Clinical Research Details

Descriptive Information
An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis (CONSONANCE)

Samia Khoury

MN39159 / BIO-2018-0165

Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 3  

Conditions and Keywords
multiple sclerosis
multiple sclerosis,ocrelizumab
Study Design
Eligibility and IRB
Min: 18
Max: 65

This study will evaluate the effectiveness and safety of ocrelizumab in progressive multiple sclerosis (PMS) patients

  1. Definite diagnosis of PMS (as per revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS)
  2. Age 18 - 65 years, inclusive, at screening
  3. EDSS ≤ 6.5 at screening
  4. Have a length of disease duration since PMS disease symptom onset ≤10 years if baseline EDSS ≤ 5.0, and ≤ 15 years if baseline EDSS >5.0
  5. Have a documented evidence of disability progression independent of relapse activity at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician’s judgment.
  6. Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist (Appendix 3)
  7. Have experience using smartphone and connecting to Wi-Fi, and able to comply with the study protocol in investigator’s judgement
  8. For women of childbearing potential: Agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 6 months, or longer if the local label is more stringent, after the last dose of the study drug

Main exclusion criteria

  • Inability to complete MRI for any reason, or inability to tolerate gadolinium
  • Pregnant or lactating women
  • Lack of peripheral venous access
  • Known presence of other neurological disorders, known active malignancies or being actively monitored for recurrence of malignancy, know presence of significant or uncontrolled somatic disease
  • Any concomitant disease that requires chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History of or currently active primary or secondary immunodeficiency
  • Active infections (if present, they must be treated and resolved before possible inclusion in the study)
  • Patients in a severely immunocompromised state (until the condition resolves).
  • Patients who have or have had confirmed progressive multifocal leukoencephalopathy (PML).

Absolute Exclusions Related to Medications:

  • Hypersensitivity to ocrelizumab or to any of its excipients
  • Previous treatment with B-cell targeted therapies (rituximab, ocrelizumab, atacicept, tabalumab,  belimumab, ofatumumab, or obinutizumab).
  • Any previous treatment with alemtuzumab, total body irradiation, or bone marrow transplantation
  • Previous treatment with natalizumab where PML has not been excluded according to specific algorithm in Appendix 8 of the protocol
  • Contraindications/intolerance of oral or IV corticosteroids, according to the country label, including: psychosis not yet controlled by treatment, hypersensitivity to any of the constituents

Relative Exclusions Related to Medications:

4 to 8 weeks prior to screening

·         Systemic corticosteroid therapy within 4 weeks prior to screening.

·         Vaccines administered within 6 weeks before the first infusion of ocrelizumab.

·         Previous treatment with daclizumab or fingolimod in the last 8 weeks.

·         Treatment with fampridine/dalfampridine (Fampyra®)/Ampyra®) or other symptomatic MS treatment unless on stable dose for ≥30 days prior to screening.

12 weeks prior to screening 

·         Previous treatment with natalizumab in the last 12 weeks. (A different wash-out period when switching from natalizumab to ocrelizumab can be used. An assessment should be made to balance risk of return of MS disease activity with possible additive immunosuppressive effects of each drug.)

·         Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks. 

24 weeks prior to screening

Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS (e.g., treatment for chronic cerebrospinal venous insufficiency) within 24 weeks of screening (Visit 1).

96 weeks prior to screening

·         Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks.

·         Patients previously treated with teriflunomide within the last two years, unless measured plasma concentrations are less than 0.02 mg/l. If levels are above 0.02 mg/l or not known an accelerated elimination procedure should be implemented before screening visit