Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03477500 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Randomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for RRMS (RAM-MS)

Study acronym: RAM-MS
StatusActive, Not Recruiting
PhasePhase 3
Started2018-03-21
View on ClinicalTrials.gov ↗

Amendment history

2025-06-24
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-03-21→2026-11-21
Completion date2026-03-21→2028-03-21
Study sitesdetails revised at 8 of 8 sites
2024-01-05
Study Identification, Study Status v9
Study title+9 characters
RCT ComparingRandomized Autologous HematopoieticheMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab infor RRMS (RAM-MS)
2023-08-30
Study Status v8
Primary completion date2025-12-21→2024-03-21
2022-10-05
Study Identification, Study Status, Study Description, Arms and Interventions, Contacts/Locations v7
Primary completion date2024-12-21→2025-12-21
Completion date2025-03-21→2026-03-21
InterventionsAlemtuzumab (Drug), Cyclophosphamide and ATG (Drug)→Alemtuzumab (Drug), Cladribine Pill (Drug), Cyclophosphamide and ATG (Drug), Ocrelizumab (Drug)
Study description+21 characters
[...] umed best available immunomodulatory medication (alemtuzumab, cladribine or ocrelizumab) in RRMS patients with significant inflammatory disease act [...] our the use of a new comparator (replacing or supplementing alemtuzumabthe as a comparatorcomparators). This will be evaluated by the PMC if applicable during th [...] tient populations in Sweden, Norway and Denmark. Alemtuzumab, hascladribine or ocrelizumab have been chosen as the primary comparatorcomparators, because itthey isare the immunomodulatory medication currently authorised by the [...] eta-analysis of immunomodulatory treatment effects in RRMS, alemtu [...] [...]
Study sitesdetails revised at 2 of 8 sites
Study title+27 characters
RCT Comparing Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab in MS
2022-08-02
Study Status v6
Primary completion date2022-03-21→2024-12-21
Completion date2024-03-21→2025-03-21
Show 5 earlier versions
2022-03-18
2 amendments v4-v5
2 re-verifications since 2021-02-09, no change to tracked fields
2019-06-03
Study Status, Eligibility, Contacts/Locations v3
Eligibility criteria+503 characters
[...] h-dose glucocorticosteroids Any ongoing infection, including Tbc, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HTV, HIV or syphilis infections, as well as hepatitisheaptitis B surface antigen positivity and/or hepatitis C PCR positiv [...] tricted to previous treatment with rituximab, mitoxantrone, cladribinealemtuzumab, cladribin and alemtuzumabocrelizumab Immunocompromised patients, or patients currently reveiving immunosuppressive or myelosuppressive therapy Treatment with glucocorticoids or ACTH within one month prior to start of study inclusiontreatment Having experienced an MS relapse wi [...] [...]
Study sitesdetails revised at 3 of 8 sites
2018-05-08
Study Status, Contacts/Locations v2
Study sitesdetails revised at 3 of 8 sites
2018-03-31
Study Status, Document Section v1
Primary completion date2022-03→2022-03-21
Completion date2024-03→2024-03-21
Start dateestimated 2018-03→confirmed 2018-03-21
2018-03-19
Original filing
This study is a randomized multicentre, multinational, treatment interventional study of RRMS patients with breakthrough inflammatory disease activity in spite of ongoing standard immunomodulatory medication. The study has two treatment arms; arm A: HSCT (hematopoietic stem cell transplantation) and arm B: alemtuzumab, cladribine or ocrelizumab. A pre-planned 3-year follow-up extension period will be performed depending on future funding. The aim of the study is to assess the effectiveness and side effects of a new treatment intervention in RRMS; HSCT, and, thereby, the value of HSCT in clinical practice. Data from recently published patient series indicate that HSCT may have a significantly higher treatment effect than currently registered RRMS immunomodulatory treatments. This study will determine the relative role of HSCT versus alemtuzumab, cladribine or ocrelizumab.
Trial Details
NCT Number NCT03477500
Lead Sponsor Haukeland University Hospital
Conditions Multiple Sclerosis
Enrollment 100 participants
Start Date 2018-03-21
Primary Completion 2026-11-21 (estimated)
Study Completion 2028-03-21 (estimated)
Updated on ClinicalTrials.gov 2025-06-25