Multiple SclerosisNCT05081700
A Systems Approach to Understanding Disease Processes in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Providence Health & Services at 2 sites in United States.
Trial summary
This pilot study will establish a proof of concept for using a systems biology approach to characterize the dynamics of MS disease processes. The primary objective of the study is to identify multi-omic (genetic, proteomic, biochemical and/or microbial) factors that correlate with clinical and subclinical MS disease… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- All patients in the study will be treated with ocrelizumab
- Type of treatment
- Injection or infusion
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 May 2020to 3 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Adult
Study population: Study patients will be recruited from the population of relapsing MS patients initiating treatment with ocrelizumab, who are being followed at the Swedish MS Center in Seattle, Washington and the Providence MS Center in Portland, Oregon. MS population and a reference non-MS population
Who may be able to join
- Able to understand the purpose and risk of the study and provide written informed consent.
- Male or female patients aged 18 to 60, inclusive at time of consent, who meet FDA approved indications to receive ocrelizumab treatment.
- Have a definite diagnosis of relapsing MS (RMS) (Lublin et al. 2014).
- Screening EDSS ≤ 5.0.
- Have a length of disease duration since disease symptom onset ≤ 15 years.
- Documentation of 1 or more on-DMT relapses, or 1 brain MRI revealing new or enlarged T2 lesion(s) over the 2 years prior to the screening visit (this could include DMT naïve patients).
Show all 16Show fewer
- Patient does not have any clinically significant medical conditions based on medical history, physical examination, and laboratory screening, as defined by the investigator, which would interfere with the conduct of the study.
- Patient is willing and able to comply with the protocol assessments and visits, in the opinion of the investigator.
- For women of childbearing potential: agreement to use an effective birth control method and avoid breastfeeding during the study period, and for those patients who have received ocrelizumab, for at least 6 months after the last dose.
- Inclusion criteria for those patients who have completed the core study and are re-consenting and re-enrolling to complete the month 30 visit. Patients must fulfill all of the following criteria to participate in the study:
- Able to understand the purpose and risk of the study and provide written informed consent.
- Have participated in the core study and continue to receive ocrelizumab.
- Have not passed week 120±14 days post initial ocrelizumab dose in the core study.
- Diagnosis of relapsing MS at time of consent.
- Patient is willing and able to comply with the protocol assessments and visits, in the opinion of the investigator.
- For women of childbearing potential: agreement to use an effective birth control method and avoid breastfeeding during the study period and for at least 6 months after the last dose of ocrelizumab.
Who cannot join
- Diagnosis of progressive MS at screening.
- Patient is unable to undergo MRI with gadolinium contrast imaging for any reason.
- Known presence of other neurological disorders, including but not limited to, the following:
- History of cerebrovascular disorders.
- History or known presence of CNS tumor.
- History or known presence of potential metabolic causes of myelopathy.
Show all 49Show fewer
- History of peripheral neuropathy.
- History or known presence of infectious disease of the CNS.
- History of genetically inherited CNS degenerative disorder.
- Neuromyelitis optica spectrum disorder, anti-Aquaporin 4 IgG, or Anti-MOG IgG .
- History of progressive multifocal leukoencephalopathy (PML).
- History or known presence of any other concurrent systemic or nervous system autoimmune disorders, potentially causing progressive neurologic disease.
- History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression).
- Exclusions related to general health:
- Pregnancy or lactation.
- Chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
- History or currently active primary or secondary immunodeficiency.
- Lack of peripheral venous access.
- Hypersensitivity to ocrelizumab or to any of its excipients.
- Significant or uncontrolled non-neurological systemic disease.
- Significant active infections must be treated and resolved before possible inclusion in the study.
- Patients in an immunocompromised state.
- Patients with history of malignancy, except for adequately treated basal cell skin cancer or in situ cervical cancer.
- Exclusions Related to Medications:
- Your last COVID-19 vaccine should be given at least 2 weeks before and all vaccines should be given at least 6 weeks before the first infusion of ocrelizumab. Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted to at least the lower limit of normal. COVID-19 vaccines are permitted per investigator discretion during ocrelizumab treatment.
- Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS (e.g., treatment for chronic cerebrospinal venous insufficiency) within 24 weeks of screening (Visit 1).
- Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, tabalumab, belimumab, ofatumumab, or obinutuzumab).
- Any previous treatment with total body irradiation, or bone marrow transplantation.
- Previous treatment with natalizumab in the past 4 weeks prior to baseline (Day 0) or fingolimod in the last 2 weeks prior to screening (Visit 1).
- Patients previously treated with teriflunomide, unless an accelerated elimination procedure is implemented and/or teriflunomide serum level of less than 2 mcg/ml is documented prior to screening (Visit 1).
- Previous treatment with azathioprine, mycophenolate mofetil or methotrexate in the last 12 weeks prior to screening (Visit 1).
- Previous treatment with cyclosporine or cladribine at any time in the past in the last 96 weeks prior to screening (Visit 1).
- Previous treatment with mitoxantrone, alemtuzumab, or cyclophosphamide at any time.
- Treatment with dalfampridine unless on stable dose for ≥30 days prior to screening (Visit 1). Wherever possible, patients should remain on stable doses throughout the treatment period.
- Exclusions related to laboratory findings:
- Positive serum β-human chorionic gonadotropin (hCG) measured at screening.
- Positive screening tests for hepatitis B (hepatitis B surface antigen [HbsAg] positive, or positive hepatitis B core antibody [total HbcAb], or other comparable tests confirmed by a positive viral DNA polymerase chain reaction [PCR]), within the 6 months prior to Day 0.
- Positive tuberculin skin test or Quantiferon Gold TB test, unless previously documented treatment for latent TB within the 12 months prior to Day 0 or a negative test within the 12 months prior to Day 0.
- Evidence of acute or chronic hepatitis, or evidence of clinically significantly impaired hepatic function through clinical and laboratory evaluation including alkaline phosphatase >1.5x ULN, ALT or AST >2x ULN; GGT>3x ULN or bilirubin >ULN.
- Any other clinically significant laboratory abnormality which may put the patient at risk.
- Exclusion criteria for those patients who have completed the core study and are re-consenting and re-enrolling to complete the month 30 visit. Patients must be excluded from participating in the study if they meet any of the following criteria:
- Exclusions related to general health:
- Pregnancy or lactation.
- Chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
- Exclusions Related to Medications:
- Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted to at least the lower limit of normal. COVID-19 vaccines are permitted per investigator discretion during ocrelizumab treatment.
- Treatment with dalfampridine unless on stable dose. Wherever possible, patients should remain on stable doses throughout the treatment period.
- Exclusions related to laboratory findings:
- Any clinically significant laboratory abnormality during the study which may put the patient at risk.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Providence Neurological Specialties West
Portland, Oregon, 97225
Swedish Medical Center Multiple Sclerosis Center
Seattle, Washington, 98122
About this study
This pilot study will establish a proof of concept for using a systems biology approach to characterize the dynamics of MS disease processes. The primary objective of the study is to identify multi-omic (genetic, proteomic, biochemical and/or microbial) factors that correlate with clinical and subclinical MS disease activity. Identification of such biomarkers could have an immediate clinical utility in identification of MS patients prone to more aggressive disease earlier in their disease course, thus affording the opportunity to better individualize therapy.
In addition, insights from better understanding of the complex interplay of various systems biology factors should improve our understanding of MS in general. The study will recruit 14 patients with relapsing MS who are initiating treatment with ocrelizumab, and follow them for 30 months.
Read the detailed description
The main purpose of the study is to improve the understanding of MS and to look at the genetic factors that may influence how MS progresses. This will involve collecting blood and stool samples, patient questionnaires, and MS-related assessments.
About 67 mL (13 tsp) of blood will be collected at the first visit, and again at 6 months, 12 months, and 30 months after first visit.
Participants will receive standard treatment (ocrelizumab) and have standard exams, MRIs, and tests while on the study.
Study participation is about 30 months, which includes about 9 study visits. Some study visits may be up to 5 hours long. 14 people will take part in this study.
- Conditions
- Multiple Sclerosis
- Being tested
- All patients in the study will be treated with ocrelizumab
- Keywords
- multi-omic factors
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All patients in the study will be treated with ocrelizumabDrug
Also called OCREVUS
300 mg of OCR IV infusion will be given on Day 0 followed by a second dose of 300 mg OCR 14 days later ± 2 days, and then 600 mg of OCR as a single infusion will be given every 24 weeks thereafter per standard medical care.
| Study group | Role | What they receive |
|---|---|---|
| Patients with relapsing MS | Patients with relapsing remitting MS who are intending to receive ocrelizumab. Receives: Drug: All patients in the study will be treated with ocrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of relapse free patients
Number of participants free of MS relapse at 6, 12, and 30 months divided by total number of participants.
Measured: 6, 12, and 30 months
Secondary outcomes (10)
Annualized relapse rate (ARR)
Changes in ARR to assess MS activity levels at baseline compared to 12 and 30 months. Total number of relapses divided by total number of participants.
Measured: 12 and 30 months
Correlates of T2 lesions on-study MRI activity
Number of new and/or unique T2 lesions for each participant compared to screening
Measured: 12, 24, and 30 months
Correlates of gadolinium enhancing lesions on-study MRI activity
Number of new and/or enlarged gadolinium enhancing lesions for each participant compared to screening
Measured: 12, 24, and 30 months
Expanded Disability Status Scale (EDSS)
Changes in EDSS to assess MS activity levels at baseline compared to 12 and 30 months. The EDSS provides a total score on a scale that ranges from minimum 0 to maximum 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability
Measured: 12 and 30 months
Timed 25-Foot Walk (T25FW)
Changes in T25FW to assess MS activity levels at baseline compared to 6, 12, and 30 months. Scale ranges from minimum 0 seconds to maximum 180 seconds. Lower score indicates better result.
Measured: 6, 12, and 30 months
9-Hole Peg Test (9HPT)
Changes in 9HPT to assess MS activity levels at baseline compared to 6, 12, and 30 months. Scales ranges from minumum 0 seconds to maximum 300 seconds (5 minutes). Lower score indicates better result.
Measured: 6, 12, and 30 months
Low Contrast Visual Acuity (LCVA)
Changes in LCVA to assess MS activity levels at baseline compared to 6, 12, and 30 months. Test performed on right eye, left eye, and binocular (both eyes). Scale ranges from minimum 20/200 to maximum 20/16. Higher score indicates better result.
Measured: 6, 12, and 30 months
Symbol digit modality test (SDMT)
Changes in SDMT to assess MS activity levels at baseline compared to 6, 12, and 30 months. Scale ranges from minimum 0 to maximum 110. Higher score indicates better result.
Measured: 6, 12, and 30 months
Modified Fatigue Impact Scale (MFIS)
Changes in MFIS to assess MS activity levels at baseline compared to 6, 12, and 30 months. Scale ranges from minimum 0 to maximum 84. Lower score indicates better result.
Measured: 6, 12, and 30 months
Beck Depression Inventory (BDI-2)
Changes in BDI-2 to assess MS activity levels at baseline compared to 6, 12, and 30 months. Scale ranges from minimum 0 to maximum 63. Lower score indicates better result.
Measured: 6, 12, and 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start11 May 2020
- Primary completion27 Jun 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Systems Biology, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Stanley Cohan, MD, PhD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081700
- Sponsor's protocol ID
- ISB_PHS 2019-01
- Status last verified
- Sep 2024
- First submitted
- 13 Nov 2020
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is expected that the results of this study will be presented at the annual meetings of American Academy of Neurology (AAN) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In addition, a manuscript reporting the results of this study will be submitted for publication in a leading neurology journal in aggregate, no intention to disclose individual personal data.
