A Phase 1 interventional study of RPH-035 and Ocrevus® in Multiple Sclerosis, sponsored by R-Pharm. Active, not recruiting at 23 sites in Russia. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by R-Pharm · Phase 1, Interventional, and Treatment
Among 27 studies testing ocrelizumab in Multiple Sclerosis — 3 open to participants now, 14 under way, 8 of them phase 3. ocrelizumab · Multiple Sclerosis.
Among the 27 studies testing ocrelizumab in Multiple Sclerosis, this one is the 12th largest by planned enrollment, is one of 2 that started in 2025, is one of 2 in phase 1, reaches primary completion later than 6 of the 13 other live ones, and was the 26th registered.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 180 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →3 of the 27 studies testing ocrelizumab in Multiple Sclerosis are open now, in 8 countries. Each count lists the studies.
ocrelizumab: first FDA approval 2017 (OCREVUS), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →27 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 2 started in 2025.
Median enrollment 170 across the 27 interventional studies. Of the 12 that completed or were terminated, 8 (67%) have results posted.
18 of 27 have an industry lead sponsor. The 10 most frequent:
R-Pharm is the lead sponsor of 58 studies on the registry; 2 are open to participants now.
R-Pharm has 1 study filed under Multiple Sclerosis — fewer than ten, so there is no comparison to draw.
2 of the studies testing ocrelizumab in Multiple Sclerosis that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06847724Phase 3SandozComparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis | 2026-11 |
| NCT04466150University of California, San FranciscoImpact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset | 2026-12 |
Among the 27 studies testing ocrelizumab in Multiple Sclerosis, from their registry updates:
The study goal is to establish the equivalence of pharmacokinetic (PK) properties, as well as the comparability of safety, immunogenicity (IG) and pharmacodynamics (PD) of the drug product RPH-035 (R-Pharm JSC, Russia) in comparison with the drug product Ocrevus® (F. Hoffmann-La Roche Ltd., Switzerland) when used in patients with multiple sclerosis (MS)
This study is a multicentre, double-blind, randomised, comparative Phase I study
The clinical study includes the following periods:
Main period: weeks [1-49]
Patients who meet the eligibility criteria shall be randomised in a 1: 1 ratio to one of two study arms: RPH-035 and Ocrevus®
During the Main Period, the patients will receive their first infusion of ocrelizumab (RPH-035 or Ocrevus®) at a dose of 300 mg, followed by another 300 mg of the drug product after 2 weeks. The duration of ocrelizumab administration will be 2.5 hours ± 15 minutes. The third infusion at a dose of 600 mg should be administered 6 months after the first infusion of the initial dose. The administration is scheduled for the "Week 25" visit.
The Main Period includes regular collection of data on complaints and symptoms, physical examination, assessment of vital signs (measurement of body temperature, blood pressure (BP), pulse), body weight measurement, monitoring of laboratory parameters (clinical and biochemical blood tests, measurement of the concentration of immunoglobulin type G (IgG), general urine analysis), IG analysis, electrocardiogram (ECG), magnetic resonance imaging (MRI) at weeks 9, 17, 25, 49, neurological examination, assessment according to the Expanded Disability Status Scale (EDSS), registration of adverse events/serious adverse events (AEs/SAEs). MRI and assessment of response to therapy within the Main Period will be performed approximately once every 8 weeks during the first six months of the study (week 1 - week 25), then at week 49
The week 49 visit consists of two stages: prior to drug administration, procedures are performed to assess the safety and effectiveness of the blinded therapy. After receiving and analysing the results, the research physician decides whether to terminate or extend therapy. If therapy needs to be continued, the patient is transferred to the follow-up period
After-Therapy period: weeks [49-97]
During the After-Therapy Period, beginning at week 49, all patients will receive RPH-035 therapy, including those who received Ocrevus® therapy during the Main Period. Visits are also included in this period, which are conducted in the form of telephone contacts to assess the patient's well-being, collect data on concomitant therapy and possible AEs
During the After-Therapy Period, patients will receive an IV infusion of ocrelizumab (RPH-035) at a dose of 600 mg at "Week 49", "Week 73", and "Week 97" visits
The first follow-up visit (FU) is performed 28 ± 3 days after the last visit (scheduled or unscheduled)
Patients shall meet all of the following inclusion criteria:
The patient has one of the following signs of disease activity:
Patients cannot be included in the study if they meet at least one of the following exclusion criteria:
Medical history of other neurological diseases (excluding migraines) or first diagnosed on screening, including but not limited to the following:
Medical history of the patient includes the following therapy:
The patient received any of the following therapies (subject to the time/dose restrictions specified):
Concomitant diseases that increase the patient's risk of AE development during the use of the investigational therapy or may affect the assessment of MS symptoms severity; mask, intensify, modify MS symptoms or cause clinical and laboratory-instrumental symptoms similar to those in MS as confirmed by primary documentation data:
Haematological disorders:
Renal impairment:
a. creatinine > 1.5 × (ULN) or \< 45 mL/min, calculated using CKD-EPI formula
Hepatic impairment:
a. , (AST) and/or alanine aminotransferase (ALT) ≥ 2 × ULN
Diseases (e.g., asthma, psoriasis) that require treatment with immunosuppressive biological drugs or systemic during the study
One or more signs of depressed immune system function in the patient:
Presence of the following infections in a patient:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During the Main Period, the patients receive their first infusion of ocrelizumab (RPH-035) at a dose of 300 mg, followed by another 300 mg of the drug product after 2 weeks. The duration of ocrelizumab administration is 2.5 hours ± 15 minutes. The third infusion at a dose of 600 mg is administered 6 months after the first infusion of the initial dose During the After-Therapy Period, patients will receive an IV infusion of 600 mg of ocrelizumab (RPH-035) at weeks 49, 73, and 97 Premedication is mandatory and is carried out according to the following scheme: * methylprednisolone at a dose of 100 mg (or dexamethasone at a dose of 18.8 mg, or an equivalent drug product) intravenously 30 ± 10 minutes before the start of each infusion * antihistamine drug (e.g., diphenhydramine, suprastin, or an equivalent drug product) 30-60 minutes before the start of each infusion * antipyretic drug (e.g., paracetamol) 30-60 minutes before the start of each infusion
Drug: RPH-035
During the Main Period, the patients receive their first infusion of ocrelizumab (Ocrevus®) at a dose of 300 mg, followed by another 300 mg of the drug product after 2 weeks. The duration of ocrelizumab administration is 2.5 hours ± 15 minutes. The third infusion at a dose of 600 mg is administered 6 months after the first infusion of the initial dose Premedication is mandatory and is carried out according to the following scheme: * methylprednisolone at a dose of 100 mg (or dexamethasone at a dose of 18.8 mg, or an equivalent drug product) intravenously 30 ± 10 minutes before the start of each infusion * antihistamine drug (e.g., diphenhydramine, suprastin, or an equivalent drug product) 30-60 minutes before the start of each infusion * antipyretic drug (e.g., paracetamol) 30-60 minutes before the start of each infusion
Drug: Ocrevus®
300 mg/10 mL (30 mg/mL) concentrate for solution for infusions in a single-dose vial For the 1st and 2nd infusions, 300 mg (10 mL) of ocrelizumab is diluted in 0.9% sodium chloride to a final concentration of approximately 1.2 mg/mL. For the 3rd infusion, 600 mg (20 mL) of ocrelizumab is diluted in 0.9% sodium chloride to a final concentration of approximately 1.2 mg/mL
Also known as: ocrelizumab, L04785
300 mg/10 mL (30 mg/mL) concentrate for solution for infusions in a single-dose vial For the 1st and 2nd infusions, 300 mg (10 mL) of ocrelizumab is diluted in 0.9% sodium chloride to a final concentration of approximately 1.2 mg/mL. For the 3rd infusion, 600 mg (20 mL) of ocrelizumab is diluted in 0.9% sodium chloride to a final concentration of approximately 1.2 mg/mL
Also known as: ocrelizumab
The area under the concentration-time pharmacokinetic curve (AUC (14-169 days)) of ocrelizumab
The area under the concentration-time pharmacokinetic curve of ocrelizumab after the second (single) administration, truncated at Day 169 (AUC (14-169 days))
