Multiple SclerosisNCT05162638
Immune Profiles in Multiple Sclerosis (MS) Patients and Healthy Volunteers Through Thoracic Duct Cannulation
A study testing thoracic duct cannulation in people with Multiple Sclerosis and Healthy, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Healthy
- What is being tested?
- thoracic duct cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants eligible for inclusion in this study must meet all of the following 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
- For participants with MS following additional criteria need to be met:
Show all 11Show fewer
- 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
- Neurologically stable within one month prior to interventional procedure.
Who cannot join
- 1. Participants suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator.
- 2. Participants with primary progressive MS (Polman C et al., 2011) 3. Participants meeting criteria for neuromyelitis optica (Wingerchuck D et al., 2015) 4. Participants with disease duration of more than 10 years 5. Participants who are pregnant or nursing (lactating) 6. Participants with active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency) 7. Participants with active systemic bacterial, viral or fungal infections, or known to have acquired immunodeficiency syndrome (AIDS) 8. Participants with neurological symptoms consistent with PML or confirmed PML 9. Participants at risk of developing or having reactivation of syphilis or tuberculosis 10. History of cardiovascular disease or uncontrolled hypertension 11. History of diabetes mellitus 12. History of cancer (other than localized skin cancer) in the previous 5 years 13. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to first study drug administration 14. Immunization with non-live vaccines within 2 weeks of the study procedure 15. Participants at risk of developing or having reactivation of hepatitis: Positive results at Screening for serological markers for hepatitis (H) B and C indicating acute or chronic infection:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Analysis of Lymphatic Fluid From the Thoracic Duct of Healthy People and People With Multiple Sclerosis (MS) Before and After Ofatumumab Treatment
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.
- Conditions
- Multiple Sclerosis, Healthy
- Being tested
- thoracic duct cannulation
- Keywords
- multiple sclerosis, thoracic duct
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic duct cannulationProcedure or surgery
Contrast is injected into lymph nodes until lymphatics visualized at about level of L3 lumbar spine. After target lymphatic vessel is identified, needle is passed transabdominally into the vessel. Guidewire is advanced through the needle into the lymph vessel \& advanced into thoracic duct. Microcatheter is then advanced into thoracic duct over the wire.
IN \& OUT-up to 100mL collected via catheter over 30-min at 2 levels within thoracic duct, then catheter removed.
INDWELLING-As described above, then guidewire placed through original catheter \& advanced into subclavian vein. Vascular sheath is placed into vein in the upper arm under ultrasound/fluoroscopy guidance. Wire in the subclavian vein then snared through venous access sheath \& pulled out. Catheter then threaded \& advanced over the wire until tip is in thoracic duct. Catheter from thoracic duct removed, leaving catheter extending from arm into thoracic duct. Catheter left in place up to 21 days for sampling.
| Study group | Role | What they receive |
|---|---|---|
| 'In-and-out' catheterization | Other | Safety and immune-cell profile of lymphatic fluid in MS patients with a single time-point sampling of lymphatic fluids and peripheral blood compared to healthy controls.
Two healthy controls and six patients with early MS (never treated or at least 90 days after discontinued treatment with glatiramer acetate or interferons), who consent to the 'In-and-out' catheter procedure. MS participants can also consent to OMB treatment with 2-year follow-up. Receives: Procedure: thoracic duct cannulation |
| "Indwelling" catheterization | Other | immune-biology in people with MS before and during/after OMB treatment within thoracic duct and peripheral blood via indwelling catheter and multiple time-point sampling compared to healthy controls (without drug treatment).
