INFLUENCE OF B CELL DEPLETION BY MONOCLONAL ANTI-CD20 ANTIBODIES IN SYSTEMIC SCLERODERMA - RItuximab In Scleroderma ( RITIS)

• Conditions: systemic sclerosis; MedDRA version: 9.1Level: PTClassification code 10039710Term: Scleroderma

• Registration Number: EUCTR2008-007180-16-NL
• Lead Sponsor: MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-24
• 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. Age between 18 and 70 years.
2. Established diagnosis of systemic sclerosis according to ARA-criteria (appendix).
3. Informed consent

Appendix . Definition and classification of systemic sclerosis

Systemic sclerosis can be classified according to criteria set up by the American Rheumatism Association:

ARA scleroderma criteria cooperative study: Preliminary criteria for the classifica¬tion of
syste¬mic sclerosis (scleroderma)
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1. Major criterion:- Proximal scleroderma
2. Minor criteria :- Sclerodactyly
- Digital pitting scars or loss of substance of the digital finger pad
- Bibasilar pulmonary fibrosis

One major or two or more minor criteria are necessary to establish a diagnosis of SSc. A further subclas¬sification can be made in limited (cuta¬neous) SSc (lSSc) and diffuse (cutaneous) SSc (dSSc).
Limited SSc is characterized by skin involvement limited to hands, feet, face and/or fore¬arms, is associ¬ated with a high incidence of anticentro¬mere autoantibodies (70-80%), the existen¬ce for years of Ray¬naud's phenomenon and a significant late incidence of pulmonary hyper¬tensi¬on. The acronym CREST (Ca¬lcinosis, Raynaud's phenom¬enon, Esophageal dysmo¬tility, Sclero¬dac¬tyly and Telean¬giectasia) fits into this subclassification.
Diffuse SSc is characterized by skin involvement on upperarms and trunk, is as¬sociated with an early incidence of interstitial lung disease, hypertensive crisis and renal failure, diffuse gastrointesti¬nal disease and myocardial involvement.

Reference:

Subcommittee for scleroderma criteria of the American Rheumatism Association diagnostic and therapeutic criteria commit¬tee. Preliminary criteria for the classification of systemic sclerosis (scleroderma). Arthritis Rheum 1980;23:581-590.

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

. Pregnancy or unwillingness to use adequate contraception during study
2. Previous treatments with biological agents, cell depleting therapies including investigational
agents.
3. Significant exposure to bleomycin, tainted rapeseed oil, vinyl chloride, trichlorethylene or silica; eosinophilic myalgia syndrome; eosinophilic fasciitis.
5. History of allergic or anaphylactic reaction to a biological agent or known hypersensitivity to any component of anti-CD20 monoclonal antibodies or to murine proteins.
6. History of deep tissue infection (e.g. Fasciitis, abscess, osteomyelitis) within 1 year prior to baseline.
7. History of serious chronic or recurrent infection within 12 weeks prior to baseline, including HIV, HTLV-1,2 positivity.
8. 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).
9. Concurrent liver failure as defined by a sustained 3-fold increase in serum transaminase or bilirubin.
10. Active drug or alcohol abuse or persistent psychiatric disorders that prevent inclusion.
11. Uncontrolled hypertension.
12. Poor compliance of the patient as assessed by the referring physicians.
13. Receipt of any vaccine 28 days prior to baseline.
14. Intolerance or contraindications to IV glucocorticoids.
15. Positive tests for HbsAg, Hepatitis core antibody or hepatitis C serology.
16. Concentrations of serum IgG and /or IgM below 5.0 and 0.40 mg/ mL.
17. Absolute neutrophil count of less than 1.0x 109/L.

Study & Design

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