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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517309-95-00
Acronym
6621
Enrollment
24
Registered
2024-10-08
Start date
2019-06-19
Completion date
2025-04-10
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

-Peripheral neuropathy clinically defined: *Pure sensitive (lymph node disease) or sensorimotor neuropathies *Proved EMG, -Primary Sjögren's syndrome defined as per the European and American criteria

Brief summary

Improvement of at least 20% over placebo in one of the following 2 scales, 3 weeks after the last treatment course (week 11): - Objective neurological criterion using the R-ODS scale (Rasch-built Overall Disability Scale) - Numerical Pain Scale (0 to 10)

Detailed description

1) Primary Sjögren's Syndrome Criteria o Quality of life scale (SF 36) o HAD depression score o Numerical Fatigue Scale : score between 0 and 10 o A fatigue scale (EMIF) : o Numerical Dry mouth Scale : score between 0 and 10 o Numerical Dry eye Scale : score between 0 and 10 o Flow of saliva (non stimulated o ESSPRI (Eular Sjogren's Syndrome Patient Reported Index) o ESSDAI (Eular Sjögren Syndrome Disease Activity index), 2) Neurological criteria o Overall Neuropathy Limitations Scale (ONLS), 3) Adverse reactions rate

Interventions

Sponsors

Les Hopitaux Universitaires De Strasbourg
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
1) Primary Sjögren's Syndrome Criteria o Quality of life scale (SF 36) o HAD depression score o Numerical Fatigue Scale : score between 0 and 10 o A fatigue scale (EMIF) : o Numerical Dry mouth Scale : score between 0 and 10 o Numerical Dry eye Scale : score between 0 and 10 o Flow of saliva (non stimulated o ESSPRI (Eular Sjogren's Syndrome Patient Reported Index) o ESSDAI (Eular Sjögren Syndrome Disease Activity index), 2) Neurological criteria o Overall Neuropathy Limitations Scale (ONLS), 3) Adverse reactions rate

Primary

MeasureTime frame
Improvement of at least 20% over placebo in one of the following 2 scales, 3 weeks after the last treatment course (week 11): - Objective neurological criterion using the R-ODS scale (Rasch-built Overall Disability Scale) - Numerical Pain Scale (0 to 10)

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026