Multiple SclerosisPhase 2NCT00893217
BEYOND Pilot Study
A Phase 2 study testing Betaseron (Interferon beta-1b, BAY86-5046) in people with Multiple Sclerosis and Relapsing-Remitting, run by Bayer at 14 sites in United States.
Trial summary
The purpose of this study is to valuate safety and tolerability of Betaseron. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Betaseron (Interferon beta-1b, BAY86-5046)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 14 sitesUnited States
- Study dates
- Nov 2002to Jun 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Study site
Ann Arbor, Michigan, 48109-0330
Study site
Atlanta, Georgia, 30309-1465
Study site
Chicago, Illinois, 60637-1470
Study site
Columbus, Ohio, 43210-1240
Study site
Durham, North Carolina, 27710
Study site
High Point, North Carolina, 27262
Study site
Kansas City, Kansas, 66160
Study site
Los Angeles, California, 90095
Study site
Louisville, Kentucky, 40205
Study site
Nashville, Tennessee, 37232
Study site
Reno, Nevada, 89557-0035
Study site
Stony Brook, New York, 11794
Study site
Washington D.C., District of Columbia, 20037
Study site
Winston-Salem, North Carolina, 27157-1009
About this study
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
The purpose of this study is to valuate safety and tolerability of Betaseron.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Betaseron (Interferon beta-1b, BAY86-5046)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betaseron (Interferon beta-1b, BAY86-5046)Drug
250 mcg
Betaseron (Interferon beta-1b, BAY86-5046)Drug
500 mcg
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: Betaseron (Interferon beta-1b, BAY86-5046) |
| Arm 2 | Experimental | Not described Receives: Drug: Betaseron (Interferon beta-1b, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startNov 2002
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893217
- Sponsor's protocol ID
- 91232
- Other IDs
- BEYOND pilot, 307000
- Status last verified
- Nov 2009
- First submitted
- 4 May 2009
- Last updated
- 9 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00893217
- Acronym / sponsor ID
- 91232
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Jun 2003 (actual)
- First posted
- 5 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to valuate safety and tolerability of Betaseron.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Betaseron (Interferon beta-1b, BAY86-5046) |
| Arm 2 | Experimental | Drug: Betaseron (Interferon beta-1b, BAY86-5046) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (23 listed)
- 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:
- renal dysfunction: creatinine >1.8 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betaseron (Interferon beta-1b, BAY86-5046)250 mcg | Drug | Arm 1 |
| Betaseron (Interferon beta-1b, BAY86-5046)500 mcg | Drug | Arm 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Betaseron (Interferon beta-1b, BAY86-5046) in people with Multiple Sclerosis and Relapsing-Remitting, run by Bayer at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2009; AzTrials last refreshed its copy on 29 Oct 2026.