Time frame: Day 14 to Day 169
The area under the concentration-time pharmacokinetic curve (AUC (0-14 days)) of ocrelizumab
The area under the concentration-time pharmacokinetic curve of ocrelizumab after the first (single) IV administration, truncated at Day 14 (AUC (0-14 days))
Time frame: Up to Day 14
Maximum serum concentration of ocrelizumab after the first administration (Cmax (0-14 days))
Maximum serum concentration of ocrelizumab after the first administration (Cmax (0-14 days))
Time frame: Up to Day 14
Maximum serum concentration of ocrelizumab after the second administration (Cmax (14-169 days))
Maximum serum concentration of ocrelizumab after the second administration (Cmax (14-169 days))
Time frame: Day 14 to Day 169
Percentage of patients with adverse reactions (ARs) of any severity
Adverse reactions (ARs) are all unfavourable and unintended reactions to the drug products associated with their administration in any dose, the causal relationship between their administration and adverse events (AEs) is at least possible, meaning that such a relationship cannot be excluded
Time frame: Up to Day 337
Percentage of patients with adverse events (AEs) of any severity
An adverse event (AE) is any event observed in a clinical trial subject after the drug product administration, which is unfavourable from a medical point of view and may not have a causal relationship with its administration
Time frame: Up to Day 337
Percentage of patients with AEs of severity grade ≥ 3
Percentage of patients with AEs of severity grade ≥ 3 per CTCAE 5.0
Time frame: Up to Day 337
Percentage of patients with ARs of severity grade ≥ 3
Percentage of patients with ARs of severity grade ≥ 3 per CTCAE 5.0
Time frame: Up to Day 337
Percentage of patients with serious adverse events (SAEs)
A serious adverse event (SAE) is any unfavourable medical event that, regardless of the drug product dose: * leads to death * poses a threat to life * requires hospitalisation or its prolongation * leads to persistent or severe disability/incapacitation * is a congenital abnormality or developmental defect * requires medical intervention to prevent the development of the conditions listed above
Time frame: Up to Day 337
Percentage of patients with serious adverse reactions (SARs)
A serious adverse reaction (SAR) is an adverse reaction that is characterised by the criteria of seriousness: * leads to death * poses a threat to life * requires hospitalisation or its prolongation * leads to persistent or severe disability/incapacitation * is a congenital abnormality or developmental defect * requires medical intervention to prevent the development of the conditions listed above
Time frame: Up to day 337
Percentage of patients who required discontinuation of therapy due to adverse events/adverse reactions (AEs/ARs)
Percentage of patients who required discontinuation of therapy due to AEs/ARs
Time frame: Up to Day 337
Binding anti-drug antibodies (ADA) to ocrelizumab over a period of up to 24 weeks from the start of the therapy
Binding anti-drug antibodies (ADA) to ocrelizumab are assessed on Day 1 (pre-dose), 57, 113, 169 (pre-dose)
Time frame: Up to Day 169
Binding anti-drug antibodies (ADA) to ocrelizumab over a period of up to 48 weeks from the start of the therapy
Binding anti-drug antibodies (ADA) to ocrelizumab are assessed on Day 1 (pre-dose), 57, 113, 169 (pre-dose), 225, 281, 337 (pre-dose)
Time frame: Up to Day 337
Neutralizing antibodies (nAB) to ocrelizumab over a period of up to 24 weeks from the start of therapy
Neutralizing antibodies (nAB) to ocrelizumab are assessed on Day 1 (pre-dose), 57, 113, 169 (pre-dose)
Time frame: Up to Day 169
Neutralizing antibodies (nAB) to ocrelizumab over a period of up to 48 weeks from the start of therapy
Neutralizing antibodies (nAB) to ocrelizumab are assessed on Day 1 (pre-dose), 57, 113, 169 (pre-dose), 225, 281, 337 (pre-dose)
Time frame: Up to Day 337
Time to reach the maximum ocrelizumab concentration in serum after the first administration (Tmax (0-14 days))
Time to reach the maximum ocrelizumab concentration in serum after the first administration (Tmax (0-14 days))
Time frame: Up to Day 14
Elimination half-life of ocrelizumab after the first administration (T1/2 (0-14 days))
Elimination half-life of ocrelizumab after the first administration (T1/2 (0-14 days))
Time frame: Up to Day 14
Volume of distribution of ocrelizumab after the first administration (Vd (0-14 days))
Volume of distribution of ocrelizumab after the first administration (Vd (0-14 days))
Time frame: Up to Day 14
Elimination rate constant of ocrelizumab after the first administration (Kel (0-14 days))
Elimination rate constant of ocrelizumab after the first administration (Kel (0-14 days))
Time frame: Up to Day 14
Time to reach the maximum serum concentration of ocrelizumab after the second administration (Tmax (14-169d))
Time to reach the maximum serum concentration of ocrelizumab after the second administration (Tmax (14-169d))
Time frame: Day 14 to Day 169
Elimination half-life of ocrelizumab after the second administration (T1/2 (14-169d))
Elimination half-life of ocrelizumab after the second administration (T1/2 (14-169d))
Time frame: Day 14 to Day 169
Volume of distribution of ocrelizumab after the second administration (Vd (14-169d))
Volume of distribution of ocrelizumab after the second administration (Vd (14-169d))
Time frame: Day 14 to Day 169
Elimination rate constant of ocrelizumab after the second administration (Kel (14-169d))
Elimination rate constant of ocrelizumab after the second administration (Kel (14-169d))
Time frame: Day 14 to Day 169
Area under the pharmacokinetic curve "concentration-time" (AUC(0-∞)) of ocrelizumab
Area under the pharmacokinetic "concentration-time" curve of ocrelizumab after the second administration, truncated at the point from zero to infinity (AUC(0-∞))
Time frame: Up to Day 169
The average value of the absolute and relative number of CD19+ B-lymphocytes for a period of up to 2 weeks from the start of the therapy inclusively
The average value of the absolute and relative number of CD19+ B-lymphocytes for a period of up to 2 weeks from the start of the therapy inclusively
Time frame: Up to Day 14
The average value of the absolute and relative number of CD19+ B-lymphocytes for a period of up to 24 weeks from the start of the therapy inclusively
The average value of the absolute and relative number of CD19+ B-lymphocytes for a period of up to 24 weeks from the start of the therapy inclusively
Time frame: Up to Day 169
The average value of the absolute and relative number of CD19+ B-lymphocytes for a period of up to 48 weeks from the start of the therapy inclusively
The average value of the absolute and relative number of CD19+ B-lymphocytes for a period of up to 48 weeks from the start of the therapy inclusively
Time frame: Up to Day 337
Average incidence of MS exacerbations for a period of up to 24 weeks from the start of the therapy inclusively
Disease exacerbation is considered to be subjective symptoms (reported by the patient) and/or (detected during a neurological examination) objective symptoms characteristic of an acute inflammatory demyelinating (focal or multifocal) process in the central nervous system, either in the form of an aggravation of existing neurological symptoms or in the form of the appearance of new not observed previously neurological symptoms, with an acute or, more often, subacute onset, with complete or incomplete regression of symptoms. The deviation must be present for ≥ 24 hours and must be not associated with concomitant clinical factors (e.g., fever, infection, trauma, drug-related adverse reactions)
Time frame: Up to Day 169
The number of combined lesions for a period of up to 24 weeks from the start of the therapy inclusively
The number of combined lesions assessed at baseline and on Days 57, 113, 169 of the Main Period The number of combined lesions defined as the total number of new contrast-enhancing lesions in T1-WI and new lesions in T2-WI or enlarging lesions in T2-WI, without double addition
Time frame: Up to Day 169
The number of new Gd+ lesions on T1-WI for a period of up to 24 weeks from the start of the therapy inclusively
The number of new Gd+ lesions on T1-WI assessed at baseline and on Days 57, 113, 169 of the Main Period
Time frame: Up to Day 169
The number of new or enlarging hyperintense lesions on T2-weighted images for a period of up to 24 weeks from the start of the therapy
The number of new or enlarging hyperintense lesions on T2-weighted images assessed at baseline and on Days 57, 113, 169 of the Main Period
Time frame: Up to Day 169
Percentage of patients with new or enlarging hyperintense lesions on T2-WI for a period of up to 24 weeks from the start of the therapy
New or enlarging hyperintense lesions on T2-WI are assessed at baseline and on Days 57, 113, 169 of the Main Period
Time frame: Up to Day 169
The number of new hypointense lesions on T1-WI for a period of up to 24 weeks from the start of the therapy inclusively
