BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE)

• ClinicalTrials.gov Identifier: NCT00835770
• Recruitment Status: Completed
• First Posted: February 4, 2009
• Results First Posted: December 31, 2020
• Last Update Posted: December 31, 2020
• Sponsor: Biogen
• Information provided by (Responsible Party): Biogen

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Relapsing-Remitting Multiple Sclerosis
• Interventions: Drug: dimethyl fumarate; Drug: Placebo
• Enrollment: 1736

Participant Flow

Recruitment Details	Participants were enrolled at 298 investigative sites from 03 February 2009 to 08 November 2019.
Pre-assignment Details	The study included participants who completed studies NCT00420212 and NCT00451451. A total of 1736 participants were treated in the open label phase extension study NCT00835770, out of which 759 completed the study.

Arm/Group Title	BG00012 240 mg BID	BG00012 240 mg TID
Arm/Group Description	Participants received BG00012 240 milligram (mg), 2 capsules (120 mg each) orally, twice a day (BID) and 2 matching placebo capsules once a day (QD) for up to 8 years.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, three times a day (TID) for up to 8 years.
Period Title: Overall Study
Started	868	868
Completed	384	375
Not Completed	484	493
Reason Not Completed
MS Relapse	17	23
MS Progression	14	9
Adverse Event	113	124
Lost to Follow-up	22	19
Consent Withdrawn	144	156
Investigator Decision	42	42
Participant Non-Compliance	11	9
Death	4	6
Other	115	104
Other	2	1

Baseline Characteristics

Arm/Group Title		BG00012 240 mg BID	BG00012 240 mg TID	Total
Arm/Group Description		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	Total of all reporting groups
Overall Number of Baseline Participants		868	868	1736
Baseline Analysis Population Description		Intent-to-Treat (ITT) population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for ethnicity was not evaluated in the study.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	868 participants	868 participants	1736 participants
		39.6 (8.93)	40.1 (9.23)	39.8 (9.08)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	868 participants	868 participants	1736 participants
	Female	616 71.0%	596 68.7%	1212 69.8%
	Male	252 29.0%	272 31.3%	524 30.2%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	868 participants	868 participants	1736 participants
	White	285 32.8%	309 35.6%	594 34.2%
	Black or African American	10 1.2%	16 1.8%	26 1.5%
	Asian	82 9.4%	80 9.2%	162 9.3%
	Other	32 3.7%	24 2.8%	56 3.2%
	Not Reported Due To Confidentiality Regulations	459 52.9%	439 50.6%	898 51.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs)
Description	An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame	Day 1 up to Week 561

Outcome Measure Data

Analysis Population Description

Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.

Arm/Group Title	BG00012 240 mg BID	BG00012 240 mg TID
Arm/Group Description:	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.
Overall Number of Participants Analyzed	868	868
Measure Type: Count of Participants; Unit of Measure: Participants
	824 94.9%	814 93.8%

2. Secondary Outcome

Title	Percentage of Participants Who Had Relapses
Description	Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours.
Time Frame	Day 1 up to Week 384

Outcome Measure Data

Analysis Population Description

ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this outcome measure (OM) was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title	BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed	501	502	249	248	118	118
Measure Type: Number; Unit of Measure: percentage of participants
	40	41	34	36	31	31

3. Secondary Outcome

Title	Annualized Relapse Rate (ARR)
Description	The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of participant-years followed in the period.
Time Frame	Day 1 up to Week 384

Outcome Measure Data

Analysis Population Description

ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title	BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed	501	502	249	248	118	118
Measure Type: Number; Unit of Measure: relapses per participant-years
	0.159	0.179	0.200	0.199	0.184	0.212

4. Secondary Outcome

Title	Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384
Description	EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Sustained disability progression was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS ≥1.0 that was sustained for at least 24 weeks, or a 1.5 point increase on the EDSS from a baseline EDSS =0 that was sustained for at least 24 weeks.
Time Frame	Baseline, Week 384

Outcome Measure Data

Analysis Population Description

ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		501	502	249	248	118	118
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	499 participants	502 participants	249 participants	248 participants	118 participants	118 participants
		2.44 (1.251)	2.43 (1.144)	2.50 (1.135)	2.54 (1.218)	2.57 (1.249)	2.68 (1.231)
Change at Week 384	Number Analyzed	226 participants	219 participants	90 participants	98 participants	42 participants	50 participants
		0.28 (1.160)	0.26 (1.213)	0.37 (1.328)	0.53 (1.278)	0.39 (1.217)	0.49 (1.319)

5. Secondary Outcome

Title	Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
Description	The Gd-enhancing lesions was evaluated using MRI technique.
Time Frame	Baseline up to Week 288

Outcome Measure Data

Analysis Population Description

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		213	222	105	103	49	60
Mean (Standard Deviation); Unit of Measure: lesions
Week 48	Number Analyzed	191 participants	195 participants	83 participants	78 participants	41 participants	48 participants
		0.4 (1.87)	0.4 (1.29)	0.2 (0.66)	0.3 (1.14)	0.5 (1.19)	0.4 (1.14)
Week 96	Number Analyzed	183 participants	186 participants	77 participants	75 participants	39 participants	46 participants
		0.4 (1.77)	0.4 (1.28)	0.1 (0.38)	0.2 (0.82)	0.6 (1.33)	0.3 (0.73)
Week 144	Number Analyzed	156 participants	159 participants	66 participants	60 participants	32 participants	41 participants
		0.3 (1.66)	0.4 (1.30)	0.2 (0.44)	0.1 (0.29)	0.5 (2.48)	0.3 (1.59)
Week 192	Number Analyzed	144 participants	149 participants	59 participants	55 participants	33 participants	38 participants
		0.4 (2.02)	0.5 (1.85)	0.5 (1.72)	0.3 (0.96)	0.2 (0.60)	0.6 (2.01)
Week 240	Number Analyzed	135 participants	134 participants	55 participants	53 participants	29 participants	34 participants
		0.5 (3.14)	0.5 (2.29)	0.2 (0.50)	0.2 (0.51)	0.2 (0.58)	0.3 (0.75)
Week 288	Number Analyzed	90 participants	97 participants	30 participants	32 participants	6 participants	16 participants
		0.2 (0.74)	0.5 (1.81)	0.1 (0.40)	0.7 (2.76)	0.0 (0.00)	0.3 (0.77)

6. Secondary Outcome

Title	Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
Description	The Gd-enhancing lesions was evaluated using MRI technique.
Time Frame	Baseline up to Week 288

Outcome Measure Data

Analysis Population Description

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		213	222	105	103	49	60
Mean (Standard Deviation); Unit of Measure: millimeter cube (mm^3)
Baseline	Number Analyzed	209 participants	220 participants	104 participants	99 participants	47 participants	60 participants
		31.7 (179.28)	48.6 (205.43)	96.0 (260.79)	142.5 (459.76)	37.1 (138.82)	41.7 (116.55)
Week 48	Number Analyzed	190 participants	197 participants	83 participants	77 participants	40 participants	48 participants
		59.6 (526.51)	70.0 (366.63)	18.8 (91.47)	25.3 (108.19)	42.5 (123.67)	42.7 (148.11)
Week 96	Number Analyzed	182 participants	185 participants	77 participants	73 participants	38 participants	46 participants
		49.1 (245.14)	56.1 (271.29)	27.7 (204.80)	13.3 (67.01)	64.3 (183.16)	22.3 (60.83)
Week 144	Number Analyzed	155 participants	160 participants	66 participants	59 participants	31 participants	41 participants
		44.1 (291.14)	47.0 (169.68)	18.8 (66.15)	3.8 (25.03)	42.6 (142.55)	92.9 (397.69)
Week 192	Number Analyzed	143 participants	148 participants	59 participants	54 participants	32 participants	38 participants
		39.1 (217.89)	54.5 (251.31)	45.8 (156.88)	19.9 (79.19)	12.0 (40.56)	55.1 (169.16)
Week 240	Number Analyzed	134 participants	133 participants	55 participants	52 participants	28 participants	34 participants
		96.8 (650.06)	69.3 (374.67)	21.7 (77.87)	14.1 (45.22)	17.5 (46.19)	17.1 (48.41)
Week 288	Number Analyzed	89 participants	97 participants	30 participants	31 participants	6 participants	16 participants
		18.2 (93.28)	53.1 (250.87)	7.9 (30.09)	230.2 (1092.11)	0.0 (0.00)	34.1 (102.87)

7. Secondary Outcome

Title	Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
Description	The T2 lesions was evaluated using MRI technique.
Time Frame	Baseline up to Week 288

Outcome Measure Data

Analysis Population Description

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		213	222	105	103	49	60
Mean (Standard Deviation); Unit of Measure: lesions
Week 48	Number Analyzed	198 participants	201 participants	84 participants	81 participants	42 participants	50 participants
		1.6 (4.07)	2.2 (6.15)	2.7 (4.96)	2.4 (5.45)	3.4 (6.57)	2.1 (3.83)
Week 96	Number Analyzed	191 participants	192 participants	78 participants	77 participants	40 participants	47 participants
		3.4 (8.35)	4.1 (10.01)	3.8 (7.24)	2.9 (6.78)	4.9 (8.51)	3.4 (5.13)
Week 144	Number Analyzed	163 participants	168 participants	67 participants	63 participants	35 participants	44 participants
		4.2 (9.81)	5.2 (10.01)	4.0 (7.27)	4.3 (10.12)	5.7 (9.45)	5.2 (9.68)
Week 192	Number Analyzed	151 participants	155 participants	61 participants	56 participants	33 participants	40 participants
		5.8 (14.04)	7.5 (15.14)	5.6 (10.09)	5.6 (14.19)	5.5 (9.94)	5.6 (13.35)
Week 240	Number Analyzed	139 participants	142 participants	55 participants	55 participants	30 participants	37 participants
		7.4 (17.09)	9.5 (20.33)	8.2 (14.87)	7.7 (17.89)	6.8 (11.74)	7.5 (16.76)
Week 288	Number Analyzed	123 participants	123 participants	45 participants	49 participants	26 participants	32 participants
		8.2 (18.53)	12.4 (28.23)	7.5 (13.89)	10.4 (22.05)	8.9 (15.04)	6.0 (8.90)

8. Secondary Outcome

Title	Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
Description	The T2 lesions was evaluated using MRI technique.
Time Frame	Baseline up to Week 288

Outcome Measure Data

Analysis Population Description

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		213	222	105	103	49	60
Mean (Standard Deviation); Unit of Measure: mm^3
Baseline	Number Analyzed	209 participants	220 participants	104 participants	99 participants	47 participants	60 participants
		10231.9 (11214.17)	10408.3 (12166.80)	8883.7 (8570.10)	10806.3 (12060.05)	12628.9 (11258.69)	13044.4 (14608.50)
Week 48	Number Analyzed	194 participants	199 participants	84 participants	78 participants	40 participants	50 participants
		9951.9 (10750.15)	9849.6 (10986.36)	8992.1 (7952.13)	10114.5 (10121.61)	11160.7 (9565.55)	12979.0 (14415.86)
Week 96	Number Analyzed	187 participants	190 participants	78 participants	74 participants	38 participants	47 participants
		10331.3 (11359.81)	10434.0 (12201.38)	8645.2 (7787.60)	9985.7 (10715.73)	11318.1 (9873.73)	13974.1 (15432.10)
Week 144	Number Analyzed	162 participants	167 participants	67 participants	61 participants	34 participants	44 participants
		9930.1 (10686.26)	10280.7 (11324.58)	8829.4 (7482.93)	9792.3 (9842.28)	10188.5 (8064.09)	12949.7 (14036.15)
Week 192	Number Analyzed	149 participants	154 participants	61 participants	55 participants	32 participants	40 participants
		9837.7 (10845.04)	10760.0 (11987.16)	9077.6 (7794.52)	10576.3 (12029.26)	10421.9 (8773.41)	11671.5 (13124.47)
Week 240	Number Analyzed	138 participants	141 participants	55 participants	54 participants	29 participants	37 participants
		10611.2 (11633.95)	11087.5 (12464.90)	9711.1 (8709.46)	10591.4 (11613.26)	11009.9 (9551.94)	12254.4 (13732.10)
Week 288	Number Analyzed	121 participants	122 participants	45 participants	49 participants	26 participants	32 participants
		9611.8 (9447.18)	9800.8 (11279.84)	8819.8 (8866.90)	10537.6 (10684.47)	11586.3 (9728.19)	10404.8 (12245.75)

9. Secondary Outcome

Title	Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
Description	The T1 hypointense lesions was evaluated using MRI technique.
Time Frame	Baseline up to Week 288

Outcome Measure Data

Analysis Population Description

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		213	222	105	103	49	60
Mean (Standard Deviation); Unit of Measure: lesions
Week 48	Number Analyzed	183 participants	184 participants	79 participants	76 participants	41 participants	48 participants
		0.8 (2.13)	1.0 (2.37)	1.8 (3.81)	1.7 (3.71)	2.0 (4.22)	1.3 (2.64)
Week 96	Number Analyzed	171 participants	178 participants	75 participants	72 participants	39 participants	45 participants
		1.7 (3.63)	1.9 (3.91)	1.8 (3.33)	2.1 (5.00)	3.0 (5.85)	1.9 (3.44)
Week 144	Number Analyzed	148 participants	155 participants	63 participants	53 participants	32 participants	41 participants
		2.0 (4.61)	2.8 (5.19)	2.0 (3.69)	2.6 (7.02)	3.1 (6.20)	2.9 (5.19)
Week 192	Number Analyzed	141 participants	145 participants	58 participants	53 participants	33 participants	38 participants
		2.9 (7.03)	3.4 (6.79)	2.9 (5.12)	3.8 (10.71)	3.3 (6.74)	3.0 (7.14)
Week 240	Number Analyzed	134 participants	136 participants	55 participants	53 participants	29 participants	34 participants
		3.4 (8.25)	4.8 (9.39)	4.0 (7.52)	4.9 (13.30)	4.0 (8.06)	4.2 (10.20)
Week 288	Number Analyzed	88 participants	94 participants	30 participants	32 participants	6 participants	16 participants
		2.7 (5.72)	5.9 (12.02)	4.5 (7.38)	3.6 (4.51)	1.0 (1.10)	5.6 (6.81)

