E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
patients with chronic inflammatory bowel disease, more specific Crohn's disease |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
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 evaluate the effects of infusion of a FO-based lipid emulsion on TNF-α production in patients with Crohn's disease |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effects of infusion of a FO-based lipid emulsion on other relevant immune functions in patients with Crohn's disease |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Histologically proven Crohn’s disease in the ileum or colon
-Previous bowel surgery because of Crohn’s disease activity (> 6 months before screening)
-Currently in remission (Crohn’s Disease Activity Index (CDAI) <150)
-No use of one the following immunosuppressive drugs (or its variants) within the last 6 months : corticosteroids (with exclusion of inhalation- or dermatological ointment containing steroids), methotrexate, thiopurines, anti-TNF-α agents, cyclosporine, tacrolimus, sirolimus or Cellcept®
-Willingness and ability to give written informed consent
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E.4 | Principal exclusion criteria |
- Incapacitated people (people unable to reasonably judge -what is in their own interests)
- Patients with other active inflammatory / immune mediated underlying diseases
- Smoking > 5 cigarettes a day [70]
- Diet with >2 portions of fatty fish (tuna, salmon, mackerel, herring, trout and haring) a week
- History of metabolic disorder (especially diabetes or lipid disorders)
- Crohn’s disease activity, including the presence of active fistulas
- On need for medical (other that 5-ASA preparations) or surgical treatment for Crohn’s disease activity
- Use of NSAIDs or asprin
- C-reactive protein levels of >10 mg/l
- History of venous or arterial thrombosis
- Active malignancy
- Presence of severe pulmonary, cardiovascular, renal, liver, coagulation or hematological disease
- Pregnancy or lactation
- Age <18 yrs
- Allergy for one of the following components: fish, chicken, eggs or soy beans
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E.5 End points |
E.5.1 | Primary end point(s) |
difference in pre- and post supplementation TNF-a production by LPS stimulated Peripheral Blood Mononuclear Cells |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
pre supplementation (day 0)
post supplementation early effects: day 4 (= 1 day after the last infusion)
post supplementation late effects: day 11 (= 8 days after the last infusion) |
|
E.5.2 | Secondary end point(s) |
- Ex vivo production of relevant cytokines
- Serum levels of TNF-α
- Analysis of SNPs related with a high inherent TNF-α production
- leukocyte function tests |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
pre supplementation (day 0)
post supplementation early effects: day 4 (= 1 day after the last infusion)
post supplementation late effects: day 11 (= 8 days after the last infusion) |
|
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
nutritious substance: Intralipid 10% |
|
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |