Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00235989
First received: October 10, 2005
Last updated: June 1, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Drug: Interferon beta 1b (Betaseron, BAY86-5046) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]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).
| Enrollment: | 63 |
| Study Start Date: | June 2003 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ET: IFNB-1b 250 mcg => 250 mcg
Extension Treatment 250 mcg continued
|
Drug: Interferon beta 1b (Betaseron, BAY86-5046)
250 mcg administered s.c.(subcutaneous) every other day
Other Name: Betaferon
|
|
Experimental: ET: IFNB-1b 500 mcg => 250 mcg
Extension Treatment 500 mcg reduced to 250 mcg
|
Drug: Interferon beta 1b (Betaseron, BAY86-5046)
250 mcg administered s.c. every other day (for patients having received 500 mcg before)
Other Name: Betaferon
|
|
Experimental: ET: IFNB-1b 500 mcg => 500 mcg
Extension Treatment 500 mcg continued
|
Drug: Interferon beta 1b (Betaseron, BAY86-5046)
500 mcg administered s.c. every other day
Other Name: Betaferon
|
|
Experimental: ET: IFNB-1b 250 mcg => 500 mcg
Extension Treatment 250 mcg increased to 500 mcg
|
Drug: Interferon beta 1b (Betaseron, BAY86-5046)
500 mcg administered s.c. every other day (for patients having received 250 mcg before)
Other Name: Betaferon
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed and dated statement of informed consent
- Completion of Protocol 307000A
- Negative serum pregnancy test results
- Agreement to adequate contraception, for female patients
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235989
Locations
| United States, California | |
| Los Angeles, California, United States, 90095-1721 | |
| San Francisco, California, United States, 94117 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30309-1465 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60637 | |
| United States, Kansas | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Ann Arbor, Michigan, United States, 48109-0022 | |
| United States, Nevada | |
| Reno, Nevada, United States, 89509 | |
| United States, New York | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Durham, North Carolina, United States, 27710 | |
| High Point, North Carolina, United States, 27262 | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Columbus, Ohio, United States, 43221 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37232 | |
| Nashville, Tennessee, United States, 37212 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00235989 History of Changes |
| Other Study ID Numbers: | 91272, 307320, Beyond |
| Study First Received: | October 10, 2005 |
| Results First Received: | January 30, 2009 |
| Last Updated: | June 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Relapsing multiple sclerosis interferon beta 1b Betaferon Betaseron |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Interferon-beta |
Interferons Interferon beta-1b Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 16, 2013