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

Information source: Therakos
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Methoxsalen (Drug); Extracorporeal Photopheresis (Procedure)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Therakos

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.

Clinical Details

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 are considered to have failed treatment with these medications if they are refractory or intolerant to their use, regardless of prior or ongoing treatment with corticosteroids.

Refractoriness to immunosuppressant therapies and/or anti-TNF agents is defined as patients continuing to have active Crohn’s disease despite prior or current treatment with one or more of the following: AZA 2-3 mg/kg/day for 12 weeks; 6-MP 1. 0-1. 5 mg/kg/day for 12 weeks; MTX 25 mg/wk for 8 weeks; infliximab greater than or equal to 5 mg/kg for 4 weeks (at least one infusion); adalimumab greater than or equal to 40 mg subcutaneous (SC) for 4 weeks (at least two injections).

Intolerance to immunosuppressants and/or anti-TNF agents is defined as patients experiencing related side effects to one or more of the agents listed above that limit or proscribe their use (e. g. leukopenia, hepatitis, infusion reactions, or drug-induced lupus) at doses needed to adequately control the activity of their Crohn’s disease.

- 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 2 weeks; 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 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.

Locations and Contacts

General Hospital of Vienna, Vienna, Austria

Hospital Erasme/ULB, Brussels, Belgium

UZ Leuven, Leuven, Belgium

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

NIH, Bethesda, Maryland, United States

Metropolitian Gastroenterology Group, Chevy Chase, Maryland, United States

Morristown Memorial Hospital, Morristown, New Jersey, United States

Mount Sinai Medical Center, New York, New York, United States

Additional Information


Last updated: January 6, 2006

Page last updated: June 20, 2008

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