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

Mallinckrodt15 sites in 4 countries25 target enrollmentDecember 2004

ConditionsCrohn's Disease

InterventionsMethoxsalen +ECP Extracorporeal Photopheresis

DrugsMethoxsalen +ECP

Overview

Phase: Phase 2
Intervention: Methoxsalen +ECP
Conditions: Crohn's Disease
Sponsor: Mallinckrodt
Enrollment: 25
Locations: 15
Primary Endpoint: Crohns Disease Activity Index
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

his study will explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i.e., a CDAI decrease greater than or equal to 100 from baseline and/or a CDAI < 150) over a 12-week period in moderately active Crohn's disease (CDAI greater than or equal to 220 to < 450) patients who are refractory or intolerant to immunosuppressants and/or anti-TNF agents. This study will also assess response to continued treatment during a 12-week Extension Period in patients who have a clinical response at Week 12 of the Treatment Period and elect to participate in the Extension Period.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

June 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mallinckrodt

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed and dated informed consent must be obtained prior to conducting any study procedure.
•Patients must be greater than or equal to 18 years of age.
•Patients must have a body weight greater than or equal to 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 greater than or equal to 220 to \<
•Patients must have a CRP concentration \> 10.0 mg/L (1.0 mg/dL) or evidence of active inflammatory luminal Crohn's disease as demonstrated by superficial and/or deep ulcerations, pseudopolyps, and/or ulcerated stenosis on colonoscopy within 8 weeks of screening.
•Patients who are receiving corticosteroids must be on a prednisone equivalent dose less than or equal to 25 mg/day or an oral (PO) budesonide dose less than or equal to 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 MP, MTX, or 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 fistulae are permitted, provided: patients have predominantly luminal Crohn's disease, and fistulae are not associated with abscess formation.

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 during the 12-week Treatment Period.
•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 screening.
•Patients with a poor tolerability of venipuncture or a lack of adequate venous access for required treatments and blood sampling.