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Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)

Primary Purpose

Granulomatosis With Polyangiitis (Wegener's), Granulomatosis With Polyangiitis, Wegener's Granulomatosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abatacept
placebo
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Granulomatosis With Polyangiitis (Wegener's) focused on measuring Granulomatosis with polyangiitis (Wegener's), Granulomatosis with polyangiitis, GPA, Wegener's granulomatosis, Wegener granulomatosis, Anti Neutrophil Cytoplasmic Antibody Associated Vasculitis, ANCA Associated Vasculitis, AAV, Vasculitis, Systemic vasculitis, Systemic inflammatory disease, Lung Diseases, Respiratory Tract Diseases, Vascular Diseases, Abatacept, CTLA4-Ig, Immunosuppressive agent, Prednisone, Glucocorticoids, Glucocorticoid, Corticosteroid, Corticosteroids, Treatment, Pharmacologic Actions, Therapeutic Uses, Anti Inflammatory Agents

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients must be considered as being best characterized as GPA and not microscopic polyangiitis (MPA) or eosinophilic granulomatosis with polyangiitis (EGPA) and must have met at least 2 of the 5 modified ACR classification criteria for GPA. These do not need to be present at the time of study entry. The modified ACR criteria are:

    1. Nasal or oral inflammation, defined as the development of painful or painless oral ulcers or purulent or bloody nasal discharge
    2. Abnormal chest radiograph, defined as the presence of nodules, fixed infiltrates, or cavities
    3. Active urinary sediment, defined as microscopic hematuria (>5 red blood cells per high power field) or red blood cell casts
    4. Granulomatous inflammation on biopsy, defined as histologic changes showing granulomatous inflammation within the wall of an artery or in the perivascular or extravascular area (artery or arteriole)
    5. Positive anti-neutrophil cytoplasmic antibody (ANCA) test specific for proteinase-3 or myeloperoxidase measured by enzyme-linked immunoassay
  2. Relapse of GPA within the 28 days prior to screening where the active disease features meet the following definition of non-severe disease:

    1. No disease manifestations that would be scored as a major element in the BVAS/WG
    2. Absence of any disease feature that poses an immediate threat to either a critical individual organ or the patient's life
  3. Age 15 and older
  4. Willing and able to comply with treatment and follow-up procedures
  5. Both women and men must be willing to use an effective means of birth control while receiving treatment through this study. Women should continue the use of an effective means of birth control for a minimum of 14 weeks after the last dose of study drug. Effective contraception methods include abstinence, oral contraceptives (birth control pills), IUD, diaphragm, Norplant, approved hormone injections, condoms, or medical sterilization. If applicable, participating sites will defer to their local authorities if they require stricter guidelines on the types of allowable contraception methods.
  6. Willing and able to provide written informed consent (and written assent of minor participants if applicable.)

Exclusion Criteria:

