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Use of Infliximab for the Treatment of Pemphigus Vulgaris

Primary Purpose

Pemphigus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Infliximab
Placebo Comparator
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pemphigus focused on measuring Skin Diseases, Autoimmune Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Positive direct immunofluorescence of patient's skin showing IgG or complement C3 protein on cell surface with histopathology of lesional skin biopsies consistent with diagnosis of pemphigus vulgaris Failure to completely respond to standard steroid therapy (equivalent to prednisone 1 to 2 mg/kg/day followed by tapering) Systemic corticosteroid therapy of at least 20 mg prednisone daily and no more than 120 mg/day Inability to reduce systemic corticosteroid dosage below 20 mg/day for at least 8 weeks Stable dosage of prednisone for at least 2 weeks prior to study entry Oral/mucosal disease or skin disease. Detailed information about this criterion can be found in the protocol Willing to comply with the study protocol Willing to use acceptable means of contraception for the duration of the study and for 6 months after the end of the study Exclusion Criteria: Positive tuberculosis (TB) test within 1 month prior to first administration of study drug History of latent or active TB prior to screening Signs or symptoms suggestive of TB disease by medical history or physical examination within 3 months prior to first administration of study drug Posterior/anterior/lateral chest radiograph within 3 months prior to screening showing evidence of cancer, infection, or abnormalities (apical scarring) suggestive of previous TB Serious infection, hospitalization for an infection, or treatment with intravenous (IV) antibiotics for an infection within 2 months prior to screening. Patients who have had less serious infections are eligible for this study at the discretion of the investigator. History or presence of opportunistic infections within 6 months prior to screening History of receiving human/murine recombinant products Known allergy to murine products or other chimeric proteins Human immunodeficiency virus (HIV) infected Chronic hepatitis B or hepatitis C virus infection History of hepatitis C virus infection Cancer within the 5 years prior to study entry. Patients with completely resected non-melanoma skin cancers are not excluded. History or presence of congestive heart failure History or presence of seizure or demyelinating disorder History of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis Received a Bacillus Calmette-Guerin (BCG) vaccine within 12 months of screening History of lymphoproliferative disease, including lymphoma or signs and symptoms of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location or enlarged spleen Current signs or symptoms of severe progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, neurologic, or cerebral disease Have had chronic or recurrent infectious disease including, but not limited to, chronic kidney infection, chronic chest infection, sinusitis, recurrent urinary tract infection, infected skin wound, or ulcer Previous treatment with infliximab, other monoclonal antibodies, or antibody fragments Previous treatment with etanercept or other anti-tumor necrosis factor (TNF) agents in the 3 months prior to screening Treatment with methotrexate, azathioprine, mycophenolate mofetil, plasmapheresis, IV immunoglobulin, pulse systemic corticosteroids, or other systemic immunosuppressive agents within the 4 weeks prior to study entry History of alcohol or drug abuse within the 3 years prior to study entry History of noncompliance to medical regimens History of a systemic inflammatory disease other than pemphigus vulgaris History of a medical condition that would interfere with participation or increase the risk to the participant Unable or unwilling to undergo blood draws because of poor tolerability or lack of easy access Use of any investigational drug within 30 days prior to screening OR within 5 half-lives of the investigational agent, whichever is longer Participation in another investigative clinical trial Presence of transplanted solid organ. Participants who have received a corneal transplant more than 3 months prior to screening are not excluded. Require certain medications Other conditions or circumstances that could interfere with participant's adherence to the study requirements Pregnancy, breastfeeding, or plans to become pregnant

Sites / Locations

  • Norris Cancer Center, University of Southern California
  • University of Iowa Hospitals and Clinics
  • Duke University Medical Center
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Infliximab

Placebo Comparator

Arm Description

Participants are randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a masked (blinded) fashion. Refer to section titled, "Detailed Description" for additional treatment information.

Participants are randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a masked (blinded) fashion. Refer to section titled, "Detailed Description" for additional treatment information.

