Using intravenous immunoglobulins to treat painful neuropathies in Sjögren's syndrome
Prospective, Randomised, Placebo-controlled Study of Polyvalent Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies
This study is testing whether intravenous immunoglobulins can help people with Sjögren's syndrome who have painful nerve issues feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Drugs / interventions | Rituximab, belimumab, tocilizumab, chemotherapy, methotrexate, cyclophosphamide, prednisone |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT03700138 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of intravenous immunoglobulins (IVIg) in treating painful sensory neuropathies associated with primary Sjögren's syndrome. The study aims to address the significant disability and pain experienced by patients due to peripheral neurological complications, which currently lack standard treatment options. Participants will receive Privigen® at a dosage of 2g/kg of body weight, and their eligibility will be determined based on specific criteria related to their condition and overall health. The trial is designed to evaluate the potential benefits of immunomodulatory therapy in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 diagnosed with primary Sjögren's syndrome and experiencing clinically defined peripheral neuropathy.
Not a fit: Patients with vascularitis-related multiplex mononeuropathy or neuropathies linked to alcohol, diabetes, or chemotherapy are unlikely to benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate pain and improve the quality of life for patients suffering from neuropathies related to primary Sjögren's syndrome.
How similar studies have performed: While the use of IVIg for other conditions has shown promise, this specific application for primary Sjögren's syndrome-related neuropathies is relatively novel and has not been extensively tested.
Eligibility criteria
Show full 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 βHCG blood test negative * Pregnant or nursing (lactating) women * Patient under legal guardianship * Prisoners
Where this trial is running
Strasbourg
- University Hospital, Strasbourg, france — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Jacques-Eric Jacques-Eric, MD — University Hospital, Strasbourg, France
- Study coordinator: Jacques-Eric GOTTENBERG, MD
- Email: jacques-eric.gottenberg@chru-strabourg.fr
- Phone: 03 88 12 79 53
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.