Microscopic Polyangiitis Clinical Trial
— PedVasOfficial title:
Chronic Childhood Vasculitis: Characterizing the Individual Rare Diseases to Improve Patient Outcomes
Childhood chronic vasculitis describes a group of rare life-threatening diseases that have in common inflammation of blood vessels in vital organs such as kidneys, lungs and brain. Most knowledge about them comes from adult patients. Severe disease requires aggressive life-saving treatments with steroids and some cancer drugs which can themselves cause damage, and increase risks of cancer and severe infections. Conversely, milder disease can be treated with less toxic drugs. Different classification and "scoring tools" are used to define the types and severity of vasculitis and to measure damage caused by disease or drugs. These in turn help direct how aggressively to treat a patient and to measure outcome. None of these tools however have been assessed in children and the best balance of disease and treatment risks against outcome for children is not known. Although causes of these diseases in children and adults are probably the same, the effects of the disease and the response (good and bad) to drugs will differ in growing children. Because specialists may see only one new child with vasculitis each year, obtaining enough information to learn about childhood vasculitis requires cooperation. We will use an international web-based registry to which doctors from 50 or more centers can contribute patient data. We will determine the features which help better classify and diagnose children compared to adults. Through the web we will collect and analyze information on patients similarly classified and "scored" so that most successful treatments can be identified. Children with vasculitis are less likely to have diseases associated with aging, alcohol and smoking etc., and therefore may be a better group in whom to study the underlying biology of vasculitis. We will use this opportunity and collect spit, blood and tissue from registry patients for laboratory study with an aim to find biomarkers to better classify, define and direct optimal treatment and outcomes.
Status | Recruiting |
Enrollment | 1600 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 20 Years |
Eligibility | Inclusion criteria for vasculitis subjects: - Diagnosed with ANCA-associated vasculitis (AAV: such as Granulomatosis with Polyangiitis (GPA), Eosinophilic Granulomatosis with Polyangiitis (EGPA) and Microscopic Polyangiitis (MPA)), Primary Angiitis of the Central Nervous System (PACNS), Unclassified vasculitis, Takayasu's Arteritis (TA) or Polyarteritis Nodosa (PAN) before age 18 Inclusion criteria for healthy controls: - Healthy adult or child Exclusion Criteria for vasculitis subjects: - Diagnosed with other vasculitis subtypes not listed above - More than 20 years of age Exclusion criteria for healthy controls: - Donated greater than 20 ml of blood in the previous three weeks - Has an immune disorder or blood borne infectious diseases (such as HIV or Hepatitis) - Has vasculitis, multiple sclerosis, diabetes, an autoimmune disease, a thyroid condition, or other chronic conditions involving the heart, lungs, gut or kidney - Has a previous history of anaemia or abnormal blood clotting - Has a current or previous drug abuse problem |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary / Alberta Children's Hospital | Calgary | Alberta |
Canada | IIWK Health Centre | Halifax | Nova Scotia |
Canada | London Health Sciences Centre | London | Ontario |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Canada | Janeway Childrens Health and Rehabilitation Centre | St. John's | Newfoundland and Labrador |
Canada | Hospital for Sick Children | Toronto | Ontario |
Canada | BC Children's Hospital | Vancouver | British Columbia |
Denmark | Rigshospitalet | Copenhagen | |
Germany | University Children's Hospital | Munster | |
India | Sanjay Gandhi Post Graduate Institute | Lucknow | |
Thailand | Siriraj Hospital | Bangkok | |
United Kingdom | Birmingham Children's Hospital NHS Foundation Trust | Birmingham | |
United Kingdom | Royal Hospital for Children | Glasgow | |
United Kingdom | Leeds Children's Hospital | Leeds | |
United Kingdom | Alder Hey Children's Hospital | Liverpool | |
United Kingdom | Royal Manchester Children's Hospital | Manchester | |
United Kingdom | Great North Children's Hospital | Newcastle upon Tyne | |
United Kingdom | Nottingham Children's Hospital | Nottingham | |
United Kingdom | Nuffield Orthopaedic Centre | Oxford | |
United Kingdom | Sheffield Children's Foundation Trust | Sheffield | |
United Kingdom | Southampton General Hospital | Southampton | |
United States | Akron Children's Hospital | Akron | Ohio |
United States | Children's Hospital at Montefiore | Bronx | New York |
United States | Comer Children's Hospital | Chicago | Illinois |
United States | University of Florida | Gainesville | Florida |
United States | The Joseph M. Sanzari Children's Hospital | Hackensack | New Jersey |
United States | Texas Children's Hospital | Houston | Texas |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | University of Utah / Primary Children's Hospital | Salt Lake City | Utah |
United States | University of San Francisco | San Francisco | California |
United States | Seattle Children's Hospital | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | BC Childrens Hospital Research Institute, University of Oxford |
United States, Canada, Denmark, Germany, India, Thailand, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Develop new benchmarks for outcome in pediatric patients with systemic vasculitis | Specific and generic disease assessment tools will be used to analyze our registry cohorts to enable the first-ever benchmarks of outcome in children with GPA who have had a minimum of 12 months follow up. | within 3 yrs |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01729624 -
PRO Development for ANCA Associated Vasculitis
|
N/A | |
Terminated |
NCT02474888 -
Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis
|
||
Active, not recruiting |
NCT02198248 -
Low-dose Glucocorticoid Vasculitis Induction Study
|
Phase 4 | |
Completed |
NCT02190916 -
Vasculitis Illness Perception (VIP) Study
|
N/A | |
Recruiting |
NCT01241305 -
One-Time DNA Study for Vasculitis
|
||
Completed |
NCT00748644 -
Efficacy Study of Two Treatments in the Remission of Vasculitis
|
Phase 3 | |
Recruiting |
NCT02967068 -
VCRC Tissue Repository
|
||
Completed |
NCT01731561 -
Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis
|
Phase 3 | |
Not yet recruiting |
NCT06350110 -
Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT02126098 -
Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis
|
N/A | |
Completed |
NCT02190942 -
VCRC Patient Contact Registry Patient-Reported Data Validation Study
|
||
Terminated |
NCT01586858 -
Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study
|
N/A | |
Completed |
NCT00307593 -
RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
|
N/A | |
Completed |
NCT02190929 -
Educational Needs of Patients With Systemic Vasculitis
|
N/A | |
Terminated |
NCT01408836 -
Plasma Exchange for Renal Vasculitis
|
Phase 2/Phase 3 | |
Terminated |
NCT05376319 -
PR3-AAV Resilient Remission or PRRR
|
Phase 2 | |
Completed |
NCT02476292 -
Impact of Vasculitis on Employment and Income
|
N/A | |
Completed |
NCT02169219 -
Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
|
Phase 4 | |
Completed |
NCT01613599 -
An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
|
||
Active, not recruiting |
NCT05716334 -
Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator
|