The number of new hypointense lesions on T1-WI assessed at baseline and on days 57, 113, 169 of the Main Period
Time frame: Up to Day 169
Change in EDSS score after 24 weeks of the therapy inclusively compared to values obtained at screening
The EDSS scale is a rating system with a range from 0 (normal neurological status) to 10 (death due to MS) in 0.5-point increments
Time frame: Baseline, Day 169
Annualized rate of MS exacerbations for a period of up to 48 weeks from the start of the therapy inclusively
Disease exacerbation is considered to be subjective symptoms (reported by the patient) and/or (detected during a neurological examination) objective symptoms characteristic of an acute inflammatory demyelinating (focal or multifocal) process in the central nervous system, either in the form of an aggravation of existing neurological symptoms or in the form of the appearance of new not observed previously neurological symptoms, with an acute or, more often, subacute onset, with complete or incomplete regression of symptoms. The deviation must be present for ≥ 24 hours and must be not associated with concomitant clinical factors (e.g., fever, infection, trauma, drug-related adverse reactions).
Time frame: Up to Day 337
The number of combined lesions for a period of up to 48 weeks from the start of the therapy inclusively
The number of combined lesions assessed at baseline and on Days 57, 113, 169, 337 of the Main Period The number of combined lesions defined as the total number of new contrast-enhancing lesions in T1-WI and new lesions in T2-WI or enlarging lesions in T2-WI, without double addition
Time frame: Up to Day 337
The number of new Gd+ lesions on T1-WI for a period of up to 48 weeks from the start of the therapy inclusively
The number of new Gd+ lesions on T1-WI assessed at baseline and on Days 57, 113, 169, 337 of the Main Period
Time frame: Up to Day 337
The number of new or enlarging hyperintense lesions on T2-weighted images for a period of up to 48 weeks from the start of the therapy
The number of new or enlarging hyperintense lesions on T2-weighted images assessed at baseline and on Days 57, 113, 169, 337 of the Main Period
Time frame: Up to Day 337
Percentage of patients with new or enlarging hyperintense lesions on T2-WI for a period of up to 48 weeks from the start of the therapy
New or enlarging hyperintense lesions on T2-WI are assessed at baseline and on Days 57, 113, 169, 337 of the Main Period
Time frame: Up to Day 337
The number of new hypointense lesions on T1-WI for a period of up to 48 weeks from the start of the therapy inclusively
The number of new hypointense lesions on T1-WI assessed at baseline and on Days 57, 113, 169, 337 of the Main Period
Time frame: Up to Day 337
Change in EDSS score after 48 weeks of the therapy inclusively compared to values obtained at screening
The EDSS scale is a rating system with a range from 0 (normal neurological status) to 10 (death due to MS) in 0.5-point increments
Time frame: Up to Day 337
Percentage of patients with confirmed disability progression according to the EDSS scale after 48 weeks of the therapy inclusively compared with the values obtained at screening
Confirmed disability progression is considered to be a persistent increase in neurological abnormality according to the EDSS scale compared to the baseline, beyond the period of exacerbations and not associated with a previous exacerbation. Confirmed disability progression is defined as a patient's EDSS score maintaining or increasing compared to the date of the first recorded increase in neurological impairment for at least 6 months, provided there have been no exacerbations during the measurement period. A significant neurological disorders increase is EDSS ≥ 1.5 points with an initial EDSS score of 0, EDSS ≥ 1.0 points for patients with an initial EDSS of 1.0-5.5 points, or EDSS ≥ 0.5 points for patients with EDSS ≥ 6.0 at baseline
Time frame: Baseline, Day 337
Percentage of patients with confirmed disability reduction according to the EDSS scale after 48 weeks of the therapy inclusively compared with the values obtained at screening
A confirmed disability reduction is defined as a sustained reduction in neurological abnormality as measured by the EDSS compared to the baseline EDSS score. A confirmed reduction is scored when a patient's EDSS score reduction, compared to the first recorded reduction in neurological abnormality, is maintained for 6 months. A reduction in neurological abnormality is defined as a decrease in EDSS by 1.0 point compared to the baseline score.
