ANTI-IGE THERAPY (OMALIZUMAB) IN IGE-ACPA POSITIVE RHEUMATOID ARTHRITIS Addendum: An open label extension study to provide continuation of anti-IgE therapy to Rheumatoid Arthritis patients who participated in the TIGER study P10.161

Phase 2

Completed

• Conditions: rheumatism; rheumatoid arthritis; 10003816; 10023213

• Registration Number: NL-OMON37983
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• 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
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.
Addendum: Rheumatoid arthritis patients included in placebo controlled TIGER study during 6 months according to the inclusion and exclusion criteria (see original protocol P10.161) can be included in the open label extension protocol, regardless their previous treatment (omalizumab or placebo).

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
• Study Design: Not specified