Participating in Clinical Research Trials
It is very important for patients with vasculitis to support research to advance a better understanding of this rare disease. Research may lead to determining the cause of vasculitis, earlier diagnosis, more effective treatment, prevention of flares and hopefully, some day a cure.
Be informed about studies pertaining to any of the diseases. Enroll in a study. Researchers of rare diseases sometimes have difficulty finding subjects. Patient participation is key to research. Check back here often for information about relevant ongoing studies.
Clinical trials are people-based studies of new drugs or procedures. Doctors use clinical trials to learn whether a new treatment is safe and effective in patients. Such studies are vital to the development of new treatments for diseases such as vasculitis.
The VF works closely with doctors around the world to inform patients with vasculitis about ongoing clinical trials. Participating in a clinical trial gives patients access to expert doctors, new research treatments and the opportunity to help further medical research on vasculitis.
To learn more about clinical trials click here or download the document attached below.
To review trials currently recruiting patients with vasculitis at the NIH click here.
The following is a list of clinical trials currently enrolling patients.
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Study Status: Recruiting Summary: Please Note: The Rare Diseases Clinical Research Network will make every effort to enroll all the patients we can, but we cannot make any guarantees that we will be able to enroll everyone in a particular study who wants to participate. Background Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause redness and swelling of blood vessels (vasculitis). These diseases are likely to affect the large sized blood vessels that supply blood to different parts of the body including the brain, eyes, arms, legs, lungs, kidneys, intestines, heart, and other parts. The purpose of this study is to determine if the medication abatacept is safe and effective in giant cell arteritis or Takayasu's arteritis. About this Study In the beginning of this study, all subjects will receive abatacept (by vein) combined with standard doses of prednisone. If there is no sign of GCA or TAK at month 3, you will be assigned by chance (like flipping a coin) to continue abatacept or switch to a placebo (fake treatment or inactive look-a-like) for the rest of the study. Your total time on the study will range from 12 to 48 months (1-4 years). About 66 people will take part in this study (33 with GCA and 33 with TAK) across 4 medical centers. You will be examined by the following: · Medical history review · Physical exam · Imaging (x-rays, MRI) · Blood/urine tests · Lung function tests · Study questionnaires · Skin test Target Enrollment: To be eligible to participate, you must: 1. have a diagnosis of GCA or TAK 2. have presence of GCA or TAK within the past 2 months 3. be 18 years of age or older 4. be willing and able to follow treatment and follow-up procedures 5. be willing to use an effective means of birth control during this study 6. be willing and able to give written informed consent You are not eligible to participate if: 1. you have signs of an infection 2. you are pregnant or breast feeding 3. you are infected with HIV, hepatitis C, or hepatitis B 4. you are not able to follow study guidelines 5. you are not able to give informed consent 6. you have a reduced number of blood cells 7. you have a poor kidney(s)
Participation in research studies is voluntary. Deciding not to participate in a research study does not affect your ability to receive care at any of our Clinical Centers or from other physicians. |
Update your contact information! We want to keep you informed with the latest news and information. Keeping your contact information up to date can be done quickly and easily on the Web: Click Here to Update Your Information About the VCRC The Vasculitis Clinical Research Consortium (VCRC) is an integrated group of academic medical centers, patient support organizations, and clinical research resources dedicated to conducting clinical research in different forms of vasculitis and improving the care of patients with vasculitis. The Vasculitis Clinical Research Consortium is part of the National Institutes of Health's Rare Diseases Clinical Research Network. The VCRC continues to grow and is working on several new research projects concerning vasculitis. Check back with the VCRC website regularly for updates: w |
This study looks at causes of atherosclerosis (hardening of the blood vessels) in patients with Wegener’s Granulomatosis. The study entails collection of clinical information, and blood samples. In addition all patients with Wegener’s Granulomatosis will undergo ultrasound of the carotid arteries to assess for hardening of these vessels located in the neck. By correlating clinical information with findings from the research blood and ultrasound, scientists may be able to study the reasons of atherosclerosis (hardening of the vessels) in Wegener’s Granulomatosis.
Population needed: Patients older than 18 years of age with Wegener’s Granulomatosis; patients who are in remission with no previous diagnosis of heart failure, blockage of the arteries (heart or leg arteries), or stroke are welcome to participate. Candidates will be screened with a history and physical examination, blood tests for research purposes and for lipids and fasting sugar measurements and ultrasound of the carotids. Patients or their third party payers will not be responsible for any cost which is out of the standard care.
WHO CAN PARTICIPATE IN THIS RESEARCH STUDY?
· Age >18 years old.
· An established diagnosis of Wegener Granulomatosis, currently in remission.
· The ability to understand and sign informed consent.
· Normal kidney function.
YOU MAY NOT PARTICIPATE IN THIS STUDY IF YOU HAVE:
· Diagnosis of heart disease, stroke, or blockage of arteries in the legs.
· Recent infection.
· Diagnosis of chronic inflammatory diseases other than Wegener's Granulomatosis.
· Diagnosis of Cancer or clotting tendency.
WHAT IS INVOLVED?
If you are interested in participating please contact:
Rula Hajj-Ali, MD at 216.444.9643
Cleveland Clinic Center for Vasculitis Care and Research
Cleveland, Ohio USA
This study looks at causes of atherosclerosis (hardening of the blood vessels) in patients with Wegener’s Granulomatosis. The study entails collection of clinical information, and blood samples. In addition all patients with Wegener’s Granulomatosis will undergo ultrasound of the carotid arteries to assess for hardening of these vessels located in the neck. By correlating clinical information with findings from the research blood and ultrasound, scientists may be able to study the reasons of atherosclerosis (hardening of the vessels) in Wegener’s Granulomatosis.
Population needed: Patients older than 18 years of age with Wegener’s Granulomatosis patients who are in remission with no previous diagnosis of heart failure, blockage of the arteries (heart or leg arteries), or stroke are welcome to participate. Candidates will be screened with a history and physical examination, blood tests for research purposes and for lipids and fasting sugar measurements and ultrasound of the carotids. Patients or their third party payers will not be responsible for any cost which is out of the standard care.
WHO CAN PARTICIPATE IN THIS RESEARCH STUDY?
YOU MAY NOT PARTICIPATE IN THIS STUDY IF YOU HAVE:
WHAT IS INVOLVED?
If you are interested in participating please contact Rula Hajj-Ali, MD at 216.444.9643
Cleveland Clinic Center for Vasculitis Care and Research
The Mayo Clinic Nephrology Collaborative Group (MNCG) announces a new pilot study on the use of Rituximab in the treatment of Churg Strauss Syndrome with renal involvement.
The plan is to enroll five patients in the open label study using four weekly doses of Rituximab. Patients will be followed for one year after beginning of the remission induction regimen. Disease relapses, as defined in the protocol will be treated according to the standard of practice for patients with this disease.
To learn more:
Study Coordinators:
Lori Riess, 507.266.1047
Shirley Jennison, 507.255.0231
Email: MNCG@mayo.edu
Summary: This study will examine the safety and effectiveness of the drug Rituximab in treating hepatitis C-associated cryoglobulinemic vasculitis.
About 5 percent of patients with hepatitis C develop cryoglobulinemic vasculitis. This syndrome, characterized by inflammation of blood vessels (vasculitis), may involve the skin, joints, kidneys, nerves and other sites, and cause skin rashes, joint pain, weakness, fatigue, and numbness.
About 10 to 30 percent of patients develop kidney disease, which, in some cases, can lead to kidney failure. Although the cause of cryoglobulinemic vasculitis is not known, a critical component is the presence of cryoglobulins-abnormal proteins that white blood cells called B lymphocytes produce in response to the chronic hepatitis C infection. Rituximab decreases the number of B cells.
The Food and Drug Administration approved Rituximab in 1997 for the treatment of B-cell non-Hodgkin's lymphoma.
