Study:
ACR/EULAR Endorsed Study to Develop New Diagnostic and Classification Criteria for Primary Systemic Vasculitis
Rationale:
n/a
Purpose:
Vasculitis is group of diseases where inflammation of blood vessels is the common feature.
Patients typically present with fever, fatigue, weakness and muscle and joint aches. These
symptoms are very common among many different diseases, not just vasculitis. A clustering
of other symptoms, physical examination findings, blood tests, radiology and biopsy help
make the diagnosis. There are currently no criteria to help doctors make a diagnosis of
vasculitis when a patient presents with these non specific symptoms and they are reliant on
previous experience and disease definitions. One of the aims of this project is to develop
diagnostic criteria for the primary systemic vasculitides (granulomatosis with polyangiitis
(Wegener`s), microscopic polyangiitis, Churg Strauss syndrome, polyarteritis nodosa, giant
cell arteritis, Takayasu arteritis). We, the investigators, will do this by studying a large
group of patients with vasculitis and comparing them to a large group of patients that
present in a similar way, but do not have vasculitis. By comparing the 2 groups we will
create a list of items to differentiate between vasculitis and `vasculitis mimics`.
We also aim to update the current classification criteria. Classification criteria are used
to group patients into different types of vasculitis, once a diagnosis of vasculitis has
been made, and are useful for studying patients in clinical trials with similar or identical
diseases. The current classification criteria (American college of Rheumatology 1990
criteria) were developed 20 years ago, before the availability of some important diagnostic
tests (e.g. antineutrophil cytoplasmic antibodies [ANCA]), and are now not consistent with
some of the current disease definitions. Therefore to progress future research in
vasculitis, it is important that the classification criteria are updated. We will recruit
260 patients with each of the 6 types of vasculitis and compare them with 1300 controls
(patients with the 5 other types of vasculitis), in order to determine the optimal
combination of symptoms, signs and investigations that classify each person into the
appropriate group.
Study Status: Recruiting
Recruiting:
Carol Langford LANGFOC@ccf.org
| Condition |
Intervention |
Phase |
Wegener`s Granulomatosis
Microscopic Polyangiitis
Churg Strauss Syndrome
Polyarteritis Nodosa
Giant Cell Arteritis
Takayasu Arteritis |
n/a |
N/A |
Verified by
University of Oxford
January, 2013
Sponsored by: University of Oxford
Information provided by: University of Oxford
ClinicalTrials.gov identifier: NCT01066208
Study Type: Interventional
Study Design: Observational Model: Case Control, Time Perspective: Prospective
Cleveland Clinic
Cleveland, Ohio 44195
United States
Raashid A Luqmani, DM, FRCP(E)., Principal Investigator
Peter Merkel, MD, MPH., Principal Investigator
Richard Watts, DM, FRCP., Principal Investigator