To summarise, the peripheral neurological complications experienced by patients with primary Sjögren's syndrome are particularly bothersome since they are common and often result in significant disability related to pain or motor impairment. There is currently no standard treatment for these patients. As these neuropathies are caused by an immune system dysfunction, which is related to a variety of different pathogenic mechanisms, the use of immunosuppressant or immunomodulator drugs is often justified. With the exception of the vascularitis-related multiplex mononeuropathies, other pSS-related neuropathies could be suitable candidates for IV Ig treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
The treatment (IV Ig, 100mg/ml at the dose of 2g/kg of body weight) will be administered by perfusion every 4 weeks, with a total of 3 perfusions administered (W0, W4, W8).
The treatment (NaCl 0,9% 20 ml/kg) will be administered by perfusion every 4 weeks, with a total of 3 perfusions administered (W0, W4, W8).
University Hospital, Strasbourg, france
Strasbourg, France
Improvement of at least 20% over placebo of numerical Pain Scale
Time frame: At week 11
Improvement of at least 20% over placebo with the R-DS scale (Rasch-built Overall Disability Scale)
Time frame: At week 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.
o Quality of life scale (SF 36)
Time frame: Weeks 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.
o HAD depression score
Time frame: Weeks 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.
o Numerical Fatigue Scale
Time frame: Weeks 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.
o A fatigue scale (EMIF)
Time frame: Weeks 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. intensity.
o Numerical Dry mouth Scale
Time frame: Weeks 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. intensity.
o Numerical Dry eye Scale
Time frame: Weeks11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.
o ESSPRI
Time frame: Weeks 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.
o ESSDAI
Time frame: Weeks 11
Evaluate intensity of the IV Ig effect on neurological scales
o Overall Neuropathy Limitations Scale (ONLS)
Time frame: Weeks 11
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