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Compares treatment options for Optic Neuritis
Official title Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
ClinicalTrials.gov ID: NCT07100990
What this study is testing
What is High-dose corticosteroids (HDCS)?
High-dose corticosteroids (HDCS) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for optic neuritis.
Also referred to as Rescue Plex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research is to evaluate if early vs rescue Therapeutic Plasma Exchange (PLEX) treatment algorithm leads to better visual outcomes in severe Optic Neuritis and leads to better neurological disability outcomes in severe Transverse Myelitis.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Study Population and Setting
- The proposal will recruit participants presenting to participating sites with severe ON or severe TM to two separate sub-trials. The detailed...
You likely can't join if
- for each sub-trial are listed below: Optic Neuritis Sub-Trial: Inclusion criteria:
- ≥18 years of age
- MRI orbits demonstrating evidence of new T2 hyperintensity and/or post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical...
- Visual acuity 20/200 or worse
- Within 8 days of onset of visual symptoms
- Able to initiate PLEX within 72h of the first dose of HDCS (if assigned by chance to the "Early PLEX" treatment arm)
See the full eligibility criteria
Who can join
- Study Population and Setting
- The proposal will recruit participants presenting to participating sites with severe ON or severe TM to two separate sub-trials. The detailed inclusion and
What rules you out
- for each sub-trial are listed below: Optic Neuritis Sub-Trial: Inclusion criteria:
- ≥18 years of age
- MRI orbits demonstrating evidence of new T2 hyperintensity and/or post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical criteria for Optic Neuritis
- Visual acuity 20/200 or worse
- Within 8 days of onset of visual symptoms
- Able to initiate PLEX within 72h of the first dose of HDCS (if assigned by chance to the "Early PLEX" treatment arm)
- Able to sign and date informed consent form
- Willingness to comply with all study procedures and availability for the duration of the study Exclusion criteria:
- Evidence of prior episode of optic neuritis in the affected eye (by history or ophthalmological evaluation)
- Ophthalmological comorbidity that would significantly affect best corrected visual acuity or visual fields
- Pregnancy
- Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding/coagulopathy, or sepsis.
- Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but...
- Treatment with any investigational agent within 6 months of baseline or five half-lives of the investigational agent (whichever is longer)
- Ongoing/prior treatment with immune-modulating/immunosuppressive therapy including:
- Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization
- Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization
- Intravenous or subcutaneous immune globulin within 3 months of randomization
- Plasma exchange within 3 months of randomization
- Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization
- Teriflunomide use within prior 24 months
- Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization
- Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide
- Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer) Transverse Myelitis Sub-Trial: Inclusion criteria:
- ≥18 years of age
- Diagnosis of Transverse Myelitis (defined based on modified criteria adapted from the 2002 Transverse Myelitis Consortium Working Group; ALL are required)
- Development of sensory, motor and/or autonomic symptomatology attributable to spinal cord dysfunction
- Onset of symptoms to nadir \>12 hours
- Exclusion of extra-axial compressive etiology by neuroimaging
- Demonstration of inflammation within the spinal cord by presence of intramedullary T2 lesion (post-gadolinium enhancing OR non-enhancing) on MRI
- Expanded Disability Status Scale [EDSS] ≥3.0 (excluding visual and cerebral functional systems)
- EDSS Pyramidal Functional System Score ≥ 2
- Within 8 days of onset of motor symptoms
- Able to initiate PLEX within 48h of the first dose of HDCS (if assigned by chance to the "Early PLEX" treatment arm)
- Able to sign and date informed consent form
- Willingness to comply with all study procedures and availability for the duration of the study Exclusion criteria:
- Pre-existing ambulatory, motor, sensory, or bowel/bladder disability of any cause that could confound trial assessments
- Fulfillment of possible, probable or definite spinal cord infarction diagnosis per proposed diagnostic criteria (Zalewski et al. JAMA Neurology 2018)
- History of radiation to the spine
- Pregnancy
- High clinical suspicion for infectious etiology of myelitis (e.g., fever, rash or other findings)
- Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding/coagulopathy, or sepsis.
- Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but...
- Treatment with any investigational agent within 24 weeks of baseline or five half-lives of the investigational agent (whichever is longer)
- Ongoing/prior treatment with immune-modulating/immunosuppressive therapy including: Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or...
- Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization
- Intravenous or subcutaneous immune globulin within 3 months of randomization
- Plasma exchange within 3 months of randomization
- Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization
- Teriflunomide use within prior 24 months
- Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization
- Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide
- Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer)
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Loma Linda, California, United States
- Sacramento, California, United States
- Aurora, Colorado, United States
- North Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Evanston, Illinois, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Columbia, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- Jackson, Mississippi, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Loma Linda, California, United States; Sacramento, California, United States; Aurora, Colorado, United States; North Haven, Connecticut, United States; Jacksonville, Florida, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.