Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis

Summary

This is an open-label trial investigating the efficacy and safety of abatacept in ankylosing spondylitis. It is planned to treat 30 patients with ankylosing spondylitis from baseline up to week 30. Abatacept will be administered intravenously according to the prescription used in rheumatoid arthritis.

Timeline

Start

2008-01

Primary completion

2009-10

Completion

2009-12

Publications

• Background Zochling J, van der Heijde D, Burgos-Vargas R, Collantes E, Davis JC Jr, Dijkmans B, Dougados M, Geher P, Inman RD, Khan MA, Kvien TK, Leirisalo-Repo M, Olivieri I, Pavelka K, Sieper J, Stucki G, Sturrock RD, van der Linden S, Wendling D, Bohm H, van Royen BJ, Braun J; 'ASsessment in AS' international working group; European League Against Rheumatism. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2006 Apr;65(4):442-52. doi: 10.1136/ard.2005.041137. Epub 2005 Aug 26.
• Background Appel H, Kuhne M, Spiekermann S, Ebhardt H, Grozdanovic Z, Kohler D, Dreimann M, Hempfing A, Rudwaleit M, Stein H, Metz-Stavenhagen P, Sieper J, Loddenkemper C. Immunohistologic analysis of zygapophyseal joints in patients with ankylosing spondylitis. Arthritis Rheum. 2006 Sep;54(9):2845-51. doi: 10.1002/art.22060.
• Background Appel H, Loddenkemper C, Grozdanovic Z, Ebhardt H, Dreimann M, Hempfing A, Stein H, Metz-Stavenhagen P, Rudwaleit M, Sieper J. Correlation of histopathological findings and magnetic resonance imaging in the spine of patients with ankylosing spondylitis. Arthritis Res Ther. 2006;8(5):R143. doi: 10.1186/ar2035.
• Background Appel H, Kuhne M, Spiekermann S, Kohler D, Zacher J, Stein H, Sieper J, Loddenkemper C. Immunohistochemical analysis of hip arthritis in ankylosing spondylitis: evaluation of the bone-cartilage interface and subchondral bone marrow. Arthritis Rheum. 2006 Jun;54(6):1805-13. doi: 10.1002/art.21907.
• Background Sieper J, Braun J. Pathogenesis of spondylarthropathies. Persistent bacterial antigen, autoimmunity, or both? Arthritis Rheum. 1995 Nov;38(11):1547-54. doi: 10.1002/art.1780381105.
• Background Maksymowych WP. Ankylosing spondylitis--at the interface of bone and cartilage. J Rheumatol. 2000 Oct;27(10):2295-301. No abstract available.
• Background Weinblatt M, Combe B, Covucci A, Aranda R, Becker JC, Keystone E. Safety of the selective costimulation modulator abatacept in rheumatoid arthritis patients receiving background biologic and nonbiologic disease-modifying antirheumatic drugs: A one-year randomized, placebo-controlled study. Arthritis Rheum. 2006 Sep;54(9):2807-16. doi: 10.1002/art.22070.
• Background Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Li T, Ge Z, Becker JC, Westhovens R. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2006 Jun 20;144(12):865-76. doi: 10.7326/0003-4819-144-12-200606200-00003.

Drugs

Indications