10. Secondary Outcome

Title	Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
Description	The T1 hypointense lesions was evaluated using MRI technique.
Time Frame	Baseline up to Week 288

Outcome Measure Data

Analysis Population Description

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		213	222	105	103	49	60
Mean (Standard Deviation); Unit of Measure: mm^3
Baseline	Number Analyzed	209 participants	220 participants	104 participants	99 participants	47 participants	60 participants
		3640.1 (5598.31)	3447.3 (4900.96)	2754.2 (3552.30)	3623.1 (5549.13)	3204.3 (4221.55)	3572.6 (4915.24)
Week 48	Number Analyzed	190 participants	197 participants	83 participants	77 participants	40 participants	48 participants
		3829.5 (5824.26)	3715.5 (5112.21)	2891.9 (3034.00)	3936.0 (5271.89)	3271.0 (4157.24)	3743.3 (5374.24)
Week 96	Number Analyzed	183 participants	186 participants	77 participants	73 participants	38 participants	46 participants
		3841.2 (5682.74)	3853.7 (5428.66)	2921.0 (3327.93)	3849.4 (5167.13)	3510.4 (4672.80)	3949.7 (5018.63)
Week 144	Number Analyzed	157 participants	164 participants	67 participants	58 participants	33 participants	42 participants
		3767.4 (4969.23)	4074.0 (5413.85)	3145.6 (3366.27)	4006.9 (5062.08)	3499.2 (4198.50)	4126.1 (5695.44)
Week 192	Number Analyzed	145 participants	149 participants	60 participants	54 participants	32 participants	38 participants
		3834.9 (4942.19)	4177.4 (5301.68)	3385.4 (3575.44)	4330.0 (5136.67)	3592.0 (4069.39)	4089.3 (4996.13)
Week 240	Number Analyzed	135 participants	137 participants	55 participants	52 participants	28 participants	34 participants
		4038.6 (5145.85)	4238.2 (5248.84)	3406.4 (3936.73)	3823.9 (4274.82)	3503.4 (3933.75)	4057.7 (5223.62)
Week 288	Number Analyzed	113 participants	121 participants	40 participants	45 participants	20 participants	29 participants
		3603.3 (4394.60)	3973.1 (5202.05)	3350.6 (4140.34)	4187.5 (4835.43)	3264.9 (3639.91)	2959.1 (3918.62)

11. Secondary Outcome

Title	Percent Change From Baseline in Brain Atrophy
Description	Brain atrophy was measured using magnetic resonance imaging (MRI) technique.
Time Frame	Baseline up to Week 288

Outcome Measure Data

Analysis Population Description

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		213	222	105	103	49	60
Mean (Standard Deviation); Unit of Measure: percent change
Change at Week 48	Number Analyzed	162 participants	162 participants	56 participants	64 participants	33 participants	42 participants
		-1.206 (1.1006)	-1.263 (1.0848)	-1.487 (1.3086)	-1.320 (1.4021)	-1.496 (1.1316)	-1.414 (1.1882)
Change at Week 96	Number Analyzed	144 participants	145 participants	50 participants	56 participants	30 participants	37 participants
		-1.372 (1.1382)	-1.500 (1.0893)	-1.589 (1.3630)	-1.775 (1.7191)	-1.883 (1.2383)	-1.810 (1.4556)
Change at Week 144	Number Analyzed	122 participants	133 participants	44 participants	49 participants	28 participants	36 participants
		-1.708 (1.4109)	-1.876 (1.2604)	-2.139 (1.5884)	-2.353 (1.7897)	-2.386 (1.3168)	-2.252 (2.2124)
Change at Week 192	Number Analyzed	114 participants	120 participants	41 participants	45 participants	29 participants	36 participants
		-2.138 (1.6831)	-2.117 (1.4000)	-2.230 (1.7755)	-2.476 (1.7062)	-2.645 (1.2284)	-2.417 (2.0486)
Change at Week 240	Number Analyzed	92 participants	95 participants	37 participants	40 participants	18 participants	26 participants
		-2.313 (1.6309)	-2.253 (1.3721)	-2.271 (1.4817)	-2.593 (1.9043)	-2.249 (1.2985)	-2.790 (2.2188)
Change at Week 288	Number Analyzed	71 participants	72 participants	25 participants	30 participants	15 participants	23 participants
		-2.216 (1.5744)	-2.271 (1.2193)	-2.470 (1.6757)	-2.849 (1.9648)	-2.657 (1.7051)	-2.496 (1.3699)

12. Secondary Outcome

Title	Percent Change From Baseline in Magnetization Transfer Ratio (MTR)
Description	Magnetization Transfer Ratio (MTR) was measured using MRI technique.
Time Frame	Baseline up to Week 288

Outcome Measure Data

Analysis Population Description

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		213	222	105	103	49	60
Mean (Standard Deviation); Unit of Measure: percent change
Change at Week 48	Number Analyzed	126 participants	118 participants	49 participants	56 participants	20 participants	23 participants
		-0.325 (5.4932)	-0.383 (4.8621)	1.034 (7.3548)	-0.567 (4.4766)	-0.081 (13.6416)	-0.334 (1.5103)
Change at Week 96	Number Analyzed	118 participants	113 participants	46 participants	50 participants	20 participants	20 participants
		-0.427 (6.6493)	-0.532 (4.9880)	1.630 (7.6584)	-0.947 (7.0771)	-4.269 (12.6065)	0.215 (1.4270)
Change at Week 144	Number Analyzed	103 participants	107 participants	45 participants	37 participants	19 participants	24 participants
		-0.042 (9.2548)	0.509 (7.2692)	1.525 (8.6421)	1.411 (12.2825)	-4.460 (10.3887)	3.119 (8.1676)
Change at Week 192	Number Analyzed	100 participants	100 participants	42 participants	41 participants	25 participants	23 participants
		1.038 (10.8680)	0.955 (8.6105)	3.012 (9.3831)	3.103 (13.0046)	1.384 (15.7611)	3.841 (10.8600)
Change at Week 240	Number Analyzed	91 participants	90 participants	40 participants	42 participants	23 participants	20 participants
		-0.002 (15.6190)	1.647 (8.3094)	3.213 (9.6621)	4.108 (13.8103)	2.959 (16.8386)	0.673 (25.9962)
Change at Week 288	Number Analyzed	65 participants	71 participants	19 participants	25 participants	5 participants	14 participants
		0.002 (4.0206)	-0.391 (4.6415)	-0.666 (2.0741)	-0.622 (2.2922)	-0.466 (0.9410)	-1.114 (2.4539)

13. Secondary Outcome

Title	Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384
Description	The SF-36 is a brief (36-item) scale reflecting the impact of both dysfunctions and general health perception the questionnaire measures: 1.physical function (PF),2. role physical (RF),3. bodily pain (BP),4. role emotional (RE),5. social function (SF), 6. general health (GH),7. vitality (VT), 8. mental health (MH). Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score), with higher scores indicating better function.
Time Frame	Baseline, Week 384

Outcome Measure Data

Analysis Population Description

ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		501	502	249	248	118	118
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline: Physical Functioning Score	Number Analyzed	494 participants	487 participants	244 participants	240 participants	115 participants	112 participants
		68.48 (25.938)	71.78 (24.849)	69.67 (24.481)	67.97 (26.279)	69.10 (25.226)	68.20 (25.370)
Change at Week 384: Physical Functioning Score	Number Analyzed	236 participants	215 participants	90 participants	97 participants	43 participants	48 participants
		0.73 (21.972)	-4.79 (24.641)	-7.37 (22.253)	-6.89 (23.194)	-6.19 (21.719)	-6.25 (28.350)
Baseline: Role-Physical Score	Number Analyzed	494 participants	486 participants	244 participants	238 participants	114 participants	112 participants
		56.46 (41.254)	58.42 (41.280)	56.35 (40.896)	59.87 (41.747)	55.26 (40.390)	53.57 (42.029)
Change at Week 384: Role-Physical Score	Number Analyzed	232 participants	215 participants	90 participants	94 participants	43 participants	48 participants
		3.20 (48.259)	-2.75 (47.283)	-10.00 (43.188)	-8.24 (53.177)	-12.21 (40.595)	-1.04 (54.568)
Baseline: Bodily-Pain Score	Number Analyzed	494 participants	490 participants	244 participants	240 participants	115 participants	112 participants
		69.68 (25.587)	70.42 (24.688)	68.51 (26.163)	69.44 (26.016)	69.30 (25.766)	68.59 (26.102)
Change at Week 384: Bodily-Pain Score	Number Analyzed	237 participants	216 participants	90 participants	97 participants	43 participants	48 participants
		1.32 (28.525)	-1.47 (25.779)	-2.92 (23.486)	-4.36 (25.935)	-3.60 (22.138)	-4.46 (33.297)
Baseline: General Health Score	Number Analyzed	493 participants	489 participants	240 participants	238 participants	115 participants	110 participants
		53.99 (21.563)	55.44 (20.768)	54.45 (18.690)	52.42 (20.028)	51.21 (18.707)	52.58 (19.675)
Change at Week 384: General Health Score	Number Analyzed	234 participants	213 participants	86 participants	95 participants	42 participants	47 participants
		0.87 (18.744)	-2.12 (20.595)	-2.28 (16.752)	-0.52 (22.035)	-5.64 (18.270)	1.21 (21.674)
Baseline: Vitality Score	Number Analyzed	492 participants	486 participants	242 participants	239 participants	115 participants	111 participants
		50.48 (20.966)	52.21 (19.842)	50.63 (19.130)	50.64 (21.069)	51.30 (19.703)	50.33 (20.019)
Change at Week 384: Vitality Score	Number Analyzed	235 participants	214 participants	87 participants	96 participants	41 participants	47 participants
		1.11 (19.857)	-0.73 (19.033)	-4.67 (17.934)	0.40 (20.822)	-6.71 (20.236)	1.03 (19.829)
Baseline: Social Functioning Score	Number Analyzed	494 participants	490 participants	244 participants	239 participants	115 participants	112 participants
		71.46 (24.451)	71.53 (24.394)	69.67 (24.581)	72.23 (24.699)	69.02 (24.688)	69.53 (25.100)
Change at Week 384: Social Functioning Score	Number Analyzed	237 participants	216 participants	90 participants	96 participants	43 participants	48 participants
		-2.16 (25.575)	-3.30 (24.912)	-5.69 (22.184)	-2.08 (27.724)	-10.76 (34.350)	-0.52 (25.780)
Baseline: Role-Emotional Score	Number Analyzed	491 participants	485 participants	241 participants	238 participants	115 participants	111 participants
		64.87 (40.653)	65.57 (40.015)	62.86 (42.715)	62.61 (41.280)	60.29 (41.393)	64.26 (41.854)
Change at Week 384: Role-Emotional Score	Number Analyzed	233 participants	214 participants	90 participants	96 participants	43 participants	47 participants
		0.43 (49.950)	0.47 (43.513)	-12.22 (42.532)	4.17 (44.656)	-13.18 (42.501)	-3.55 (48.769)
Baseline: Mental Health Score	Number Analyzed	492 participants	486 participants	242 participants	239 participants	115 participants	111 participants
		65.01 (19.818)	66.24 (19.060)	65.42 (17.658)	65.15 (19.233)	62.30 (17.347)	63.61 (18.414)
Change at Week 384: Mental Health Score	Number Analyzed	235 participants	214 participants	87 participants	96 participants	41 participants	47 participants
		1.32 (19.715)	2.31 (18.095)	-3.91 (19.897)	2.33 (17.524)	-0.29 (21.989)	-2.06 (20.066)
Baseline: Mental Component Score	Number Analyzed	488 participants	480 participants	237 participants	235 participants	114 participants	108 participants
		45.40 (11.130)	45.63 (10.272)	45.13 (10.932)	45.31 (10.907)	44.00 (10.702)	45.03 (10.642)
Change at Week 384: Mental Component Score	Number Analyzed	226 participants	211 participants	85 participants	92 participants	41 participants	45 participants
		0.05 (12.415)	0.87 (10.028)	-2.55 (10.328)	1.97 (10.657)	-2.59 (12.895)	0.08 (10.328)
Baseline: Physical Component Score	Number Analyzed	488 participants	480 participants	237 participants	235 participants	114 participants	108 participants
		43.53 (9.884)	44.44 (10.048)	43.74 (9.739)	43.56 (10.267)	43.68 (10.359)	43.15 (10.091)
Change at Week 384: Physical Component Score	Number Analyzed	226 participants	211 participants	85 participants	92 participants	41 participants	45 participants
		0.55 (9.373)	-1.94 (10.532)	-2.29 (8.929)	-3.25 (9.998)	-2.70 (8.860)	-1.59 (10.765)

14. Secondary Outcome

Title	Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384
Description	The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. The EQ-5D provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has (1) "no problems", (2) "some problems", or (3) "severe problems". A positive change from baseline indicates improvement.
Time Frame	Baseline, Week 384

Outcome Measure Data

Analysis Population Description

ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		501	502	249	248	118	118
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	488 participants	484 participants	239 participants	239 participants	115 participants	112 participants
		0.73 (0.210)	0.73 (0.222)	0.72 (0.223)	0.71 (0.244)	0.71 (0.246)	0.72 (0.189)
Change at Week 384	Number Analyzed	230 participants	212 participants	86 participants	96 participants	42 participants	48 participants
		0.01 (0.251)	0.00 (0.233)	-0.07 (0.269)	0.00 (0.249)	-0.04 (0.253)	-0.03 (0.241)

15. Secondary Outcome

Title	Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384
Description	The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. In EQ-VAS participants are asked to rate their current health on a 20 centimeter (cm) scale from 0 to 100 where 0 represents "worst imaginable health state" and 100 represents "best imaginable health state". A positive change from baseline indicates improvement.
Time Frame	Baseline, Week 384

Outcome Measure Data

Analysis Population Description

ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		501	502	249	248	118	118
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	492 participants	488 participants	243 participants	238 participants	113 participants	112 participants
		70.97 (18.460)	70.48 (19.993)	70.40 (17.630)	69.44 (19.907)	66.80 (18.846)	69.07 (20.094)
Change at Week 384	Number Analyzed	235 participants	215 participants	91 participants	95 participants	42 participants	48 participants
		-0.48 (19.631)	-1.67 (18.855)	-7.24 (18.419)	-3.17 (22.003)	-1.71 (25.330)	-4.11 (16.270)

