Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202103563404333 Date of Approval: 10/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab.
Official scientific title Open-label, prospective, single-arm, multi-center study to assess disease activity and biomarker of neuronal damage in minority patients (self-identified Black or African American (AA) and Hispanic/Latino (HA) patients with relapsing multiple sclerosis (RMS) receiving treatment with Ocrelizumab.
Brief summary describing the background and objectives of the trial Background It is thought that Multiple Sclerosis is potentially more severe in patients who identify as Black or African Americans (and Hispanic Americans) as compared to the general population. It has been hypothesized that greater role of B cell pathology may be responsible. In view of this distinct phenotype, this study explores the underlying disease biology and the effect of ocrelizumab in minority patients in a systematic, prospective study Primary Objective The primary objective of this study is to assess disease activity during treatment with ocrelizumab over 48 weeks in minorities represented by Black or African Americans with RMS (AAwMS) and Hispanic/Latinos with RMS (HAwMS). Secondary Objectives The secondary objectives of this study are to evaluate other clinical measures of effectiveness, and biomarkers of disease activity and neuronal damage in serum, before and during treatment with ocrelizumab Exploratory Objectives The exploratory objectives of this study are to evaluate additional immune, ancestral, genomic, and other exploratory markers of disease and their correlations with disease severity and progression, including patient reported outcomes (PROs), before and during treatment with ocrelizumab.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 30/07/2020
Actual trial start date 30/07/2020
Anticipated date of last follow up 08/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ocrelizumab Ocrelizumab will be administered intravenously (IV) at a dose of 600 mg every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks. Ocrelizumab will be administered intravenously (IV) at a dose of 600 mg every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks. Ocrelizumab will be administered intravenously (IV) at a dose of 600 mg every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks. 150
Control Group Not Applicable Not Applicable Not Applicable Not Applicable 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diagnosis of RMS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment Participants who self-identify as Black or African American or Hispanic/Latino American Treatment-naïve or initiating first or second switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethyl fumarate (DMF); or siponimod; or fingolimod; or diroximel fumarate; or teriflunomide; or ozanimod; or natalizumab For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab Neurologically stable for at least 30 days prior to randomization and baseline assessments Diagnosis of secondary progressive MS without relapses for at least 1 year (nonactive or inactive SPMS) Primary Progressive Multiple Sclerosis (PPMS) Participants with contraindication to gadolinium based contrast agent for MRI and participants who cannot tolerate MRI procedure Infection Related Cancer Related Pregnant or lactating, or intending to become pregnant during the study Other Medical Conditions Known presence or history of other neurologic disorders Vaccinations: Receipt of a live vaccine, or attenuated, or inactivated / component vaccine within 6 weeks prior to first administration of ocrelizumab Laboratory: abnormalities or findings at screening Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/03/2021 Aga Khan University Institutional Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue, Nairobi-Kenya Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment [ Time Frame: 48 Weeks ] A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain magnetic resonance imaging (MRI) 48 weeks
Secondary Outcome Time to onset of 24 weeks confirmed disability progression (CDP) at week 48 [ Time Frame: Week 48 ] 48 weeks
Secondary Outcome Time to protocol-defined event [ Time Frame: Week 48 ] A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain MRI 48 weeks
Secondary Outcome Annualized relapse rate at week 48 [ Time Frame: Week 48 ] 48 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital 3rd Parklands Avenue, Nairobi-Kenya Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Genentech Inc. Building 35, 350 DNA Way San Francisco 94080 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Genentech Inc. Building 35, 350 DNA Way San Francisco 94080 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
There are no collaborators Not applicable - There are no collaborators Not applicable There are no collaborators United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mansoor Saleh mansoor.saleh@aku.edu +254709931500 3rd Parklands Avenue, Nairobi
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Professor of Medicine and Pathology
Role Name Email Phone Street address
Scientific Enquiries Juan Acosta acostaj9@gene.com +16505345397 Building 35, 350 DNA Way
City Postal code Country Position/Affiliation
San Francisco 94080 United States of America Medical Director
Role Name Email Phone Street address
Public Enquiries Huwaida Bulhan Huwaida.Bulhan@roche.com +254780888997 The Atrium, 6th Floor Chaka Road, off Lenana Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Clinical Operations and RWD Lead
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). Study Protocol Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information