ANTI-IGE THERAPY (OMALIZUMAB) IN IGE-ACPA POSITIVE RA. - TIGER

• Conditions: RHEUMATOID ARTHRITIS; MedDRA version: 12.1Level: LLTClassification code 10003268Term: Arthritis rheumatoid

• Registration Number: EUCTR2009-017306-36-NL
• Lead Sponsor: eiden University Medical Center, Department of Rheumatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
3. Age above 18 years
4. WHO performance status 0, 1 or 2
5. Informed consent according to rules and regulations of Leiden University Medical Center.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.
3 No previous therapy with rituximab, leflunomide
4. Life expectation of less than 6 months
5. History of severe CNS disturbances and psychiatric problems
6. Severe uncontrolled infections including parasitosis
7. Irreversible major organ dysfunction, defined by any of the following criteria:
-creatinine clearance < 40 ml/min.
-left ventricular ejection fraction < 40%;
-pericardial effusion with haemodynamic consequences.
-resting arterial oxygen tension (PaO2) < 8 kPa (<60 mmHg) and / or resting arterial carbon dioxide tension (PaCO2) > 6.7 kPa (>50 mmHg).
-sustained 3-fold increase in serum transaminase or bilirubin.
8. HIV positivity
9. Positive pregnancy test or unwillingness to use adequate contraception for the duration of the study
10. History of cancer, including solid tumors, hematological malignancies and carcinoma in situ (except for basal cell and squamous cell carcinoma of the skin that have been treated and cured).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified