Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283712
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2006-01-26
Brief Title:
Use of Infliximab for the Treatment of Pemphigus Vulgaris
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase II Trial of Infliximab in Subjects With Pemphigus Vulgaris Receiving Prednisone
Status:
COMPLETED
Status Verified Date:
2017-11
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:
Pemphigus vulgaris PV is a rare skin disorder that causes blistering of the skin and mucous membranes Infliximab is a man-made antibody used to treat certain types of immune system disorders including rheumatoid arthritis and Crohns disease This study will determine if infliximab given in combination with prednisone is a safe and effective treatment for adults with PV
Detailed Description:
PV involves blistering of the outer layer of skin and mucous membranes causing a separation of epidermal cells The disease occurs when the immune system produces antibodies to specific proteins in the skin and mucous membranes the cause for production of these autoantibodies is unknown Infliximab is a genetically engineered monoclonal antibody directed against tumor necrosis factor TNF-alpha a chemical messenger that activates an immune response Infliximab has been used to treat other autoimmune disorders including rheumatoid arthritis ankylosing spondylitis and Crohns disease This study will evaluate the safety and efficacy of infliximab given in combination with prednisone for the treatment of adults with PV
This study will last 26 weeks At study entry all patients will be taking a stable dose of prednisone or an equivalent corticosteroid of 20 to 120 mgday for at least 2 weeks prior to study entry Patients will be randomly assigned to one of two arms experimental or placebo comparator The experimental treatment arm will receive infusions of infliximab and the control arm will receive placebo Infusions will be given at study entry and Weeks 2 6 and 14 Before the start of each infusion a physical exam vital signs measurement medical and medication history review of a disease activity log a skin evaluation and blood collection will occur During each infusion and for 1 hour postinfusion patients vital signs will be monitored for any adverse events Patients will need a responsible adult to take them home after they are discharged from the treatment facility this person should remain with the patient overnight in case any problems arise from the treatment The patient will be contacted by phone that night and the next morning after infusion and will be asked about any adverse effects they may have experienced Those patients that experience adverse effects may be asked to return to the treatment facility for examination Prednisone doses may be tapered by 15 percent every 2 weeks during the study at the investigators discretion
There will be a total of 9 study visits until Week 26 screening study entry Week 2 and every 4 weeks thereafter Each study visit will include a physical exam vital signs measurement medical and medication history a review of the disease activity log and adverse events experienced since the last visit skin assessments and blood collection patients will also be asked to complete a tuberculosis TB questionnaire Patients will be asked to complete quality of life questionnaires at study entry and Weeks 10 18 and 26 Skin biopsies of unaffected skin will be done at study entry and Weeks 10 18 and 26 if patients have PV-associated lesions additional skin biopsies of affected skin will be done at study entry and Week 18
This study will last 26 weeks At study entry all patients will be taking a stable dose of prednisone or an equivalent corticosteroid of 20 to 120 mgday for at least 2 weeks prior to study entry Patients will be randomly assigned to one of two arms experimental or placebo comparator The experimental treatment arm will receive infusions of infliximab and the control arm will receive placebo Infusions will be given at study entry and Weeks 2 6 and 14 Before the start of each infusion a physical exam vital signs measurement medical and medication history review of a disease activity log a skin evaluation and blood collection will occur During each infusion and for 1 hour postinfusion patients vital signs will be monitored for any adverse events Patients will need a responsible adult to take them home after they are discharged from the treatment facility this person should remain with the patient overnight in case any problems arise from the treatment The patient will be contacted by phone that night and the next morning after infusion and will be asked about any adverse effects they may have experienced Those patients that experience adverse effects may be asked to return to the treatment facility for examination Prednisone doses may be tapered by 15 percent every 2 weeks during the study at the investigators discretion
There will be a total of 9 study visits until Week 26 screening study entry Week 2 and every 4 weeks thereafter Each study visit will include a physical exam vital signs measurement medical and medication history a review of the disease activity log and adverse events experienced since the last visit skin assessments and blood collection patients will also be asked to complete a tuberculosis TB questionnaire Patients will be asked to complete quality of life questionnaires at study entry and Weeks 10 18 and 26 Skin biopsies of unaffected skin will be done at study entry and Weeks 10 18 and 26 if patients have PV-associated lesions additional skin biopsies of affected skin will be done at study entry and Week 18
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