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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


Phase 1
N/A
N/A
Not Enrolling
Both
Crohn Disease

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Trial Information

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


This protocol aims to measure the safety and effectiveness of extracorporeal photopheresis
(ECP) therapy for maintaining remission of symptoms during withdrawal of corticosteroids
from patients with steroid-dependent Crohn's disease. Potential subjects will be
asymptomatic or have a low level of symptoms that respond to an increase in their steroid
dose; furthermore potential subjects will be dependent on steroids to control their symptoms
and have a history of failing other immunosuppressive drugs to control their symptoms.

This is an unblinded, single-arm study of ECP in Crohn's disease. This trial will use ECP
twice a week every two weeks over 24 weeks during which time the dose of corticosteroids
will be tapered. If the corticosteroids are able to be withdrawn without an increase in
symptoms, then subjects may be eligible for further ECP (twice a week every four weeks over
24 weeks) as a maintenance regimen.

Outcome parameters include the rates of complete and partial steroid tapering while
maintaining remission, the rates of adverse events, and secondary clinical outcomes such as
duration of response, rate of and time to relapse, and changes in symptom index scores. In
addition, the NIH will perform a substudy that includes serial colonoscopy to measure
cytokine and cell population changes in mononuclear cells extracted from biopsies.

The long-term goals of this study are to test the safety and efficacy of ECP as a
steroid-sparing and remittive therapy in Crohn's disease, to determine the immune response
it effects in the gut mucosa, and identify factors associated with responders versus
non-responders to ECP.

Inclusion Criteria


INCLUSION CRITERIA:

Patients must meet each of the following criteria to be eligible for enrollment in this
study.

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
disease;

- 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
screening.

OR

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
Crohn's disease;

- 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).

EXCLUSION CRITERIA:

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
overgrowth).

8. Patients who are concomitantly using an anti-TNF agent, antibiotics, nonsteroidal
anti-inflammatory drugs (NSAIDs), cyclosporine, tacrolimus, mycophenolate mofetil, or
investigational therapies.

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
to enrollment.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

030117

NCT ID:

NCT00056355

Start Date:

March 2003

Completion Date:

November 2005

Related Keywords:

  • Crohn Disease
  • Pheresis
  • Cytokine
  • Lymphocyte
  • Remission
  • Ultraviolet A Light
  • Crohn's Disease
  • Crohn Disease
  • Crohn Disease

Name

Location

National Institute of Allergy and Infectious Diseases (NIAID)Bethesda, Maryland  20892