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 Summary table of ongoing studies

GPA on prednisone for maintenance

TAPIR (website)

Relapsing non-severe GPA

ABROGATE

Skin vasculitis

ARAMIS (treatment), CUTIS (biopsy)... soon

All

VCRC cohorts (any time)

 

VCRC/VPPRN contact registry (any time)

 

DCVAS (<2 years)

 

CanVasc database (any time, in CanVasc centers)

PACNS

INTERSpace

 

BrainWorks (for children and adults)

 To read more information on each study, click on the name on the study when a link is available and/or read below.

NOTE 29 December 2016: ARAMIS, a randomized control trial for the treatment of patients with primary isolated skin vasculitis (including small, medium and IgA isolated skin vasculitides), and CUTIS, a study on skin biopsy in patients with any type of skin vasculitis, will begin enrolling soon in several Canadian Centers. More information coming soon.

NOTE (1 October 2016): Inclusions in the PEXIVAS study are closed (704 patients enrolled worlwide). Treatment and follow-up of enrolled patients are ongoing. First results expected in early 2018. Visit the official trial website HERE .

If you still need more detail on these studies or if you think that one of your patients could be eligible for any of this study, do not hesitate to contact us as well (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, Hamilton, Ottawa, Calgary and Toronto.

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).


INTERSPACE

The primary objective of INTERnational Study on Primary Angiitis of the CEntral nervous system (INTERSPACE) is to identify markers of death or dependance at the end of a follow-up period of >1 years. INTERSPACE is coordinated by Dr. S Lanthier and several CanVasc centers will participate. Patients with a diagnosis of PACNS proven by histopathology or presumed from clinical manifestations and investigation results (without of confirmation by histopathology) are eligible. The sample size is 200 patients.

INTERSPACE also comprises several secondary objectives and proposes a few optional substudies.  Baseline and follow-up data are recorded in a web-based database hosted in Finland (database committee: Jukka Putaala, Daniel Strbian). Radiological studies are reviewed at the CHUM, Montreal, Canada (radiology committee: Laurent Guillon-Létourneau, Jean Raymond, François Guilbert) and histopathology slides at the Mass General, Boston, USA (histopathology committee: Matthew P. Frosch). Diagnosis of PACNS and outcome events are adjudicated following predefined criteria (adjudication committee: Aneesh Singhal, Sylvain Lanthier, Alex Y Poppe).

STUDY SYNOPSIS
Primary objective:
To identify predictors of death or dependence at the end of follow-up (mRS = 3 to 6).
Secondary objectives: To identify predictors of dependence or death (mRS = 3 to 6) at 1 year following initiation of immunosuppressive therapy. To identify predictors of neurological deterioration defined by the combination of clinical manifestations and investigation results consistent with active vasculitis more than 14 days after initiation of immunosuppressive therapy. To describe long-term outcome, more than 1 year following initiation of immunosuppressive therapy. To describe recognizable subsets of PACNS with specific clinical manifestations or investigation results
Inclusion criteria:
- Age 16 or older at study enrolment
- Acquired neurological dysfunction consistent with PACNS and unexplained by other causes. Qualifying neurological dysfunctions include headaches, cognitive decline, seizures, and focal or multifocal neurological deficits
- A “high-probability" imaging study of the CNS vessels demonstrating alternating areas of stenosis, ectasia, or both in more than one vascular beds, unexplained by intracranial arteriosclerosis, reversible cerebral vasoconstriction syndrome or other diseases that may mimic PACNS OR CNS histopathology confirming PACNS
- Exclusion of underlying diseases that can mimic PACNS
Exclusion criteria:
- MRI of the brain (and spinal cord if the disease is limited to the spinal cord) was not obtained before initiation of immunosuppressive therapy
- The patient was treated with immunosuppressive therapy for more than 30 days before study enrolment
- The patient or his/her surrogate did not sign consent to study participation
Mandatory clinical visits: At baseline, at 3, 6 and 12 months following initiation of immunosuppressive therapy, at each additional year of follow-up, and at neurological deteriorations.

Contact and info for physicians and centers interested in particpating:

Dr. Sylvain Lanthier MD OD CSPQ
Directeur scientifique, Programme de neurologie vasculaire/Scientific Director, Vascular Neurology Programme, Service de Neurologie/Division of Neurology, CHUM, Université de Montréal
Tél.: Secrétaire admin. de recherche/Admin. Research Secretary: 1-514-890-8000 x 26268
 sylanthier@gmail.com

 

This Web Page was updated the 29 December 2016 by Dr. Christian Pagnoux