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A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

Information source: Genentech, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: interferon beta-1a (Drug); methylprednisolone (Drug); ocrelizumab (Drug); placebo (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Genentech, Inc.

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Genentech, Inc.

Summary

This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with RRMS.

Clinical Details

Official title: Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain.

Secondary outcome:

Annualized protocol defined relapse rate

Proportion of patients who remain relapse-free

Change in total volume of T2 lesions on MRI scans of the brain

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Ability to provide written informed consent and to be compliant with the schedule of

protocol assessments

- Relapsing-remitting MS

- Ages 18-55 years inclusive

- For sexually active female and male patients of reproductive potential, use of

reliable means of contraception Exclusion Criteria:

- Secondary or primary progressive multiple sclerosis at screening

- Incompatibility with MRI

- Contra-indications to or intolerance of oral or i. v. corticosteroids

- Known presence of other neurologic disorders

- Pregnancy or lactation

- Lack of peripheral venous access

- History of severe allergic or anaphylactic reactions to humanized or murine

monoclonal antibodies

- Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic,

endocrine or gastrointestinal

- Congestive heart failure

- Known active bacterial, viral, fungal, mycobacterial infection or other infection or

any major episode of infection requiring hospitalization or treatment with i. v. antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening

- History or known presence of recurrent or chronic infection

- History of cancer, including solid tumors and hematological malignancies (except

basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved)

- History of alcohol or drug abuse within 24 weeks prior to randomization

- History of or currently active primary or secondary immunodeficiency

- History of coagulation disorders

- Treatment with any investigational agent within 4 weeks of screening

- Receipt of a live vaccine within 6 weeks prior to randomization

- Incompatibility with Avonex use

- Previous treatment with rituximab

- Previous treatment with lymphocyte-depleting therapies except mitoxantrone

- Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization

- Treatment with beta interferons, glatiramer acetate, i. v. immunoglobulin,

plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization

- Systemic corticosteroid therapy within 4 weeks prior to randomization

Locations and Contacts

Edegem 2650, Belgium

Sijsele-Damme 8340, Belgium

Sofia 1113, Bulgaria

Sofia 1142, Bulgaria

Sofia 1309, Bulgaria

Sofia 1407, Bulgaria

Sofia 1527, Bulgaria

Sofia 1606, Bulgaria

Ostrava 708 52, Czech Republic

Pardubice 532 03, Czech Republic

Prague 12808, Czech Republic

Praha 150 06, Czech Republic

Teplice 415 29, Czech Republic

Arhus 8000, Denmark

Helsinki 00290, Finland

Turku 20100, Finland

Bordeaux 33076, France

Bron 69677, France

Caen 14033, France

Clermont-Ferrand 63003, France

Montpellier 34295, France

Nimes 30029, France

Berlin 13088, Germany

Berlin 13347, Germany

Hamburg 20099, Germany

Hamburg 22083, Germany

Hamburg 22417, Germany

Hamburg 22291, Germany

Marburg 35039, Germany

Regensburg 93053, Germany

Siegen 57072, Germany

Tübingen 72076, Germany

Ulm 89081, Germany

Aguascalientes 20127, Mexico

Chihuahua 31205, Mexico

Chihuahua 31328, Mexico

Monterrey, Nuevo León 64060, Mexico

Breda 4818 CK, Netherlands

Bucuresti 020125, Romania

Targu Mures 540136, Romania

Ekaterinburg 620102, Russian Federation

Kazan 4420029, Russian Federation

Mosow 129128, Russian Federation

Nizhny Novgorod 603076, Russian Federation

Novosibirsk 630090, Russian Federation

Tyumen 625000, Russian Federation

Belgrade 11000, Serbia

NIS 18000, Serbia

Nova sad 21000, Serbia

Banska Bystrica 975 17, Slovakia

Bratislava 813 69, Slovakia

Kosice 041 66, Slovakia

Nitra 949 01, Slovakia

Spisska Nova Ves 05201, Slovakia

Barcelona 08035, Spain

Barcelona 08036, Spain

Madrid 28034, Spain

Malaga 29010, Spain

Sevilla 41009, Spain

Valencia 46026, Spain

Basel 4031, Switzerland

Kharkov 61068, Ukraine

Kyiv 03110, Ukraine

Propetrovsk 49027, Ukraine

Vinnytsya 21005, Ukraine

Liverpool L9 7LJ, United Kingdom

Newcastle Upon Tyne NE1 4LP, United Kingdom

Nottingham NG7 2UH, United Kingdom

Sheffield S10 2JF, United Kingdom

Phoenix, Arizona 85006, United States

Phoenix, Arizona 85013, United States

Vancouver, British Columbia V6T 2B5, Canada

Berkeley, California 94705, United States

San Francisco, California 94117, United States

Fort Collins, Colorado 80528, United States

Bradenton, Florida 34205, United States

Vero Beach, Florida 32960, United States

Atlanta, Georgia 30309, United States

Chicago, Illinois 60637, United States

Kansas City, Kansas 66160, United States

Roma, Lazio 00189, Italy

Milano, Lombardia 20132, Italy

Baltimore, Maryland 21205, United States

Farmington Hills, Michigan 48334, United States

Lebanon, New Hampshire 03756, United States

Albuquerque, New Mexico 87131, United States

New York, New York 10032, United States

Plainview, New York 11803, United States

Stony Brook, New York 11794, United States

Charlotte, North Carolina 28204, United States

Winston Salem, North Carolina 27103, United States

Cleveland, Ohio 44195, United States

Columbus, Ohio 43221, United States

Toronto, Ontario M5B 1W8, Canada

Tualatin, Oregon 97062, United States

Montreal, Quebec H3A 2B4, Canada

Nashville, Tennessee 37212, United States

Houston, Texas 77030, United States

Round Rock, Texas 78681, United States

San Antonio, Texas 78229, United States

Burlington, Vermont 05401, United States

Charlottesville, Virginia 22903, United States

Additional Information

Starting date: January 2008
Last updated: July 1, 2015

Page last updated: August 23, 2015

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