BEYOND Pilot Study

NCT ID: NCT00893217

Last Updated: 2009-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2003-06-30

Brief Summary

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

Conditions

Multiple Sclerosis; Relapsing-Remitting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Group Type: ACTIVE_COMPARATOR

Betaseron (Interferon beta-1b, BAY86-5046)

Intervention Type: DRUG

250 mcg

Arm 2

Group Type: EXPERIMENTAL

Betaseron (Interferon beta-1b, BAY86-5046)

Intervention Type: DRUG

500 mcg

Interventions

Betaseron (Interferon beta-1b, BAY86-5046)

250 mcg

Intervention Type: DRUG

Betaseron (Interferon beta-1b, BAY86-5046)

500 mcg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Healthcare Pharmaceuticals Inc.

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Los Angeles, California, United States

Washington D.C., District of Columbia, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Kansas City, Kansas, United States

Louisville, Kentucky, United States

Ann Arbor, Michigan, United States

Reno, Nevada, United States

Stony Brook, New York, United States

Durham, North Carolina, United States

High Point, North Carolina, United States

Winston-Salem, North Carolina, United States

Columbus, Ohio, United States

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

BEYOND pilot

Identifier Type: -

Identifier Source: secondary_id

307000

Identifier Type: -

Identifier Source: secondary_id

91232

Identifier Type: -

Identifier Source: org_study_id