Patients between 18 and 75 years of age with hepatitis C and signs and symptoms of cryoglobulinemic vasculitis may be eligible for this study. They must have failed, or been unable to tolerate, treatment with IFN-a and ribavirin. Candidates will be screened with a history and physical examination, electrocardiogram (ECG), blood and urine tests, 24-hour urine collection and chest X-ray, if clinically indicated.
Participants will be randomly assigned to receive Rituximab upon entering the study or 6 months after entering the study. Those whose treatment is delayed 6 months will be followed once a month at NIH for disease evaluation and blood tests during that time.
Patients will be given Rituximab intravenously (through a vein) once a week for 4 weeks. For the first dose, patients will be admitted to the hospital for at least 24 hours after the infusion for monitoring. Subsequent infusions will be given on an inpatient or outpatient basis, depending on how the infusion is tolerated. The day before each infusion they will have a history and physical examination, blood work, and other tests, such as X-rays, as clinically indicated. After the four infusions, patients will be followed for drug side effects and response to treatment. They will have blood tests every week for 4 weeks and will then return to NIH for 1 day every month for 12 months for a physical examination, blood tests, and X-rays, if medically indicated. Visits may be more frequent, if necessary, and patients may be asked to stay longer than a day if test findings require further investigation.
Patients whose cryoglobulinemic vasculitis improves and remains inactive for 12 months after completing Rituximab therapy will have completed the study. Those who benefit from treatment but have a later worsening of disease may receive a second course of four infusions, with follow-up for 12 months after the last infusion. Patients who do not respond to treatment and whose disease worsens will be advised of other treatment options, but will be asked to return to NIH monthly for 12 months for follow-up.
Sponsoring Institute: National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail Type: Participants currently recruited/enrolled
Gender: Male & Female Referral Letter Required: No Population Exclusion(s): Children Eligibility Criteria:
INCLUSION CRITERIA
Diagnosis of HCV-CV: must have all of the following HCV infection documented by serology and/or plasma HCV RNA.
One or more organ system with objective evidence of active vasculitis such as: Palpable purpura; Glomerulonephritis (defined by the presence of glomerular hematuria and/or new or worsening proteinuria); Acute peripheral neuropathy. Detectable cryoglobulins and/or RF.
Failure of treatment with IFN-alpha and ribavirin to control manifestations of HCV-CV OR intolerance to IFN-alpha/ribavirin regimen.
Patients must have a personal physician responsible for the care of their HCV.
Ages of 18 and 75 years
Willingness to use effective contraception during and for 12 months following Rituximab treatment. Effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or hormonal contraception.
EXCLUSION CRITERIA
Recent (within 4 weeks) initiation of or increase in immunosuppressive therapy.
Active systemic infection (other than hepatitis C).
Pregnancy or breast feeding.
Prior treatment with Rituximab.
Known allergy to murine proteins.
Significant renal insufficiency (creatinine clearance less than 30 ml/min).
Presence of life-threatening HCV-CV; defined as rapidly progressive glomerulonephritis (defined as a doubling of the serum creatinine over a 3 month period), CNS vasculitis, cardiac disease due to active vasculitis, or GI vasculitis (defined by ischemic bowel, perforation, or infarction).
Significant hepatic insufficiency as manifested by Child-Pugh classification of B or C.
History of variceal bleeding, encephalopathy.
History of liver transplantation.
Co-infection with either HBV or HIV.
Any underlying medical condition that in the judgment of the investigator would put the patient at increased risk for serious infusion-related adverse events. Special Instructions: Currently Not Provided Keywords: Hepatitis Vasculitis Rituximab Cryoglobulinemia Recruitment Keyword(s): Hepatitis C Vasculitis HcV-cV Cryoglobulinemic Vasculitis Cryoglobulinemia Condition(s): Hepatitis C
Vasculitis Investigational Drug(s): Rituximab Investigational Device(s): None Intervention(s): Drug: Rituximab Supporting Site: National Institute of Allergy and Infectious Diseases
Contact:
National Institutes of Health Building 10 Room 8C416 10 Center Drive
Bethesda, Maryland 20892
Phone: 1-(800) 411-1222
Patients, both male and female, between the ages of 18 and 25, with non-infectious acute anterior uveitis and any previous episodes of acute anterior ileitis occurring at least four weeks before starting the study are being invited to enroll in a safety and efficacy study of iontophoresis and dexamethasone phosphate to treat anterior uveitis. The study is being sponsored by EyeGate Pharmaceutical.
