BEYOND Pilot Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00893217
First received: May 4, 2009
Last updated: November 6, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis
Relapsing-Remitting
Drug: Betaseron (Interferon beta-1b, BAY86-5046)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Parallel Group, Multicenter Study of the Safety and Tolerability of Betaseron 500 Mcg Subcutaneously Every Other Day and Betaseron 250 Mcg Subcutaneously Every Other Day for at Least 12 Weeks in Patients With RRMS

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of IFNB-1b 500 mcg given subcutaneously (SC) QOD compared with the standard dose of 250 mcg QOD in patients with RRMS. [ Time Frame: 8 Months ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: November 2002
Study Completion Date: June 2003
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: Betaseron (Interferon beta-1b, BAY86-5046)
250 mcg
Experimental: Arm 2 Drug: Betaseron (Interferon beta-1b, BAY86-5046)
500 mcg

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893217

Locations
United States, California
Los Angeles, California, United States, 90095
United States, District of Columbia
Washington, District of Columbia, United States, 20037
United States, Georgia
Atlanta, Georgia, United States, 30309-1465
United States, Illinois
Chicago, Illinois, United States, 60637-1470
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
Louisville, Kentucky, United States, 40205
United States, Michigan
Ann Arbor, Michigan, United States, 48109-0330
United States, Nevada
Reno, Nevada, United States, 89557-0035
United States, New York
Stony Brook, New York, United States, 11794
United States, North Carolina
Durham, North Carolina, United States, 27710
High Point, North Carolina, United States, 27262
Winston-Salem, North Carolina, United States, 27157-1009
United States, Ohio
Columbus, Ohio, United States, 43210-1240
United States, Tennessee
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00893217     History of Changes
Other Study ID Numbers: 91232, BEYOND pilot, 307000
Study First Received: May 4, 2009
Last Updated: November 6, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta-1b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on August 01, 2014