A Single Arm Study of Extracorporeal Photoimmune Therapy With Uvadex For Corticosteroid Sparing in Patients With Corticosteroid-Dependent Crohn's Disease Who May Also Be Refractory or Intolerant to Immunosuppressants and/or Anti-Tumor Necrosis Factor Agen
Patients must meet each of the following criteria to be eligible for enrollment in this
1. Patients with Crohn's disease of at least 6 months duration (with colitis, ileitis,
or ileocolitis) confirmed by radiography or endoscopy.
2. Patient must have a CDAI score less than 220.
3. Patients with corticosteroid-dependent Crohn's disease who have failed at least one
attempt at corticosteroid tapering within the previous 6 months.
Corticosteroid-dependent patients are defined as those patients who have relapse of
Crohn's disease within 60 days following completion of corticosteroid treatment; OR
during corticosteroid tapering at doses greater than or equal to 10 mg/day
(prednisone equivalent); OR within 3 months following corticosteroid tapering, while
receiving a corticosteroid dose greater than or equal to 10 mg/day.
4. Patients with a CDAI score of less than 150 MUST:
- be on oral corticosteroids (other than oral budesonide) greater than or equal to
10 mg/day to be on oral corticosteroids (prednisone equivalent) for Crohn's
- be on a stable dose of oral corticosteroids (other than oral budesonide) for at
least 2 weeks prior to screening;
- have had clinically inactive Crohn's disease for at least 2 weeks prior to
Patients with a CDAI score of greater than or equal to 150 to less than 220 MUST:
- be on oral corticosteroids (othern than oral budesonide) greater than or equal
to 10 mg/day to less than or equal to 40 mg/day (prednisone equivalent) for
- have had no worse than mild disease for at least 2 weeks prior to screening.
5. Patients on aminosalicylates must have been on a stable dose for at least 4 weeks
prior to screening; and patients on the immunosuppressants, azathioprine,
6-mercaptopurine, or methotrexate must have been on a stable dose for at least 8
weeks prior to screening.
6. Patients not using aminosalicylates must have discontinued treatment at least 4 weeks
prior to screening. Patients not using immunosuppressants such as azathioprine,
6-mercaptopurine, or methotrexate must have discontinued treatment at least 4 weeks
prior to screening. Patients who had been receiving infliximab must have stopped
therapy at least 8 weeks prior to screening. Patients who had been receiving
adalimumab, cyclosporine, tacrolimus, or mycophenolate mofetil must have stopped
therapy for at least 4 weeks prior to screening.
7. Patients who have incidental (e.g. perianal) fistulae are permitted, provided:
- patients have predominantly luminal Crohn's disease, and
- fistulae are not associated with retention.
8. Patient's platelet count must be greater than or equal to 20,000/cmm.
9. Female patients must be one of the following: postmenopausal, surgically incapable
of bearing children, practicing an acceptable method of birth control (acceptable
methods may 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.
10. Patients must be able and willing to comply with all study procedures.
11. Signed informed consent must be obtained prior to conducting any study procedures.
12. Patients must be men and women greater than or equal to 18 years of age.
13. Patients must have a body weight greater than or equal to 40 kg (88 lb).
The presence of any of the following criteria will exclude the patient from from
participating in the study:
1. Patients with symptomatic intestinal strictures.
2. Patients with local manifestations of Crohn's disease such as abscesses, or 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).
3. Patients with stomas.
4. Patients with rectovaginal fistulae.
5. Patients who require antibiotics for the treatment of Crohn's disease.
6. Patients using oral budesonide.
7. Patients with diarrhea, due to conditions other than inflammatory Crohn's disease
(e.g. bacterial or parasitic gastroenteritis, bile salt diarrhea, or bacterial
8. Patients who are concomitantly using an anti-TNF agent, antibiotics, nonsteroidal
anti-inflammatory drugs (NSAIDs), cyclosporine, tacrolimus, mycophenolate mofetil, or
9. Patients 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.
10. Patients with a poor tolerability of venipuncture or a lack of adequate venous access
for required blood sampling.
11. Patients receiving total parenteral nutrition (TPN), as the sole source of nutrition,
within 3 weeks of screening.
12. Patients with hypersensitivity or allergy to psoralen (methoxsalen).
13. Patients with hypersensitivity or allergy to both heparin and citrate products.
14. Patients with active bleeding.
15. Females who are pregnant and/or lactating.
16. Patients must not have been enrolled in any investigational study for 30 days prior