This is a randomized, double-masked exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infectious acute anterior segment uveitis. The current study will evaluate the safety, tolerability, and efficacy of the technology at the four dose levels to determine a safe, effective dose that is appropriate for future trials.
Five centers currently enrolling patients are located in Cambridge and Boston, MA; New York, NY; Norfolk, VA; and Columbus, OH.
For more information or to enroll, go to www.clinicaltrials.gov(study#NCT00694135); or contact Debbie Chmielewski at 887-334-0050 (a Texas number) or e-mail debbiechmielewski@pleiad.com.
Source: EyeGate Pharmaceuticals, Waltham, MA
Autoimmune Diseases Association, InFocus, Vol. 16 No. 3, September 2008
5523: Concurrent Pilot Studies in Giant Cell Arteritis and Takayasu’s Arteritis to Examine the Safety, Efficacy, and Immunologic Effects of Abatacept (CTLA4-Ig) in Large Vessel Vasculitis (AGATA)
Status: Recruiting
Summary:
Please Note: The Rare Diseases Clinical Research Network will make every effort to enroll all the patients we can, but we cannot make any guarantees that we will be able to enroll everyone in a particular study who wants to participate.
Background
Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause redness and swelling of blood vessels (vasculitis). These diseases are likely to affect the large sized blood vessels that supply blood to different parts of the body including the brain, eyes, arms, legs, lungs, kidneys, intestines, heart, and other parts. The purpose of this study is to determine if the medication abatacept is safe and effective in giant cell arteritis or Takayasu's arteritis.
About this Study
In the beginning of this study, all subjects will receive abatacept (by vein) combined with standard doses of prednisone. If there is no sign of GCA or TAK at month 3, you will be assigned by chance (like flipping a coin) to continue abatacept or switch to a placebo (fake treatment or inactive look-a-like) for the rest of the study. Your total time on the study will range from 12 to 48 months (1-4 years). About 66 people will take part in this study (33 with GCA and 33 with TAK) across 4 medical centers. You will be examined by the following:
Target Enrollment:
To be eligible to participate, you must:
You are not eligible to participate if:
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How to Participate: |
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In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation. |
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· Cleveland Clinic Foundation (VCRC) |
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Cleveland, Ohio |
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Principal Investigator: Carol Langford, MD, MHS |
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Contact Person: Katherine Tuthill, RN, MSN, CNP |
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Office: 216-444-9606 |
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Email: TUTHILLK@ccf.org |
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Participation in research studies is voluntary. Deciding not to participate in a research study does not affect your ability to receive care at any of our Clinical Centers or from other physicians.
Study Name: 5515 - VCRC Imaging Protocol for Magnetic Resonance and Positron Emission Tomography in Large-Vessel Vasculitis (Takayasu's Arteritis): Development as clinical trial outcome measures
Study Status: Recruiting
For:
Summary:
Please Note: The Rare Diseases Clinical Research Network will make every effort to enroll all the patients we can, but we cannot make any guarantees that we will be able to enroll everyone in a particular study who wants to participate.
Background
Takayasu's arteritis is a rare disease that affects the blood vessels. Takayasu's arteritis can cause swelling of large and medium-sized blood vessels. The blood vessels that are commonly affected are the branches of the aorta (the main blood vessel that leaves the heart). The purpose of this study is to help doctors learn more about this disease by using x-ray-like tests to see if they are helpful in taking care of patients with Takayasu's arteritis.
About this Study
This is an imaging study that compares x-ray-like tests that would not be a part of your regular care (PET/CT) with x-ray-like tests that are a part of your regular care (MRI). At two visits, three months apart, patients will have a PET/CT scan performed at the same time as their MRI scan; some patients with also have a third PET/CT scan. A total of 36 people with Takayasu's arteritis at several hospitals will take part in this study. Doctors will use images from the different time points, along with information from exams and symptoms, to learn more about the disease.
Target Enrollment:
To be eligible to participate, you must:
Active disease will be defined by the presence of clinical features or imaging or both:
Clinical features:
You are not eligible to participate if:
How to Participate:
In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation.
| How to Participate: |
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In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation. |
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| Boston, Massachusetts |
| Principal Investigator: Peter Merkel, MD, MPH |
| Contact Person: Jessica Martin |
| Office: 617-414-2507 |
| Email: jmartin@bu.edu |
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| Cleveland, Ohio |
| Principal Investigator: Carol Langford, MD, MHS |
| Contact Person: Geetha Krishnan |
| Office: 216-445-5930 |
| Email: Krishng@ccf.org |
Participation in research studies is voluntary. Deciding not to participate in a research study does not affect your ability to receive care at any of our Clinical Centers or from other physicians.
Background
Wegener's granulomatosis (WG) is an illness characterized by inflammation of blood vessels. It may involve many different parts of the body, but typically affects the upper respiratory tract (nose and sinuses), the lower respiratory tract (lungs), and kidneys. The current standard treatment for WG involves various medications and is based on disease severity. Unfortunately, more than 50% of people experience a relapse after remission, placing them at risk for additional organ damage and toxicity from medication. To prevent this, safer and more effective treatments for mild-moderate relapses are needed. We especially need to find treatments to help reduce the amount of prednisone patients need to take. The purpose of this pilot study is to determine the safety of the medication abatacept in WG and to gain information about whether abatacept may be effective in the treatment of mild relapsing WG.
About this Study
This is a treatment study, with a total of 20 people with WG taking part in this study at several hospitals. In this study abatacept is given intravenously at study visits on Days 1, 15, 29 and once a month thereafter. Participation in this study may last between 7 and 24 months. Study visits include the following:
To be eligible to participate, you must:
You are not eligible to participate if:
How to Participate:
Please use the information below to inquire about participation.
Boston University School of Medicine, Boston, MA
Jessica Pettit
Study Coordinator
jlpettit@bu.edu
Phone: 617.414.2508
Cleveland Clinic Foundation, Cleveland, OH
Katherine Tuthill
Study Coordinator
tuthillk@ccf.org
Phone: 216.444.5257
Johns Hopkins Vasculitis Center, Baltimore, MD
Lourdes P. Sejismundo
Study Coordinator
lsejism1@jhmi.edu
Phone: 410.550.6818
Mayo Clinic College of Medicine, Rochester, MN
Kathy Mieras
Lead Study Coordinator/Project Manager
Mieras.kathleen@mayo.edu
Phone: 507.284.9187
University of Toronto Mount Sinai Hospital, Toronto, ON (site soon to open)
Sara Sutherland, RN BScN
Study Coordinator
SWebster2@mtsinai.on.ca
Phone: 416.586.8616
Vasculitis Clinical Research Consortium (VCRC)
The VCRC was established in 2004 to address the challenges inherent in diagnosing and treating rare vasculitic diseases. Dr. Peter Merkel, of Boston University School of Medicine, is the Principal and Overall Lead Investigator for the VCRC, along with Co-Investigators from Johns Hopkins, Cleveland Clinic and the Mayo Clinic. The VCRC is conducting Longitudinal Studies (now enrolling patients) in different forms of vasculitis to identify biomarkers for disease risk, disease severity and activity, and clinical outcome. The VCRC is also planning to conduct experimental trials of new drugs for vasculitis. The VCRC Patient Contact Registry is a method for patients with vasculitis to register themselves with the VCRC so that they will be notified of new clinical research studies conducted by the VCRC. The contact registry is free of charge and anonymous, and patients can register by using a paper form, by calling a toll-free number (866-313-9879), or online by clicking “Join the VCRC Contact Registry” at http://rarediseasesnetwork.org/vcrc. By taking action, patients can help researchers develop a better understanding about vascultis. Patients who participate in research make it possible for researchers to create new studies and to find new treatments.
Dear Interested Participant:
You are invited to participate in a new research study on the genetics of vasculitis. Some examples of the diseases classified as vasculitis include Wegener's granulomatosis, Takayasu's arteritis, microscopic polyangiitis, the Churg-Strauss syndrome, and polyarteritis nodosa.
Vasculitis is a group of diseases about which much remains unknown. This is particularly true about risk factors for the disease: who gets the disease and why?
We believe that genes contribute to a person's risk of getting vasculitis. This study is designed to identify some of the genes that may be important in leading to the condition of your specific form of vasculitis.
Your participation in the study would involve the following:
(1) You must have a diagnosis of vasculitis and be willing to answer a series of questions regarding your health and medications. We may also ask your doctor some questions regarding your health and test results. Before starting this study, we will have you sign a form that tells you about this study and how we plan to keep your information private during the study.
(2) You must have two living biological parents or one parent and two siblings who are also willing to participate in the study.
(3) You would provide a blood sample that could be drawn at your doctor's office using materials we send in the mail. The sample will be mailed back to us, using a pre-packaged mailing kit.
(4) After completing the consent process, your parents and/or siblings would provide a swab from inside their cheek (this can be done at home, without requiring a visit to their doctor's office or drawing blood) using materials we would send in the mail. The swab would then be mailed back to us, using a pre-packaged mailing kit.
If you are interested in participating in this study, you may contact us in one of two ways:
Telephone (on a toll-free number): 1-800-226-6023
Email: jhvc@jhmi.edu
We appreciate your interest in the study.
Sincerely,
Dr. Stuart Levine
Assistant Professor of Medicine
Co-Director, The Johns Hopkins Vasculitis Center
Johns Hopkins Bayview Medical Center
Division of Rheumatology
Enrollment is Open: Participants Needed
Sponsored by The National Institute of Allergy and Infectious Disease and The Immune Tolerance Network
A randomized, multicenter trial for patients with severe ANCA-associated vasculitis.
Participants will be randomized to either a treatment of cyclophosphamide (CYC) and prednisone or rituximab and prednisone.
The primary objective of this trial is to determine the efficacy of rituximab and glucocorticoids in the induction of remission of ANCA-associated vasculitis.
For further detailed information: http://vasculitis.med.jhu.edu
Study Coordinators:
Lourdes Sejismundo (410) 550-6818 or
Yavette Goldsborough (410) 550-4580
Email: jhvc@jhmi.edu
Lead Investigators:
Ulrich Specks, M.D.,
Division of Pulmonary and Critical Care, Mayo Clinic
Co-directors: Philip Seo, M.D./Stuart Levine, M.D.,
The Johns Hopkins Vasculitis Center
Participating Medical Centers
Boston University
Cleveland Clinic
Duke University
Hospital for Special Surgery, New York City
Mayo Clinic
The Johns Hopkins Vasculitis Center
University of Alabama at Birmingham
Investigator:
Katherine A. Siminovitch, MD Location: Mount Sinai Hospital, Toronto, Ontario, Canada
Timeline: March 1, 2004 – ongoing
Dr. Katherine Siminovitch’s study “Identification of Novel Wegener’s granulomatosis Susceptibility Genes” is an ongoing project to collect blood samples from Wegener's patients and their family members.
The goal of the study is to collect blood samples and prepare DNA from 500 patients and their immediate family members, and to conduct a comprehensive clinical chart review in order to obtain powerful data for results stratification and analysis.
The study needs at least 250 more WG patients to donate samples to have sufficient data to develop definitive results. It is very easy to participate in the study. Patients enroll in the study and have a blood sample drawn at their local doctor’s office and shipped to Dr. Siminovitch with the materials provided.
For more information please contact:
Alida Pokoradi, Clinical Research Coordinator
Phone: 416-946-4501 x3297
Fax: 416-946-4531
Email: clinicalgenet.research@gmail.com
To read the complete abstract for the study:
Identification of Novel Wegener’s granulomatosis Susceptibility Genes