Publications
Ontaneda D, Thompson AJ, Fox RJ, Cohen JA. Progressive multiple sclerosis: prospects for disease therapy, repair, and restoration of function. Lancet. 2017 Apr 1;389(10076):1357-1366. doi: 10.1016/S0140-6736(16)31320-4. Epub 2016 Nov 24.
PubMed 27889191Steinman L, Zamvil SS. Beginning of the end of two-stage theory purporting that inflammation then degeneration explains pathogenesis of progressive multiple sclerosis. Curr Opin Neurol. 2016 Jun;29(3):340-4. doi: 10.1097/WCO.0000000000000317.
PubMed 27027554Fraussen J, de Bock L, Somers V. B cells and antibodies in progressive multiple sclerosis: Contribution to neurodegeneration and progression. Autoimmun Rev. 2016 Sep;15(9):896-9. doi: 10.1016/j.autrev.2016.07.008. Epub 2016 Jul 7.
PubMed 27396817Price ND, Magis AT, Earls JC, Glusman G, Levy R, Lausted C, McDonald DT, Kusebauch U, Moss CL, Zhou Y, Qin S, Moritz RL, Brogaard K, Omenn GS, Lovejoy JC, Hood L. A wellness study of 108 individuals using personal, dense, dynamic data clouds. Nat Biotechnol. 2017 Aug;35(8):747-756. doi: 10.1038/nbt.3870. Epub 2017 Jul 17.
PubMed 28714965Hellberg S, Eklund D, Gawel DR, Kopsen M, Zhang H, Nestor CE, Kockum I, Olsson T, Skogh T, Kastbom A, Sjowall C, Vrethem M, Hakansson I, Benson M, Jenmalm MC, Gustafsson M, Ernerudh J. Dynamic Response Genes in CD4+ T Cells Reveal a Network of Interactive Proteins that Classifies Disease Activity in Multiple Sclerosis. Cell Rep. 2016 Sep 13;16(11):2928-2939. doi: 10.1016/j.celrep.2016.08.036.
PubMed 27626663Hakansson I, Tisell A, Cassel P, Blennow K, Zetterberg H, Lundberg P, Dahle C, Vrethem M, Ernerudh J. Neurofilament light chain in cerebrospinal fluid and prediction of disease activity in clinically isolated syndrome and relapsing-remitting multiple sclerosis. Eur J Neurol. 2017 May;24(5):703-712. doi: 10.1111/ene.13274. Epub 2017 Mar 6.
PubMed 28261960Cekanaviciute E, Yoo BB, Runia TF, Debelius JW, Singh S, Nelson CA, Kanner R, Bencosme Y, Lee YK, Hauser SL, Crabtree-Hartman E, Sand IK, Gacias M, Zhu Y, Casaccia P, Cree BAC, Knight R, Mazmanian SK, Baranzini SE. Gut bacteria from multiple sclerosis patients modulate human T cells and exacerbate symptoms in mouse models. Proc Natl Acad Sci U S A. 2017 Oct 3;114(40):10713-10718. doi: 10.1073/pnas.1711235114. Epub 2017 Sep 11.
PubMed 28893978Kornilov SA, Price ND, Gelinas R, Acosta J, Brunkow ME, Gervasi-Follmar T, Winger RC, Aldershoff D, Lausted C, Troisch P, Smith B, Heath JR, Repovic P, Cohan S, Magis AT. Multi-Omic characterization of the effects of Ocrelizumab in patients with relapsing-remitting multiple sclerosis. J Neurol Sci. 2024 Dec 15;467:123303. doi: 10.1016/j.jns.2024.123303. Epub 2024 Nov 10.
PubMed 39561535
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systems Approach to Understanding Disease Processes in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05081700
- Acronym / sponsor ID
- ISB_PHS 2019-01
- Conditions
- Multiple Sclerosis
- Keywords
- multi-omic factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Institute for Systems Biology, Genentech, Inc.
- Study start
- 11 May 2020 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 18 Oct 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.
