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出境医 / 临床实验 / Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies (TINISS)
Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies (TINISS)
Study Description
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Primary Sjögren's Syndrome Painful Sensory Neuropathies | Drug: Privigen® 100mg/ml at the dose of 2g/kg of body weight Drug: NaCl 0,9% | Phase 3 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Prospective, Randomised, Placebo-controlled Study of Polyvalent Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies |
| Actual Study Start Date : | June 24, 2019 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | July 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Privigen
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).
|
Drug: Privigen® 100mg/ml at the dose of 2g/kg of body weight
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).
|
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Placebo Comparator: Placebo
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).
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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).
|
Outcome Measures
Primary Outcome Measures :
- 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 Measures :
- Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [ Time Frame: Weeks 11 ]o Quality of life scale (SF 36)
- Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [ Time Frame: Weeks 11 ]o HAD depression score
- Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [ Time Frame: Weeks 11 ]o Numerical Fatigue Scale
- Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [ Time Frame: Weeks 11 ]o A fatigue scale (EMIF)
- Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. intensity. [ Time Frame: Weeks 11 ]o Numerical Dry mouth Scale
- Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. intensity. [ Time Frame: Weeks11 ]o Numerical Dry eye Scale
- Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [ Time Frame: Weeks 11 ]o ESSPRI
- Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [ Time Frame: Weeks 11 ]o ESSDAI
- Evaluate intensity of the IV Ig effect on neurological scales [ Time Frame: Weeks 11 ]o Overall Neuropathy Limitations Scale (ONLS)
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 with INCAT score of at least 2
- 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
Contacts and Locations
Contacts
| Contact: Jacques-Eric GOTTENBERG, MD | 03 88 12 79 53 ext 0033 | jacques-eric.gottenberg@chru-strabourg.fr | |
| Contact: Jérôme DE SEZE, MD | 03 88 12 85 43 ext 0033 | Jerome.DESEZE@chru-strasbourg.fr |
Locations
| France | |
| University Hospital, Strasbourg, france | Recruiting |
| Strasbourg, France, 67000 | |
| Contact: Jacques -Eric Gottenberg, MD 03 88 12 79 53 ext 0033 jacques-eric.gottenberg@chru-strasbourg.fr | |
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
| Principal Investigator: | Jacques-Eric Jacques-Eric, MD | University Hospital, Strasbourg, France |
| Tracking Information | |||||||||
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| First Submitted Date ICMJE | August 24, 2018 | ||||||||
| First Posted Date ICMJE | October 9, 2018 | ||||||||
| Last Update Posted Date | September 28, 2020 | ||||||||
| Actual Study Start Date ICMJE | June 24, 2019 | ||||||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies | ||||||||
| Official Title ICMJE | Prospective, Randomised, Placebo-controlled Study of Polyvalent Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies | ||||||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Primary Sjögren's Syndrome Painful Sensory Neuropathies | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
24 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 2021 | ||||||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03700138 | ||||||||
| Other Study ID Numbers ICMJE | 6621 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | University Hospital, Strasbourg, France | ||||||||
| Study Sponsor ICMJE | University Hospital, Strasbourg, France | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University Hospital, Strasbourg, France | ||||||||
| Verification Date | August 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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