Treatment With Leflunomide in Patients With Polymyalgia Rheumatica

• Conditions: Polymyalgia Rheumatica PMRSpierreuma

• Registration Number: NL-OMON21927
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

1. Salvarani C, Cantini F, Hunder GG. 2. Dasgupta B, et al. BSR and BHPR guidelines for the management of GCA. Rheumatology2010: 8:1594-1597. 3. Hernandez-Rodriguez J,et al. Treatment of PMR: a review. ArchIntMed 2009 Nov 9;169(20):1839-1850. 4. van der Veen MJ, Dinant HJ, van Booma-Frankfort C, van Albada-Kuipers GA, Bijlsma JW. Can methotrexate be used as a steroid sparing agent in the treatment of PMR and GCA? ARD 1996 Apr;55(4):218-223. 5. Wagener P. MTX therapy of PMR . Zeitschrift fur Rheumatologie 1995 Nov-Dec;54(6):413-416. 6. Ferraccioli G, et al. MTX in PMR : preliminary results of an open, RCT. JRheum1996 Apr;23(4):624-628. 7. Feinberg HL, et al. The use of methotrexate in PMR. JRheum 1996 Sep;23(9):1550-1552. 8. Caporali R, Cimmino MA, et al. Prednisone plus MTX for PMR: a RCT. AnnIntMed2004 Oct 5;141(7):493-500. 9. Cimmino MA, Salvarani C, Macchioni P, et al. Long-term follow-up of PMR patients treated with methotrexate and steroids. Clinical and experimental rheumatology 2008 May-Jun;26(3):395-400. 10. Catanoso MG, Macchioni P, Boiardi L, Pipitone N, Salvarani C. Treatment of refractory polymyalgia rheumatica with etanercept: an open pilot study. Arthritis and Rheumatism 2007 Dec 15;57(8):1514-1519. 11. Salvarani C, Macchioni P, Manzini C,. Infliximab plus prednisone or placebo plus prednisone for the initial treatment of PMR: a randomized trial. Annals of Internal Medicine 2007 May 1;146(9):631-639. 12. Kreiner F, Galbo H. Effect of etanercept in PMR: a RCT. Arthritis research & therapy 2010;12(5):R176. 13. Lally L, Forbess L, Hatzis C, Spiera R. A prospective open-label phase II trial of tocilizumab in the treatment of Polymyalgia Rheumatica. Arthritis Rheumatology 2016; Oct;68(10):2550-4 14. Devauchelle-Pensec V, Berthelot JM, Cornec D, Renaudineau Y, Marhadour T, Jousse-Joulin S, Querellou S, Garrigues F, De Bandt M, Gouillou M, Saraux A. Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study. Ann Rheum Dis. 2016 Aug;75(8):1506-10 15. Adizie T, Christidis D, Dharmapaliah C, Borg F, Dasgupta B. Efficacy and tolerability of Leflunomide in difficult-to-treat PMR and GCA: a case series. International journal of clinical practice 2012 Sep;66(9):906-909. 16. Diamantopoulos AP, Hetland H, Myklebust G. Leflunomide as a corticosteroid-sparing agent in giant cell arteritis and polymyalgia rheumatica: a case series. BioMed research international 2013;2013:120638. 17. Dasgupta B, Cimmino MA, Kremers HM, Schmidt WA, Schirmer M, Salvarani C, et al. 2012 Provisional classification criteria for PMR: a EULAR/ACR collaborative initiative. AR 2012 Apr;64(4):943-954. 18. Gran JT, Myklebust G. The incidence of PMR and temporal arteritis in the county of Aust Agder, south Norway: a prospective study 1987-94. The Journal of rheumatology 1997 Sep;24(9):1739-1743. 19. Kermani TA, Warrington KJ. Polymyalgia rheumatica. Lancet 2013 Jan 5;381(9860):63-72. 20. Matteson EL, Maradit-Kremers H, Cimmino MA, Schmidt WA, Schirmer M, Salvarani C, et al. Patientreported outcomes in polymyalgia rheumatica. The Journal of rheumatology 2012 Apr;39(4):795-803. 21. Dasgupta B, Borg FA, Hassan N, Barraclough K, Bourke B, Fulcher J, et al. BSR and BHPR guidelines for the management of polymyalgia rheumatica. Rheumatology (Oxford, England) 2010 Jan;49(1):186-190. 22. Dejaco C, Singh YP, Perel P, Hutchings A et al. 2015 Recommendations for the Management of Polymyalgia Rheumatica. A European League Against Rheumatism/American College of Rheumatology Collaborative Initiative. Arthritis & Rheumatology, 2015, 67(10):2569�C2580. 23. Metzler, C., Fink, C., Lamprecht, P., Gross, W. L. & Reinhold-Keller, E. Maintenance of remission with Leflunomide in Wegener's granulomatosis. Rheumatology (Oxford) 43, 315�C320 (2004).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 94

Inclusion Criteria

1.Signed written informed consent

2.Female or male aged ¡Ý 50 years

Exclusion Criteria

1.Presence of any other connective tissue disease, including vasculitis/giant-cell arteritis

2.PMR on glucocorticoids for >4 week or >25 mg/day

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PMR relaps, timepoint: first 12 months of the study

Secondary Outcome Measures

Name	Time	Method
Efectiveness concerning disease activity <br /><br>a.Time till first relaps within first 24 months<br /><br>b.Percentage of patients with at least 1 relaps in the first 12 or 24 months<br /><br>c.Total relapses within the first 12 and 24 months<br /><br>d.Time till gucocorticoid free remission<br /><br /><br><br>Gucocorticoid-sparing effect <br /><br>a.Gucocorticoid dose after 6, 12, 18 and 24 months.<br /><br>b.Cumulative glucocorticoid dose after 12, 18 and 24 months<br /><br /><br><br><br>Safety/side-effects <br /><br>a.Amount of side effects<br /><br>b.Amount of severe side effects<br>