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PEXIVAS
PEXIVAS trial is a multicentre, international, phase III, open label randomised controlled therapeutic trial to investigate plasma exchange and glucocorticoid dosing in the treatment of ANCA-associated vasculitis . It is conducted under the aegis of the VCRC, EUVAS and NIH. Several centers in Canada are to participate, including centers involved in CanVasc, like Hamilton, where Dr. M. Walsh (associated member of CanVasc), who originally worked on the trial design and is the main investigator for Canada, is established.
The first open center in Canada was Hamilton. Almost all other Canadian centers are now opened (Hamilton, London, Edmonton, Vancouver, SMH-Toronto, MSH-Toronto, Calgary) or close to open (TGH-Toronto). The first Canadian patient has been enrolled in late March 2011. At present and after more than18 months of recruitment, 97 patients have already been enrolled worldwide over the 500 aimed to be enrolled within 5 years (20 in Canada).
Download the trial synopis HERE .
Visit the official trial website HERE .
ABAVAS-GCA/TA
ABAVAS trial is a VCRC prospective, double-blinded, randomized therapeutic study to evaluate the adjunction of abatacept (CTL4-Ig) to corticosteroids in patients with either giant cell arteritis or Takayasu's arteritis (newly diagnosed or relapsing). The study started recruiting one year ago in the USA and in 2 Canadian centers (MSH-Toronto - Drs. Carette and Pagnoux; St-Joseph-Hamilton - Dr. Khalidi). Patients can have started prednisone or increased their daily dose, for the relapsers (further prednisone schedule is adjusted based on the dose received prior to enrollment).
Abatacept (CTLA4-Ig) is a biologic that modulates the costimulation signal required for antigen-specific T cell activation. ABAVAS-GCA/TA study seeks to randomize 66 participants (33 with GCA and 33 with TAK) to be studied over a 4 year period. Subjects will receive abatacept 10mg/kg given intravenously on days 1, 15, 29 and week 8 together with prednisone 40 to 60mg/day that will be tapered according to a standardized schedule. At week 12, subjects in remission will undergo a double blinded randomization to continue abatacept or be switched to placebo together with continuing a standardized prednisone taper. All subjects will be followed until the common closing date, defined as 1 year after the randomization of the 33rd subject for each disease. So far, 44 patients have been enrolled.The primary study endpoint is remission duration (relapse-free survival).
Click HERE for more information, or contact us admin@canvasc.ca
DCVAS
DCVAS is a non interventional study conducted under the combined aegis of the EUVAS, VCRC and the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) for the establishment of Diagnostic and new Classification Criteria for Primary Systemic Vasculitis (DCVAS).
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). 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 a list of items will be created to differentiate between vasculitis and 'vasculitis mimics'. A total of 3600 patients with vasculitis or vasculits 'mimics' are needed.
The second aim is 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. For this study, 260 patients with each of the 6 types of vasculitis will be recruited and compared 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.
It is an international study and several Canadians centers (all part of CanVasc) are participating, including London and Hamilton (Toronto to join soon).
Click for here for more information or, alternatively, here.
Click here to download the trial text.
Click here to download to the record form (CRF).