Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001901
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Etanercept to Treat Wegeners Granulomatosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase III Trial of TNFRFc Etanercept in Patients With Wegeners Granulomatosis
Status:
COMPLETED
Status Verified Date:
2005-03
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 use of etanercept also called Enbrel or TNFRFc in patients with Wegeners granulomatosis a type of vasculitis blood vessel inflammation Wegeners granulomatosis may affect many parts of the body including the brain nerves eyes sinuses lungs kidneys intestinal tract skin joints heart and other sites Generally the greater the disease involvement the more life-threatening it is Standard treatment is a combination of prednisone and a cytotoxic agent-usually cyclophosphamide or methotrexate However many patients treated with this regimen have a disease relapse and others cannot take these drugs because of severe side effects This study will evaluate etanercepts safety and effectiveness and particularly its value in reducing the need for prednisone and preventing disease relapse
The Food and Drug Administration has approved etanercept for treating rheumatoid arthritis another inflammatory disease The drug works by blocking the activity of TNF-a protein made by white blood cells that is involved in the inflammatory process Since prednisone also affects inflammatory proteins and lowers TNF production the use of etanercept may reduce the need for prednisone in patients with Wegeners granulomatosis and thus the risk of its side effects
Patients between 10 and 70 years of age with Wegeners granulomatosis who have never taken prednisone methotrexate or cyclophosphamide or have taken these drugs for less than 3 weeks may be eligible for this study
Participants will have a medical history review and physical examination including laboratory studies If medically indicated X-rays consultations and biopsies surgical removal of a small tissue sample of affected organs will also be done All patients will begin treatment with prednisone methotrexate and etanercept Those who improve on this regimen will stop prednisone gradually over 3 months Those who achieve disease remission at the end of another 3 months will be randomly assigned to either continue taking etanercept and methotrexate for another 12 months or to stop etanercept and continue only methotrexate for the next 12 months after which methotrexate will gradually be stopped Patients who are not in remission by the 6-month point will continue taking etanercept until they go into remission when they will be assigned to stop or not stop etanercept as described above Patients who do not achieve remission within 12 months of beginning treatment will be taken off the study Patients who have a disease relapse while on the study will likely be switched to treatment with prednisone and either methotrexate or cyclophosphamide Patients randomized to stop etanercept and who have a relapse within a year of stopping the drug may be offered re-treatment on this protocol but with continuing etanercept for a full year after remission
Patients will be evaluated in the outpatient clinic every 2 to 4 weeks for the first 4 months and every 1 to 3 months after that Patients whose disease is in remission and who stop all medications will be followed every 3 to 6 months for 2 years Follow-up evaluations include a physical examination blood draws and if medically indicated X-rays The total study duration is 60 to 70 months
The Food and Drug Administration has approved etanercept for treating rheumatoid arthritis another inflammatory disease The drug works by blocking the activity of TNF-a protein made by white blood cells that is involved in the inflammatory process Since prednisone also affects inflammatory proteins and lowers TNF production the use of etanercept may reduce the need for prednisone in patients with Wegeners granulomatosis and thus the risk of its side effects
Patients between 10 and 70 years of age with Wegeners granulomatosis who have never taken prednisone methotrexate or cyclophosphamide or have taken these drugs for less than 3 weeks may be eligible for this study
Participants will have a medical history review and physical examination including laboratory studies If medically indicated X-rays consultations and biopsies surgical removal of a small tissue sample of affected organs will also be done All patients will begin treatment with prednisone methotrexate and etanercept Those who improve on this regimen will stop prednisone gradually over 3 months Those who achieve disease remission at the end of another 3 months will be randomly assigned to either continue taking etanercept and methotrexate for another 12 months or to stop etanercept and continue only methotrexate for the next 12 months after which methotrexate will gradually be stopped Patients who are not in remission by the 6-month point will continue taking etanercept until they go into remission when they will be assigned to stop or not stop etanercept as described above Patients who do not achieve remission within 12 months of beginning treatment will be taken off the study Patients who have a disease relapse while on the study will likely be switched to treatment with prednisone and either methotrexate or cyclophosphamide Patients randomized to stop etanercept and who have a relapse within a year of stopping the drug may be offered re-treatment on this protocol but with continuing etanercept for a full year after remission
Patients will be evaluated in the outpatient clinic every 2 to 4 weeks for the first 4 months and every 1 to 3 months after that Patients whose disease is in remission and who stop all medications will be followed every 3 to 6 months for 2 years Follow-up evaluations include a physical examination blood draws and if medically indicated X-rays The total study duration is 60 to 70 months
Detailed Description:
The purpose of the study is to assess the safety pharmacokinetics and immunologic effects of a recombinant fusion protein that consists of the soluble tumor necrosis factor receptor linked to the Fc portion of human IgG1 TNFRFc in patients with Wegeners granulomatosis A secondary objective is to determine if TNFRFc demonstrates anti-inflammatory activity in the treatment of Wegeners granulomatosis Specifically we will seek to examine whether TNFRFc is able to reduce the need for glucocorticoid treatment and lower relapse rates Patients will be eligible to participate in this protocol when there is evidence that the disease is active but is not immediately life-threatening In this study patients will receive TNFRFc 25mg subcutaneously twice weekly together with methotrexate and prednisone In all patients the prednisone will be tapered over a 3 month schedule At the end of 6 months patients in remission will be randomized to either continue TNFRFc for another 12 months or stop All patients will continue methotrexate for 1 year after they enter remission after which time it will be tapered and discontinued
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 |
|---|---|---|---|
| 99-I-0040 | None | None | None |