  1. Presence of involvement that does not meet the criteria for non-severe disease
  2. Treatment with CYC within 3 months prior to screening
  3. Treatment with methylprednisolone 1000 mg within 28 days prior to enrollment
  4. Treatment with prednisone or prednisolone> 30 mg/day for > 28 days immediately prior to study entry
  5. Initiation or dose increase of the maintenance immunosuppressive agent (MTX, AZA, MA) within 3 months prior to screening
  6. Evidence of active infection (includes chronic infection)
  7. Patients who are pregnant or who are nursing
  8. Known infection with human immunodeficiency virus (HIV), hepatitis C, or a positive hepatitis B surface antigen
  9. Inability to comply with study guidelines
  10. Cytopenia: platelet count < 100,000/mm3, white blood cell count (WBC) < 3,000/mm3 (3 x 109/L), absolute neutrophil count < 1500/mm3, hemoglobin (Hgb) < 8.5 g/dL
  11. Chronic renal insufficiency defined by a creatinine clearance of less than or equal to 20 ml/min
  12. AST or ALT > 3 times above the upper limit of the normal laboratory range
  13. Known current use of illegal drugs
  14. Other uncontrolled disease (co-morbidity) that could prevent a patient from fulfilling the study requirements or that would substantially increase the risk of study procedures
  15. History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure
  16. Receipt of an investigational agent or device within 30 days prior to enrollment or 5 half lives of the investigational drug (whichever is longer)
  17. A live vaccination fewer than 3 months before enrollment
  18. Current clinical, radiographic, or laboratory evidence of active tuberculosis
  19. A history of active tuberculosis within the past 3 years even if treated
  20. A history of active tuberculosis greater than 3 years ago unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type
  21. Latent tuberculosis unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type
  22. Latent tuberculosis currently being treated with isoniazid (INH) or other therapy for latent tuberculosis given according to local health authority guidelines (e.g., Center for Disease Control (CDC)) who have received such therapy for 4 weeks or less prior to randomization (Day 1). Subjects with a positive tuberculosis screening test indicative of latent tuberculosis will be eligible for the study if they have no evidence of current tuberculosis on chest xray at screening and they are actively being treated for tuberculosis with INH or other therapy for latent tuberculosis given according to local health authority guidelines (e.g., CDC) that has been given for at least 4 weeks prior to randomization (Day 1). These subjects must complete treatment according to local health authority guidelines.
  23. History of herpes zoster that resolved less than 2 months prior to enrollment
  24. Treatment with rituximab or any other biologic B cell depleting agent within the past 6 months
  25. Treatment with alemtuzumab or anti-thymocyte globulin within the last 12 months
  26. Treatment with intravenous immunoglobulin given at an immunomodulatory dosage or plasma exchange within the past 3 months. Patients can be enrolled if they are otherwise eligible and receiving immunoglobulin replacement for hypogammaglobulinemia.
  27. Treatment with infliximab, etanercept, adalimumab, tocilizumab, or any other biologic agent within the past 3 months or 5 half lives of the agent (whichever is longer)

Sites / Locations

  • Cedars Sinai Medical Center, Los Angeles
  • University of South Florida Rheumatology
  • University of Kansas Medical Center
  • University of Michigan
  • Mayo Clinic Rochester
  • Hospital for Special Surgery
  • Cleveland Clinic
  • Oregon Health & Science University
  • University of Pennsylvania
  • Vanderbilt University
  • University of Calgary
  • University of British Columbia, St. Paul's Rheumatology Clinic
  • St. Joseph's Hospital, Hamilton
  • Mount Sinai Hospital, Toronto
  • Medius Kliniken
  • St. Vincent's University Hospital
  • University of Aberdeen
  • University of Cambridge- Addenbrookes Hospital
  • Nottingham University Hospitals
  • Royal Berkshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Blinded abatacept

blinded placebo

Arm Description

Participants will receive blinded abatacept 125 mg administered by subcutaneous injection once a week for at least 12 months. Subjects may be removed from treatment earlier due to a disease relapse, disease worsening, or if they have not achieved remission by treatment month 6.

Participants will receive blinded placebo. Placebo will be administered by subcutaneous injection once a week for at least 12 months. Subjects may be removed from treatment earlier due to a disease relapse, disease worsening, or if they have not achieved remission by treatment month 6.

Outcomes

Primary Outcome Measures

Ability of abatacept to reduce the treatment failure rate
Treatment failure will be defined as relapse, disease worsening, or failure to achieve a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) = 0 or 1 by 6 months. Relapse will be defined as any of the following after remission: an increase in BVAS/WG, development of a new BVAS/WG item, or symptoms/signs of GPA that cannot be attributed to any cause other than GPA and that requires institution or dosage increase of prednisone. Disease worsening will be defined as any of the following prior to remission: an increase in BVAS/WG, development of a new BVAS/WG item, or symptoms/signs of GPA that cannot be attributed to any cause other than GPA and that requires institution or dosage increase of prednisone.

