VCRC5502: Longitudinal Protocol for Giant Cell Arteritis

The development and validation of accurate biological markers and predictors of disease activity and outcome for Giant Cell Arteritis, a form of idiopathic vasculitis, would have a major positive impact on the clinical care of patients with this rare disease, be an important insight into the design of clinical trials and feasibility of new drug development, and provide important insight into the pathogenesis of this condition. Current measures of disease activity, including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), while helpful in selected settings, are mostly considered highly flawed and markers whose poor correlation with disease flares makes them inadequate to help guide therapy. Similarly, ESR and CRP are clearly unhelpful as diagnostic tests for vasculitis. The current state of clinical investigation for vasculitis relies heavily upon determination of disease status solely by clinical presentation and investigator opinion. Thus, discovery and validation of more precise markers that quantifiably measure activity, predict disease course, and correlate with an important biological process, would be of great importance. Knowledge to be gained from this study could potentially be highly important. Discovery of effective biomarkers of vasculitis and assessment of long term disease course and complications by the collection of clinical and diagnostic imaging studies proposed could lead to better care and less toxic treatment regimens. Furthermore, insight into the pathophysiology of vasculitis could be gained and this might lead to better treatments and improved outcomes in terms of reduction of vascular and treatment related complications. Ideally, excellent biomarkers reflect a sophisticated understanding of the pathophysiology of a disease.]]>
VCRC Baseline Comorbidity FormVCRC LVV (GCA/TAK) Baseline Medical History FormVCRC LVV (GCA/TAK) Physical Exam FormVCRC Baseline Vasculitis Medication FormBirmingham Vasculitis Activity Score (BVAS)VCRC GCA Eligibility ChecklistVCRC Follow-up Comorbidity FormVCRC LVV (GCA/TAK) Follow-up Medical History FormVCRC LVV (GCA/TAK) Physical Exam FormVCRC Follow-up Vasculitis Medication FormVCRC Laboratory Results FormVCRC LVVID WorksheetVCRC Patient Global Assessment FormVCRC Vasculitis Damage Index (VDI)VCRC Angiogram Study Form - Aorta and BranchesVCRC Angiogram Study Form – Celiac/Mesenteric/RenalVCRC Angiogram Study Form - CerebralVCRC Angiogram Study Form - CoronaryVCRC Angiogram Study Form - Left Lower ExtremityVCRC Angiogram Study Form - Left Upper ExtremityVCRC Angiogram Study Form - PulmonaryVCRC Angiogram Study Form - Right Lower ExtremityVCRC Angiogram Study Form - Right Upper ExtremityVCRC Change of Information FormVCRC Demographics FormVCRC Hospitalization FormVCRC Pregnancy FormVCRC Protocol TerminationSF-36 Health SurveyVCRC Tobacco, Alcohol and Drug FormInclusion Criteria: Patients will have a diagnosis of Giant Cell Arteritis (GCA), according to the American College of Rheumatology (ACR) criteria for classification of GCA, meeting at least 2 of the following 5 remaining criteria at the time of diagnosis of GCA. Age of disease onset >50 years (required) New onset or new type of localized pain in the head Temporal artery abnormality (i.e. temporal artery tenderness to palpation or deceased pulsation, unrelated to arteriosclerosis of cervical arteries) ESR of >40 mm in the first hour by the Westergren method Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells. Large Vessel Vasculitis (LVV) by angiogram or biopsy not explained by something else Exclusion Criteria: Inability to give informed consent and to sign the consent form.]]>
This study is a project of the Vasculitis Clinical Research Consortium (VCRC), which is a consortium of investigators in 8 major North American vasculitis centers (Boston University, Cleveland Clinic, Johns Hopkins, Mayo Clinic, Mount Sinai Hospital, St. Joseph's Healthcare Hamilton, University of Pennsylvania, University of Pittsburgh, and University of Utah. The VCRC is funded through the National Institutes of Health as a Rare Diseases Clinical Research Network with the purpose of promoting research in vasculitis. This study was opened to enrollment on April 17, 2006. ]]>