16. Secondary Outcome

Title	Change From Baseline in Visual Function Test Scores at Week 384
Description	Participants were tested using the contrast level of 100%, 2.5%, and 1.25% charts, and the scores were defined as the number of letters identified correctly for each chart (the maximum score was 60). Higher scores indicate better functioning. A positive change from baseline indicates better functioning.
Time Frame	Baseline, Week 384

Outcome Measure Data

Analysis Population Description

ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Arm/Group Title		BG00012 240 mg BID (Prior BG00012 240 mg BID)	BG00012 240 mg TID (Prior BG00012 240 mg TID)	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	BG00012 240 mg TID (Prior BG00012 Matched Placebo)	BG00012 240 mg BID (Prior Glatiramer Acetate [GA])	BG00012 240 mg TID (Prior Glatiramer Acetate [GA])
Arm/Group Description:		Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received Glatiramer Acetate (GA) in the previous studies were included in this arm group.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received GA in the previous studies were included in this arm group.
Overall Number of Participants Analyzed		501	502	249	248	118	118
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline: 100% Chart	Number Analyzed	501 participants	502 participants	249 participants	248 participants	118 participants	118 participants
		54.7 (7.95)	55.0 (7.84)	55.1 (7.26)	54.8 (7.12)	54.3 (8.26)	55.0 (6.73)
Change at Week 384: 100% Chart	Number Analyzed	231 participants	216 participants	87 participants	99 participants	42 participants	50 participants
		-0.4 (6.76)	-1.9 (6.81)	-1.4 (8.48)	-1.2 (7.53)	-1.6 (8.05)	-0.7 (5.17)
Baseline: 2.5% Chart	Number Analyzed	501 participants	502 participants	249 participants	248 participants	118 participants	118 participants
		32.4 (12.17)	32.6 (11.76)	32.4 (11.42)	32.3 (11.99)	31.8 (12.36)	31.7 (12.41)
Change at Week 384: 2.5% Chart	Number Analyzed	231 participants	216 participants	87 participants	99 participants	42 participants	50 participants
		-2.4 (10.77)	-3.3 (10.43)	-1.5 (11.77)	-4.9 (11.14)	-4.0 (11.90)	-2.1 (9.86)
Baseline: 1.25% Chart	Number Analyzed	499 participants	502 participants	249 participants	247 participants	118 participants	118 participants
		24.1 (12.45)	24.2 (12.28)	23.8 (12.11)	23.7 (12.96)	23.4 (11.76)	22.2 (13.25)
Change at Week 384: 1.25% Chart	Number Analyzed	231 participants	216 participants	87 participants	99 participants	42 participants	50 participants
		-5.8 (13.39)	-6.0 (11.77)	-4.1 (13.04)	-7.4 (12.42)	-6.7 (13.78)	-5.0 (12.74)