Twelve patients with early MS (never treated or at least 90 days after discontinued treatment with glatiramer acetate or interferons), who consent to treatment with OMB and to the indwelling catheter procedure with serial sampling and up to four healthy controls (no drug treatment) Receives: Procedure: thoracic duct cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Quantified as percent of the study population experiencing serious adverse event from in-and-out catherization procedure and from "indwelling" catheterization procedure
Measured: up to 21 days
B Cells
Change in proportion of flow cytometry defined naïve (CD27-) and memory (CD27+) B cells in thoracic duct of patients with MS prior to and following anti-CD20 therapy with Ofatumumab
Measured: up to 21 days
Secondary outcomes (2)
Immune cell profiles (MS and healthy controls)
Comparison of immune cell profiles determined by flow cytometry of lymphatic fluid and blood between MS and healthy controls
Measured: up to 21 days
Immune cell profiles (ofatumumab)
Comparison of immune cell profiles determined by flow cytometry of lymphatic fluid and blood of MS patients prior to and following treatment with the anti-CD20 Ofatumumab
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start19 Apr 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Novartis Institutes for BioMedical Research
- Responsible party
- Sponsor
- Investigators
- Amit Bar-Or, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162638
- Sponsor's protocol ID
- 849114
- Status last verified
- Jan 2026
- First submitted
- 2 Nov 2021
- Last updated
- 9 Jan 2026
- 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Lymphatic Fluid From the Thoracic Duct of Healthy People and People With Multiple Sclerosis (MS) Before and After Ofatumumab Treatment
- ClinicalTrials.gov ID
- NCT05162638
- Acronym / sponsor ID
- 849114
- Conditions
- Multiple Sclerosis, Healthy
- Keywords
- multiple sclerosis, thoracic duct
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Novartis Institutes for BioMedical Research
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Dec 2021 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'In-and-out' catheterization | Other | Procedure: thoracic duct cannulationSafety and immune-cell profile of lymphatic fluid in MS patients with a single time-point sampling of lymphatic fluids and peripheral blood compared to healthy controls. Two healthy controls and six patients with early MS (never treated or at least 90 days after discontinued treatment with glatiramer acetate or interferons), who consent to the 'In-and-out' catheter procedure. MS participants can also consent to OMB treatment with 2-year follow-up. |
| "Indwelling" catheterization | Other | Procedure: thoracic duct cannulationimmune-biology in people with MS before and during/after OMB treatment within thoracic duct and peripheral blood via indwelling catheter and multiple time-point sampling compared to healthy controls (without drug treatment). Twelve patients with early MS (never treated or at least 90 days after discontinued treatment with glatiramer acetate or interferons), who consent to treatment with OMB and to the indwelling catheter procedure with serial sampling and up to four healthy controls (no drug treatment) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Participants eligible for inclusion in this study must meet all of the following criteria:
- 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
Key exclusion criteria (5 listed)
- 1. Participants suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator.
- 2. Participants with primary progressive MS (Polman C et al., 2011) 3. Participants meeting criteria for neuromyelitis optica (Wingerchuck D et al., 2015) 4. Participants with disease duration of more than 10 years 5. Participants who are pregnant or nursing (lactating) 6. Participants with active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency) 7. Participants with active systemic bacterial, viral or fungal infections, or known to have acquired immunodeficiency syndrome (AIDS) 8. Participants with neurological symptoms consistent with PML or confirmed PML 9. Participants at risk of developing or having reactivation of syphilis or tuberculosis 10. History of cardiovascular disease or uncontrolled hypertension 11. History of diabetes mellitus 12. History of cancer (other than localized skin cancer) in the previous 5 years 13. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to first study drug administration 14. Immunization with non-live vaccines within 2 weeks of the study procedure 15. Participants at risk of developing or having reactivation of hepatitis: Positive results at Screening for serological markers for hepatitis (H) B and C indicating acute or chronic infection:
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 |
|---|---|---|
| thoracic duct cannulationContrast is injected into lymph nodes until lymphatics visualized at about level of L3 lumbar spine. After target lymphatic vessel is identified, needle is passed transabdominally into the vessel. Guidewire is advanced through the needle into the lymph vessel \& advanced into thoracic duct. Microcatheter is then advanced into thoracic duct over the wire. IN \& OUT-up to 100mL collected via catheter over 30-min at 2 levels within thoracic duct, then catheter removed. INDWELLING-As described above, then guidewire placed through original catheter \& advanced into subclavian vein. Vascular sheath is placed into vein in the upper arm under ultrasound/fluoroscopy guidance. Wire in the subclavian vein then snared through venous access sheath \& pulled out. Catheter then threaded \& advanced over the wire until tip is in thoracic duct. Catheter from thoracic duct removed, leaving catheter extending from arm into thoracic duct. Catheter left in place up to 21 days for sampling. | Procedure or surgery | "Indwelling" catheterization, 'In-and-out' catheterization |
Primary outcome
Safety and Tolerability
Time frame: up to 21 days
Quantified as percent of the study population experiencing serious adverse event from in-and-out catherization procedure and from "indwelling" catheterization procedure
B Cells
Time frame: up to 21 days
Change in proportion of flow cytometry defined naïve (CD27-) and memory (CD27+) B cells in thoracic duct of patients with MS prior to and following anti-CD20 therapy with Ofatumumab
2 secondary outcomes
Immune cell profiles (MS and healthy controls)
Time frame: up to 21 days
Immune cell profiles (ofatumumab)
Time frame: up to 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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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.
Amit Bar-Or, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic duct cannulation in people with Multiple Sclerosis and Healthy, run by University of Pennsylvania at 1 site in United States.
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 11 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 9 Jan 2026. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Safety and Tolerability (time frame: up to 21 days). 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 9 Jan 2026.