Status:
COMPLETED
Tolerance and Efficacy of Rituximab in Sjogren's Disease
Lead Sponsor:
University Hospital, Brest
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Sjogren's Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief 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 si...
Detailed Description
TARGET POPULATION Inclusion criteria : Patients will be eligible if : they fulfill the new American-European Consensus Group criteria for pSS and have : * a recent (less than 10 years) and active di...
Eligibility Criteria
Inclusion
- they fulfill the new American-European Consensus Group criteria for pSS and have :
- a recent (less than 10 years) and active disease as assessed by :
- values \> 50 mm on 2 of 4 visual analogue scales (VAS) (0-100mm) that evaluated global scores of the disease (activity of the disease including extra glandular manifestations), pain, sicca syndrome and fatigue over the last week.
- Rheumatoid factor or anti SSA\>1.5N or cryoglobulinemia or
- hypergammaglobulinemia or high level of beta2 microglobulinemia or
- hypocomplémentemia.
- and/or at least one of the following severe signs:
- parotidomegaly,
- arthritis,
- purpura,
- pulmonary involvement,
- tubulopathy,
- neurological involvement,
- informed consent age 18-80 years, stable non-steroidal anti-inflammatory drugs and no prescription of immunosuppressive agents for at least 4 weeks prior to inclusion Use of a reliable mean of contraception (for patients of reproductive potential)
Exclusion
- Patients should be excluded if they have a secondary SS,
- if they received cytotoxic drugs during the previous 4 months,
- if they have severe renal or haematological failure, a history of cancer, hepatitis B or C, HIV, tuberculosis, severe diabetes or any other chronic disease or evidence of infection,
- if they have had severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- or if they are unable to understand the protocol.
- Other : neutrophil count \< 1.5 x 103/L, live/attenuated vaccine within 28 days prior to baseline, pregnancy, breast feeding,
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00740948
Start Date
March 1 2008
End Date
January 1 2013
Last Update
February 5 2025
Active Locations (14)
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1
CHU de Brest
Brest, France, 29200
2
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
3
GH Le Havre
Le Havre, France, 76 083
4
AP-HP Bicêtre
Le Kremlin-Bicêtre, France, 94275