E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis |
Kronisk pouchitis efter proktokolektomi og rekonstruktion med en J-pouch og med colitis ulcerosa som primære diagnose |
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E.1.1.1 | Medical condition in easily understood language |
Chronic inflammation in a reservoir of small intestine after removal of the colon and with ulcerative colitis as primary diagnosis |
Kronisk betændelsestilstand i et tyndtarmsreservoir (pouch) efter fjernelse af tyktarmen med colitis ulcerosa som primære diagnose |
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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 | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036463 |
E.1.2 | Term | Pouchitis |
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 |
The primary objective is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis.
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Det primære formål er at evaluere den kliniske effekt af biologisk behandling (adalimumab) hos patienter med kronisk pouchitis.
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E.2.2 | Secondary objectives of the trial |
Secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity. |
De sekundære formål er at evaluere effekten af biologisk behandling på den endoskopiske og den histologiske inflammatoriske aktivitet.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Operated with proctocolectomy and construction of an IPAA
• Prior to surgery diagnosed with ulcerative colitis according to established clinically, radiologic, endoscopic and histological criteria.
• Diagnosed with chronic pouchitis as defined above
• PDAI ≥ 7, with the clinically part of PDAI >2 and the endoscopic part of PDAI >3
• Age >18 years
• Negative stool cultures for bacterial bowel pathogens and negative stool microscopy for parasites
• Serology negative for chronic hepatitis B
• Negative examination for tuberculosis (including x-ray of thorax and a interferon gamma test)
• Signed informed consent
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• Opereret med proktokolektomi og konstruktion af en IPAA
• Forud for kirurgi diagnosticeret med colitis ulcerosa ifølge etablerede kliniske, radiologiske, endoskopiske og histologiske kriterier.
• Diagnosticeret med kronisk pouchitis, som defineret ovenfor
• PDAI> 7, med den kliniske del af PDAI> 2 og den endoskopiske del af PDAI> 3
• Alder> 18 år
• Anvendelse af sikker antikonception hos fertile kvinder og negativ urin HCG ved inklusion
• Negativ fæces dyrkning for tarmpatogene bakterier og negative fæces mikroskopi for parasitter
• Negativ serologi for kronisk hepatitis B og HIV
• Negativ undersøgelse for tuberkulose (herunder rgt.af thorax og en interferon gamma-test)
• Underskrevet informeret samtykke
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E.4 | Principal exclusion criteria |
• Treatment with glucocorticoids within the last 4 weeks
• Diagnosed with Crohn’s disease
• Need of an interpreter or if patients do not understand oral or written information.
• Surgical complications as anal stenosis, leak of the anastomosis, or fistula arising from the pouch
• Abuse of medicine, alcohol or drugs
• Ongoing treatment with NSAID (non steroid anti inflammatory drug)
• Pregnancy or nursing
• A diverting stoma
• Malignancy or other severe chronic disease or expected longevity less than one year
• Patients diagnosed with immune deficiency
• Ongoing infectious disease
• Contraindications against treatment with tumor necrosis factor-alpha antibody, such as heart disease, former cancer disease, in vivo vaccination within the last 4 weeks
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• Behandling med glukokortikoider inden for de sidste 4 uger
• Diagnosticeret med Crohns sygdom
• Behov for en tolk, eller hvis patienten ikke forstår mundtlig eller skriftlig information.
• Kirurgiske komplikationer som anal stenose, anastomoselækage eller fistler udgående fra pouchen
• Medicin-, alkohol- eller narkotikamisbrug
• Igangværende behandling med NSAID (non steroide anti inflammatoric drug)
• Graviditet og amning
• En aflastende stomi
• Malignitet eller andre alvorlige kroniske sygdomme eller forventet levetid mindre end et år
• Patienter diagnosticeret med immundefekt
• Pågående infektiøs sygdom
• Kontraindikationer mod behandling med tumornekrosefaktor-alfa-antistof, såsom hjertesygdomme, tidligere kræftsygdom, in vivo vaccination inden for de sidste 4 uger
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of patients with chronic pouchitis achieving a clinical improvement, defined as a reduction in clinically Pouchitis Disease Activity Index (PDAI) ≥ 2 at any time within the 12 weeks of treatment with adalimumab (Humira). |
Antallet af patienter med kronisk pouchitis, der opnår en klinisk forbedring defineret som en reduktion i klinisk Pouchitis Disease Activity Index (PDAI) ≥ 2 når som helst inden for 12 ugers behandling med adalimumab (Humira). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
(1) The number of patients with a clinical improvement at week 12
(2) The number of patients with pouchitis in remission at week 12 (total PDAI <=4)
(3) Effect of adalimumab (Humira) on the endoscopical and histological activity in chronic pouchitis.
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(1) Antallet af patienter med en klinisk forbedring ved uge 12
(2) Antallet af patienter med remission i uge 12 (total PDAI ≤ 4)
(3) Effekt af adalimumab (Humira) på endoskopisk og histologisk aktivitet ved kronisk pouchitis
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | Yes |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |