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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab

Study Purpose

This study will evaluate the pharmacokinetics of ocrelizumab in the breastmilk of lactating women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] treated with ocrelizumab, by assessing the concentration of ocrelizumab in mature breastmilk, as well as the corresponding exposure and pharmacodynamic effects (blood B cell levels) in the infants.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 40 Years
Gender Female
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Woman is between 18 and 40 years of age at screening.
  • - Woman is willing to breastfeed for at least 60 days after the first post-partum ocrelizumab infusion (this decision is to be taken prior to and independent from study participation) - Woman is willing to provide breastmilk samples.
  • - Woman has a diagnosis of MS or CIS (in line with the locally approved indications) - Woman has delivered a healthy term singleton infant (≥37 weeks gestation) - Infant is between 2-24 weeks of age at the time of the mother's first post-partum dose of ocrelizumab.
  • - For women who received commercial ocrelizumab (OCREVUS) before enrolment: documentation that last exposure to ocrelizumab occurred more than 3 months before the last menstrual period (LMP) and was given at the approved dose of 2 x 300 mg or 1 x 600 mg.
  • - Woman agrees to use acceptable contraceptive methods during the study.
Exclusion Criteria related to the Mother:
  • - Hypersensitivity to ocrelizumab or to any of its excipients.
  • - Received last dose of ocrelizumab <3 months before the LMP or during pregnancy.
  • - Active infections (may be included once the infection is treated and is resolved; women with bilateral mastitis infection should not have samples collected until the infection is completely resolved) - Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state.
  • - Known active malignancies, or being actively monitored for recurrence of malignancy.
  • - History of breast implants, breast augmentation, breast reduction surgery or mastectomy.
  • - Prior or current history of chronic alcohol abuse or drug abuse.
  • - Positive screening tests for hepatitis B.
  • - Treatment with a DMT for CIS or MS during pregnancy and/or first weeks post-partum, with the exception of formulations of interferon-beta, glatiramer acetate or pulsed corticosteroids.
  • - Treatment with drugs known to transfer to the breastmilk and with established or potential deleterious effects for the infant.
  • - Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the LMP.
Exclusion Criteria related to the Infant:
  • - >24 weeks of life at the time of the mother's first dose of ocrelizumab.
  • - Any abnormality that may interfere with breastfeeding or milk absorption.
  • - Active infection (may be included once the infection resolves) - Infant has any other medical condition or abnormality that, in the opinion of the investigator, could compromise the infant's ability to participate in this study, including interference with the interpretation of study results.
- At least one documented brief resolved unexplained event (BRUE), as defined by the 2016 Guidelines of the American Academy of Pediatrics

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04998851
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries Germany, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis, Clinically Isolated Syndrome
Arms & Interventions

Arms

Experimental: Women with CIS or MS

Lactating women with CIS or MS (in line with the locally approved indications) who decided together with their treating physician to continue on, or start treatment with, OCREVUS (ocrelizumab) post-partum. Women resuming treatment with ocrelizumab post-partum will be included only if the last exposure to ocrelizumab occurred more than 3 months before the last menstrual period to exclude any interference between fetal exposure and exposure via lactation.

Interventions

Drug: - Ocrelizumab

Women will receive the ocrelizumab dose regimen as per the locally-approved label. The ocrelizumab dose will be administered as an initial split dose of two 300 mg infusions separated by 14 days or a single 600 mg infusion according to the local prescribing information.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94117

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

University Of Colorado, Aurora, Colorado

Status

Recruiting

Address

University Of Colorado

Aurora, Colorado, 80045

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Northwestern Memorial Hospital, Chicago, Illinois

Status

Recruiting

Address

Northwestern Memorial Hospital

Chicago, Illinois, 60611

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Brigham and Womens Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Womens Hospital

Boston, Massachusetts, 02115

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Owosso, Michigan

Status

Recruiting

Address

Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

Owosso, Michigan, 48867

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Philadelphia, Pennsylvania

Status

Recruiting

Address

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

International Sites

St. Josef Hospital GmbH, Bochum, Germany

Status

Recruiting

Address

St. Josef Hospital GmbH

Bochum, , 44791

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Dresden, Germany

Status

Recruiting

Address

Universitaetsklinikum Carl Gustav Carus an der TU Dresden

Dresden, , 01307

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Hosp. Clinico San Carlos, Madrid, Spain

Status

Recruiting

Address

Hosp. Clinico San Carlos

Madrid, , 28040

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Queen Mary University of London, London, United Kingdom

Status

Recruiting

Address

Queen Mary University of London

London, , EC1M 6BQ

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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