Trial of anti IgE in RA.

• Conditions: Rheumatoid arthritis

• Registration Number: NL-OMON28491
• Lead Sponsor: eiden University Medical Center

Brief Summary

Schuerwegh AJM, Ioan A, Dorjée AL, Roos J, Bajema IM, van de Voort EIH, Huizinga TWJ, Toes REM. Evidence for a functional role of IgE anticitrullinated protein antibodies in rheumatoid arthritis. Proc Natl Acad Sci U S A. 2010 Feb 9;107(6):2586-91. 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.

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: 80

Inclusion Criteria

1. Patients with refractory active rheumatoid arthritis (RA). 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 3.6;

2. Presence of IgE-ACPA;

Exclusion Criteria

1. History of allergic or anaphylactic reaction to any therapeutic agent or known hypersensitivity to any component of anti-IgE monoclonal antibodies or to murine proteins;

2. No previous therapy with corticosteroids or a biological agent during the last 3 months;

Study & Design

• Study Type: Interventional
• Study Design: Not specified