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Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies

NCT03700138 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-08

No results posted yet for this study

Summary

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.

Conditions

  • Primary Sjögren's Syndrome Painful Sensory Neuropathies

Interventions

DRUG

Privigen® 100mg/ml at the dose of 2g/kg of body weight

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).

DRUG

NaCl 0,9%

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).

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Jacques-Eric Jacques-Eric, MD · University Hospital, Strasbourg, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2025-04-10
Completion
2025-04-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03700138 on ClinicalTrials.gov