| NCT ID | NCT01241305 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2010-10 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2010-10 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to identify genes that increase the risk of developing vasculitis, a group of severe diseases that feature inflammation of blood vessels. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.
Eligibility Criteria
Inclusion Criteria: 1\. Diagnostic criteria for Giant Cell Arteritis Age at disease onset \>50 years (required) 1. New onset or new type of localized pain in the head 2. Temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries) 3. ESR of \>40mm in the first hour by the Westergren method 4. Abnormal artery biopsy (i.e. temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells) 5. Large Vessel Vasculitis (LVV) by angiogram or biopsy not explained by something else Inclusion Criteria: 2\. Diagnostic criteria for Takayasu's Arteritis 1. Age at disease onset \<50 years 2. Claudication of extremities 3. Decreased brachial artery pulse (one or both arteries) 4. Blood pressure difference of \>10mm Hg between the arms 5. Bruit over subclavian arteries or aorta 6. Arteriogram abnormalities compatible with TAK (includes conventional dye angiography or MR angiography or CT angiography) Inclusion Criteria: 3\. Diagnostic criteria for Polyarteritis Nodosa Major criteria (not explained by other causes) felt by investigator to be due to vasculitis 1. Arteriographic abnormality 2. Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy 3. Mononeuropathy or polyneuropathy Minor criteria (not explained by other causes) felt by investigator to be due to vasculitis 1. Weight loss \> 4 kg 2. Livedo reticularis, cutaneous ulcerations, or skin nodules 3. Testicular pain or tenderness 4. Myalgias 5. Diastolic blood pressure \> 90 mm Hg 6. Elevated BUN or serum creatinine levels 7. Ischemic abdominal pain Isolated cutaneous Polyarteritis Nodosa 1. Biopsy-proven cutaneous PAN Inclusion Criteria: 4\. Diagnostic criteria for Granulomatosis with Polyangiitis (Wegener's) (GPA) and Microscopic Polyangitis (MPA) * Diagnosis of GPA or MPA. Widely accepted diagnostic criteria, as opposed to classification criteria or definitions, have not been developed for GPA \& MPA. * For diagnosis of GPA meets at least 2 of the following 5 modified ACR criteria: 1. Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood 2. Abnormal chest radiograph with nodules, fixed infiltrates, or cavities 3. Urinary sediment with microhematuria or red cell casts 4. Granulomatous inflammation within the wall of an artery or in the perivascular area on biopsy 5. Antineutrophil cytoplasmic antibody (ANCA) positive by enzyme immunoassay for either PR3- or MPO-ANCA * For diagnosis of MPA, meets the Chapel Hill Consensus Conference Definition for MPA: 1. Necrotizing vasculitis, with few or no immune deposits, that affects small vessels (i.e., capillaries, venules, arterioles) 2. Necrotizing arteritis involving small- and medium-sized arteries may be present 3. Necrotizing glomerulonephritis is very common 4. Pulmonary capillaritis often occurs Inclusion Criteria: 5\. Diagnostic criteria for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss) 1. Asthma 2. Peak peripheral blood eosinophilia of \>10% of total WBC 3. Peripheral neuropathy attributable to vasculitis 4. Transient pulmonary infiltrates on chest imaging studies 5. Paranasal sinus abnormalities or nasal polyposis 6. Eosinophilic inflammation on tissue biopsy If patients have 4 of the above 6 criteria but lack clearcut documentation of small vessel vasculitis, they are also eligible for enrollment. General Exclusion Criteria: * Inability to give informed consent and to sign the consent form * Enrolled in VCRC protocols 5502, 5503, 5504, 5505, 5506, 5522, or 5523 * Unwilling to provide blood for DNA collection
Contact & Investigator
Carol McAlear, MA
✉ cmcalear@upenn.eduPeter Merkel, MD, MPH
STUDY DIRECTOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT01241305 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, studying Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01241305 currently recruiting?
Yes, NCT01241305 is actively recruiting participants. Contact the research team at cmcalear@upenn.edu for enrollment information.
Where is the NCT01241305 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Francisco, United States, Chicago, United States, Kansas City, United States and 10 additional locations.
Who is sponsoring the NCT01241305 clinical trial?
NCT01241305 is sponsored by University of Pennsylvania. The principal investigator is Peter Merkel, MD, MPH at University of Pennsylvania. The trial plans to enroll 1,000 participants.