E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Luminal Crohns Disease, moderate to severe, refractory to steroids and/or antimetabolitets and controlled with anti-TNF therapy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
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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 investigate in a randomized comparative cohort study if patients in clinical remission or full response on infliximab maintain in remission when changed to systematic adalimumab therapy compared to maintenance infliximab and to enquire about their preferred treatment strategy. Primary endpoint: The proportion of patients in clinical remission defined as a CDAI<150. |
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E.2.2 | Secondary objectives of the trial |
1. The median numbers of flares experienced while patients are in the study. A flare will be defined as an increase in CDAI of 100 points above baseline (and more than 150). 2. The proportion of patients needing rescue therapy with short courses or oral corticosteroids and the median number of steroid courses in both groups or switch to another anti-TNF agent. 3. The proportion of patients who develop injection-site or infusion related reactions and require institution of prophylactic treatment for infusion related reactions while in the study. 4. Quality of life assessment based on the disease specific IBD Questionaire (IBDQ) and patient preference based on a newly developed questionnaire. (appendix 1). 5. The median number of infusion-related or injection-site related reactions. 6. The occurrence of adverse events 7. The change in antibody status and trough levels for adalimumab and infliximab after the infusion or injection
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men and women of 18 years and older willing and able to give written informed consent. 2. Patients in clinical remission and/or complete response (as judged by the investigator) (CDAI<200) on infliximab treatment (5mg/kg q8 weeks) for at least 6 months. 3. Patients with a documented clinical response to infliximab of 8 weeks duration. Patients with a draining perianal fistula at the time of diagnosis, who receive infliximab for luminal disease are eligible.
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E.4 | Principal exclusion criteria |
1. Patients receiving infliximab doses exceeding 5 mg/kg 2. Incomplete response to infliximab (CDAI>200) 3. Pregnant or lactating women. Men and women of childbearing potential should use a effective double barrier method for contraception. 4. Patients with intercurrent medical conditions or laboratory abnormalities that preclude further administration of anti-TNF agents such as demyelinating diseases or severe heart failure. 5. Patients with an imminent need for surgery such as those with a symptomatic fibrotic stricture. 6. Patients with a draining abdominal enterocutaneous fistula.
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients in clinical remission defined as a CDAI<150 at 54 weeks |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | Information not present in EudraCT |
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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Last visit in last patient enrolled |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |