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SNCTP000002327 | NCT03085810 | BASEC2017-00862

EINE OFFENE, EINARMIGE STUDIE ZUR UNTERSUCHUNG DER WIRKSAMKEIT UND SICHERHEIT VON OCRELIZUMAB BEI PATIENTEN MIT SCHUBFÖRMIG REMITTIERENDER MULTIPLER SKLEROSE (MS) IM FRÜHSTADIUM

Data source: BASEC (Imported from 28.03.2024), WHO (Imported from 20.03.2024)
Changed: Mar 20, 2024, 9:08 AM
Disease category: Nervous System diseases

Brief description of trial (Data source: BASEC)

Das Ziel der Studie ist es festzustellen, ob Ocrelizumab die Verschlechterung der Anzeichen und Symptome der MS im Frühstadium zum Stillstand bringt. In dieser Studie wird den Patienten Ocrelizumab in Form von intravenösen Infusionen verabreicht. Die Studie dauert etwa 6 Jahre. Ungefähr 600 Patienten werden weltweit an dieser Studie teilnehmen, davon ungefähr 20 in der Schweiz.

Health conditions investigated(Data source: BASEC)

SCHUBFÖRMIG REMITTIERENDE MULTIPLE SKLEROSE IM FRÜHSTADIUM

Health conditions (Data source: WHO)

Multiple Sclerosis, Relapsing-Remitting

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Die erste Dosis Ocrelizumab wird in Form von zwei intravenösen Infusionen mit je 300 mg im Abstand von 14 Tagen verabreicht, jede in einer Lösung aus 250 ml Natriumchlorid 0,9 %. Nach der ersten Ocrelizumab Dosis erhalten die Patienten 600 mg Ocrelizumab in einer Lösung aus 500 ml Natriumchlorid 0,9% im Abstand von 24 Wochen und über einen Zeitraum von bis zu 168 Wochen (insgesamt 8 vollständige Dosisgaben). Im Abstand von 24 Wochen wird die Wirksamkeit und Sicherheit beurteilt.

Interventions (Data source: WHO)

Drug: Ocrelizumab

Criteria for participation in trial (Data source: BASEC)

- Alter zwischen 18 und einschliesslich 55 Jahre
- Diagnose einer schubförmig remittierenden Multiplen Sklerose nach den 2010 geänderten McDonald-Kriterien
-Krankheitsdauer von ≤3 Jahren seit dem ersten dokumentierten klinischen Schub in Zusammenhang mit MS
-Innerhalb der letzten 12 Monate: Ein oder mehrere klinisch dokumentierte(r)Schub/Schübe ODER Ein oder mehrere Anzeichen von MRI Aktivität

Exclusion criteria (Data source: BASEC)

-Sekundär-progrediente MS oder Vorgeschichte einer primär-progredienten oder schubförmig progredienten MS
-Undurchführbarkeit einer MRT-Untersuchung
-Bekanntsein von anderen neurologischen Beeinträchtigungen

Inclusion/Exclusion Criteria (Data source: WHO)

Gender: All
Maximum age: 55 Years
Minimum age: 18 Years

Inclusion Criteria:

- Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria

- Have a length of disease duration, from first documented clinical attack consistent
with MS disease of less than or equal to (
- Within the last 12 months one or more clinically reported relapse(s) or one or more
signs of MRI activity

- EDSS of 0.0 to 3.5 inclusive, at screening

- An agreement to use an acceptable birth control method for women of childbearing
potential, during the treatment period and for at least 6 months or longer after the
last dose of study drug

Exclusion Criteria:

- Secondary progressive multiple sclerosis or history of primary progressive or
progressive relapsing MS

- Inability to complete an MRI

- Known presence of other neurological disorders

Exclusions Related to General Health:

- Pregnancy or lactation

- Participants intending to become pregnant during the study or within 6 months after
the last dose of the study drug

- Any concomitant disease that may require 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

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies

- Significant or uncontrolled somatic disease or any other significant disease that may
preclude participant from participating in the study

- Congestive heart failure (New York Heart Association III or IV functional severity)

- Known active bacterial, viral, fungal, mycobacterial infection or other infection,
(excluding fungal infection of nail beds) or any major episode of infection requiring
hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or
oral antibiotics 2 weeks prior to screening

- History of malignancy, major opportunistic infections, alcohol or drug abuse,
recurrent or chronic infection, and/or coagulation disorders

Exclusions Related to Medications:

- Received any prior approved disease modifying treatment (DMT) with a label for MS, for
example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab,
fingolimod, teiflunomide and dimethylfumarate

- Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the
baseline visit

- Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab,
atacicept, belimumab, or ofatumumab)

- Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic
therapies (cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine,
methotrexate, cladribine, mitoxantrone, laquinimod, total body irradiation, or bone
marrow transplantation)

- Treatment with investigational DMT

- Treatment with fampridine/dalfamipridine unless on stable dose for >/=30 days prior to
screening

Exclusion related to Shorter Infusion Substudy:

- Any previous serious IRRs experienced with ocrelizumab treatment

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/ct2/show/NCT03085810

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03085810
Further information on trial

Recruitment status

Completed

Academic title (Data source: WHO)

An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 and 48 Weeks, As Measured Using Expanded Disability Status Scale (EDSS);Percentage of Participants With Confirmed Disability Improvement (CDI) at Year 1, As Measured Using EDSS;Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 1, As Measured Using EDSS;Percentage of Participants With CDI at Year 2, As Measured Using EDSS;Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 2, As Measured Using EDSS;Percentage of Participants With CDI at Year 4, As Measured Using EDSS;Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 4, As Measured Using EDSS;Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 1, As Measured Using EDSS;Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 2, As Measured Using EDSS;Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 3, As Measured Using EDSS;Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 4, As Measured Using EDSS;Mean Change From Baseline in EDSS Score at Week 24;Mean Change From Baseline in EDSS Score at Week 48;Mean Change From Baseline in EDSS Score at Week 72;Mean Change From Baseline in EDSS Score at Week 96;Mean Change From Baseline in EDSS Score at Week 120;Mean Change From Baseline in EDSS Score at Week 144;Mean Change From Baseline in EDSS Score at Week 168;Mean Change From Baseline in EDSS Score at Week 192;Time to First Protocol-Defined Event of Disease Activity;Time to First Relapse;Annualized Relapse Rate;Proportion of Participants with Infusion Related Reactions (IRRs) Occurring During or Within 24 Hours Following the First Infusion After Randomization to the Shorter Infusion Substudy

Secundary end point (Data source: WHO)

Percentage of Participants Who Are Relapse Free;Percentage of Participants With No Evidence of Protocol Defined Disease Activity;Percentage of Participants With no Evidence of Progression (NEP);Percentage of Participants With no Evidence of Progression Sustained for At Least 24 Weeks and no Active Disease (NEPAD);Change from Baseline in Multiple Sclerosis Functional Composite (MSFC) Total Score;Change from Baseline in MSFC Composite Timed 25 Foot Walk Test (T25FW) Score;Change from Baseline in MSFC Composite 9 Hole Peg Test (9HPT) Score;Change from Baseline in MSFC Composite (Paced Auditory Serial Addition Test [PASAT]) Score;Change from baseline in cognitive performance as measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS);Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI;Total Number of New and/or Enlarging T2 Lesion as Detected by Brain MRI;Change from baseline in total T1 hypointense lesion volume as Detected by Brain MRI;Total Number of Fluid-Attenuated Inversion-Recovery (FLAIR) Lesion as Detected by Brain MRI;Change From Baseline in Brain Volume as Detected by Brain MRI;Time to Treatment Discontinuation;Employment Status: Work Productivity and Activity Impairment Questionnaire (WAPI) Score;SymptoMScreen Composite Score;Quality of Life: Multiple Sclerosis Impact Scale (MSIS)-29 Questionnaire Score;Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Proportion of Participants with IRR (overall) in the Shorter Infusion Substudy;Proportion of Participants with IRR By Dose at Randomization in the Shorter Infusion Substudy;Proportion of Participants with IRRs Leading to Treatment Discontinuation in the Shorter Infusion Substudy

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Basel, Bern, Lugano, Luzern, St. Gallen

Countries (Data source: WHO)

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Denmark, Finland, France, Germany, Hungary, Italy, Kuwait, Lebanon, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Clinical Trials
+41 61 715 43 91
switzerland.clinical-research@roche.com

Contact for general information (Data source: WHO)

Clinical Trials
Hoffmann-La Roche

Contact for scientific information (Data source: WHO)

Clinical Trials
Hoffmann-La Roche

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Date of authorisation by the ethics committee

07.08.2017

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2017-00862

Secondary ID (Data source: WHO)

2016-002937-31
MA30143
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