Outcomes

Primary Outcome Measures

Participant Response to Treatment at Week 18
Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <= 10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.
Treatment-Related Adverse Events >= Grade 3 On or Before Week 18
Grades were based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0. An adverse event (AE) was considered treatment-related if it was classified as unlikely, possibly, probably, or definitely related to study treatment. Participants who experienced at least one treatment-related, grade 3 or higher AE were counted only once. AEs of skin including rash, skin ulceration, and chelitis as defined by the NCI-CTCAE V3.0 System Organ Class of "Skin and Subcutaneous Tissues Disorders" were excluded.

Secondary Outcome Measures

Participant Response to Treatment at Week 18
Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <=10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.
Participant Modified Response Status at Week 18
Modified responder status was defined as participants achieving a prednisone dosage <=25% of the initial starting dose or <=10 mg/day (whichever is greater) at Week 18 regardless of status on new blister formation during the previous 4 weeks.
Participant Time to Cessation of New Blisters
Time to cessation of new blisters was defined as the time from a participant's first treatment infusion date to the first date where that date and all subsequent dates had no new blisters. Participant diaries were used to assess new blister formation. To achieve cessation, participants had to be free of new blisters at least 3 weeks prior to their last assessment. In order to analyze missing or incomplete data, the data was censored at the date where a participant had no more data or on the date where 50% of the participant's data was missing past that point.
Time to 80% Lesion Healing
Time to 80% healing of existing erosions/ulcerations at time of enrollment was assessed using the SAGE II computerized burn-mapping system. The date of 80% healing of existing erosions/ulcerations at time of enrollment was defined as follows: the first date at which the percent of total body surface area (BSA) involved is at least 80% less than the percent of total BSA calculated at the time of enrollment, where the baseline percent of total BSA must be greater than zero percent. If a participant had missing post-baseline assessments, their data was censored at their last non-missing assessment date.
Total Prednisone Dosage Required for Participants to Achieve Cessation of New Blisters
Each participant's prednisone dose was summed from the time of enrollment until the date of cessation of new blisters. Actual prednisone use per day was computed as the average over all days in the week.
Total Prednisone Dosage Required for Participants to Achieve 80% Healing of Existing Erosions
Each participant's prednisone dose was summed from the time of enrollment until the date of 80% healing of existing erosions. Actual prednisone use per day was computed as the average over all days in the week.
Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18
The Medical Outcome Study Short Form 36 (MOS SF-36) measures health -related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from baseline is computed as the value at Week 18 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value worsening.
Participant Dermatology-Related Quality of Life Changes From Baseline to Week 18
The Dermatology Life Quality Index (DLQI) is a 10-question questionnaire with a weighted value to each question. The DLQI score was calculated by summing the score of each question, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the greater quality of life is impaired. Change from baseline values (defined as the visit value - baseline value) were calculated. A negative change indicates better quality of life; a positive change indicates poorer quality of life.
Participant Duration of Clinical Response
The primary efficacy endpoint of response to treatment at Week 18 was reassessed at study weeks 22 and 26 for participants who were responders at Week 18. Participants classified as responders had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <= 10 mg/day (whichever is greater), and 2. had no new blisters within the previous 4 weeks.
Participants Who Experienced Severe Infusion Reactions
Participants who experienced severe infusion reactions of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.
Participants Who Experienced Severe Infectious Complications
Serious and life-threatening infections of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.
Adverse Events Resulting in Treatment Discontinuation
Adverse events experienced by participants resulting in study treatment discontinuation and assessed by the investigators as at least possibly related to treatment (i.e., possibly, probably, definitely) were assessed.
Participant Pemphigus Vulgaris Disease Activity Score
The Pemphigus Vulgaris Disease Activity (PVDA) score was used to grade a participant's disease activity using the SAGE II computerized burn mapping system, which calculated the total body surface area (BSA) involved. Scores were based on the number of new lesions and blisters present, old lesion history and BSA involved. Scores range from 0 to 3 (none to severe disease activity). A new disease activity score of 3 or an old lesion score of 3 indicates active disease. New disease activity scores of 3 for a 1-month duration or an old lesion score of 3 for 2 consecutive months was cause for removal from the study treatment

Full Information

First Posted
January 26, 2006
Last Updated
November 1, 2017
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Autoimmunity Centers of Excellence
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1. Study Identification

Unique Protocol Identification Number
NCT00283712
Brief Title
Use of Infliximab for the Treatment of Pemphigus Vulgaris
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Infliximab in Subjects With Pemphigus Vulgaris Receiving Prednisone
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Autoimmunity Centers of Excellence