Secondary Outcome Measures

Duration of glucocorticoid-free periods
Effect of abatacept on increasing duration of glucocorticoid-free periods for participants. Patients will be treated with abatacept for a minimum of 12 months unless they reach study criteria for early termination or until common closing. Common closing will be 12 months after randomization of the final patient.
Severity of relapses in those treated with abatacept versus placebo
Severity of GPA disease relapses in those treated with abatacept versus placebo. Patients will be treated with abatacept for a minimum of 12 months unless they reach study criteria for early termination or until common closing. Common closing will be 12 months after randomization of the final patient.
Health-related quality of life in those treated with abatacept versus placebo
Health-related quality of life in those treated with abatacept versus placebo as assessed using the SF-36 and PROMIS questionnaires. Patients will be treated with abatacept for a minimum of 12 months unless they reach study criteria for early termination or until common closing. Common closing will be 12 months after randomization of the final patient.
Prevention of disease- or treatment-related damage with abatacept versus placebo
Prevention of disease or treatment related damage as assessed by the infection rate in both treatment arms. Patients will be treated with abatacept for a minimum of 12 months unless they reach study criteria for early termination or until common closing. Common closing will be 12 months after randomization of the final patient.
Safety of abatacept in GPA
Safety of abatacept in patients with GPA as assessed by reported adverse events. Patients will be treated with abatacept for a minimum of 12 months unless they reach study criteria for early termination or until common closing. Common closing will be 12 months after randomization of the final patient.

