Granulomatosis With Polyangiitis (Wegener's)Phase 3NCT02108860
Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)
A Phase 3 study testing Abatacept in people with Granulomatosis With Polyangiitis (Wegener's) and Granulomatosis With Polyangiitis, run by University of South Florida at 20 sites in 5 countries.
Trial 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) . Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Granulomatosis With Polyangiitis (Wegener's), Granulomatosis With Polyangiitis, Wegener's Granulomatosis
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 25 Apr 2015to 20 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.)
Who cannot join
- 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)
Show all 27Show fewer
- 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)
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48109
Cleveland Clinic
Cleveland, Ohio, 44195
University of Kansas Medical Center
Kansas City, Kansas, 66160
Cedars Sinai Medical Center, Los Angeles
Los Angeles, California, 90048
Vanderbilt University
Nashville, Tennessee, 37240
Hospital for Special Surgery
New York, New York, 10021
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic Rochester
Rochester, Minnesota, 55902
University of South Florida Rheumatology
Tampa, Florida, 33612
Canada4 sites
University of Calgary
Calgary, Alberta, T3M 1M4
St. Joseph's Hospital, Hamilton
Hamilton, Ontario
Mount Sinai Hospital, Toronto
Toronto, Ontario, M5T 3L9
University of British Columbia, St. Paul's Rheumatology Clinic
Vancouver, British Columbia, V6Z 1Y6
United Kingdom4 sites
University of Aberdeen
Aberdeen, AB25 2ZD
University of Cambridge- Addenbrookes Hospital
Cambridge
Nottingham University Hospitals
Nottingham, NG7 2UH
Royal Berkshire Hospital
Reading, RG1 5AN
About this study
Official title: Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) (ABROGATE)
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.
Read the 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.
- Conditions
- Granulomatosis With Polyangiitis (Wegener's), Granulomatosis With Polyangiitis, Wegener's Granulomatosis, ANCA-Associated Vasculitis
- Being tested
- Abatacept, placebo
- 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
- Medical subject headings
- Granulomatosis with Polyangiitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Vasculitis, Systemic Vasculitis, Lung Diseases, Respiratory Tract Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called CTLA4-Ig, Orencia
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. .
placeboDrug
Those randomized to placebo will receive a sterile placebo solution administered by subcutaneous injection once a week.
| Study group | Role | What they receive |
|---|---|---|
| Blinded abatacept | Experimental | 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. Receives: Drug: Abatacept |
| blinded placebo | Placebo comparator | 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study start25 Apr 2015
- Primary completion25 Jul 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Granulomatosis With Polyangiitis (Wegener's)Studies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Sponsor
- Investigators
- Carol A Langford, MD, MHS, Principal investigator, The Cleveland ClinicJeffrey P Krischer, PhD, Principal investigator, University of South FloridaPeter A Merkel, MD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108860
- Sponsor's protocol ID
- ABROGATE 5527
- Other IDs
- 2013-005535-24, U54AR057319
- Status last verified
- Jul 2024
- First submitted
- 27 Mar 2014
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33367837
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) (ABROGATE)
- ClinicalTrials.gov ID
- NCT02108860
- Acronym / sponsor ID
- ABROGATE 5527
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- 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)
- Study start
- 25 Apr 2015 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded abatacept | Experimental | Drug: AbataceptParticipants 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. |
| blinded placebo | Placebo comparator | Drug: placeboParticipants 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Relapse of GPA within the 28 days prior to screening where the active disease features meet the following definition of non-severe disease:
- 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.
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbataceptAlso: CTLA4-Ig, OrenciaThose 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. . | Drug | Blinded abatacept |
| placeboThose randomized to placebo will receive a sterile placebo solution administered by subcutaneous injection once a week. | Drug | blinded placebo |
Primary outcome
Ability of abatacept to reduce the treatment failure rate
Time frame: 12 months
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.
5 secondary outcomes
Duration of glucocorticoid-free periods
Time frame: 12 months
Severity of relapses in those treated with abatacept versus placebo
Time frame: 12 months
Health-related quality of life in those treated with abatacept versus placebo
Time frame: 12 months
Prevention of disease- or treatment-related damage with abatacept versus placebo
Time frame: 12 months
Safety of abatacept in GPA
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Derived from this study: PubMed 33367837Hung 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.
Related trials for Granulomatosis With Polyangiitis (Wegener's)
Active, not recruitingPhase 1/2
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
Lupus Nephritis, Immunoglobulin A Nephropathy
RecruitingPhase 2
Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis
Granulomatosis With Polyangiitis
RecruitingObservational study
Vasculitis Pregnancy Registry
Vasculitis, Behcet's Disease
RecruitingObservational study
VCRC Tissue Repository
Aortitis, Cutaneous Vasculitis
RecruitingObservational study
One-Time DNA Study for Vasculitis
Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss), Giant Cell Arteritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol A Langford, MD, MHS principal investigator
The Cleveland Clinic
Jeffrey P Krischer, PhD principal investigator
University of South Florida
Peter A Merkel, MD, MPH principal investigator
University of Pennsylvania
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abatacept in people with Granulomatosis With Polyangiitis (Wegener's) and Granulomatosis With Polyangiitis, run by University of South Florida at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada, United Kingdom, Germany, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of abatacept to reduce the treatment failure rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02108860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.