Sjogren's Syndrome Trial, Recruiting NCT03509064 Sponsor: Assistance Publique - Hôpitaux de Paris Condition: Sjogren's Syndrome
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Sjogren's Syndrome Trial, Recruiting

NCT03509064
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been formally diagnosed with primary Sjögren's syndrome
  • You are over 18 years old
  • You have not received biologic medications or intravenous immunoglobulin therapy in the 6 months before the study starts

If joining the main study group (Arm 1):

  • You have symptoms suggesting damage to small nerve fibres — such as reduced ability to feel heat or pain, problems with automatic body functions (like sweating or heart rate), or nerve pain scoring 4 or above on a specific pain questionnaire
  • AND you also have at least one abnormal test result, such as nerve function tests (measuring temperature/pain sensitivity or sweat responses) OR a skin biopsy showing reduced nerve fibre density

If joining the control group (Arm 2):

  • You have Sjögren's syndrome but show no signs of nerve damage (either small or large nerve fibres)

Who may not be able to join:

  • You have another known condition that can cause nerve damage, such as diabetes, alcoholism, HIV, coeliac disease, sarcoidosis, Guillain-Barré syndrome, certain drug or toxic exposures, or specific inherited conditions affecting the nerves (confirm with trial site)
  • You have symptoms that suggest small nerve fibre damage (such as reduced heat/pain sensation, automatic body function problems, or significant nerve pain), but all your diagnostic tests — including nerve function tests and skin biopsy — have come back normal

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Damien SÈNE, Assistance Publique - Hôpitaux de Paris

Phone: +33149956380

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
14 January 2019
Est. completion
14 January 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Measure of quality of life impairment by SF 36 scale

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov