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NCT03523858: CONSONANCE
A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis
Active, enrolled
Phase 3
Last updated 30 January 2026
What this trial tests
Phase 3 trial testing Ocrelizumab in Progressive Multiple Sclerosis (PMS) in 927 participants. Participants enrolled and being followed up; not accepting new ones.
Timeline
28 May 2018
Primary endpoint
12 November 2026
12 November 2026
12 November 2026
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 927 |
| Start date | 28 May 2018 |
| Primary completion | 12 November 2026 |
| Estimated completion | 12 November 2026 |
| Sites | 124 locations across Italy, Colombia, Panama, Ireland, Poland, Lebanon, Guatemala, Denmark |
Drugs / interventions tested
- Ocrelizumab (OCRELIZUMAB) — full drug profile →
Conditions studied
- Progressive Multiple Sclerosis (PMS) — all drugs for Progressive Multiple Sclerosis (PMS) →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
Adults 18 to 65, any sex, with Progressive Multiple Sclerosis (PMS). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
B cell depletion therapies in autoimmune disease: advances and mechanistic insights.
Lee DSW, Rojas OL, Gommerman JL. · · 2021 · cited 496× · PMID 33324003 · DOI 10.1038/s41573-020-00092-2 -
Sex and gender differences and biases in artificial intelligence for biomedicine and healthcare.
Cirillo D, Catuara-Solarz S, Morey C, Guney E, et al · · 2020 · cited 204× · PMID 32529043 · DOI 10.1038/s41746-020-0288-5 -
Chronic white matter lesion activity predicts clinical progression in primary progressive multiple sclerosis.
Elliott C, Belachew S, Wolinsky JS, Hauser SL, et al · · 2019 · cited 166× · PMID 31497864 · DOI 10.1093/brain/awz212 -
Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis.
Hauser SL, Kappos L, Montalban X, Craveiro L, et al · · 2021 · cited 131× · PMID 34475123 · DOI 10.1212/wnl.0000000000012700 -
Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study.
Midaglia L, Mulero P, Montalban X, Graves J, et al · · 2019 · cited 94× · PMID 31471961 · DOI 10.2196/14863 -
Diagnosis and Management of Progressive Multiple Sclerosis.
Macaron G, Ontaneda D. · · 2019 · cited 47× · PMID 31362384 · DOI 10.3390/biomedicines7030056 -
Practice Effects of Mobile Tests of Cognition, Dexterity, and Mobility on Patients With Multiple Sclerosis: Data Analysis of a Smartphone-Based Observational Study.
Woelfle T, Pless S, Wiencierz A, Kappos L, et al · · 2021 · cited 30× · PMID 34792480 · DOI 10.2196/30394 -
Targeting B Cells to Modify MS, NMOSD, and MOGAD: Part 1.
Graf J, Mares J, Barnett M, Aktas O, et al · · 2021 · cited 30× · PMID 33406479 · DOI 10.1212/nxi.0000000000000918
Verify or expand the search:
- PubMed search for NCT03523858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03523858 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
- Last refreshed: 30 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03523858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing