BEYOND Pilot Study
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
3 other identifiers
interventional
71
1 country
14
Brief Summary
The purpose of this study is to valuate safety and tolerability of Betaseron.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-sclerosis
Started Nov 2002
Shorter than P25 for phase_2 multiple-sclerosis
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 4, 2009
CompletedFirst Posted
Study publicly available on registry
May 5, 2009
CompletedNovember 9, 2009
November 1, 2009
May 4, 2009
November 6, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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.
8 Months
Study Arms (2)
Arm 1
ACTIVE COMPARATORArm 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (14)
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
Washington D.C., District of Columbia, 20037, United States
Unknown Facility
Atlanta, Georgia, 30309-1465, United States
Unknown Facility
Chicago, Illinois, 60637-1470, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Louisville, Kentucky, 40205, United States
Unknown Facility
Ann Arbor, Michigan, 48109-0330, United States
Unknown Facility
Reno, Nevada, 89557-0035, United States
Unknown Facility
Stony Brook, New York, 11794, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
High Point, North Carolina, 27262, United States
Unknown Facility
Winston-Salem, North Carolina, 27157-1009, United States
Unknown Facility
Columbus, Ohio, 43210-1240, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 4, 2009
First Posted
May 5, 2009
Study Start
November 1, 2002
Study Completion
June 1, 2003
Last Updated
November 9, 2009
Record last verified: 2009-11