BEYOND Pilot Study

November 6, 2009 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 2
Drug: Betaseron (Interferon beta-1b, BAY86-5046)
250 mcg
Drug: Betaseron (Interferon beta-1b, BAY86-5046)
500 mcg
Active Comparator: Arm 1
Drug: Betaseron (Interferon beta-1b, BAY86-5046)
250 mcg
Drug: Betaseron (Interferon beta-1b, BAY86-5046)
500 mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

May 4, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

November 9, 2009

Last Update Submitted That Met QC Criteria

November 6, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91232
  • BEYOND pilot
  • 307000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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