Relapsing-Remitting Multiple SclerosisPhase 2EXPLORENCT01156311

BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis

A Phase 2 study testing dimethyl fumarate in people with Relapsing-Remitting Multiple Sclerosis and Multiple Sclerosis, run by Biogen at 16 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 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). Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
What is being tested?: dimethyl fumarate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 16 sitesUnited States
Study dates: Jun 2010to Mar 2012
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

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 magnetic resonance imaging (MRI) demonstrating lesion (s) consistent with multiple sclerosis (MS) from any point in time.
Must have an Expanded Disability Status Scale (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.

Who cannot join

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, or pulmonary 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.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Research Site
Atlanta, Georgia
Research Site
Baltimore, Maryland
Research Site
Boston, Massachusetts
Research Site
Cleveland, Ohio
Research Site
Cordova, Tennessee
Research Site
Danbury, Connecticut
Research Site
Dayton, Ohio
Research Site
Fort Wayne, Indiana
Research Site
Franklin, Tennessee
Research Site
Gilbert, Arizona
Research Site
Golden Valley, Minnesota
Research Site
Milwaukee, Wisconsin
Research Site
Patchogue, New York
Research Site
Phoenix, Arizona
Research Site
Portland, Oregon
Research Site
Teaneck, New Jersey

Other trials in United States

About this study

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)

Conditions: Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
Being tested: dimethyl fumarate
Keywords: BG00012, MS, RRMS
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

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

dimethyl fumarateDrug
Also called Tecfidera, DMF, BG00012
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.

Study groups in NCT01156311
Study group	Role	What they receive
Glatiramer acetate (GA) and dimethyl fumarate	Experimental	Participants taking a stable dose of GA for at least 12 months prior to the study remain on that dose throughout the study. Dimethyl fumarate is administered at 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). Receives: Drug: dimethyl fumarate
Interferon beta (IFNβ) and dimethyl fumarate	Experimental	Participants taking a stable dose of one of the IFNβ products for at least 12 months prior to the study remain on that product and dose throughout the study. Dimethyl fumarate is administered at 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). Receives: Drug: dimethyl fumarate

What is being measured

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

Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. TEAE was defined as having an onset date that was on or after the start of study treatment (BG00012), or that worsened after the start of study treatment.
Measured: AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).
Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy
Percentage of participants with potentially clinically significant hematology laboratory abnormalities.
Measured: collected from the start of BG00012 administration through to Week 26 +/- 5 days
Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy
Percentage of participants with post-baseline liver enzyme values above the upper limit of normal (ULN). Liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and bilirubin. Elevated ALT/AST (ALT/AST ≥ 3*ULN) concurrent with elevated total bilirubin was also evaluated.
Measured: collected from the start of BG00012 administration through to Week 26 +/- 5 days
Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy
Percentage of participants with post-baseline values for selected urinalysis parameters requiring further evaluation. For urine microscopy, results were categorized for male and female participants. For males, normal/negative was considered 0 to 3 red blood cells/high-power field (rbc/hpf), and positive was categorized in the following stages: 4 to 10, 11 to 20, 21 to 149, and ≥ 150 rbc/hpf. For females, normal/negative was considered 0 to 8 rbc/hpf, and positive was categorized in the following stages: 9 to 20, 21 to 30, 31 to 149, and ≥ 150 rbc/hpf.
Measured: collected from the start of BG00012 administration through to Week 26 +/- 5 days

Timeline

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

Jun 2010Mar 2012

First posted2 Jul 2010 (estimated)
Study startJun 2010
Primary completionMar 2012
Study completionMar 2012

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
More trials run by BiogenThe 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: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01156311
Sponsor's protocol ID: 109MS201
Acronym: EXPLORE
Status last verified: Feb 2017
First submitted: 1 Jul 2010
Last updated: 21 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Calkwood J, Vollmer T, Fox RJ, Zhang R, Novas M, Sheikh SI, Viglietta V. Safety and Tolerability of Delayed-Release Dimethyl Fumarate Administered with Interferon Beta or Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis. Int J MS Care. 2016 May-Jun;18(3):138-46. doi: 10.7224/1537-2073.2015-020.
PubMed 27252601

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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REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
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RecruitingPhase 2
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All Relapsing-Remitting Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01156311
Acronym / sponsor ID: EXPLORE / 109MS201
Conditions: Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
Keywords: BG00012, MS, RRMS
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 2 Jul 2010 (estimated)
Results: Posted 9 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Glatiramer acetate (GA) and dimethyl fumarate	Experimental	Drug: dimethyl fumarateParticipants taking a stable dose of GA for at least 12 months prior to the study remain on that dose throughout the study. Dimethyl fumarate is administered at 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).
Interferon beta (IFNβ) and dimethyl fumarate	Experimental	Drug: dimethyl fumarateParticipants taking a stable dose of one of the IFNβ products for at least 12 months prior to the study remain on that product and dose throughout the study. Dimethyl fumarate is administered at 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).

Who may qualify

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

Key inclusion criteria (3 listed)

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 magnetic resonance imaging (MRI) demonstrating lesion (s) consistent with multiple sclerosis (MS) from any point in time.
Must have an Expanded Disability Status Scale (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 (5 listed)

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, or pulmonary 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.

