Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS)

Summary

Efficacy - To assess efficacy of etanercept versus sulfasalazine when added to NSAIDs in patients with moderate to severe active early axial spondyloarthritis duration of ongoing axial symptoms of less than 5 years. Primary outcome is change of active inflammatory lesions in sacroiliac joints and spine as detected by MRI at 12 months. Secondary outcome parameters are clinical and laboratory efficacy parameters and MRI changes at 6 months and 2 years. Comparisons will be made within the two treatment arms and compared to baseline. At the 1 year extension phase comparisons will be also made between year 1 and year 2. At the end of the extended study a pelvic x-ray is planned.

Timeline

Start

2005-11

Primary completion

2013-07

Completion

2013-07

Publications

• Torgutalp M, Rademacher J, Proft F, Hermann KG, Althoff C, Haibel H, Protopopov M, Sieper J, Rios Rodriguez V, Poddubnyy D. Association between resolution of MRI-detected inflammation and improved clinical outcomes in axial spondyloarthritis under long-term anti-TNF therapy. RMD Open. 2025 Jan 6;11(1):e004921. doi: 10.1136/rmdopen-2024-004921.
• Song IH, Hermann KG, Haibel H, Althoff CE, Poddubnyy D, Listing J, Weiss A, Lange E, Freundlich B, Rudwaleit M, Sieper J. Prevention of new osteitis on magnetic resonance imaging in patients with early axial spondyloarthritis during 3 years of continuous treatment with etanercept: data of the ESTHER trial. Rheumatology (Oxford). 2015 Feb;54(2):257-61. doi: 10.1093/rheumatology/keu263. Epub 2014 Aug 19.
• Song IH, Hermann KG, Haibel H, Althoff CE, Poddubnyy D, Listing J, Weiss A, Buss B, Freundlich B, Lange E, Alten R, Rudwaleit M, Sieper J. Consistently Good clinical response in patients with early axial spondyloarthritis after 3 years of continuous treatment with etanercept: longterm data of the ESTHER trial. J Rheumatol. 2014 Oct;41(10):2034-40. doi: 10.3899/jrheum.140056. Epub 2014 Jul 15.
• Weiss A, Song IH, Haibel H, Listing J, Sieper J. Good correlation between changes in objective and subjective signs of inflammation in patients with short- but not long duration of axial spondyloarthritis treated with tumor necrosis factor-blockers. Arthritis Res Ther. 2014 Jan 30;16(1):R35. doi: 10.1186/ar4464.

Drugs

Indications