TerminatedPhase 2

Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled Trial

Stopped: Lack of recruitment due to low acceptance of the control arm.

Germany1 participantsStarted 2021-08-27

Plain-language summary

A multicentre controlled phase II trial to compare the efficacy and safety of ocrelizumab or alemtuzumab and autologous Hematopoietic Stem Cell Transplantation (aHSCT). Active relapsing-remitting MS-Patients will be included and randomised to ocrelizumab or alemtuzumab versus aHSCT. Primary endpoint will be the time to treatment failure as assessed by failure of NEDA (no evidence of disease activity) as represented by: no expanded disability status scale (EDSS) progression, no relapse, no new T2 lesion and no Gd-enhancing lesion. This trial offers the opportunity to gain further information about efficacy and safety of all treatments and will give new insights into the immunology of highly active RRMS.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (Based on CARE-MS-II3, guidelines and Rio-criteria for treatment failure): * Written informed consent and agreement to comply to study protocol * Age: 18-55 years * EDSS: 0.0 - 6.0 * RRMS according to McDonald 2010 * \< 10 years of disease course after symptom onset * Active disease with one of the following treatment failures occur-ring not earlier than 6 months after initiation of an approved DMT * 2 or more relapses within the last 12 months or * 1 relapse within the last 12 months and a Gd-enhancing lesion on MRI \> 3 mm \> 3 months before or after relapse onset or 2 new T2-lesions or * On-going signs of MRI activity in the last 6 months (either Gd-en-hancing of ≥ 3 mm lesion at any exam in the last year; or more than 5 new T2 lesions (≥ 3 mm) or * Patients stable under natalizumab but who have to stop treatment due to an increasing PML risk are defined as active, if a MRI within 6 months after termination of natalizumab shows new T2 or Gd-enhancing lesions and at least one other treatment fail-ure prior to natalizumab is documented. Exclusion Criteria: * Secondary or primary progressive MS * Pregnancy, or other medical condition incompatible with aHSCT * Any treatment or medical condition that, according to the haematologist / transplant specialist precludes the use of aHSCT * John Cunningham virus (JCV) antibody index of \> 1.5 in previ-ously natalizumab-treated patients, if a negative CSF JCV-PCR prior to screening is not available * Relapse…

What they're measuring

Time to treatment failure as assessed by failure of NEDA (no evidence of disease activity)

Timeframe: through study completion, on average at least 2 years

Trial details

NCT IDNCT04971005

SponsorUniversitätsklinikum Hamburg-Eppendorf

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-04