BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis - Full Text View

Purpose

The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).

Condition	Intervention	Phase
Relapsing-Remitting Multiple Sclerosis Multiple Sclerosis	Drug: BG00012 (dimethyl fumarate) Drug: Glatiramer Acetate Drug: Interferon beta 1a	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, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNβ) or Glatiramer Acetate (GA)

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Formic acid Dimethyl fumarate Interferon Glatiramer Interferon beta Interferon beta-1a Glatiramer acetate Avonex

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

Summary of Participants with Adverse Events [ Time Frame: Up to 34 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	108
Study Start Date:	May 2010
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Glatiramer Acetate and BG00012 (dimethyl fumarate) Participants have been taking a stable dose of glatiramer acetate for 12 months prior to the study, and remain on that dose throughout the study. BG00012 (dimethyl fumarate) is administered 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).	Drug: BG00012 (dimethyl fumarate) Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally. Other Names: Tecfidera DMF Drug: Glatiramer Acetate A stable dose of glatiramer acetate 20 mg daily by subcutaneous injection taken 12 months prior to study start and throughout the study. Biogen-Idec does not supply this intervention. Other Names: GA Copaxone
Experimental: Interferon beta 1a and BG00012 (dimethyl fumarate) Participants have been taking a stable dose of one of the interferon beta 1a products for 12 months prior to the study, and remain on that product and dose throughout the study. BG00012 (dimethyl fumarate) is administered 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).	Drug: BG00012 (dimethyl fumarate) Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally. Other Names: Tecfidera DMF Drug: Interferon beta 1a A stable dose of one of the following interferon beta 1a drugs: Avonex (30 μg by intramuscular injection), Betaseron (0.25 mg by subcutaneous injection), or Rebif (44 mcg by subcutaneous injection) taken in accordance with instructions on the Labe for 12 months prior to study start and throughout the study. Biogen-Idec does not supply these interventions. Other Names: IFNβ Rebif Avonex Betaseron

Arms

Assigned Interventions

Experimental: Glatiramer Acetate and BG00012 (dimethyl fumarate)

Participants have been taking a stable dose of glatiramer acetate for 12 months prior to the study, and remain on that dose throughout the study. BG00012 (dimethyl fumarate) is administered 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).

Drug: BG00012 (dimethyl fumarate)

Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.

Other Names:

Tecfidera
DMF

Drug: Glatiramer Acetate

A stable dose of glatiramer acetate 20 mg daily by subcutaneous injection taken 12 months prior to study start and throughout the study. Biogen-Idec does not supply this intervention.

Other Names:

GA
Copaxone

Experimental: Interferon beta 1a and BG00012 (dimethyl fumarate)

Participants have been taking a stable dose of one of the interferon beta 1a products for 12 months prior to the study, and remain on that product and dose throughout the study. BG00012 (dimethyl fumarate) is administered 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).

Drug: BG00012 (dimethyl fumarate)

Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.

Other Names:

Tecfidera
DMF

Drug: Interferon beta 1a

A stable dose of one of the following interferon beta 1a drugs: Avonex (30 μg by intramuscular injection), Betaseron (0.25 mg by subcutaneous injection), or Rebif (44 mcg by subcutaneous injection) taken in accordance with instructions on the Labe for 12 months prior to study start and throughout the study. Biogen-Idec does not supply these interventions.

Other Names:

IFNβ
Rebif
Avonex
Betaseron

Eligibility


Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Must have a confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald criteria #1-4 (Polman et al, 2005 [Appendix I]), and have a prior brain MRI demonstrating lesion (s) consistent with MS from any point in time.
Must have an EDSS between 0.0 and 5.0, inclusive.
Must be taking the same dose of a prescribed IFNβ (either Avonex, Betaseron, Rebif) or GA for at least 12 months consecutively at the time of enrollment and remain on this treatment for the duration of the study. Participants receiving Rebif must be prescribed 44 μg by subcutaneous injection three times per week.

Key Exclusion Criteria:

Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Polman et al. 2005
Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
Pregnant or nursing women.
Participation within 6 months prior to study enrollment in any other drug, biologic, or device study.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156311

Show 21 Study Locations

Sponsors and Collaborators

Biogen Idec

Investigators


Study Director:	Medical Director	Biogen Idec

More Information

No publications provided


Responsible Party:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT01156311 History of Changes
Other Study ID Numbers:	109MS201
Study First Received:	July 1, 2010
Last Updated:	September 5, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:


BG00012 MS RRMS

Additional relevant MeSH terms:


Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Pathologic Processes Copolymer 1 Dimethyl fumarate Interferon beta 1a	Interferon-beta Interferons Adjuvants, Immunologic Anti-Infective Agents Antineoplastic Agents Antiviral Agents Dermatologic Agents Immunologic Factors Immunosuppressive Agents Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis (EXPLORE)