Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Se… (NCT03700138) | Clinical Trial Compass
CompletedPhase 3
Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies
France24 participantsStarted 2019-06-19
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Im…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement of at least 20% over placebo of numerical Pain Scale
Timeframe: At week 11
2
Improvement of at least 20% over placebo with the R-DS scale (Rasch-built Overall Disability Scale)