Multiple Sclerosis, Relapsing-RemittingPhase 2NCT00235989

Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis

A Phase 2 study testing Interferon beta 1b (Betaseron, BAY86-5046) in people with Multiple Sclerosis, Relapsing-Remitting, run by Bayer at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis. 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?: Interferon beta 1b (Betaseron, BAY86-5046)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 17 sitesUnited States
Study dates: Jun 2003to Jan 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Signed and dated statement of informed consent
Completion of Protocol 307000A
Negative serum pregnancy test results
Agreement to adequate contraception, for female patients

Who cannot join

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
Any significant change in the patient's medical condition after enrollment in Study 307000A which would have lead to his/her exclusion from participation that study

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Study site
Ann Arbor, Michigan, 48109-0022
Study site
Ann Arbor, Michigan, 48109
Study site
Atlanta, Georgia, 30309-1465
Study site
Chicago, Illinois, 60637
Study site
Columbus, Ohio, 43221
Study site
Durham, North Carolina, 27710
Study site
High Point, North Carolina, 27262
Study site
Kansas City, Kansas, 66160
Study site
Los Angeles, California, 90095-1721
Study site
Louisville, Kentucky, 40202
Study site
Nashville, Tennessee, 37212
Study site
Nashville, Tennessee, 37232
Study site
Reno, Nevada, 89509
Study site
San Francisco, California, 94117
Study site
Stony Brook, New York, 11794
Study site
Washington D.C., District of Columbia, 20037
Study site
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: An Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)

The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.

Read the detailed description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Conditions: Multiple Sclerosis, Relapsing-Remitting
Being tested: Interferon beta 1b (Betaseron, BAY86-5046)
Keywords: Relapsing multiple sclerosis, interferon beta 1b, Betaferon, Betaseron
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interferon beta 1b (Betaseron, BAY86-5046)Drug
Also called Betaferon
250 mcg administered s.c.(subcutaneous) every other day
Interferon beta 1b (Betaseron, BAY86-5046)Drug
Also called Betaferon
250 mcg administered s.c. every other day (for patients having received 500 mcg before)
Interferon beta 1b (Betaseron, BAY86-5046)Drug
Also called Betaferon
500 mcg administered s.c. every other day
Interferon beta 1b (Betaseron, BAY86-5046)Drug
Also called Betaferon
500 mcg administered s.c. every other day (for patients having received 250 mcg before)

Study groups in NCT00235989
Study group	Role	What they receive
ET: IFNB-1b 250 mcg => 250 mcg	Active comparator	Extension Treatment 250 mcg continued Receives: Drug: Interferon beta 1b (Betaseron, BAY86-5046)
ET: IFNB-1b 500 mcg => 250 mcg	Experimental	Extension Treatment 500 mcg reduced to 250 mcg Receives: Drug: Interferon beta 1b (Betaseron, BAY86-5046)
ET: IFNB-1b 500 mcg => 500 mcg	Experimental	Extension Treatment 500 mcg continued Receives: Drug: Interferon beta 1b (Betaseron, BAY86-5046)
ET: IFNB-1b 250 mcg => 500 mcg	Experimental	Extension Treatment 250 mcg increased to 500 mcg Receives: Drug: Interferon beta 1b (Betaseron, BAY86-5046)

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities
Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests.
Measured: At End of Study Visit (week 234)

Secondary outcomes (1)

Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b
Serum samples for analysis of NAbs to interferon (IFN) beta-1b were collected in Study 307000A. In the extension study, NAbs were also monitored for information on persistence or resolution. Serum samples of about 6 mL for NAbs were drawn at Weeks 10, 24, 52, 78, 104 130, 156, 182, 208, 234, 260, 286 or the EOS visit. (NU/ml=neutralizing units/ml).
Measured: At End of Study Visit (week 234)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2003Jan 2008

First posted12 Oct 2005 (estimated)
Study startJun 2003
Primary completionJan 2008
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00235989
Sponsor's protocol ID: 91272
Other IDs: 307320, Beyond
Status last verified: Apr 2014
First submitted: 10 Oct 2005
Last updated: 8 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)
ClinicalTrials.gov ID: NCT00235989
Acronym / sponsor ID: 91272
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Relapsing multiple sclerosis, interferon beta 1b, Betaferon, Betaseron
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Jun 2003
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 12 Oct 2005 (estimated)
Results: Posted 3 Jul 2009

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 determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.