4. Oversight

5. Study Description

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 Crohn's 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 Crohn's 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 mg/day 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 investigator's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pemphigus
Keywords
Skin Diseases, Autoimmune Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infliximab
Arm Type
Experimental
Arm Description
Participants are randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a masked (blinded) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Participants are randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a masked (blinded) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
Intervention Type
Drug
Intervention Name(s)
Infliximab
Other Intervention Name(s)
Remicade®
Intervention Description
Chimeric IgG monoclonal antibody that binds to TNF-alpha, generally used to treat Crohn's disease, given in a dosage of 5 mg/kg
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Other Intervention Name(s)
Control Arm
Intervention Description
Placebo administered in place of infliximab for control group
Primary Outcome Measure Information:
Title
Participant Response to Treatment at Week 18
Description
Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <= 10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.
Time Frame
Baseline to Week 18
Title
Treatment-Related Adverse Events >= Grade 3 On or Before Week 18
Description
Grades were based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0. An adverse event (AE) was considered treatment-related if it was classified as unlikely, possibly, probably, or definitely related to study treatment. Participants who experienced at least one treatment-related, grade 3 or higher AE were counted only once. AEs of skin including rash, skin ulceration, and chelitis as defined by the NCI-CTCAE V3.0 System Organ Class of "Skin and Subcutaneous Tissues Disorders" were excluded.
Time Frame
Baseline to Week 18
Secondary Outcome Measure Information:
Title
Participant Response to Treatment at Week 18
Description
Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <=10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.
Time Frame
Baseline to Week 18
Title
Participant Modified Response Status at Week 18
Description
Modified responder status was defined as participants achieving a prednisone dosage <=25% of the initial starting dose or <=10 mg/day (whichever is greater) at Week 18 regardless of status on new blister formation during the previous 4 weeks.
Time Frame
Baseline to Week 18
Title
Participant Time to Cessation of New Blisters
Description
Time to cessation of new blisters was defined as the time from a participant's first treatment infusion date to the first date where that date and all subsequent dates had no new blisters. Participant diaries were used to assess new blister formation. To achieve cessation, participants had to be free of new blisters at least 3 weeks prior to their last assessment. In order to analyze missing or incomplete data, the data was censored at the date where a participant had no more data or on the date where 50% of the participant's data was missing past that point.
Time Frame
Baseline to Week 26
Title
Time to 80% Lesion Healing
Description
Time to 80% healing of existing erosions/ulcerations at time of enrollment was assessed using the SAGE II computerized burn-mapping system. The date of 80% healing of existing erosions/ulcerations at time of enrollment was defined as follows: the first date at which the percent of total body surface area (BSA) involved is at least 80% less than the percent of total BSA calculated at the time of enrollment, where the baseline percent of total BSA must be greater than zero percent. If a participant had missing post-baseline assessments, their data was censored at their last non-missing assessment date.
Time Frame
Baseline to Week 26
Title
Total Prednisone Dosage Required for Participants to Achieve Cessation of New Blisters
Description
Each participant's prednisone dose was summed from the time of enrollment until the date of cessation of new blisters. Actual prednisone use per day was computed as the average over all days in the week.
Time Frame
Baseline to Week 26
Title
Total Prednisone Dosage Required for Participants to Achieve 80% Healing of Existing Erosions
Description
Each participant's prednisone dose was summed from the time of enrollment until the date of 80% healing of existing erosions. Actual prednisone use per day was computed as the average over all days in the week.
Time Frame
Baseline to Week 26
Title
Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18
Description
The Medical Outcome Study Short Form 36 (MOS SF-36) measures health -related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from baseline is computed as the value at Week 18 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value worsening.
Time Frame
Baseline to Week 18
Title
Participant Dermatology-Related Quality of Life Changes From Baseline to Week 18
Description
