Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial

Study acronym: TREAT-MS
StatusCompleted
PhaseNot applicable
Started

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Record History

The 50 most recent of 63 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of Sep 2026 to Aug 31, 2026
    • Interventions: Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl)… to Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl)…
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 4 of 26 entries
    • Site details revised at 1 of 47 sites
  2. Study completion date: Aug 2026 to Sep 2026v62
  3. Primary completion date changed from estimate of Aug 1, 2026 to Jul 31, 2026
    • Study completion date: Aug 1, 2026 to Aug 2026
    v61
  4. 2 versions Re-verified since May 28, 2025, no change to tracked fieldsv59-v60
  5. Primary and study completion dates: Aug 1, 2025 to Aug 1, 2026v58 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 52 to 47
    • Interventions: Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl)… to Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl)…
    • Secondary endpoints: details revised at 25 of 26 entries
Show 44 earlier versionsHide 44 earlier versions
  1. Secondary endpoints: details revised at 25 of 26 entries
    • Site details revised at 12 of 52 sites
    v57
  2. Interventions: Early Aggressive Therapy or Traditional Therapy (Other) to Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl)…
    • Study sites revised (52)
    v56
  3. Study sites revised (52)v55
  4. Site contacts updated at 1 of 52 sitesv54
  5. Site details revised at 6 of 52 sitesv53
  6. Primary and study completion dates: Aug 1, 2024 to Aug 1, 2025
    • Site contacts updated at 6 of 52 sites
    v52
  7. Site details revised at 4 of 52 sitesv51
  8. Site details revised at 11 of 52 sitesv50
  9. Site details revised at 8 of 52 sitesv49
  10. Site contacts updated at 3 of 52 sitesv48
  11. Site details revised at 3 of 52 sitesv47
  12. Secondary endpoints: details revised at 25 of 26 entries
    • Site details revised at 1 of 52 sites
    v46
  13. Site contacts updated at 1 of 52 sitesv45
  14. Site details revised at 4 of 52 sitesv44
  15. Study sites: 51 to 52v43
  16. Primary and study completion dates: Aug 1, 2023 to Aug 1, 2024
    • Site details revised at 3 of 51 sites
    v42
  17. Site details revised at 5 of 51 sitesv41
  18. Study sites: 50 to 51v40
  19. Site contacts updated at 2 of 50 sitesv39
  20. Site contacts updated at 6 of 50 sitesv38
  21. Study sites: 49 to 50v37
  22. Site details revised at 6 of 49 sitesv36
  23. Study sites: 46 to 49v35
  24. Primary and study completion dates: Oct 31, 2022 to Aug 1, 2023
    • Site details revised at 9 of 46 sites
    v34
  25. Site contacts updated at 4 of 46 sitesv33
  26. Site contacts updated at 1 of 46 sitesv32
  27. Site contacts updated at 4 of 46 sitesv31
  28. Site details revised at 6 of 46 sitesv30
  29. Re-verified, no change to tracked fieldsv29
  30. Site contacts updated at 1 of 46 sitesv28
  31. Site contacts updated at 6 of 46 sitesv27
  32. Site contacts updated at 1 of 46 sitesv26
  33. Site contacts updated at 1 of 46 sitesv25
  34. Study sites: 45 to 46v24
  35. Study sites: 44 to 45v23
  36. Study sites: 43 to 44v22
  37. Site contacts updated at 2 of 43 sitesv21
  38. Site contacts updated at 2 of 43 sitesv20
  39. Site contacts updated at 2 of 43 sitesv19
  40. Study sites: 39 to 43v18
  41. Site contacts updated at 4 of 39 sitesv17
  42. Site contacts updated at 1 of 39 sitesv16
  43. Study sites: 36 to 39v15
  44. Site contacts updated at 1 of 36 sitesv14
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability. The infectious risks and other complications associated with higher-efficacy treatments highlight the need to quantify their effectiveness in preventing disability. The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.
Trial Details
NCT Number NCT03500328
Lead Sponsor Johns Hopkins University
Collaborators: Patient-Centered Outcomes Research Institute, National Multiple Sclerosis Society
Conditions
(from sponsor)		 Multiple Sclerosis, Relapsing-Remitting
Related terms Multiple Sclerosis, Relapsing-Remitting
Enrollment 900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov