorticoids =20 mg/d prednisolon equivalent: stable for one week at least
•Systemic glucocorticoids <20 mg/d prednisolon equivalent: stable for one week at least
•MMX budesonid (9mg/day) stable for eight weeks at least
•5-aminosalicylate: stable dose for two weeks at least and initiated since eight weeks at least
•Immunsuppressive agents (except ciclosporine A and tacrolimus): treatment for three months at least and stable dose for eight weeks at least prior to enrolment
?For subjects with child-bearing potential: adequate contraception
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Colitis of unclear origin
Stenosis within the Framework of colitis ulcerosa
Fulminant course of disease
Toxic megacolon
Colectomy (done or planned), ileo-anal pouch, ileorectostomy or ileostoma
Proctitis only
Pre-treatment with adalimumab
Administration of vedolizumab, anti-TNF treatment within the last four weeks prior to enrolment
Administration of methotrexate, ciclosporine A or tacrolimus within the last eight weeks prior to enrolment
Compromised coagulation (Quick <50% and/or PTT >55 sec and/or thrombocytes <50.000/µl)
Pregnant or breast-feeding female
Contraindications for adalimumab treatment
Known hypersensitivity to an ingredient of the IMP or to a MP with similar chemical structure

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Safety and tolerability of small doses of FITC-adalimumab after two-time topical application to the intestinal<br>mucosa during an endomicroscopic investigation of patients affected by ulcerative colitis;Secondary Objective: ?Quantification of mTNF-expressing mucosal cells<br>?Predictive power for response to adalimumab treatment;Primary end point(s): ?ARs grade =2 at the site of FITC-adalimumab administration<br>?AEs, ARs, SAEs and SARs during the course of the study;Timepoint(s) of evaluation of this end point: ?Up to 24 hours after IMP administration<br>?Visit 2 (after IMP administration) to visit 7