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.
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
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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
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