This pilot study will establish a proof of concept for using a systems biology approach to characterize the dynamics of MS disease processes. The primary objective of the study is to identify multi-omic (genetic, proteomic, biochemical and/or microbial) factors that correlate with clinical and subclinical MS disease activity. Identification of such biomarkers could have an immediate clinical utility in identification of MS patients prone to more aggressive disease earlier in their disease course, thus affording the opportunity to better individualize therapy.
In addition, insights from better understanding of the complex interplay of various systems biology factors should improve our understanding of MS in general. The study will recruit 14 patients with relapsing MS who are initiating treatment with ocrelizumab, and follow them for 30 months.
Detailed description
The main purpose of the study is to improve the understanding of MS and to look at the genetic factors that may influence how MS progresses. This will involve collecting blood and stool samples, patient questionnaires, and MS-related assessments.
About 67 mL (13 tsp) of blood will be collected at the first visit, and again at 6 months, 12 months, and 30 months after first visit.
Participants will receive standard treatment (ocrelizumab) and have standard exams, MRIs, and tests while on the study.
Study participation is about 30 months, which includes about 9 study visits. Some study visits may be up to 5 hours long. 14 people will take part in this study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with relapsing MS | – | Drug: All patients in the study will be treated with ocrelizumabPatients with relapsing remitting MS who are intending to receive ocrelizumab. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Study patients will be recruited from the population of relapsing MS patients initiating treatment with ocrelizumab, who are being followed at the Swedish MS Center in Seattle, Washington and the Providence MS Center in Portland, Oregon. MS population and a reference non-MS population
Key inclusion criteria (16 listed)
- Able to understand the purpose and risk of the study and provide written informed consent.
- Male or female patients aged 18 to 60, inclusive at time of consent, who meet FDA approved indications to receive ocrelizumab treatment.
- Have a definite diagnosis of relapsing MS (RMS) (Lublin et al. 2014).
- Screening EDSS ≤ 5.0.
- Have a length of disease duration since disease symptom onset ≤ 15 years.
Key exclusion criteria (49 listed)
- Diagnosis of progressive MS at screening.
- Patient is unable to undergo MRI with gadolinium contrast imaging for any reason.
- Known presence of other neurological disorders, including but not limited to, the following:
- Exclusions related to general health:
- Exclusions Related to Medications:
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 |
|---|---|---|
| All patients in the study will be treated with ocrelizumabAlso: OCREVUS300 mg of OCR IV infusion will be given on Day 0 followed by a second dose of 300 mg OCR 14 days later ± 2 days, and then 600 mg of OCR as a single infusion will be given every 24 weeks thereafter per standard medical care. | Drug | Patients with relapsing MS |
Primary outcome
Proportion of relapse free patients
Time frame: 6, 12, and 30 months
Number of participants free of MS relapse at 6, 12, and 30 months divided by total number of participants.
10 secondary outcomes
Annualized relapse rate (ARR)
Time frame: 12 and 30 months
Correlates of T2 lesions on-study MRI activity
Time frame: 12, 24, and 30 months
Correlates of gadolinium enhancing lesions on-study MRI activity
Time frame: 12, 24, and 30 months
Expanded Disability Status Scale (EDSS)
Time frame: 12 and 30 months
Timed 25-Foot Walk (T25FW)
Time frame: 6, 12, and 30 months
9-Hole Peg Test (9HPT)
Time frame: 6, 12, and 30 months
Low Contrast Visual Acuity (LCVA)
Time frame: 6, 12, and 30 months
Symbol digit modality test (SDMT)
Time frame: 6, 12, and 30 months
Modified Fatigue Impact Scale (MFIS)
Time frame: 6, 12, and 30 months
Beck Depression Inventory (BDI-2)
Time frame: 6, 12, and 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Background: PubMed 27889191Ontaneda D, Thompson AJ, Fox RJ, Cohen JA. Progressive multiple sclerosis: prospects for disease therapy, repair, and restoration of function. Lancet. 2017 Apr 1;389(10076):1357-1366. doi: 10.1016/S0140-6736(16)31320-4. Epub 2016 Nov 24.
