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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT03700138
• Date of registration: 24/08/2018
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Strasbourg, France
• Public title: Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies TINISS
• Scientific title: Prospective, Randomised, Placebo-controlled Study of Polyvalent Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies
• Date of first enrolment: June 19, 2019
• Target sample size: 24
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03700138
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Jacques-Eric GOTTENBERG, MD

• Name: Jacques-Eric Jacques-Eric, MD
• Affiliation: University Hospital, Strasbourg, France

• Name: Jacques -Eric Gottenberg, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Corticosteroid treatment at a dose greater than 20 mg/d of prednisone equivalent or no
stable dose for at least 1 month before inclusion

- Conventional immunosuppressant treatment with azathioprin, cyclophosphamide or
mycophenolate mofetil on-going or interrupted less than one month before inclusion

- Rituximab or other biotherapy (belimumab, tocilizumab, …) less than 6 months before
the start of the study treatment

- Immunomodulating treatment with methotrexate no stable dose for at least 2 months
before inclusion

- Hydroxychloroquine no stable dose for at least 3 months before inclusion

- Pilocarpine hydrochloride secretagogue treatment no stable dose for at least one month
before inclusion

- Treatment with amitriptyline, clomipramine, carbamazepine, clonazepam, pregabaline,
duloxetine or gabapentine if the dose has not been stable for at least one month
before inclusion (possible dose reduction to be documented).

- 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

- Immunization with live attenuated vaccine within 2 weeks prior to inclusion

- Participation in a clinical study with an investigational product with an exclusion
period

- Women of child bearing potential or intends to become pregnant, unless they are using
an effective method of birth control* and a ßHCG blood test negative

- Pregnant or nursing (lactating) women

- Patient under legal guardianship

- Prisoners



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sjögren's Syndrome Painful Sensory Neuropathies

Intervention(s)

Drug: NaCl 0,9%

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

Primary Outcome(s)

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]

Secondary Outcome(s)

Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. intensity. [Time Frame: Weeks 11]

Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [Time Frame: Weeks 11]

Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. intensity. [Time Frame: Weeks11]

Evaluate intensity of the IV Ig effect on neurological scales [Time Frame: Weeks 11]

Secondary ID(s)

6621

Source(s) of Monetary Support

Please refer to primary and secondary sponsors