Full Information

First Posted
March 27, 2014
Last Updated
August 10, 2023
Sponsor
University of South Florida
Collaborators
The Cleveland Clinic, Bristol-Myers Squibb, University of Pennsylvania, National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT02108860
Brief Title
Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)
Official Title
Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) (ABROGATE)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 25, 2015 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
The Cleveland Clinic, Bristol-Myers Squibb, University of Pennsylvania, National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous injection once a week. Participants will continue on study treatment for a minimum of 12 months unless they experience a disease relapse or disease flare. Participants who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would receive open-label abatacept.
Detailed Description
Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe GPA. Patients who enter the trial will be maintained on a stable dose of their maintenance immunosuppressive agent which may include methotrexate (MTX), azathioprine (AZA), or mycophenolate (MA) and will undergo a blinded randomization to receive abatacept or placebo. Patients will additionally receive prednisone 30 mg daily that will then be tapered to zero using a standardized tapering schedule. If an enrolled patient experiences a non-severe relapse or non-severe disease worsening though common closing, or if they have not achieved remission by month 6, they will have the option of entering an open-label trial period whereby they would receive abatacept in conjunction with their maintenance immunosuppressive and a standardized glucocorticoid taper. Patients with a severe disease relapse or severe disease worsening will have met criteria for early termination criteria and be removed from active study treatment. Patients will remain on study until reaching criteria for early termination or until common closing, 12 months after randomization of the final patient. After common closing or early termination, patients will be treated with best medical judgment and will undergo a post-treatment safety visit 3 months after coming off of study treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Granulomatosis With Polyangiitis (Wegener's), Granulomatosis With Polyangiitis, Wegener's Granulomatosis, ANCA-Associated Vasculitis
Keywords
Granulomatosis with polyangiitis (Wegener's), Granulomatosis with polyangiitis, GPA, Wegener's granulomatosis, Wegener granulomatosis, Anti Neutrophil Cytoplasmic Antibody Associated Vasculitis, ANCA Associated Vasculitis, AAV, Vasculitis, Systemic vasculitis, Systemic inflammatory disease, Lung Diseases, Respiratory Tract Diseases, Vascular Diseases, Abatacept, CTLA4-Ig, Immunosuppressive agent, Prednisone, Glucocorticoids, Glucocorticoid, Corticosteroid, Corticosteroids, Treatment, Pharmacologic Actions, Therapeutic Uses, Anti Inflammatory Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blinded abatacept
Arm Type
Experimental
Arm Description
Participants will receive blinded abatacept 125 mg administered by subcutaneous injection once a week for at least 12 months. Subjects may be removed from treatment earlier due to a disease relapse, disease worsening, or if they have not achieved remission by treatment month 6.
Arm Title
blinded placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive blinded placebo. Placebo will be administered by subcutaneous injection once a week for at least 12 months. Subjects may be removed from treatment earlier due to a disease relapse, disease worsening, or if they have not achieved remission by treatment month 6.
Intervention Type
Drug
Intervention Name(s)
Abatacept
Other Intervention Name(s)
CTLA4-Ig, Orencia
Intervention Description
Those randomized to abatacept will receive abatacept 125 mg administered by subcutaneous injection once a week Participants randomized to either the abatacept or the placebo arm who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would receive open-label abatacept. .
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Those randomized to placebo will receive a sterile placebo solution administered by subcutaneous injection once a week.
Primary Outcome Measure Information:
Title
Ability of abatacept to reduce the treatment failure rate
Description
Treatment failure will be defined as relapse, disease worsening, or failure to achieve a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) = 0 or 1 by 6 months. Relapse will be defined as any of the following after remission: an increase in BVAS/WG, development of a new BVAS/WG item, or symptoms/signs of GPA that cannot be attributed to any cause other than GPA and that requires institution or dosage increase of prednisone. Disease worsening will be defined as any of the following prior to remission: an increase in BVAS/WG, development of a new BVAS/WG item, or symptoms/signs of GPA that cannot be attributed to any cause other than GPA and that requires institution or dosage increase of prednisone.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Duration of glucocorticoid-free periods
Description
Effect of abatacept on increasing duration of glucocorticoid-free periods for participants. Patients will be treated with abatacept for a minimum of 12 months unless they reach study criteria for early termination or until common closing. Common closing will be 12 months after randomization of the final patient.
Time Frame
12 months
Title
Severity of relapses in those treated with abatacept versus placebo
Description
Severity of GPA disease relapses in those treated with abatacept versus placebo. Patients will be treated with abatacept for a minimum of 12 months unless they reach study criteria for early termination or until common closing. Common closing will be 12 months after randomization of the final patient.
Time Frame
12 months
Title
Health-related quality of life in those treated with abatacept versus placebo
Description
Health-related quality of life in those treated with abatacept versus placebo as assessed using the SF-36 and PROMIS questionnaires. Patients will be treated with abatacept for a minimum of 12 months unless they reach study criteria for early termination or until common closing. Common closing will be 12 months after randomization of the final patient.
Time Frame
12 months
Title
Prevention of disease- or treatment-related damage with abatacept versus placebo
Description
Prevention of disease or treatment related damage as assessed by the infection rate in both treatment arms. Patients will be treated with abatacept for a minimum of 12 months unless they reach study criteria for early termination or until common closing. Common closing will be 12 months after randomization of the final patient.
Time Frame
12 months
Title
Safety of abatacept in GPA
Description
