Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056355
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-03-10
Brief Title:
Extracorporeal Photopheresis to Maintain Symptoms Remission During Steroid Withdrawal in Patients With Steroid-Dependent Crohns Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Single Arm Study of Extracorporeal Photoimmune Therapy With Uvadex For Corticosteroid Sparing in Patients With Corticosteroid-Dependent Crohns Disease Who May Also Be Refractory or Intolerant to Immunosuppressants andor Anti-Tumor Necrosis Factor Agen
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the safety and effectiveness of extracorporeal photopheresis ECP in controlling Crohns disease symptoms as patients taper their corticosteroid dose Crohns disease is a chronic inflammatory bowel disease Patients commonly have chronic diarrhea with abdominal pain loss of appetite and weight loss Acute disease flares are treated with large doses of corticosteroids but long-term use of these drugs can have harmful side effects ECP described below is approved to treat skin symptoms associated with a type of cancer called cutaneous T-cell lymphoma and has been used experimentally in conditions involving abnormal inflammation
Patients 18 years of age and older who have had Crohns disease for at least 6 months who are corticosteroid-dependent and whose symptoms are controlled well enough so that their Crohns Disease Activity Index CDAI is less than 220 may be eligible for this study Candidates will be screened with a medical history and review of medical records physical examination electrocardiogram blood tests urine pregnancy test for women of childbearing potential and a questionnaire about how Crohns disease affects their life and activities
Patients with a CDAI score of less than 150 will begin ECP treatments as soon as possible Those with scores from 150 to 219 will have their corticosteroid dose increased enough to bring their CDAI score to below 150 before beginning ECP Patients who do not achieve a CDAI of less than 150 after 4 to 6 weeks of increased corticosteroids will be excluded from the study
Participants will have ECP treatments for 2 consecutive days every 2 weeks for 24 weeks for a total of 26 treatments For ECP patients undergo leukapheresis a method of collecting large numbers of white blood cells or leukocytes-cells that may be responsible for many of the medical problems in Crohns disease Whole blood is collected through a needle in an arm vein similar to donating a unit of blood The blood flows through a machine that separates it into its components by spinning The white cells are removed and collected in a plastic bag and the red blood cells and plasma are returned to the patients bloodstream through the same needle The collected white cells are mixed with a drug called UVADEX Registered Trademark exposed to ultraviolet UVA light and then returned to the patients bloodstream The UVADEX allows the blood cells to absorb more UVA The UVA changes the cells in a way that once they are back in the body they cause changes in other cells like them Each ECP treatment takes 3 to 4 hours On the first day of each 2-day treatment patients will undergo a review of symptoms check of vital signs and blood draw They will complete a CDAI diary for 7 days before the first of the two ECP treatments and a questionnaire about their life and activities at 4-week intervals During the ECP treatment period corticosteroids will be slowly reduced as long as disease symptoms do not worsen
Patients whose disease remains under control with cessation of all steroids may begin maintenance ECP 2 days in a row every 4 weeks for an additional 20 weeks another 10 treatments with the same follow-up as described above and a full physical examination 4 weeks after the final treatment Patients who were able to reduce but not stop steroid treatment may be considered for maintenance therapy if it is thought that continuing treatment may enable further reduction of steroids Patients whose disease symptoms worsen with ECP or who have not been able to decrease their steroid dose will not be eligible for maintenance therapy and their participation in the study will end
Patients 18 years of age and older who have had Crohns disease for at least 6 months who are corticosteroid-dependent and whose symptoms are controlled well enough so that their Crohns Disease Activity Index CDAI is less than 220 may be eligible for this study Candidates will be screened with a medical history and review of medical records physical examination electrocardiogram blood tests urine pregnancy test for women of childbearing potential and a questionnaire about how Crohns disease affects their life and activities
Patients with a CDAI score of less than 150 will begin ECP treatments as soon as possible Those with scores from 150 to 219 will have their corticosteroid dose increased enough to bring their CDAI score to below 150 before beginning ECP Patients who do not achieve a CDAI of less than 150 after 4 to 6 weeks of increased corticosteroids will be excluded from the study
Participants will have ECP treatments for 2 consecutive days every 2 weeks for 24 weeks for a total of 26 treatments For ECP patients undergo leukapheresis a method of collecting large numbers of white blood cells or leukocytes-cells that may be responsible for many of the medical problems in Crohns disease Whole blood is collected through a needle in an arm vein similar to donating a unit of blood The blood flows through a machine that separates it into its components by spinning The white cells are removed and collected in a plastic bag and the red blood cells and plasma are returned to the patients bloodstream through the same needle The collected white cells are mixed with a drug called UVADEX Registered Trademark exposed to ultraviolet UVA light and then returned to the patients bloodstream The UVADEX allows the blood cells to absorb more UVA The UVA changes the cells in a way that once they are back in the body they cause changes in other cells like them Each ECP treatment takes 3 to 4 hours On the first day of each 2-day treatment patients will undergo a review of symptoms check of vital signs and blood draw They will complete a CDAI diary for 7 days before the first of the two ECP treatments and a questionnaire about their life and activities at 4-week intervals During the ECP treatment period corticosteroids will be slowly reduced as long as disease symptoms do not worsen
Patients whose disease remains under control with cessation of all steroids may begin maintenance ECP 2 days in a row every 4 weeks for an additional 20 weeks another 10 treatments with the same follow-up as described above and a full physical examination 4 weeks after the final treatment Patients who were able to reduce but not stop steroid treatment may be considered for maintenance therapy if it is thought that continuing treatment may enable further reduction of steroids Patients whose disease symptoms worsen with ECP or who have not been able to decrease their steroid dose will not be eligible for maintenance therapy and their participation in the study will end
Detailed Description:
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 Crohns 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 Crohns 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 Crohns disease to determine the immune response it effects in the gut mucosa and identify factors associated with responders versus non-responders to ECP
This is an unblinded single-arm study of ECP in Crohns 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 Crohns disease to determine the immune response it effects in the gut mucosa and identify factors associated with responders versus non-responders to ECP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-I-0117 | None | None | None |