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Prospective, randomised, placebo-controlled study of polyvalent intravenous immunoglobulins for the treatment of primary Sjögren's syndrome associated painful sensory neuropathies
EU CTIS ID: 2024-517309-95-00
What this study is testing
Demonstrate the subjective or objective efficacy of IV Ig in the treatment of primary Sjögren's syndrome-related peripheral neuropathies
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years and < 80 years
- -Primary Sjögren's syndrome defined as per the European and American criteria
- -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 ml/min/1,73m2 (MDRD) (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
You likely can't join if
- Peripheral neurological damage of the type vascularitis-related multiplex mononeuropathy
- 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
See the full eligibility criteria
Who can join
- Age ≥ 18 years and < 80 years
- -Primary Sjögren's syndrome defined as per the European and American criteria
- -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 ml/min/1,73m2 (MDRD) (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
What rules you out
- Peripheral neurological damage of the type vascularitis-related multiplex mononeuropathy
- 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
- Small fibers neuropathy
- Neuropathy suspected of being related to alcohol, diabetes or postchemotherapy
- Chronic viral infection (HCV, HBV, HIV, etc.)
- Concomitant medications : • Prior treatment with polyvalent intravenous immunoglobulins in the 6 months preceding inclusion the study • Conventional immunosuppressant treatment with azathioprin, cyclophosphamide or mycophenolate mofetil on-going or interrupted less than one within one month before inclusion • Rituximab or other biotherapy (belimumab, tocilizumab, …) treatment within 6 months before the start of the study treatment inclusion • Corticosteroid treatment administered at a dose greater than > 20 mg/day of prednisone equivalent or administered at a non-stable dose <20 mg/day within the for at least 1 month before inclusion (Corticosteroid treatment administered at a stable dose < 20 mg/day for at least one month prior to inclusion is allowed) • Immunomodulating treatment with by methotrexate at a non-stable dose within for at least 2 months before inclusion (Immunomudulating treatment by methotrexate given at a stable dose for at least 2 months prior to inclusion is allowed) • Treatment by Hydroxychloroquine at a non-stable dose within for at least 3 months before inclusion (Treatment by Hydroxychloroquine given at a stable dose for at least 3 months prior to inclusion is allowed) • Pilocarpine hydrochloride secretagogue treatment at a non-stable dose within for at least one month before inclusion (Pilocardine hydrochloride secretagogue given at a stable dose for at least one month XML File Identifier: CtM2lMg6Da8T7bFdY61LAfMVsX4= Page 12/27 prior to inclusion is allowed) • Treatment by amitriptyline, clomipramine, carbamazepine, clonazepam, pregabaline, duloxetine or gabapentine at a non-stable dose within if the dose has not been stable for at least one month before inclusion (possible dose reduction to be documented) (Treatment by amitriptyline, clomipramine, carbamazepine, clonazepam, pregabaline, duloxetine or gabapentine given at a stable dose for at least one month prior to inclusion is allowed).
- Contraindication to the use of IV Ig 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
- Patients at high risk of thromboembolism and patients with history of thromboembolic event without anticoagulant treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.