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Updated on 22.02.2007

Clinical Trials

Completed trials  

CYCAZAREM (cyclophosphamide versus azathioprine for remission in generalised vasculitis) was completed and published in The New England Journal of Medicine in 2003.

SOLUTION (anti-thymocyte globulin for refractory vasculitis) was completed and published in Kidney International in 2004.

NORAM (methotrexate versus cyclophosphamide for 'early systemic' disease) was completed and published in Arthritis & Rheumatism in 2005.

CHUSPAN (Churg-Strauss and polyarteritis nodosa) was completed in 2005. Its four differnent protocols included either Churg-Strauss syndrome or polyarteritis nodosa (PAN) plus microscopic polyangiitis (MPA) both either with good and poor prognosis. The results of PAN/MPA with bad prognosis were published in Arthritis & Rheumatism in 2003. Futher reports are in preparation.

CYCLOPS (daily oral versus pulse cyclophosphamide for renal vasculitis) is completed and will be published soon.

MEPEX (methyl prednisolone or plasma exchange for severe renal vasculitis) is completed and will soon be published. The results have been presented to the American Society of Nephrology and are summerised in a recent review.

IMPROVE (International Mycophenolate mofetil to Reduce Outbreaks of Vasculitides) compares mycophenolate mofetil with azathioprine for remission therapy in renal vasculitis. The trial will be completed in 2008.

   
Trials actively recruiting  
REMAIN (long-term low dose immunosuppression versus treatment withdrawal for renal vasculitis). The protocol was revised in December 2005. Please, contact the trial office for information on actively recruiting centres.

RITUXVAS compares a rituximab based regimen with a standard cyclophophamide/ azathioprine regimen in the treatment of active, ‘generalised’ ANCA associated vasculitis. Inclusion is expected to be completed in summer 2007. Please, contact the trial office for information on actively recruiting centres.

Trials starting soon

  
MYCYC (Randomised clinical trial of mycophenolate mofetil versus cyclophos phamide for remission induction in ANCA associated vasculitis). First inclusions are sceduled for spring 2007. Please, contact the trial office for information on actively recruiting centres.

 

Parallel studies

SEROLOGY: The Serumbank continues to invite submission
of sera from patients in the trials.
Please send any outstanding sera to:
Liselotte Stummann
Building 81, room 548;
Dept. of Autoimmunology,
Statens Serum Institut,
Artillerivej 5,
DK-2300 Copenhagen S.
Denmark.
Fax: +45 3268 3876.

 

ADVERSE EVENTS:
Lorraine Harper is collating the adverse events from the
first three trials.
Contact: L.Harper@bham.ac.uk

RELAPSE and DRUG DOSING:
Elizabeth Kraup is examining the association between relapse
and steroid/immunosuppressive dosing.
Contact: krarup@dadlnet.dk

HISTOPATHOLOGY:
Rob de Lind van Wijngaarden and Chris Hagen are studying the
renal pathology from the MEPEX trial and comparing to clinical
and laboratory outcomes.
Contact: R.A.F.de_Lind_van_Wijngaarden@lumc.nl

Future projects

MALE FERTILITY:
Marion Haubitz has developed a study of male fertility after cyclophosphamide.
Contact: Haubitz.Marion@MH-Hannover.de

IMMUNISATION AND VASCULITIS:
Have you any cases of systemic vasculitis precipitated by an immunisation ?
Please contact Kerstin.Westman@skane.se