Adverse Events

Time Frame	From start of the study up to follow-up (up to Week 561)
Adverse Event Reporting Description	Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in Study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
Arm/Group Title	BG00012 240 mg BID	BG00012 240 mg TID
Arm/Group Description	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.
All-Cause Mortality
	BG00012 240 mg BID	BG00012 240 mg TID
	Affected / at Risk (%)	Affected / at Risk (%)
Total	5/868 (0.58%)	6/868 (0.69%)
Serious Adverse Events
	BG00012 240 mg BID	BG00012 240 mg TID
	Affected / at Risk (%)	Affected / at Risk (%)
Total	279/868 (32.14%)	272/868 (31.34%)
Blood and lymphatic system disorders
Anaemia † 1	0/868 (0.00%)	1/868 (0.12%)
Eosinophilia † 1	0/868 (0.00%)	1/868 (0.12%)
Iron deficiency anaemia † 1	2/868 (0.23%)	0/868 (0.00%)
Leukopenia † 1	1/868 (0.12%)	0/868 (0.00%)
Lymphopenia † 1	1/868 (0.12%)	1/868 (0.12%)
Neutropenia † 1	0/868 (0.00%)	1/868 (0.12%)
Thrombocytopenia † 1	1/868 (0.12%)	1/868 (0.12%)
Cardiac disorders
Acute coronary syndrome † 1	1/868 (0.12%)	0/868 (0.00%)
Acute myocardial infarction † 1	1/868 (0.12%)	0/868 (0.00%)
Atrial fibrillation † 1	2/868 (0.23%)	1/868 (0.12%)
Cardiac arrest † 1	0/868 (0.00%)	2/868 (0.23%)
Cardiac failure congestive † 1	1/868 (0.12%)	0/868 (0.00%)
Coronary artery disease † 1	2/868 (0.23%)	0/868 (0.00%)
Left ventricular dysfunction † 1	1/868 (0.12%)	0/868 (0.00%)
Mitral valve prolapse † 1	1/868 (0.12%)	0/868 (0.00%)
Myocardial infarction † 1	1/868 (0.12%)	5/868 (0.58%)
Myocardial ischaemia † 1	0/868 (0.00%)	1/868 (0.12%)
Wolff-parkinson-white syndrome † 1	1/868 (0.12%)	0/868 (0.00%)
Congenital, familial and genetic disorders
Cytogenetic abnormality † 1	0/868 (0.00%)	1/868 (0.12%)
Limb malformation † 1	1/868 (0.12%)	0/868 (0.00%)
Ear and labyrinth disorders
Hypoacusis † 1	0/868 (0.00%)	1/868 (0.12%)
Sudden hearing loss † 1	0/868 (0.00%)	1/868 (0.12%)
Vertigo positional † 1	0/868 (0.00%)	1/868 (0.12%)
Endocrine disorders
Autoimmune thyroiditis † 1	0/868 (0.00%)	1/868 (0.12%)
Basedow's disease † 1	2/868 (0.23%)	0/868 (0.00%)
Goitre † 1	0/868 (0.00%)	1/868 (0.12%)
Hyperthyroidism † 1	1/868 (0.12%)	0/868 (0.00%)
Eye disorders
Cataract † 1	1/868 (0.12%)	0/868 (0.00%)
Glaucoma † 1	1/868 (0.12%)	0/868 (0.00%)
Retinal ischaemia † 1	0/868 (0.00%)	1/868 (0.12%)
Ulcerative keratitis † 1	0/868 (0.00%)	1/868 (0.12%)
Vision blurred † 1	0/868 (0.00%)	1/868 (0.12%)
Gastrointestinal disorders
Abdominal hernia † 1	1/868 (0.12%)	0/868 (0.00%)
Abdominal pain † 1	0/868 (0.00%)	1/868 (0.12%)
Colitis † 1	0/868 (0.00%)	1/868 (0.12%)
Colitis ulcerative † 1	1/868 (0.12%)	1/868 (0.12%)
Crohn's disease † 1	0/868 (0.00%)	1/868 (0.12%)
Diarrhoea † 1	1/868 (0.12%)	0/868 (0.00%)
Duodenal ulcer † 1	0/868 (0.00%)	1/868 (0.12%)
Duodenal ulcer perforation † 1	1/868 (0.12%)	0/868 (0.00%)
Duodenitis † 1	0/868 (0.00%)	1/868 (0.12%)
Gastric haemorrhage † 1	1/868 (0.12%)	0/868 (0.00%)
Gastritis † 1	2/868 (0.23%)	3/868 (0.35%)
Gastrointestinal haemorrhage † 1	0/868 (0.00%)	1/868 (0.12%)
Gastrointestinal inflammation † 1	1/868 (0.12%)	0/868 (0.00%)
Gastrointestinal mucosal disorder † 1	1/868 (0.12%)	0/868 (0.00%)
Gastrointestinal necrosis † 1	1/868 (0.12%)	0/868 (0.00%)
Gastrooesophageal reflux disease † 1	1/868 (0.12%)	1/868 (0.12%)
Haemorrhoids † 1	0/868 (0.00%)	1/868 (0.12%)
Inguinal hernia † 1	1/868 (0.12%)	3/868 (0.35%)
Intestinal haemorrhage † 1	0/868 (0.00%)	1/868 (0.12%)
Intestinal obstruction † 1	0/868 (0.00%)	1/868 (0.12%)
Pancreatitis † 1	1/868 (0.12%)	0/868 (0.00%)
Peritonitis † 1	1/868 (0.12%)	0/868 (0.00%)
Small intestinal obstruction † 1	1/868 (0.12%)	0/868 (0.00%)
Subileus † 1	1/868 (0.12%)	0/868 (0.00%)
Umbilical hernia † 1	2/868 (0.23%)	0/868 (0.00%)
Volvulus † 1	0/868 (0.00%)	1/868 (0.12%)
General disorders
Capsular contracture associated with breast implant † 1	1/868 (0.12%)	0/868 (0.00%)
Chest pain † 1	0/868 (0.00%)	1/868 (0.12%)
Gait disturbance † 1	1/868 (0.12%)	0/868 (0.00%)
Impaired healing † 1	1/868 (0.12%)	0/868 (0.00%)
Non-cardiac chest pain † 1	0/868 (0.00%)	3/868 (0.35%)
Oedema peripheral † 1	0/868 (0.00%)	1/868 (0.12%)
Pyrexia † 1	3/868 (0.35%)	1/868 (0.12%)
Serositis † 1	0/868 (0.00%)	1/868 (0.12%)
Treatment failure † 1	0/868 (0.00%)	1/868 (0.12%)
Hepatobiliary disorders
Bile duct stone † 1	1/868 (0.12%)	1/868 (0.12%)
Biliary colic † 1	0/868 (0.00%)	2/868 (0.23%)
Cholecystitis † 1	3/868 (0.35%)	1/868 (0.12%)
Cholecystitis acute † 1	1/868 (0.12%)	1/868 (0.12%)
Cholecystitis chronic † 1	0/868 (0.00%)	2/868 (0.23%)
Cholelithiasis † 1	2/868 (0.23%)	7/868 (0.81%)
Chronic hepatitis † 1	1/868 (0.12%)	0/868 (0.00%)
Hepatic failure † 1	0/868 (0.00%)	1/868 (0.12%)
Immune system disorders
Anaphylactic reaction † 1	0/868 (0.00%)	1/868 (0.12%)
Drug hypersensitivity † 1	1/868 (0.12%)	0/868 (0.00%)
Infections and infestations
Appendicitis † 1	2/868 (0.23%)	4/868 (0.46%)
Bacterial infection † 1	1/868 (0.12%)	0/868 (0.00%)
Bacteriuria † 1	1/868 (0.12%)	0/868 (0.00%)
Bronchitis † 1	1/868 (0.12%)	0/868 (0.00%)
Bronchopneumonia † 1	0/868 (0.00%)	2/868 (0.23%)
Bronchopulmonary aspergillosis † 1	1/868 (0.12%)	0/868 (0.00%)
Cellulitis † 1	2/868 (0.23%)	2/868 (0.23%)
Chronic sinusitis † 1	0/868 (0.00%)	2/868 (0.23%)
Chronic tonsillitis † 1	1/868 (0.12%)	0/868 (0.00%)
Dengue fever † 1	2/868 (0.23%)	0/868 (0.00%)
Diarrhoea infectious † 1	0/868 (0.00%)	1/868 (0.12%)
Diverticulitis † 1	1/868 (0.12%)	0/868 (0.00%)
Endometritis † 1	0/868 (0.00%)	1/868 (0.12%)
Escherichia infection † 1	1/868 (0.12%)	0/868 (0.00%)
Gastroenteritis † 1	2/868 (0.23%)	1/868 (0.12%)
Gastroenteritis norovirus † 1	0/868 (0.00%)	1/868 (0.12%)
Gastroenteritis rotavirus † 1	0/868 (0.00%)	1/868 (0.12%)
Gastrointestinal bacterial infection † 1	0/868 (0.00%)	1/868 (0.12%)
Genital herpes † 1	0/868 (0.00%)	1/868 (0.12%)
Haematoma infection † 1	1/868 (0.12%)	0/868 (0.00%)
Herpes simplex † 1	1/868 (0.12%)	0/868 (0.00%)
Herpes zoster † 1	1/868 (0.12%)	3/868 (0.35%)
Infected skin ulcer † 1	1/868 (0.12%)	0/868 (0.00%)
Lower respiratory tract infection † 1	0/868 (0.00%)	1/868 (0.12%)
Meningitis viral † 1	1/868 (0.12%)	0/868 (0.00%)
Nasopharyngitis † 1	1/868 (0.12%)	0/868 (0.00%)
Oesophageal candidiasis † 1	1/868 (0.12%)	0/868 (0.00%)
Oral candidiasis † 1	0/868 (0.00%)	1/868 (0.12%)
Osteomyelitis † 1	0/868 (0.00%)	1/868 (0.12%)
Papilloma viral infection † 1	1/868 (0.12%)	0/868 (0.00%)
Pelvic abscess † 1	0/868 (0.00%)	1/868 (0.12%)
Peritonsillar abscess † 1	0/868 (0.00%)	1/868 (0.12%)
Peritonsillitis † 1	0/868 (0.00%)	1/868 (0.12%)
Pneumonia † 1	6/868 (0.69%)	1/868 (0.12%)
Pneumonia bacterial † 1	0/868 (0.00%)	1/868 (0.12%)
Post procedural infection † 1	1/868 (0.12%)	0/868 (0.00%)
Progressive multifocal leukoencephalopathy (PML) † 1	0/868 (0.00%)	1/868 (0.12%)
Pulmonary tuberculoma † 1	0/868 (0.00%)	1/868 (0.12%)
Pyelonephritis acute † 1	0/868 (0.00%)	1/868 (0.12%)
Pyelonephritis chronic † 1	1/868 (0.12%)	0/868 (0.00%)
Pyothorax † 1	1/868 (0.12%)	0/868 (0.00%)
Rectal abscess † 1	1/868 (0.12%)	0/868 (0.00%)
Respiratory tract infection † 1	1/868 (0.12%)	0/868 (0.00%)
Respiratory tract infection viral † 1	1/868 (0.12%)	0/868 (0.00%)
Scrub typhus † 1	1/868 (0.12%)	0/868 (0.00%)
Septic shock † 1	1/868 (0.12%)	0/868 (0.00%)
Sinusitis † 1	2/868 (0.23%)	0/868 (0.00%)
Subcutaneous abscess † 1	1/868 (0.12%)	0/868 (0.00%)
Tooth abscess † 1	1/868 (0.12%)	0/868 (0.00%)
Upper respiratory tract infection † 1	1/868 (0.12%)	0/868 (0.00%)
Urinary tract infection † 1	10/868 (1.15%)	4/868 (0.46%)
Urosepsis † 1	0/868 (0.00%)	1/868 (0.12%)
Vaginal infection † 1	1/868 (0.12%)	0/868 (0.00%)
Vestibular neuronitis † 1	0/868 (0.00%)	1/868 (0.12%)
Viral infection † 1	1/868 (0.12%)	1/868 (0.12%)
Injury, poisoning and procedural complications
Accident † 1	0/868 (0.00%)	1/868 (0.12%)
Accident at work † 1	1/868 (0.12%)	0/868 (0.00%)
Acetabulum fracture † 1	0/868 (0.00%)	1/868 (0.12%)
Animal bite † 1	0/868 (0.00%)	2/868 (0.23%)
Ankle fracture † 1	2/868 (0.23%)	2/868 (0.23%)
Avulsion fracture † 1	1/868 (0.12%)	0/868 (0.00%)
Brain contusion † 1	1/868 (0.12%)	0/868 (0.00%)
Clavicle fracture † 1	0/868 (0.00%)	1/868 (0.12%)
Comminuted fracture † 1	0/868 (0.00%)	1/868 (0.12%)
Concussion † 1	0/868 (0.00%)	1/868 (0.12%)
Contusion † 1	3/868 (0.35%)	1/868 (0.12%)
Drug toxicity † 1	0/868 (0.00%)	1/868 (0.12%)
Fall † 1	13/868 (1.50%)	18/868 (2.07%)
Femoral neck fracture † 1	3/868 (0.35%)	4/868 (0.46%)
Femur fracture † 1	3/868 (0.35%)	0/868 (0.00%)
Fibula fracture † 1	0/868 (0.00%)	3/868 (0.35%)
Foot fracture † 1	2/868 (0.23%)	0/868 (0.00%)
Hand fracture † 1	0/868 (0.00%)	1/868 (0.12%)
Hip fracture † 1	1/868 (0.12%)	1/868 (0.12%)
Humerus fracture † 1	0/868 (0.00%)	4/868 (0.46%)
Incision site haematoma † 1	1/868 (0.12%)	0/868 (0.00%)
Incisional hernia † 1	0/868 (0.00%)	1/868 (0.12%)
Joint dislocation † 1	1/868 (0.12%)	0/868 (0.00%)
Joint injury † 1	0/868 (0.00%)	1/868 (0.12%)
Joint sprain † 1	0/868 (0.00%)	1/868 (0.12%)
Ligament injury † 1	1/868 (0.12%)	0/868 (0.00%)
Ligament rupture † 1	2/868 (0.23%)	0/868 (0.00%)
Lower limb fracture † 1	1/868 (0.12%)	3/868 (0.35%)
Lumbar vertebral fracture † 1	0/868 (0.00%)	1/868 (0.12%)
Meniscus lesion † 1	1/868 (0.12%)	1/868 (0.12%)
Multiple injuries † 1	1/868 (0.12%)	0/868 (0.00%)
Muscle rupture † 1	0/868 (0.00%)	2/868 (0.23%)
Overdose † 1	2/868 (0.23%)	0/868 (0.00%)
Postoperative hernia † 1	1/868 (0.12%)	0/868 (0.00%)
Pubis fracture † 1	1/868 (0.12%)	0/868 (0.00%)
Radius fracture † 1	3/868 (0.35%)	0/868 (0.00%)
Respiratory fume inhalation disorder † 1	0/868 (0.00%)	1/868 (0.12%)
Rib fracture † 1	0/868 (0.00%)	2/868 (0.23%)
Road traffic accident † 1	4/868 (0.46%)	5/868 (0.58%)
Skeletal injury † 1	1/868 (0.12%)	1/868 (0.12%)
Spinal compression fracture † 1	0/868 (0.00%)	1/868 (0.12%)
Splenic rupture † 1	0/868 (0.00%)	1/868 (0.12%)
Thoracic vertebral fracture † 1	0/868 (0.00%)	2/868 (0.23%)
Tibia fracture † 1	1/868 (0.12%)	5/868 (0.58%)
Ulna fracture † 1	0/868 (0.00%)	1/868 (0.12%)
Wound † 1	1/868 (0.12%)	0/868 (0.00%)
Investigations
Anticoagulation drug level above therapeutic † 1	0/868 (0.00%)	1/868 (0.12%)
Investigation † 1	1/868 (0.12%)	0/868 (0.00%)
Lymphocyte count decreased † 1	0/868 (0.00%)	1/868 (0.12%)
Metabolism and nutrition disorders
Dehydration † 1	1/868 (0.12%)	1/868 (0.12%)
Diabetes mellitus † 1	1/868 (0.12%)	1/868 (0.12%)
Hyperglycaemia † 1	0/868 (0.00%)	1/868 (0.12%)
Obesity † 1	2/868 (0.23%)	1/868 (0.12%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	0/868 (0.00%)	1/868 (0.12%)
Arthritis † 1	1/868 (0.12%)	0/868 (0.00%)
Back pain † 1	4/868 (0.46%)	0/868 (0.00%)
Bursitis † 1	1/868 (0.12%)	0/868 (0.00%)
Chondropathy † 1	1/868 (0.12%)	0/868 (0.00%)
Foot deformity † 1	2/868 (0.23%)	2/868 (0.23%)
Intervertebral disc degeneration † 1	0/868 (0.00%)	1/868 (0.12%)