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
dimethyl fumarateAlso: Tecfidera, DMF, BG00012Days 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.	Drug	Glatiramer acetate (GA) and dimethyl fumarate, Interferon beta (IFNβ) and dimethyl fumarate

Primary outcome

Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)
Time frame: AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. TEAE was defined as having an onset date that was on or after the start of study treatment (BG00012), or that worsened after the start of study treatment.
Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy
Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days
Percentage of participants with potentially clinically significant hematology laboratory abnormalities.
Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy
Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days
Percentage of participants with post-baseline liver enzyme values above the upper limit of normal (ULN). Liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and bilirubin. Elevated ALT/AST (ALT/AST ≥ 3*ULN) concurrent with elevated total bilirubin was also evaluated.
Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy
Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days
Percentage of participants with post-baseline values for selected urinalysis parameters requiring further evaluation. For urine microscopy, results were categorized for male and female participants. For males, normal/negative was considered 0 to 3 red blood cells/high-power field (rbc/hpf), and positive was categorized in the following stages: 4 to 10, 11 to 20, 21 to 149, and ≥ 150 rbc/hpf. For females, normal/negative was considered 0 to 8 rbc/hpf, and positive was categorized in the following stages: 9 to 20, 21 to 30, 31 to 149, and ≥ 150 rbc/hpf.

Results and safety

Results posted to the registry on 9 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Monotherapy Period: Interferon Beta (IFNß)	59	57
Monotherapy Period: Glatiramer Acetate (GA)	49	47
Add-on Therapy Period: Dimethyl Fumarate Add-on to IFNß	0	0
Add-on Therapy Period: Dimethyl Fumarate Add-on to GA	0	0

Primary outcome: Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)

Time frame: AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).. Number. Unit: percentage of participants

Measure	Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) n = 57	Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) n = 47
Participants with a TEAE	95	100
Participants with a moderate or severe TEAE	72	70
Participants with a severe TEAE	14	15
Participants with a related TEAE	74	87
Participants with a serious TEAE	4	2
Participants discontinuing BG00012 due to a TEAE	14	17
Participants withdrawing from study due to a TEAE	14	17

Population analysed: The Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.

Primary outcome: Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy

Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days. Number. Unit: percentage of participants

Measure	Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) n = 56	Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) n = 47
White Blood Cells (total) < 3.0*10^9/L	9	2
White Blood Cells (total) ≥ 16*10^9/L	2	2
Lymphocytes < 0.8*10^9/L	32	6
Lymphocytes < 0.5*10^9/L	7	4
Lymphocytes > 12*10^9/L	0	0
Neutrophils ≤ 1.0*10^9/L	0	0
Neutrophils < 1.5*10^9/L	13	2
Neutrophils ≥ 12*10^9/L	2	4

Population analysed: Participants in the safety population with at least one post-baseline value. Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.

Primary outcome: Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy

Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days. Number. Unit: percentage of participants

Measure	Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) n = 57	Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) n = 47
ALT ≤ 1*ULN	47	47
ALT > 1*ULN	53	53
ALT ≥ 3*ULN	5	2
ALT > 5*ULN	2	0
ALT > 10*ULN	0	0
ALT > 20*ULN	0	0
AST ≤ 1*ULN	68	64
AST > 1*ULN	32	36

Primary outcome: Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy

Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days. Number. Unit: percentage of participants

Measure	Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) n = 57	Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) n = 47
Urine blood: normal/negative; n=57, 47	75	64
Urine blood: trace; n=57, 47	7	9
Urine blood: 1+; n=57, 47	5	15
Urine blood: 2+; n=57, 47	7	11
Urine blood: 3+; n=57, 47	5	2
Urine protein: normal/negative; n=57, 47	39	38
Urine protein: trace; n=57, 47	35	45
Urine protein: 1+; n=57, 47	26	15

Population analysed: The Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy; n=participants in the safety population with at least 1 post-baseline value.

Adverse events

Time frame: AEs for the Monotherapy Period collected from enrollment until prior to administration of BG00012. TEAEs for the Add-on Therapy Period collected from start of BG00012 until the final study visit (Week 26 +/-5 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Monotherapy Period: IFNß	0 of 59 (0%)	13 of 59 (22%)	Not reported
Monotherapy Period: GA	0 of 49 (0%)	7 of 49 (14.3%)	Not reported
Add-on Therapy Period: IFNß and BG00012	2 of 57 (3.5%)	53 of 57 (93%)	Not reported
Add-on Therapy Period: GA and BG00012	1 of 47 (2.1%)	45 of 47 (95.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27252601Calkwood J, Vollmer T, Fox RJ, Zhang R, Novas M, Sheikh SI, Viglietta V. Safety and Tolerability of Delayed-Release Dimethyl Fumarate Administered with Interferon Beta or Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis. Int J MS Care. 2016 May-Jun;18(3):138-46. doi: 10.7224/1537-2073.2015-020.

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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.

Medical Director study director

Biogen

16 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 dimethyl fumarate in people with Relapsing-Remitting Multiple Sclerosis and Multiple Sclerosis, run by Biogen at 16 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 3 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 9 Jun 2015). 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?

Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) (time frame: AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).). The study lists 4 primary outcomes in all. 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 NCT01156311, which also lists 1 linked publication.

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 21 Mar 2017.