Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis

NCT04966338 | Completed Phase 3

• 1 other identifier: OCR.CIN.MS.96.III
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Ocrelizumab produced by CinnaGen compared with Ocrevus® (Roche, Switzerland) in subjects with relapsing remitting multiple sclerosis (RRMS). All the participants will receive one of the following regimens: Ocrelizumab (CinnaGen) or Ocrevus® (Roche, Switzerland) ,600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single infusions of 600 mg on Day 1 for each 24-week treatment cycle, thereafter) every 24 weeks. The primary objective of this study is to verify the equivalency of Ocrelizumab (CinnaGen) versus Ocrevus® (Roche, Switzerland) in reducing the annualized relapse rate (ARR) in participants with relapsing remitting multiple sclerosis (RRMS) at 2 years.

Conditions

Multiple Sclerosis; Relapsing-Remitting

Keywords

RRMS; Annualized Relapse Rate; Monoclonal; Humanized; Ocrelizumab

Outcome Measures

Primary Outcomes (1)

• Annualized Relapse Rate at 48 weeks

  Total number of confirmed relapses divided by the total number of days on study A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection

  48 weeks

Secondary Outcomes (9)

• Time to onset of sustained disability progression for at least 12 weeks

  Baseline up to Week 96

• Time to onset of sustained disability progression for at least 24 weeks

  Baseline up to Week 96

• Proportion of relapse-free patients by 96 weeks

  Week 96

• Total number of new Gadolinium (Gd)-enhancing lesions as detected by brain MRI

  Baseline up to Week 96

• Total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI

  Baseline up to Week 96

Study Arms (2)

Ocrelizumab (CinnaGen, Iran)

EXPERIMENTAL

Ocrelizumab (CinnaGen, Iran) 600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single infusions of 600 mg on Day 1 for each 24-week treatment cycle, thereafter) every 24 weeks.

Biological: Ocrelizumab (CinnaGen, Iran)

Ocrelizumab (Roche, Switzerland)

ACTIVE COMPARATOR

Ocrelizumab (Roche, Switzerland) 600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single infusions of 600 mg on Day 1 for each 24-week treatment cycle, thereafter) every 24 weeks.

Biological: Ocrelizumab (Roche, Switzerland)

Interventions

Ocrelizumab (CinnaGen, Iran) BIOLOGICAL

Ocrelizumab (CinnaGen, Iran) will be administered via intravenous (IV) infusion.

Also known as: Xacrel®

Ocrelizumab (CinnaGen, Iran)

Ocrelizumab (Roche, Switzerland) BIOLOGICAL

Ocrelizumab (Roche, Switzerland) will be administered via intravenous (IV) infusion.

Also known as: Ocrevus®

Ocrelizumab (Roche, Switzerland)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments.
• Ages 18-55 years at screening, inclusive.
• Diagnosis of MS, in accordance with the revised McDonald criteria (2010).
• At least two relapses having occurred within the past 2 years or one relapse within the past 12 months prior to screening.
• Neurological stability for ≥ 30 days prior to both screening and baseline.
• EDSS, at screening, from 0 to 5.5 inclusive.
• Patients of reproductive potential must use reliable means of contraception.

You may not qualify if:

• Diagnosis of primary progressive MS.
• Disease duration of more than 10 years in patients with an EDSS ≤ 2.0 at screening.
• Inability to complete an MRI (contraindications for MRI include but are not restricted to claustrophobia, weight ≥ 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc).
• Known presence of other neurological disorders which may mimic MS including but not limited to: neuromeylitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis and cerebrovascular disorders.
• Pregnancy or lactation.
• 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 patient from participating in the study such as Congestive heart failure (NYHA III or IV functional severity).
• Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds.
• Infection requiring hospitalization or treatment with I.V. antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit.
• History or known presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV).
• History of progressive multifocal leukoencephalopathy (PML)
• History of malignancy, including solid tumors and hematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been previously completely excised with documented, clear margins.

Sponsors & Collaborators

• Cinnagen: lead

Study Sites (15)

Qaem International Hospital

Rasht, Gilan Province, Iran

Location

Qaem Hospital

Mashhad, Khorasan Razavi, Iran

Location

Golestan Hospital

Ahvāz, Khozestan, Iran

Location

Bouali Hospital, MS Clinic

Sari, Mazandaran, Iran

Location

Sina Hospital

Hamadan, Iran

Location

Ayatollah Kashani Hospital, MS Clinic

Isfahan, Iran

Location

Shafa Hospital

Kerman, Iran

Location

Imam Reza Hospital

Kermanshah, Iran

Location

Dr. Nikseresht's office

Shiraz, Iran

Location

Namazi Hospital

Shiraz, Iran

Location

Imam Reza Hospital Department of Neurology

Tabriz, Iran

Location

Amir Alam Hospital

Tehran, Iran

Location

Imam Hossein Hospital, MS Clinic

Tehran, Iran

Location

Imam Khomeini Hospital

Tehran, Iran

Location

Sina Hospital, MS Research Center

Tehran, Iran

Location

Related Publications (1)

• Sahraian MA, Abolfazli R, Shaygannejad V, Ashtari F, Majdinasab N, Navardi S, Baghbanian SM, Sedighi B, Naser Moghadasi A, Nahayati MA, Ghalyanchi Langroodi H, Mohammadianinejad SE, Beladi Moghadam N, Ayromlou H, Nikseresht A, Ghiasian M, Razazian N, Asadollahzadeh E, Sabzvari A, Kafi H, Albooyeh S. Evaluating efficacy and safety of ocrelizumab biosimilar (Xacrel) compared to the originator (Ocrevus) in relapsing multiple sclerosis: a phase III, randomized, equivalency, clinical trial. Sci Rep. 2024 Oct 22;14(1):24921. doi: 10.1038/s41598-024-75745-y.

  PMID: 39438591 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mohammad Ali Sahraian, professor

  Neurologist/MS Research Center, Neuroscience Institute ,Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 19, 2021
• Study Start: August 19, 2019
• Primary Completion: November 9, 2020
• Study Completion: October 1, 2021
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (15)