EUCTR2004-002693-37-AT进行中（未招募）不适用
A MULTICENTER, OPEN-LABEL, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY WITH UVADEX IN THE TREATMENT OF PATIENTS WITH MODERATELY ACTIVE CROHN’S DISEASE WHO ARE REFRACTORY OR INTOLERANT TO IMMUNOSUPPRESSANTS AND/OR ANTI-TNF AGENTS - N/A
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Therakos
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •- 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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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.
研究者
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