Time frame: Baseline, Day 337
Change in the quality of life assessment score for the "Physical component of health" after 24 weeks of the therapy inclusively
Change in the quality of life assessment score for the "Physical component of health" parameter according to the SF-36 questionnaire after 24 weeks of the therapy inclusively compared with the values obtained at screening. The SF-36 consists of 36 questions grouped into eight scales: physical functioning, role functioning, physical pain, general health (assesses the patient's physical well-being), and viability, social functioning, emotional state, and mental health (assesses psychological state). The scores on each scale range from 0 to 100 points, where 100 corresponds to complete health. The processing of the research results is presented in the form of point assessments with a maximum score of 100. The higher the score, the higher the quality of life
Time frame: Day 1, Day 169
Change in the quality of life assessment score for the and "Mental component of health" parameter after 24 weeks of the therapy inclusively
Change in the quality of life assessment score for the and "Mental component of health" parameter according to the SF-36 questionnaire after 24 weeks of the therapy inclusively compared with the values obtained at screening. The SF-36 consists of 36 questions grouped into eight scales: physical functioning, role functioning, physical pain, general health (assesses the patient's physical well-being), and viability, social functioning, emotional state, and mental health (assesses psychological state). The scores on each scale range from 0 to 100 points, where 100 corresponds to complete health. The processing of the research results is presented in the form of point assessments with a maximum score of 100. The higher the score, the higher the quality of life
Time frame: Day 1, Day 169
Change in the quality of life assessment score for the "Physical component of health" parameter after 48 weeks of the therapy inclusively
Change in the quality of life assessment score for the "Physical component of health" parameter according to the SF-36 questionnaire after 48 weeks of the therapy inclusively compared with the values obtained at screening. The SF-36 consists of 36 questions grouped into eight scales: physical functioning, role functioning, physical pain, general health (assesses the patient's physical well-being), and viability, social functioning, emotional state, and mental health (assesses psychological state). The scores on each scale range from 0 to 100 points, where 100 corresponds to complete health. The processing of the research results is presented in the form of point assessments with a maximum score of 100. The higher the score, the higher the quality of life
Time frame: Day 1, Day 337
Change in the quality of life assessment score for the "Mental component of health" parameter after 48 weeks of the therapy inclusively
Change in the quality of life assessment score for the "Mental component of health" parameter according to the SF-36 questionnaire after 48 weeks of the therapy inclusively compared with the values obtained at screening. The SF-36 consists of 36 questions grouped into eight scales: physical functioning, role functioning, physical pain, general health (assesses the patient's physical well-being), and viability, social functioning, emotional state, and mental health (assesses psychological state). The scores on each scale range from 0 to 100 points, where 100 corresponds to complete health. The processing of the research results is presented in the form of point assessments with a maximum score of 100. The higher the score, the higher the quality of life
Time frame: Day 1, Day 337
Ran from Apr 2025 to primary completion in Jun 2026, 13 months.
Of 38 industry-sponsored phase 1 interventional studies under Multiple Sclerosis, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 32. This study's 13 months is close to that.
Counting every sponsor, half of 91 studies reached it within 30 months; a quarter within 9 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ocrelizumab