Rituximab in Systemic Sclerosis (NCT01748084) | Clinical Trial Compass
CompletedPhase 2/3
Rituximab in Systemic Sclerosis
France22 participantsStarted 2013-04-09
Plain-language summary
The purpose of this study is to determine whether rituximab is effective in the treatment of articular symptoms that occur in systemic sclerosis related polyarthritis
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Systemic sclerosis fulfilling ACR or LeRoy's criteria
* Active polyarthritis defined by \> 6/53 tender joints and \> 4/53 swollen joints
* Ongoing first line therapy by prednisone (max 10 mg/d) and DMARDS (methotrexate, leflunomide, azathioprine or mycophenolate)
* Birth control if applicable
Exclusion Criteria:
* Overlap syndrome defined by clinical symptoms and positive specific auto-antibodies (anti-CCP, anti-SSA, anti-DNA DNA anti-Sm) (Rheumatoid factors and anti-RNP are not exclusion criteria)
* Past therapy with Rituximab.
* Severe and uncontrolled disease with renal, liver or haematological (neutropenia \< 1500 / mm3) failures, pulmonary (FVC \< 50%) or cardiac insufficiencies (LVEF \< 50%)
* Not stable corticosteroid therapy or cyclophosphamide use in the last 6 months
* Infectious risk : viral infections by B or C hepatitis or HIV, hypogammaglobulinemia (\< 6 G/L), opportunistic infection or infection requiring IV antibiotics in the last 3 months.
* Neoplastic solid tumor in the last 5 years
* Drug or alcool abuses
* Receiving patient or having received a biotherapy (anti-TNF, abatacept or tocilizumab) in the last 3 months (possible inclusion beyond 3 months)