The Dermatology Life Quality Index (DLQI) is a 10-question questionnaire with a weighted value to each question. The DLQI score was calculated by summing the score of each question, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the greater quality of life is impaired. Change from baseline values (defined as the visit value - baseline value) were calculated. A negative change indicates better quality of life; a positive change indicates poorer quality of life.
Time Frame
Baseline to Week 18
Title
Participant Duration of Clinical Response
Description
The primary efficacy endpoint of response to treatment at Week 18 was reassessed at study weeks 22 and 26 for participants who were responders at Week 18. Participants classified as responders had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <= 10 mg/day (whichever is greater), and 2. had no new blisters within the previous 4 weeks.
Time Frame
Baseline to Week 26
Title
Participants Who Experienced Severe Infusion Reactions
Description
Participants who experienced severe infusion reactions of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.
Time Frame
Baseline to Week 26
Title
Participants Who Experienced Severe Infectious Complications
Description
Serious and life-threatening infections of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.
Time Frame
Baseline to Week 26
Title
Adverse Events Resulting in Treatment Discontinuation
Description
Adverse events experienced by participants resulting in study treatment discontinuation and assessed by the investigators as at least possibly related to treatment (i.e., possibly, probably, definitely) were assessed.
Time Frame
Baseline to Week 26
Title
Participant Pemphigus Vulgaris Disease Activity Score
Description
The Pemphigus Vulgaris Disease Activity (PVDA) score was used to grade a participant's disease activity using the SAGE II computerized burn mapping system, which calculated the total body surface area (BSA) involved. Scores were based on the number of new lesions and blisters present, old lesion history and BSA involved. Scores range from 0 to 3 (none to severe disease activity). A new disease activity score of 3 or an old lesion score of 3 indicates active disease. New disease activity scores of 3 for a 1-month duration or an old lesion score of 3 for 2 consecutive months was cause for removal from the study treatment
Time Frame
Baseline to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive direct immunofluorescence of patient's skin showing IgG or complement C3 protein on cell surface with histopathology of lesional skin biopsies consistent with diagnosis of pemphigus vulgaris Failure to completely respond to standard steroid therapy (equivalent to prednisone 1 to 2 mg/kg/day followed by tapering) Systemic corticosteroid therapy of at least 20 mg prednisone daily and no more than 120 mg/day Inability to reduce systemic corticosteroid dosage below 20 mg/day for at least 8 weeks Stable dosage of prednisone for at least 2 weeks prior to study entry Oral/mucosal disease or skin disease. Detailed information about this criterion can be found in the protocol Willing to comply with the study protocol Willing to use acceptable means of contraception for the duration of the study and for 6 months after the end of the study Exclusion Criteria: Positive tuberculosis (TB) test within 1 month prior to first administration of study drug History of latent or active TB prior to screening Signs or symptoms suggestive of TB disease by medical history or physical examination within 3 months prior to first administration of study drug Posterior/anterior/lateral chest radiograph within 3 months prior to screening showing evidence of cancer, infection, or abnormalities (apical scarring) suggestive of previous TB Serious infection, hospitalization for an infection, or treatment with intravenous (IV) antibiotics for an infection within 2 months prior to screening. Patients who have had less serious infections are eligible for this study at the discretion of the investigator. History or presence of opportunistic infections within 6 months prior to screening History of receiving human/murine recombinant products Known allergy to murine products or other chimeric proteins Human immunodeficiency virus (HIV) infected Chronic hepatitis B or hepatitis C virus infection History of hepatitis C virus infection Cancer within the 5 years prior to study entry. Patients with completely resected non-melanoma skin cancers are not excluded. History or presence of congestive heart failure History or presence of seizure or demyelinating disorder History of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis Received a Bacillus Calmette-Guerin (BCG) vaccine within 12 months of screening History of lymphoproliferative disease, including lymphoma or signs and symptoms of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location or enlarged spleen Current signs or symptoms of severe progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, neurologic, or cerebral disease Have had chronic or recurrent infectious disease including, but not limited to, chronic kidney infection, chronic chest infection, sinusitis, recurrent urinary tract infection, infected skin