Detailed description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
ET: IFNB-1b 250 mcg => 250 mcg	Active comparator	Drug: Interferon beta 1b (Betaseron, BAY86-5046)Extension Treatment 250 mcg continued
ET: IFNB-1b 500 mcg => 250 mcg	Experimental	Drug: Interferon beta 1b (Betaseron, BAY86-5046)Extension Treatment 500 mcg reduced to 250 mcg
ET: IFNB-1b 500 mcg => 500 mcg	Experimental	Drug: Interferon beta 1b (Betaseron, BAY86-5046)Extension Treatment 500 mcg continued
ET: IFNB-1b 250 mcg => 500 mcg	Experimental	Drug: Interferon beta 1b (Betaseron, BAY86-5046)Extension Treatment 250 mcg increased to 500 mcg

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Signed and dated statement of informed consent
Completion of Protocol 307000A
Negative serum pregnancy test results
Agreement to adequate contraception, for female patients

Key exclusion criteria (5 listed)

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
Any significant change in the patient's medical condition after enrollment in Study 307000A which would have lead to his/her exclusion from participation that study

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
Interferon beta 1b (Betaseron, BAY86-5046)Also: Betaferon250 mcg administered s.c.(subcutaneous) every other day	Drug	ET: IFNB-1b 250 mcg => 250 mcg
Interferon beta 1b (Betaseron, BAY86-5046)Also: Betaferon250 mcg administered s.c. every other day (for patients having received 500 mcg before)	Drug	ET: IFNB-1b 500 mcg => 250 mcg
Interferon beta 1b (Betaseron, BAY86-5046)Also: Betaferon500 mcg administered s.c. every other day	Drug	ET: IFNB-1b 500 mcg => 500 mcg
Interferon beta 1b (Betaseron, BAY86-5046)Also: Betaferon500 mcg administered s.c. every other day (for patients having received 250 mcg before)	Drug	ET: IFNB-1b 250 mcg => 500 mcg

Primary outcome

Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities
Time frame: At End of Study Visit (week 234)
Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests.

1 secondary outcome

Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b
Time frame: At End of Study Visit (week 234)

Results and safety

Results posted to the registry on 3 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ET: IFNB-1b 250 mcg => 250 mcg	0	0
ET: IFNB-1b 500 mcg => 250 mcg	0	0
ET: IFNB-1b 500 mcg => 500 mcg	0	0
ET: IFNB-1b 250 mcg => 500 mcg	0	0
CT: IFNB-1b 250mcg	36	36
CT: IFNB-1b 500mcg	27	25

Primary outcome: Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities

Time frame: At End of Study Visit (week 234). Number. Unit: participants

Measure	ET: IFNB-1b 250 mcg => 250 mcg n = 16	ET: IFNB-1b 500 mcg => 250 mcg n = 6	ET: IFNB-1b 500 mcg => 500 mcg n = 19	ET: IFNB-1b 250 mcg => 500 mcg n = 20
Incidence of flu-like syndrome	1	1	4	7
Incidence of fever	1	0	1	0
Incidence of myalgia	0	0	1	0
Incidence of injection site reactions	2	3	4	3
Incidence of injection site reactions pain	0	0	1	0
Incidence of asthenia	4	1	2	3
Incidence of headache	2	0	2	3
Incidence of grade 1 toxicity (ALAT)	4	1	8	9

Population analysed: The statistical analysis was descriptive. For Liver Function Toxicity grading, the total number of patients for 250 micrograms (mcg) - 500 mcg group was 19 instead of 20 for all analyses.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ET: IFNB-1b 250 mcg => 250 mcg	2 of 16 (12.5%)	15 of 16 (93.8%)	Not reported
ET: IFNB-1b 500 mcg => 250 mcg	0 of 6 (0%)	6 of 6 (100%)	Not reported
ET: IFNB-1b 500 mcg => 500 mcg	9 of 19 (47.4%)	19 of 19 (100%)	Not reported
ET: IFNB-1b 250 mcg => 500 mcg	4 of 20 (20%)	20 of 20 (100%)	Not reported

Limitations and caveats (from the sponsor): The 40 patients in the NAb frequency summaries are the total number of patients with NAb titers at week 234. Official HARTS-to-MedDRA Mapping was used.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

17 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 Interferon beta 1b (Betaseron, BAY86-5046) in people with Multiple Sclerosis, Relapsing-Remitting, run by Bayer at 17 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 4 inclusion and 5 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

Yes. Results are posted in the registry (first posted 3 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities (time frame: At End of Study Visit (week 234)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00235989.

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 8 May 2014; AzTrials last refreshed its copy on 26 Oct 2026.