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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 15 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02108860 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
University of South Florida |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Carol A Langford, MD, MHSJeffrey P Krischer, PhDPeter A Merkel, MD, MPH |
Principal Investigator Affiliation | The Cleveland ClinicUniversity of South FloridaUniversity of Pennsylvania |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
OtherOtherIndustryOtherNIHNIH |
Overall Status | Recruiting |
Countries | Canada, Germany, Ireland, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Granulomatosis With Polyangiitis (Wegener's), Granulomatosis With Polyangiitis, Wegener's Granulomatosis, ANCA-Associated Vasculitis |
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.
Experimental: Blinded abatacept
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.
Placebo Comparator: blinded placebo
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.
Drug: - Abatacept
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. .
Drug: - placebo
Those randomized to placebo will receive a sterile placebo solution administered by subcutaneous injection once a week.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Cedars Sinai Medical Center, Los Angeles
Los Angeles, California, 90048
Status
Recruiting
Address
University of California, San Francisco
San Francisco, California, 94143
Status
Recruiting
Address
University of South Florida Rheumatology
Tampa, Florida, 33612
Status
Recruiting
Address
University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Recruiting
Address
Boston University School of Medicine
Boston, Massachusetts, 02118
Status
Recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Mayo Clinic Rochester
Rochester, Minnesota, 55902
Status
Recruiting
Address
Hospital for Special Surgery
New York, New York, 10021
Status
Recruiting
Address
Cleveland Clinic
Cleveland, Ohio, 44195
Status
Recruiting
Address
Oregon Health & Science University
Portland, Oregon, 97239
Status
Recruiting
Address
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Status
Recruiting
Address
Vanderbilt University
Nashville, Tennessee, 37240
Status
Recruiting
Address
University of Utah
Salt Lake City, Utah, 84132
Status
Recruiting
Address
University of Calgary
Calgary, Alberta, T3M 1M4
Status
Recruiting
Address
Alberta Health Services- Edmonton
Edmonton, Alberta, T6G 2C8
Status
Recruiting
Address
University of British Columbia, St. Paul's Rheumatology Clinic
Vancouver, British Columbia, V6Z 1Y6
Status
Recruiting
Address
St. Joseph's Hospital, Hamilton
Hamilton, Ontario,
Status
Recruiting
Address
The Ottawa Hospital
Ottawa, Ontario, k1H 8L6
Status
Recruiting
Address
Mount Sinai Hospital, Toronto
Toronto, Ontario, M5T 3L9
Status
Recruiting
Address
Medius Kliniken
Kirchheim unter Teck, , 73230
Status
Recruiting
Address
St. Vincent's University Hospital
Dublin, ,
Status
Recruiting
Address
University of Aberdeen
Aberdeen, , AB25 2ZD
Status
Recruiting
Address
University of Cambridge- Addenbrookes Hospital
Cambridge, ,
Status
Recruiting
Address
Nottingham University Hospitals
Nottingham, , NG7 2UH
Status
Recruiting
Address
Royal Berkshire Hospital
Reading, , RG1 5AN
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