PFF Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
Interventional
Eligible Ages 15 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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. 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 > 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 < or = to 20 ml/min 12. Known current use of illegal drugs 13. 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 14. 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 15. Receipt of an investigational agent or device within 30 days prior to enrollment or 5 half lives of the investigational drug (whichever is longer) 16. A live vaccination fewer than 3 months before enrollment 17. Current clinical, radiographic, or laboratory evidence of active tuberculosis 18. A history of active tuberculosis within the past 3 years even if treated 19. A history of active tuberculosis greater than 3 years ago unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type 20. Latent tuberculosis unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type 21. 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. 22. History of herpes zoster that resolved less than 2 months prior to enrollment 23. Treatment with rituximab or any other biologic B cell depleting agent within the past 6 months or past treatment with rituximab or any other biologic B cell depleting agent where the B lymphocyte count remains < 60 cells/uL 24. Treatment with alemtuzumab or anti-thymocyte globulin within the last 12 months 25. Treatment with intravenous immunoglobulin or plasma exchange within the past 3 months 26. 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 Details

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.

Trial ID:
NCT02108860

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
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
University of South Florida

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Carol A Langford, MD, MHSJeffrey P Krischer, PhDPeter A Merkel, MD, MPH
Principal Investigator Affiliation The Cleveland ClinicUniversity of South FloridaUniversity of Pennsylvania

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOtherIndustryOtherNIH
Overall Status Recruiting
Countries Canada, Ireland, United Kingdom, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Granulomatosis With Polyangiitis (Wegener's), Granulomatosis With Polyangiitis, Wegener's Granulomatosis, ANCA-Associated Vasculitis
Study Website: View Trial Website
Additional Details

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.

Contact a Trial Team

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.

Cedars Sinai Medical Center, Los Angeles, Los Angeles, California

Status

Recruiting

Address

Cedars Sinai Medical Center, Los Angeles

Los Angeles, California, 90048

Site Contact

Mahbuba Tusty

mahbuba.tusty@cshs.org

310-423-3032

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94143

Site Contact

Sarah Goglin

sarah.goglin@ucsf.edu

1-888-772-8315

University of South Florida Rheumatology, Tampa, Florida

Status

Recruiting

Address

University of South Florida Rheumatology

Tampa, Florida, 33612

Site Contact

Michelle Orzechowski

mpatelli@health.usf.edu

813-974-2473

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

Caitlin McMillian

cmcmillian@kumc.edu

913-588-0681

Boston University School of Medicine, Boston, Massachusetts

Status

Recruiting

Address

Boston University School of Medicine

Boston, Massachusetts, 02118

Site Contact

Naomi Amudala, NP

namudala@bu.edu

617-414-2512

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Emily Lewis

eelewis@med.umich.edu

734-936-4009

Mayo Clinic Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic Rochester

Rochester, Minnesota, 55902

Site Contact

Boleyn Andrist

Andrist.boleyn@mayo.edu

800-743-1606

Hospital for Special Surgery, New York, New York

Status

Recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Site Contact

Annel Fernandez

fernandeza@hss.edu

212-774-2123

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Carol A Langford, MD, MHS

langfoc@ccf.org

216-445-6056

Oregon Health & Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University

Portland, Oregon, 97239

Site Contact

Cailin Sibley, MD, MHS

sibleyc@ohsu.edu

503-494-6115

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Roni Devassy

Roni.Devassy@uphs.upenn.edu

215-614-4407

University of Pittsburgh, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261

Site Contact

Laurie Hope

hopelk@upmc.edu

412-647-2638

Vanderbilt University, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University

Nashville, Tennessee,

Site Contact

Meena Golchha

meenakshi.golchha@vanderbilt.edu

615-875-8356

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84132

Site Contact

Jessica Gonzalez

jessica.gonzalez@hsc.utah.edu

801-585-0797

International Sites

University of Calgary, Calgary, Alberta, Canada

Status

Recruiting

Address

University of Calgary

Calgary, Alberta, T3M 1M4

Site Contact

Aurore Fifi-Mah, MD

avfifima@ucalgary.ca

403-210-7113

Alberta Health Services- Edmonton, Edmonton, Alberta, Canada

Status

Recruiting

Address

Alberta Health Services- Edmonton

Edmonton, Alberta, T6G 2C8

Vancouver, British Columbia, Canada

Status

Recruiting

Address

University of British Columbia, St. Paul's Rheumatology Clinic

Vancouver, British Columbia, V6Z 1Y6

Site Contact

Marx Jayaraman

JJayaraman@cheos.ubc.ca

604-682-2344 #63566

St. Joseph's Hospital, Hamilton, Hamilton, Ontario, Canada

Status

Recruiting

Address

St. Joseph's Hospital, Hamilton

Hamilton, Ontario,

Site Contact

Sandra Messier

smessier@stjoes.ca

905-522-1155 #35873

The Ottawa Hospital, Ottawa, Ontario, Canada

Status

Recruiting

Address

The Ottawa Hospital

Ottawa, Ontario, k1H 8L6

Site Contact

Paula Patterson

ppatterson@toh.ca

613-738-8400 #81630

Mount Sinai Hospital, Toronto, Toronto, Ontario, Canada

Status

Recruiting

Address

Mount Sinai Hospital, Toronto

Toronto, Ontario, M5T 3L9

Site Contact

Deborah Weber

advanced@sinaithealthsystem.ca

416-586-8616

St. Vincent's University Hospital, Dublin, Ireland

Status

Recruiting

Address

St. Vincent's University Hospital

Dublin, ,

Site Contact

Phil Gallagher

P.Gallagher@st-vincents.ie

0035312214773

University of Aberdeen, Aberdeen, United Kingdom

Status

Recruiting

Address

University of Aberdeen

Aberdeen, , AB25 2ZD

Site Contact

Gayle Hutcheon

gayle.hutcheon@nhs.net

1-888-772-8315

Cambridge, United Kingdom

Status

Recruiting

Address

University of Cambridge- Addenbrookes Hospital

Cambridge, ,

Site Contact

Karen Dahlsveen

karen.dahlsveen@addenbrookes.nhs.uk

01223 349530

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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