By InvitationNot Applicable

Immune Profiles in Multiple Sclerosis (MS) Patients and Healthy Volunteers Through Thoracic Duct Cannulation

United States24 participantsStarted 2022-04-19

Plain-language summary

In this study, lymph fluid will be collected by cannulation of the thoracic duct, a minimally invasive procedure performed by interventional radiologists. Single time point and serial collection through an indwelling cannula will allow for comparisons between immune cells in the periphery and deep lymphatic system in MS and healthy controls and in MS, changes in responses to a FDA approved therapy ofatumumab.

Who can participate

Age range18 Years – 40 Years

SexALL

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Inclusion criteria

✓. Written informed consent must be obtained before any assessment is performed.
✓. Adult participants aged 18 to 40 years (inclusive) at Screening.
✓. Participants must be able to understand English and be able to review and comprehend the informed consent form independently or with the help of research staff
✓. No use of systemic glucocorticoids in the past 4 weeks
✓. Diagnosis of MS according to the 2017 Revised McDonald criteria.
✓. Ability to undergo several MRIs
✓. Disability status at Screening with an EDSS score of 0 to 4 (inclusive)
✓. MS treatment history restricted to Interferons and/glatiramer acetate treatment only or untreated to date

Exclusion criteria

✕. HBs Ag and/or anti-HBc IgM and/or HB virus deoxyribonucleic acid (DNA)
✕. anti-HBs negative and Anti-HBc positive
✕. anti-HC IgG (if positive IgG, HCV-RNA PCR will be performed and if negative, participant can be enrolled) 16. Use of other investigational drugs at the time of enrollment (Screening) or within the prior 30 days, or five elimination half-lives, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer 17. Absolute neutrophil count (ANC) \<750/mm3; 18. Hemoglobin \<10.0 g/dL 19. Platelet count \<100,000/mm3 20. Prothrombin time (PT) or international normalized ration (INR) \>1.5 x ULN

What they're measuring

Safety and Tolerability

Timeframe: up to 21 days

B Cells

Timeframe: up to 21 days

Trial details

NCT IDNCT05162638

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

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