wound, or ulcer Previous treatment with infliximab, other monoclonal antibodies, or antibody fragments Previous treatment with etanercept or other anti-tumor necrosis factor (TNF) agents in the 3 months prior to screening Treatment with methotrexate, azathioprine, mycophenolate mofetil, plasmapheresis, IV immunoglobulin, pulse systemic corticosteroids, or other systemic immunosuppressive agents within the 4 weeks prior to study entry History of alcohol or drug abuse within the 3 years prior to study entry History of noncompliance to medical regimens History of a systemic inflammatory disease other than pemphigus vulgaris History of a medical condition that would interfere with participation or increase the risk to the participant Unable or unwilling to undergo blood draws because of poor tolerability or lack of easy access Use of any investigational drug within 30 days prior to screening OR within 5 half-lives of the investigational agent, whichever is longer Participation in another investigative clinical trial Presence of transplanted solid organ. Participants who have received a corneal transplant more than 3 months prior to screening are not excluded. Require certain medications Other conditions or circumstances that could interfere with participant's adherence to the study requirements Pregnancy, breastfeeding, or plans to become pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell P. Hall, MD
Organizational Affiliation
Division of Dermatology, Duke University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
E. William St. Clair, MD
Organizational Affiliation
Division of Rheumatology and Immunology, Duke University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Garnett Kelsoe, DSci
Organizational Affiliation
Department of Immunology, Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victoria Werth, MD
Organizational Affiliation
Department of Dermatology, University of Pennsylvania School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janet Fairley, MD
Organizational Affiliation
Department of Dermatology, University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Woodley, MD
Organizational Affiliation
Department of Dermatology, Norris Cancer Center, University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norris Cancer Center, University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15243495
Citation
Anhalt GJ, Diaz LA. Pemphigus vulgaris--a model for cutaneous autoimmunity. J Am Acad Dermatol. 2004 Jul;51(1 Suppl):S20-1. doi: 10.1016/j.jaad.2004.01.011. No abstract available.
Results Reference
background
PubMed Identifier
14973643
Citation
Drosou A, Kirsner RS, Welsh E, Sullivan TP, Kerdel FA. Use of infliximab, an anti-tumor necrosis alpha antibody, for inflammatory dermatoses. J Cutan Med Surg. 2003 Sep-Oct;7(5):382-6. doi: 10.1007/s10227-002-0134-1. Epub 2003 Sep 24.
Results Reference
background
PubMed Identifier
16086769
Citation
Jacobi A, Shuler G, Hertl M. Rapid control of therapy-refractory pemphigus vulgaris by treatment with the tumour necrosis factor-alpha inhibitor infliximab. Br J Dermatol. 2005 Aug;153(2):448-9. doi: 10.1111/j.1365-2133.2005.06744.x. No abstract available.
Results Reference
background
PubMed Identifier
16029365
Citation
Pardo J, Mercader P, Mahiques L, Sanchez-Carazo JL, Oliver V, Fortea JM. Infliximab in the management of severe pemphigus vulgaris. Br J Dermatol. 2005 Jul;153(1):222-3. doi: 10.1111/j.1365-2133.2005.06672.x. No abstract available.
Results Reference
background
PubMed Identifier
25123295
Citation
Hall RP 3rd, Fairley J, Woodley D, Werth VP, Hannah D, Streilein RD, McKillip J, Okawa J, Rose M, Keyes-Elstein LL, Pinckney A, Overington A, Wedgwood J, Ding L, Welch B. A multicentre randomized trial of the treatment of patients with pemphigus vulgaris with infliximab and prednisone compared with prednisone alone. Br J Dermatol. 2015 Mar;172(3):760-8. doi: 10.1111/bjd.13350. Epub 2015 Feb 5.
Results Reference
result
Links:
URL
https://www.niaid.nih.gov/
Description
National Institute of Allergy and Infectious Diseases (NIAID)
URL
https://www.niaid.nih.gov/about/dait
Description
Division of Allergy, Immunology, and Transplantation (DAIT)
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY655
Available IPD/Information Identifier
SDY655
Available IPD/Information Comments
Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts. Data analysis tools are also available to researchers.
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY655
Available IPD/Information Identifier
SDY655
Available IPD/Information Comments
ImmPort study identifier is SDY655
Available IPD/Information Type
Study summary, -design, -adverse event(s), -summary of participant assessments, -interventions, -medications, -demographics, -lab tests, -mechanistic Assays, -study files et al.
Available IPD/Information URL
http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY655
Available IPD/Information Identifier
SDY655
Available IPD/Information Comments
ImmPort study identifier is SDY655

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Use of Infliximab for the Treatment of Pemphigus Vulgaris

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