Inflammatory bowel disease (Crohn's disease) MedDRA version: 18.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: SonoVue
Product Name: SonoVue
Pharmaceutical Form: Gas and solvent for dispersion for injection/infusion
INN or Proposed INN: sulphur hexafluoride
CAS Number: 2551-62-4
Other descriptive n
Sponsors
Medical University of Vienna (MUW)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women above the age of 18 with an established diagnosis of Crohn’s disease for at least 3 months (according to a histology from an ileocolonoscopy evidentiary for Crohn’s disease) 2) Able and willing to provide written informed consent 3) Crohn’s disease with evidence of ileal or ileocolonic disease 4) Clinically active disease as evidenced by a Harvey Bradshaw index of 8 or above 5) Planned step--up in immunosuppressive therapy with an antiTNFalpha agent 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 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1) Ulcerative colitis or indeterminate colitis 2) Isolated colonic Crohn’s disease 3) Contraindications for undergoing magnetic resonance imaging with computed tomography or other methods planned to be applied for disease/response assessment as substitute for MRI 4) Contraindications to undergo contrast enhanced ultrasound examinations 5) Contraindications against therapy with an antiTNFalpha agent 6) Inability to adhere to follow up schedule and/or provide information necessary to assess response parameters 7) Unwilling or unable to undergo blood sampling 8) Female subjects pregnant or planning pregnancy within the timeframe of the study participation 9) Significant coronary heart disease, right-to-left, bidirectional, or transient right-to-left cardiac shunt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the predicitve capacity of contrast enhanced ultrasound for response assessment in Crohn’s disease patients under newly established therapy with antiTNFalpha treatment (stratified by the Harvey Bradshaw Index in responders and non responders).;Secondary Objective: Assess the predictive capacity of CEUS for response assessment in Crohn’s disease patients under newly established therapy with antiTNFalpha treatment with biometrical parameters as stratifiers for response (fCP). Correlate results from CEUS with - MRI - Change of fecal calprotectin (Visit 1 versus Visit 2, 3 and 4) Correlate results form MRI with - Change in disease activity scores - Change of fecal calprotectin (Visit 1 versus Visit 2, 3 and 4);Primary end point(s): To assess the predicitve capacity of contrast enhanced ultrasound for response assessment in Crohn’s disease patients under newly established therapy with antiTNFalpha treatment, measured at week 12 (stratified by the Harvey Bradshaw Index in responders and non responders).;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Correlate results from CEUS with - MRI - Change of fecal calprotectin Correlate results form MRI with - Change in disease activity scores - Change of fecal calprotectin ;Timepoint(s) of evaluation of this end point: Visit 1 versus Visit 2 (week 4), 3 (week 12) and 4 (week 24) | — |
Countries
Austria
Contacts
Public ContactWorking Party IBD
Universitätsklinik fu¨r Innere Medizin III, Klinische Abteilung fu¨r Gastroenterologie und Hepatologie
Outcome results
None listed