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

NCT03700138 | Completed Phase 3

• 1 other identifier: 6621
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Improvement of at least 20% over placebo of numerical Pain Scale

  At week 11

• Improvement of at least 20% over placebo with the R-DS scale (Rasch-built Overall Disability Scale)

  At week 11

Secondary Outcomes (9)

• Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.

  Weeks 11

• Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.

  Weeks 11

• Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.

  Weeks 11

• Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.

  Weeks 11

• Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. intensity.

  Weeks 11

Study Arms (2)

Privigen

EXPERIMENTAL

TThe treatment (IV Ig, 100mg/ml at the dose of 2g/kg of body weight) will be administered by perfusion every 6 weeks, with a total of 3 perfusions administered (W0, W4, W8).

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

Placebo

PLACEBO COMPARATOR

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).

Drug: NaCl 0,9%

Interventions

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

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).

Privigen

NaCl 0,9% DRUG

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).

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and \< 80 years
• Primary Sjögren's syndrome defined as per the European and American criteria (5)
• Peripheral neuropathy clinically defined:
• Pure sensitive (lymph node disease) or sensorimotor neuropathies
• Proved EMG
• Renal function, and viral evaluation (VIH and hepatitis serology) :
• \*Clairance \> 50 (In case of biological abnormality, the second dosage can be scheduled within 2 weeks)
• Effective contraception during the study period
• Patient capable of understanding information about the study and of giving his/her consent
• Patient informed of the preliminary medical exam results
• Patient with healthcare insurance
• Written consent signed

You may not qualify if:

• Peripheral neurological damage of the type vascularitis-related multiplex mononeuropathy
• Small fibers neuropathy
• Neuropathy suspected of being related to alcohol, diabetes or post-chemotherapy
• Chronic viral infection (HCV, HBV, HIV, etc.)
• Prior treatment with polyvalent intravenous immunoglobulins in the 6 months preceding the study
• Rituximab or other biotherapy (belimumab, tocilizumab, …) less than 6 months before the start of the study treatment
• renal clairance \< 50 ml/mn
• HIV seropositivity
• HBV, or HCV viral replication
• Contraindication to the use of IV Ig: h Hypersensitivity to the active substance or to any of the excipients; hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA; patients with hyperprolinaemia.
• Contraindication to the use of Nacl
• Women of child bearing potential or intends to become pregnant, unless they are using an effective method of birth control\* and a βHCG blood test negative
• Pregnant or nursing (lactating) women
• Patient under legal guardianship
• Prisoners

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

University Hospital, Strasbourg, france

Strasbourg, 67000, France

Location

MeSH Terms

Interventions

Immunoglobulins, Intravenous; Weights and Measures

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Investigative Techniques

Study Officials

• Jacques-Eric Jacques-Eric, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: October 9, 2018
• Study Start: June 19, 2019
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

FR (1)