Tolerance and Efficacy of Rituximab in Sjogren's Disease
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
CLINICAL PHASE II INDICATION Sjogren's syndrome RATIONALE Sjögren's syndrome (SS) is an
autoimmune disorder affecting 0.2% to 3% of the general population. Pharmacological treatment
can improve the sicca symptoms, often transiently, but they are unable to modify the course
of the disease.Open label studies suggested that low-dose rituximab produced acute and
complete CD20 depletion in blood and tissue; was well tolerated without corticosteroid use;
and significantly improved glandular and extra-glandular manifestations of pSS. Larger
controlled studies are now warranted. Our hypothesis is that two infusions of 1000 mg of
Rituximab may be better than placebo to treat patients suffering from pSS. To test this
hypothesis, we propose to compare patients with recent and/or severe pSS treated with either
Rituximab or placebo.
OBJECTIVES Primary objective : Evaluation of the efficacy defined as a 30% improvement
between Day 1 and Week 24 in the values on 2 of the 4 VAS measuring global scores of the
disease (activity of the disease including extra glandular manifestations), joint pain,
fatigue, and the most disturbing dryness.Secondary objectives : Variations from baseline to
week 24 of:
The 0-100-mm VAS scores for dry mouth, dry eyes, dry trachea, dry vagina, and dry skin;
fatigue; pain; Tender and swollen joint counts; Tender points; Other systemic manifestation;
Unstimulated salivary flow rate; Schirmer and van Bijsterveld scores (2-3); C-reactive
protein (CRP) and erythrocyte sedimentation rate (ESR); rheumatoid factor (RF); ANA; serum
IgG, IgA, and IgM; complement; cryoglobulinemia; and counts of B and T cells; Evaluation of
the safety of Rituximab during the study Evaluation of the improvement evaluated on VAS by
the physician Evaluation of the disease activity scores as suggested by Bowman and Vitali
Evaluation of Chisholm score, B cells characteristics and DNA microarray on labial accessory
salivary gland (SG) biopsy samples, and salivary gland echography at inclusion and at week
24.
TRIAL DESIGN Multicenter, randomized, double-blind, placebo-controlled trial NUMBER OF
SUBJECTS : 120