E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Moderately Active Crohn’s Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011401 |
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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 objective of this study is to explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i.e., a CDAI decrease ≥ 100 from baseline and/or a CDAI < 150) over a 12-week period in moderately active Crohn’s disease (CDAI ≥ 220 to < 450) patients who are refractory or intolerant to immunosuppressants and/or anti-TNF agents. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Signed and dated informed consent must be obtained prior to conducting any study procedure. • Patients must be ≥ 18 years of age. • Patients must have a body weight ≥ 40 kg (88 lb). • Patients must have had Crohn’s disease for at least 6 months duration (with colitis, ileitis, or ileocolitis) confirmed by radiography or endoscopy. • Patients must have a CDAI ≥ 220 to < 450. • Patients must have a CRP concentration > 10.0 mg/L (1.0 mg/dL). • Patients who are receiving corticosteroids must be on a prednisone equivalent dose ≤ 25 mg/day or an oral (PO) budesonide dose ≤ 9 mg/day. • Patients who are receiving any of the following concomitant Crohn’s disease medications must have been on a stable dose of these medications for the specified period of time prior to confirmation of eligibility (this time period may include screening): - aminosalicylates, antibiotics, and immunosuppressants (i.e., 6-mercaptopurine, 6- MP; methotrexate, MTX; or azathioprine, AZA) for at least 4 weeks, - corticosteroids or PO budesonide for at least 2 weeks, - anti-TNF agents (i.e., infliximab or adalimumab) for at least 8 weeks. • Patients who have failed treatment with immunosuppressants and/or anti-TNF agents. • Patients who have discontinued treatment with any of the following Crohn’s disease medications must have done so for the specified period of time prior to confirmation of eligibility (this time period may include screening): - antibiotics, aminosalicylates, corticosteroids, or PO budesonide for at least 2weeks, - immunosuppressants (i.e., 6-MP, MTX, or AZA), or anti TNF agents (i.e., infliximab or adalimumab) for at least 8 weeks, - other investigative therapies - non biologics for at least 4 weeks and biologics for at least 8 weeks. • Patients who have fistulae are permitted, provided: - patients have predominantly luminal Crohn’s disease, and - fistulae are not associated with abscess formation. • Patients must have a platelet count ≥ 50,000/µL (50.0 x 109/L).
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E.4 | Principal exclusion criteria |
• Patients who are concomitantly using biologic agents other than anti-TNF agents, cyclosporine (CSA), tacrolimus (FK506), mycophenolate mofetil (MMF), or investigational Crohn’s disease therapies. • Patients who, in the opinion of the Investigator, may not be able to remain on a stable dose of a concomitant Crohn’s disease medication for at least 12 weeks. • Patients with currently symptomatic untreated diarrhea, due to conditions other than inflammatory Crohn’s disease (e.g., bacterial or parasitic gastroenteritis, bile salt diarrhea, or bacterial overgrowth). • Patients with symptomatic intestinal strictures. • Patients with stomas. • Patients with other local manifestations of Crohn’s disease such as abscesses, or other disease manifestations for which surgery might be indicated, or which might preclude utilization of a CDAI to assess response to therapy (such as “short gut” syndrome). • Patients who are unable to tolerate the extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe chronic obstructive pulmonary disease, severe asthma, renal failure, or hepatic failure. • Patients receiving total parenteral nutrition, as the sole source of nutrition, within 3 weeks of screening. • Female patients whose hemoglobin (Hgb) is < 8.5 g/dL or male patients whose Hgb is < 10.0 g/dL at the first screening visit.
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E.5 End points |
E.5.1 | Primary end point(s) |
clinical response (i.e., a CDAI decrease ≥ 100 from baseline and/or a CDAI < 150) over a 12-week period |
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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 | Yes |
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 | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 16 |