Primary Sjögren's Syndrome Painful Sensory NeuropathiesPhase 3TINISSNCT03700138
Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies
A Phase 3 study testing Privigen® 100mg/ml at the dose of 2g/kg of body weight and NaCl 0,9% in people with Primary Sjögren's Syndrome Painful Sensory Neuropathies, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Sjögren's Syndrome Painful Sensory Neuropathies
- What is being tested?
- Privigen® 100mg/ml at the dose of 2g/kg of body weight and NaCl 0,9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2019to 10 Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) :
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomised, Placebo-controlled Study of Polyvalent Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies
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.
- Being tested
- Privigen® 100mg/ml at the dose of 2g/kg of body weight, NaCl 0,9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Privigen® 100mg/ml at the dose of 2g/kg of body weightDrug
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: NaCl 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of at least 20% over placebo of numerical Pain Scale
Measured: At week 11
Improvement of at least 20% over placebo with the R-DS scale (Rasch-built Overall Disability Scale)
Measured: At week 11
Secondary outcomes (9)
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.
- Quality of life scale (SF 36)
Measured: Weeks 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.
- HAD depression score
Measured: Weeks 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.
- Numerical Fatigue Scale
Measured: Weeks 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.
- A fatigue scale (EMIF)
Measured: Weeks 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. intensity.
- Numerical Dry mouth Scale
Measured: Weeks 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. intensity.
- Numerical Dry eye Scale
Measured: Weeks11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.
- ESSPRI
Measured: Weeks 11
Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity.
- ESSDAI
Measured: Weeks 11
Evaluate intensity of the IV Ig effect on neurological scales
- Overall Neuropathy Limitations Scale (ONLS)
Measured: Weeks 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start19 Jun 2019
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren's Syndrome Painful Sensory NeuropathiesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques-Eric Jacques-Eric, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700138
- Sponsor's protocol ID
- 6621
- Acronym
- TINISS
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2018
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomised, Placebo-controlled Study of Polyvalent Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies
- ClinicalTrials.gov ID
- NCT03700138
- Acronym / sponsor ID
- TINISS / 6621
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Privigen | Experimental | Drug: Privigen® 100mg/ml at the dose of 2g/kg of body weightTThe 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). |
| Placebo | Placebo comparator | Drug: NaCl 0,9%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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years and < 80 years
- Primary Sjögren's syndrome defined as per the European and American criteria (5)
- Peripheral neuropathy clinically defined:
- 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)
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Privigen® 100mg/ml at the dose of 2g/kg of body weightThe 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). | Drug | Privigen |
| NaCl 0,9%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 | Placebo |
Primary outcome
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
9 secondary outcomes
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.
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.
Time frame: Weeks 11
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. intensity.
Time frame: Weeks11
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.
Time frame: Weeks 11
Evaluate intensity of the IV Ig effect on neurological scales
Time frame: Weeks 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
Related trials for Primary Sjögren's Syndrome Painful Sensory Neuropathies
Not yet recruitingPhase 2
A Study to Assess Efficacy and Safety of Efgartigimod in Adults With Sjogren's Disease-associated Sensorimotor Polyneuropathy or Sensory Polyneuropathy (SERENITY)
Sjogrens Disease, Primary Sjögren's Syndrome Painful Sensory Neuropathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques-Eric Jacques-Eric, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Privigen® 100mg/ml at the dose of 2g/kg of body weight and NaCl 0,9% in people with Primary Sjögren's Syndrome Painful Sensory Neuropathies, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of at least 20% over placebo of numerical Pain Scale (time frame: At week 11). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.