- Background: PubMed 27027554Steinman L, Zamvil SS. Beginning of the end of two-stage theory purporting that inflammation then degeneration explains pathogenesis of progressive multiple sclerosis. Curr Opin Neurol. 2016 Jun;29(3):340-4. doi: 10.1097/WCO.0000000000000317.
- Background: PubMed 27396817Fraussen J, de Bock L, Somers V. B cells and antibodies in progressive multiple sclerosis: Contribution to neurodegeneration and progression. Autoimmun Rev. 2016 Sep;15(9):896-9. doi: 10.1016/j.autrev.2016.07.008. Epub 2016 Jul 7.
- Background: PubMed 28714965Price ND, Magis AT, Earls JC, Glusman G, Levy R, Lausted C, McDonald DT, Kusebauch U, Moss CL, Zhou Y, Qin S, Moritz RL, Brogaard K, Omenn GS, Lovejoy JC, Hood L. A wellness study of 108 individuals using personal, dense, dynamic data clouds. Nat Biotechnol. 2017 Aug;35(8):747-756. doi: 10.1038/nbt.3870. Epub 2017 Jul 17.
- Background: PubMed 27626663Hellberg S, Eklund D, Gawel DR, Kopsen M, Zhang H, Nestor CE, Kockum I, Olsson T, Skogh T, Kastbom A, Sjowall C, Vrethem M, Hakansson I, Benson M, Jenmalm MC, Gustafsson M, Ernerudh J. Dynamic Response Genes in CD4+ T Cells Reveal a Network of Interactive Proteins that Classifies Disease Activity in Multiple Sclerosis. Cell Rep. 2016 Sep 13;16(11):2928-2939. doi: 10.1016/j.celrep.2016.08.036.
- Background: PubMed 28261960Hakansson I, Tisell A, Cassel P, Blennow K, Zetterberg H, Lundberg P, Dahle C, Vrethem M, Ernerudh J. Neurofilament light chain in cerebrospinal fluid and prediction of disease activity in clinically isolated syndrome and relapsing-remitting multiple sclerosis. Eur J Neurol. 2017 May;24(5):703-712. doi: 10.1111/ene.13274. Epub 2017 Mar 6.
- Background: PubMed 28893978Cekanaviciute E, Yoo BB, Runia TF, Debelius JW, Singh S, Nelson CA, Kanner R, Bencosme Y, Lee YK, Hauser SL, Crabtree-Hartman E, Sand IK, Gacias M, Zhu Y, Casaccia P, Cree BAC, Knight R, Mazmanian SK, Baranzini SE. Gut bacteria from multiple sclerosis patients modulate human T cells and exacerbate symptoms in mouse models. Proc Natl Acad Sci U S A. 2017 Oct 3;114(40):10713-10718. doi: 10.1073/pnas.1711235114. Epub 2017 Sep 11.
- Derived from this study: PubMed 39561535Kornilov SA, Price ND, Gelinas R, Acosta J, Brunkow ME, Gervasi-Follmar T, Winger RC, Aldershoff D, Lausted C, Troisch P, Smith B, Heath JR, Repovic P, Cohan S, Magis AT. Multi-Omic characterization of the effects of Ocrelizumab in patients with relapsing-remitting multiple sclerosis. J Neurol Sci. 2024 Dec 15;467:123303. doi: 10.1016/j.jns.2024.123303. Epub 2024 Nov 10.
- Individual participant dataSharing planned: No. It is expected that the results of this study will be presented at the annual meetings of American Academy of Neurology (AAN) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In addition, a manuscript reporting the results of this study will be submitted for publication in a leading neurology journal in aggregate, no intention to disclose individual personal data.
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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. This study is not recruiting at the moment.
Stanley Cohan, MD, PhD principal investigator
Providence Health & Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Providence Health & Services at 2 sites 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 16 inclusion and 49 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: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of relapse free patients (time frame: 6, 12, and 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05081700, which also lists 8 linked publications.
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 2 Oct 2024.