E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inflammatory bowel disease (Crohn's disease) |
Chronisch entzündliche Darmerkrankungen (Morbus Crohn) |
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E.1.1.1 | Medical condition in easily understood language |
chronic inflammatory bowel disease |
Chronisch entzündliche Darmerkrankungen |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
Es soll die Vorhersagekraft von Kontrastmittel-verstärktem Ultraschall am Dünndarm zur Beurteilung des Ansprechens auf eine neu begonnen Therapie mit einem TNF-alpha-Blocker gezeigt werden (stratifiziert durch den Harvey Bradshaw Index in Responder und Non Responder). |
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E.2.2 | Secondary objectives of the trial |
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) |
Bewertung der Vorhersagekraft von Kontrastmittel-verstärktem Ultraschall bei Patienten mit Morbus Crohn und neu begonnener Therapie mit einem TNF-alpha-Blocker durch biometrische Parameter. Korrelation der Ergebnisse des Kontrastmittel-verstärkten Ultraschalles mit - MRT - Veränderungen beim fäkalen Calprotectin (Visite 1 versus Visite 2, 3 und 4) Korrelation der Ergebnisse des MRT mit - Veränderungen im Aktivitätsscore - Veränderungen beim fäkalen Calprotectin (Visite 1 versus Visite 2, 3 und 4) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
1) Männer und Frauen mit einer seit mindestens drei Monaten etablierten Diagnose von Morbus Crohn (gemäß einer bei einer Ileocolonoskopie gewonnenen Histologie) 2) Imstande und bereit einen Einvertsändnisbogen (Patienteninformation) zu unterschreiben. 3) Vorliegen von ilealen oder ileocolonischen M. Crohn (abgesichert durch Bildgebung oder Histologie) 4) Klinische Aktivität der Erkrankung gemessen an einem Werte von 8 oder mehr im Harvey Bradshaw Index 5) Geplante Eskalation der Therapie zu einem TNF-alpha-Blocker. |
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E.4 | Principal 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 |
1) Colitis ulceroca oder IBDU 2) Rein colonischer M. Crohn 3) Vorliegen von Kontraindikationen für die Durchführung einer MRT 4) Vorliegen von Kontraindikationen für die Durchführung einer kontrastmittel-verstärkten Ultraschalluntersuchung 5) Kontraindikationen gegen eine Therapie mit einem TNF-alpha-Blocker 6) Unvermögen die vorgegebenen Abläufe einzuhalten und/oder Informationen zur Verfügung zu stellen, die zur Beurteilung des Ansprechens zu erheben sind 7) Unwillig oder außerstandefür eine Blutabnahme 8) Schwangere sowie Frauen, die eine Schwangerschaft im Zeitraum der klinischen Studie planen 9) Relevante KHK, Rechts-zu-Links, bidirektionaler oder vorübergehender Shunt am Herzen |
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E.5 End points |
E.5.1 | 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). |
Vorhersagekraft von Kontrastmittel-verstärktem Ultraschall am Dünndarm zur Beurteilung des Ansprechens auf eine neu begonnen Therapie mit einem TNF-alpha-Blocker, gemessen zu Woche 12 (stratifiziert durch den Harvey Bradshaw Index in Responder und Non Responder). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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
|
Korrelation der Ergebnisse des CEUS mit - MRT - Veränderungen im fäkalen Calprotectin Korrelation der Ergebnisse des MRT mit - Veränderungen der Krankheitsaktivität - Veränderungen im fäkalen Calprotectin |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Visit 1 versus Visit 2 (week 4), 3 (week 12) and 4 (week 24) |
Visite 1 verglichen mit Visite 2 (Woche 4), 3 (Woche 12) und 4 (Woche 24) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Letzter Besuch des letzten Patienten |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |