Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease

This study has been completed.
Sponsor:
Collaborator:
ICON
Information provided by:
Therakos
ClinicalTrials.gov Identifier:
NCT00221026
First received: September 13, 2005
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Drug: Methoxsalen +ECP
Procedure: Extracorporeal Photopheresis
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Therakos:

Primary Outcome Measures:
  • Crohns Disease Activity Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The CDAI is a questionaire giving the change of disease acitvity.This study wil llook or a decrease in CDAI score of at least 100.


Enrollment: 25
Study Start Date: December 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: drug
ECP + Uvadex given for 12 weeks.
Drug: Methoxsalen +ECP
ECP + Uvadex given at weeks 1-12 weeks.
Other Name: Uvadex
Procedure: Extracorporeal Photopheresis
ECP given at weeks 1 through 12.
Other Name: uvadex+ECP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 450.
  • 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.
  • Patients must have a platelet count greater than or equal to 50,000/microL (50.0 x 109/L).
  • Female patients must be: postmenopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control (acceptable methods include hormonal contraceptives, intrauterine device, and spermicide and barrier). Abstinence or partner/spouse sterility may also qualify at the Investigator's discretion. If a female patient is of childbearing potential, she must have a negative urine pregnancy test at screening. Male patients must also commit to using adequate contraceptive precautions (condoms). All patients (both males and females of childbearing potential) must commit to using adequate contraceptive precautions throughout their participation in the study and for at least 3 months following their last ECP treatment
  • Patients must be able and willing to comply with all study procedures.

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.
  • Patients who have a known hypersensitivity or allergy to psoralen (methoxsalen).
  • Patients who have a known hypersensitivity or allergy to both heparin and citrate products.
  • Female patients who are pregnant and/or lactating.
  • Patients who have been enrolled in any investigational study for the treatment of Crohn's disease within 4 weeks of enrollment for non biologic therapies and within 8 weeks of enrollment for biologic therapies.
  • Patients who have any of the following: a co-existing melanoma, squamous cell skin carcinoma, aphakia, photosensitive disease (e.g., porphyria, systemic lupus erythematosus, or albinism), a white blood cell count > 25,000 mm3, a previous splenectomy, or a clinically significant coagulation disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221026

Locations
United States, Maryland
NIH
Bethesda, Maryland, United States
Metropolitian Gastroenterology Group
Chevy Chase, Maryland, United States
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States
United States, New York
Mount Sinai Medical Center
New York, New York, United States
Austria
General Hospital of Vienna
Vienna, Austria
Belgium
Hospital Erasme/ULB
Brussels, Belgium
UZ Leuven
Leuven, Belgium
Germany
Universitat St Josef
Bochum, Germany
Krankenhaus Duren gem.GmbH
Duren, Germany
Universitatsklinik Essen
Essen, Germany
Universitatsklinikum
Jena, Germany
Universitatsklinikum Mannheim
Mannheim, Germany
University Hospital Munich-Grosshadem
Munich, Germany
Klinikum Oldenberg
Oldenburg, Germany
Medizinische Universitatsklinik Ulm
Ulm, Germany
Sponsors and Collaborators
Therakos
ICON
Investigators
Study Director: dennis parenti, MD Therakos
  More Information

No publications provided

Responsible Party: Dr Dennis Parenti, Therakos
ClinicalTrials.gov Identifier: NCT00221026     History of Changes
Obsolete Identifiers: NCT00105261
Other Study ID Numbers: CD-2
Study First Received: September 13, 2005
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunosuppressive Agents
Methoxsalen
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 21, 2014