Anti-IgE therapy (omalizumab) in IgE-ACPA positive RA.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
Schuerwegh AJM, Ioan A, Dorjée AL, van de Voort EIH, Huizinga TWJ, Toes REM. The Functional Role of IgE-Anti Citrullinated Peptide/Protein Antibodies in Rheumatoid Arthritis. Ann Rheum Dis 2009;68(suppl I):A18-A19. Oral presentation on European Workshop of Rheumatology Research (EWRR) February 26-28th, 2009, Warsaw, Poland.
Direct activation of IgE-ACPA positive cells in rheumatoid arthritis. Schuerwegh AJM, Ioan A, Dorjée AL, van de Voort EIH, Huizinga TWJ, Toes REM. Ann Rheum Dis 2009;68(supplIII):150. Oral presentation on European League of Arthritis and Rheumatism (EULAR) June 10t -13th, 2009, Copenhagen, Danmark.
Citrullinated Proteins Activate IgE-ACPA+ Cells in Rheumatoid Arthritis. Annemie JM Schuerwegh, Andreea Ioan-Facsinay, Annemarie L. Dorjée, Ellen IH van der Voort, Tom WJ Huizinga and René EM Toes. Annual Congres on Rheumatology ACR/AHRP Scientific Meeting October 2009, Philadelphia, USA.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients with active rheumatoid arthritis (RA). These include patients with risk of permanent disability, irreversible major organ failure or premature mortality. Refractory disease is defined as persistent or relapsed disease activity despite conventional treatment, i.e. combination of disease modifying antirheumatic drugs including maximal tolerable doses of methotrexate. Active disease is defined as a DAS44 (Disease Activity Score of 44 joints) score of more than 2.4;
- •2. Presence of IgE-ACPA;
排除标准
- •1. History of allergic or anaphylactic reaction to a biological agent or known hypersensitivity to any component of anti-IgE monoclonal antibodies or to murine proteins;
- •2. Life expectation of less than 6 months;