Safety of abatacept in patients with GPA as assessed by reported adverse events. Patients will be treated with abatacept for a minimum of 12 months unless they reach study criteria for early termination or until common closing. Common closing will be 12 months after randomization of the final patient.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be considered as being best characterized as GPA and not microscopic polyangiitis (MPA) or eosinophilic granulomatosis with polyangiitis (EGPA) and must have met at least 2 of the 5 modified ACR classification criteria for GPA. These do not need to be present at the time of study entry. The modified ACR criteria are: Nasal or oral inflammation, defined as the development of painful or painless oral ulcers or purulent or bloody nasal discharge Abnormal chest radiograph, defined as the presence of nodules, fixed infiltrates, or cavities Active urinary sediment, defined as microscopic hematuria (>5 red blood cells per high power field) or red blood cell casts Granulomatous inflammation on biopsy, defined as histologic changes showing granulomatous inflammation within the wall of an artery or in the perivascular or extravascular area (artery or arteriole) Positive anti-neutrophil cytoplasmic antibody (ANCA) test specific for proteinase-3 or myeloperoxidase measured by enzyme-linked immunoassay Relapse of GPA within the 28 days prior to screening where the active disease features meet the following definition of non-severe disease: No disease manifestations that would be scored as a major element in the BVAS/WG Absence of any disease feature that poses an immediate threat to either a critical individual organ or the patient's life Age 15 and older Willing and able to comply with treatment and follow-up procedures Both women and men must be willing to use an effective means of birth control while receiving treatment through this study. Women should continue the use of an effective means of birth control for a minimum of 14 weeks after the last dose of study drug. Effective contraception methods include abstinence, oral contraceptives (birth control pills), IUD, diaphragm, Norplant, approved hormone injections, condoms, or medical sterilization. If applicable, participating sites will defer to their local authorities if they require stricter guidelines on the types of allowable contraception methods. Willing and able to provide written informed consent (and written assent of minor participants if applicable.) Exclusion Criteria: Presence of involvement that does not meet the criteria for non-severe disease Treatment with CYC within 3 months prior to screening Treatment with methylprednisolone 1000 mg within 28 days prior to enrollment Treatment with prednisone or prednisolone> 30 mg/day for > 28 days immediately prior to study entry Initiation or dose increase of the maintenance immunosuppressive agent (MTX, AZA, MA) within 3 months prior to screening Evidence of active infection (includes chronic infection) Patients who are pregnant or who are nursing Known infection with human immunodeficiency virus (HIV), hepatitis C, or a positive hepatitis B surface antigen Inability to comply with study guidelines Cytopenia: platelet count < 100,000/mm3, white blood cell count (WBC) < 3,000/mm3 (3 x 109/L), absolute neutrophil count < 1500/mm3, hemoglobin (Hgb) < 8.5 g/dL Chronic renal insufficiency defined by a creatinine clearance of less than or equal to 20 ml/min AST or ALT > 3 times above the upper limit of the normal laboratory range Known current use of illegal drugs Other uncontrolled disease (co-morbidity) that could prevent a patient from fulfilling the study requirements or that would substantially increase the risk of study procedures History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure Receipt of an investigational agent or device within 30 days prior to enrollment or 5 half lives of the investigational drug (whichever is longer) A live vaccination fewer than 3 months before enrollment Current clinical, radiographic, or laboratory evidence of active tuberculosis A history of active tuberculosis within the past 3 years even if treated A history of active tuberculosis greater than 3 years ago unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type Latent tuberculosis unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type Latent tuberculosis currently being treated with isoniazid (INH) or other therapy for latent tuberculosis given according to local health authority guidelines (e.g., Center for Disease Control (CDC)) who have received such therapy for 4 weeks or less prior to randomization (Day 1). Subjects with a positive tuberculosis screening test indicative of latent tuberculosis will be eligible for the study if they have no evidence of current tuberculosis on chest xray at screening and they are actively being treated for tuberculosis with INH or other therapy for latent tuberculosis given according to local health authority guidelines (e.g., CDC) that has been given for at least 4 weeks prior to randomization (Day 1). These subjects must complete treatment according to local health authority guidelines. History of herpes zoster that resolved less than 2 months prior to enrollment Treatment with rituximab or any other biologic B cell depleting agent within the past 6 months Treatment with alemtuzumab or anti-thymocyte globulin within the last 12 months Treatment with intravenous immunoglobulin given at an immunomodulatory dosage or plasma exchange within the past 3 months. Patients can be enrolled if they are otherwise eligible and receiving immunoglobulin replacement for hypogammaglobulinemia. Treatment with infliximab, etanercept, adalimumab, tocilizumab, or any other biologic agent within the past 3 months or 5 half lives of the agent (whichever is longer)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol A Langford, MD, MHS
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey P Krischer, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter A Merkel, MD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of South Florida Rheumatology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Facility Name
University of British Columbia, St. Paul's Rheumatology Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
St. Joseph's Hospital, Hamilton
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Mount Sinai Hospital, Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Facility Name
Medius Kliniken
City
Kirchheim unter Teck
ZIP/Postal Code
73230
Country
Germany
Facility Name
St. Vincent's University Hospital
City
Dublin
Country
Ireland
Facility Name
University of Aberdeen
City
Aberdeen
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
Facility Name
University of Cambridge- Addenbrookes Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Nottingham University Hospitals
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Royal Berkshire Hospital
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33367837
Citation
Hung W, Cusnir I, Habib S, Smylie M, Solez K, Yacyshyn E. Immune checkpoint inhibitor-induced granulomatosis with polyangiitis. Rheumatology (Oxford). 2021 Jun 18;60(6):e190-e191. doi: 10.1093/rheumatology/keaa818. No abstract available.
Results Reference
derived

Learn more about this trial

Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)

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