Trial Condition(s):

Multiple Sclerosis, Relapsing-Remitting

BEYOND pilot study

Bayer Identifier:

91232

ClinicalTrials.gov Identifier:

NCT00893217

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to valuate safety and tolerability of Betaseron.

Inclusion Criteria
Diagnosis of RRMS as defined by any of the following McDonald diagnostic criteria (McDonald et al 2001; see Appendix 16.1.1 [(Protocol Appendix 5]):
 - Two relapses and objective clinical evidence (history or present) of at least 2 lesions
 - Two relapses and objective clinical evidence (history or present) of 1 lesion; and dissemination in space, demonstrated by MRI (Barkhof/Tintoré criteria) or 2 MRI T2 lesions consistent with MS plus positive CSF
 - One relapse with objective clinical evidence (history or present) of at least 2 lesions, and dissemination in time, demonstrated signs of disease activity ( new Gd+ lesion or new T2 lesion) in an MRI scan at least 3 months after the onset of that clinical event
 - One relapse and objective clinical evidence (history or present) of 1 lesion, and dissemination in space, demonstrated by MRI (Barkhof/Tintoré criteria); or 2 MRI T2 lesions consistent with MS plus positive CSF, and dissemination in time, demonstrated by signs of disease activity (new Gd+ lesion or new T2 lesion) in an MRI scan at least 3 months after the onset of that clinical event
 -- 18 to 55 years of age
 -- Score of 0-5.5 on the Kurtzke Expanded Disability Status Scale' (EDSS; see Appendix 16.1.1 [Protocol Appendix 4])
 -- Naïve to immunomodulating therapies or previously treated with immunomodulating therapies other than any interferon (IFN) more than 30 days prior to the start of the study
 -- If female of child-bearing potential, agreement to practice adequate contraception methods (IUCD, condoms, oral contraceptives, or other adequate barrier contraception)
 -- Negative serum pregnancy test results
 -- Signed and dated statement of informed consent
Exclusion Criteria
- Clinically significant heart disease such as uncontrolled cardiac dysrhythmia, angina pectoris, cardiomyopathy, or congestive heart failure
 - History of severe depression, suicide attempts, or current suicidal ideations
 - Clinically significant liver, renal, and bone marrow dysfunction as defined by any of the following laboratory evaluations:
 - bone marrow dysfunction:
 -- Hb <8.5 g/dl
 -- WBC <2.5 x 109/L
 -- platelet count <125 x 109/L
 - renal dysfunction: creatinine >1.8 mg/dL
 - liver dysfunction:
 -- ASAT (SGOT) >3xupper limit of normal
 -- bilirubin >2x upper limit of normal
 - Epilepsy not adequately controlled by treatment
 - Any conditions that could interfere with the MRI or any other evaluation in the study
 - Known allergy to human proteins including albumin and IFN, or to mannitol or gadolinium
 - Participation in any clinical study within the past 30 days or use/intake of an investigational drug within the last 3 months prior to study entry
 - Prior treatment with monoclonal antibody therapy, cladribine or total lymphoid irradiation
 - Treatment with cytotoxic or immunosuppressive therapies (except systemic steroid or adrenocorticotropic hormone [ACTH]) within 6 months prior to study entry; or systemic steroid or ACTH within 1 month prior to study entry
 - Presence of monoclonal gammopathy
 - Inability to tolerate both NSAIDs and acetaminophen
 - Pregnancy or lactation
 - History of alcohol or drug abuse
 - Inability to administer subcutaneous injections either by self or by caregiver
 - Medical, psychiatric or other conditions that compromise the patient's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study

Trial Summary

Enrollment Goal
71
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Ohio State University Medical Center

Columbus, United States, 43210-1240

Status
Completed
 
Locations

University of Kansas Medical Center

Kansas City, United States, 66160

Status
Completed
 
Locations

University of Chicago Hospitals

Chicago, United States, 60637-1470

Status
Completed
 
Locations

Vanderbilt University Medical Center

Nashville, United States, 37232

Status
Completed
 
Locations

George Washington University

Washington, United States, 20037

Status
Completed
 
Locations

University of Michigan Health System

Ann Arbor, United States, 48109-0330

Status
Completed
 
Locations

Shepherd Center

Atlanta, United States, 30309-1465

Status
Completed
 
Locations

Louisville Neuroscience Research Center, LLC

Louisville, United States, 40205

Status
Completed
 
Locations

High Point Neurological Associates

High Point, United States, 27262

Status
Completed
 
Locations

University of Nevada-Reno

Reno, United States, 89557-0035

Status
Completed
 
Locations

SUNY at Stony Brook

Stony Brook, United States, 11794

Status
Completed
 
Locations

Wake Forest University Medical Center

Winston-Salem, United States, 27157-1009

Status
Completed
 
Locations

Duke University Medical Center

Durham, United States, 27710

Status
Completed
 
Locations

University of California, Los Angeles

Los Angeles, United States, 90095

Status
Completed
 

Trial Design