Intervertebral disc disorder † 1	1/868 (0.12%)	0/868 (0.00%)
Intervertebral disc protrusion † 1	5/868 (0.58%)	1/868 (0.12%)
Musculoskeletal pain † 1	0/868 (0.00%)	1/868 (0.12%)
Myositis † 1	1/868 (0.12%)	0/868 (0.00%)
Osteoarthritis † 1	5/868 (0.58%)	4/868 (0.46%)
Osteonecrosis † 1	1/868 (0.12%)	1/868 (0.12%)
Pathological fracture † 1	0/868 (0.00%)	1/868 (0.12%)
Periarthritis † 1	1/868 (0.12%)	3/868 (0.35%)
Rhabdomyolysis † 1	2/868 (0.23%)	0/868 (0.00%)
Rotator cuff syndrome † 1	2/868 (0.23%)	0/868 (0.00%)
Spinal deformity † 1	0/868 (0.00%)	1/868 (0.12%)
Spondylolisthesis † 1	1/868 (0.12%)	0/868 (0.00%)
Synovitis † 1	0/868 (0.00%)	1/868 (0.12%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenolymphoma † 1	0/868 (0.00%)	1/868 (0.12%)
Anal cancer † 1	2/868 (0.23%)	0/868 (0.00%)
Basal cell carcinoma † 1	3/868 (0.35%)	2/868 (0.23%)
Benign breast neoplasm † 1	1/868 (0.12%)	0/868 (0.00%)
Benign ovarian tumour † 1	1/868 (0.12%)	0/868 (0.00%)
Bowenoid papulosis † 1	1/868 (0.12%)	0/868 (0.00%)
Brain cancer metastatic † 1	1/868 (0.12%)	0/868 (0.00%)
Breast cancer † 1	4/868 (0.46%)	8/868 (0.92%)
Breast cancer in situ † 1	1/868 (0.12%)	0/868 (0.00%)
Breast cancer stage II † 1	0/868 (0.00%)	1/868 (0.12%)
Breast neoplasm † 1	0/868 (0.00%)	1/868 (0.12%)
Carcinoid tumour of the pancreas † 1	1/868 (0.12%)	0/868 (0.00%)
Cervix neoplasm † 1	1/868 (0.12%)	0/868 (0.00%)
Chronic myeloid leukaemia † 1	0/868 (0.00%)	1/868 (0.12%)
Endometrial cancer † 1	1/868 (0.12%)	0/868 (0.00%)
Fibroma † 1	0/868 (0.00%)	1/868 (0.12%)
Glioma † 1	1/868 (0.12%)	0/868 (0.00%)
Haemangioma † 1	0/868 (0.00%)	1/868 (0.12%)
Leiomyoma † 1	0/868 (0.00%)	1/868 (0.12%)
Lung adenocarcinoma stage II † 1	1/868 (0.12%)	0/868 (0.00%)
Lung squamous cell carcinoma stage unspecified † 1	1/868 (0.12%)	0/868 (0.00%)
Malignant melanoma † 1	2/868 (0.23%)	2/868 (0.23%)
Meningioma † 1	1/868 (0.12%)	0/868 (0.00%)
Mesothelioma malignant † 1	1/868 (0.12%)	0/868 (0.00%)
Metastatic malignant melanoma † 1	1/868 (0.12%)	0/868 (0.00%)
Metastatic neoplasm † 1	1/868 (0.12%)	1/868 (0.12%)
Pancreatic carcinoma † 1	0/868 (0.00%)	1/868 (0.12%)
Pharyngeal neoplasm benign † 1	0/868 (0.00%)	1/868 (0.12%)
Rectal cancer † 1	0/868 (0.00%)	1/868 (0.12%)
Renal cell carcinoma † 1	3/868 (0.35%)	0/868 (0.00%)
Salivary gland cancer † 1	0/868 (0.00%)	1/868 (0.12%)
Squamous cell carcinoma † 1	1/868 (0.12%)	1/868 (0.12%)
Squamous cell carcinoma of the cervix † 1	1/868 (0.12%)	0/868 (0.00%)
Squamous endometrial carcinoma † 1	1/868 (0.12%)	0/868 (0.00%)
Thyroid cancer † 1	2/868 (0.23%)	1/868 (0.12%)
Transitional cell carcinoma † 1	0/868 (0.00%)	1/868 (0.12%)
Uterine leiomyoma † 1	6/868 (0.69%)	3/868 (0.35%)
Nervous system disorders
Cerebral haemorrhage † 1	1/868 (0.12%)	0/868 (0.00%)
Cerebral ischaemia † 1	0/868 (0.00%)	1/868 (0.12%)
Cerebrovascular insufficiency † 1	1/868 (0.12%)	0/868 (0.00%)
Cervicobrachial syndrome † 1	0/868 (0.00%)	1/868 (0.12%)
Complex partial seizures † 1	0/868 (0.00%)	1/868 (0.12%)
Convulsion † 1	3/868 (0.35%)	2/868 (0.23%)
Dementia † 1	1/868 (0.12%)	0/868 (0.00%)
Disturbance in attention † 1	0/868 (0.00%)	1/868 (0.12%)
Dysarthria † 1	1/868 (0.12%)	0/868 (0.00%)
Epilepsy † 1	1/868 (0.12%)	1/868 (0.12%)
Headache † 1	1/868 (0.12%)	0/868 (0.00%)
Hemiparesis † 1	0/868 (0.00%)	1/868 (0.12%)
Hypoaesthesia † 1	0/868 (0.00%)	2/868 (0.23%)
Intracranial aneurysm † 1	1/868 (0.12%)	0/868 (0.00%)
Lumbar radiculopathy † 1	0/868 (0.00%)	1/868 (0.12%)
Migraine † 1	1/868 (0.12%)	1/868 (0.12%)
Multiple sclerosis † 1	4/868 (0.46%)	2/868 (0.23%)
Multiple sclerosis relapse † 1	116/868 (13.36%)	122/868 (14.06%)
Muscle spasticity † 1	1/868 (0.12%)	0/868 (0.00%)
Neuralgia † 1	1/868 (0.12%)	2/868 (0.23%)
Optic neuritis † 1	0/868 (0.00%)	2/868 (0.23%)
Paraesthesia † 1	0/868 (0.00%)	1/868 (0.12%)
Paraparesis † 1	2/868 (0.23%)	0/868 (0.00%)
Parkinson's disease † 1	1/868 (0.12%)	0/868 (0.00%)
Quadriparesis † 1	1/868 (0.12%)	0/868 (0.00%)
Radiculitis † 1	1/868 (0.12%)	0/868 (0.00%)
Relapsing-remitting multiple sclerosis † 1	2/868 (0.23%)	1/868 (0.12%)
Sciatica † 1	1/868 (0.12%)	1/868 (0.12%)
Subarachnoid haemorrhage † 1	1/868 (0.12%)	0/868 (0.00%)
Syncope † 1	2/868 (0.23%)	1/868 (0.12%)
Transient global amnesia † 1	1/868 (0.12%)	0/868 (0.00%)
Trigeminal neuralgia † 1	1/868 (0.12%)	2/868 (0.23%)
Uhthoff's phenomenon † 1	1/868 (0.12%)	0/868 (0.00%)
Pregnancy, puerperium and perinatal conditions
Abortion missed † 1	0/868 (0.00%)	1/868 (0.12%)
Abortion spontaneous † 1	1/868 (0.12%)	1/868 (0.12%)
Complication of pregnancy † 1	1/868 (0.12%)	0/868 (0.00%)
Psychiatric disorders
Acute psychosis † 1	1/868 (0.12%)	1/868 (0.12%)
Alcoholism † 1	1/868 (0.12%)	0/868 (0.00%)
Anorexia nervosa † 1	0/868 (0.00%)	1/868 (0.12%)
Anxiety disorder † 1	1/868 (0.12%)	0/868 (0.00%)
Burnout syndrome † 1	1/868 (0.12%)	0/868 (0.00%)
Catatonia † 1	1/868 (0.12%)	0/868 (0.00%)
Completed suicide † 1	0/868 (0.00%)	2/868 (0.23%)
Delirium † 1	0/868 (0.00%)	1/868 (0.12%)
Depression † 1	0/868 (0.00%)	3/868 (0.35%)
Drug abuse † 1	2/868 (0.23%)	0/868 (0.00%)
Hallucination † 1	1/868 (0.12%)	0/868 (0.00%)
Major depression † 1	0/868 (0.00%)	2/868 (0.23%)
Mood disorder due to a general medical condition † 1	1/868 (0.12%)	0/868 (0.00%)
Morbid thoughts † 1	1/868 (0.12%)	0/868 (0.00%)
Neurosis † 1	1/868 (0.12%)	0/868 (0.00%)
Psychiatric decompensation † 1	0/868 (0.00%)	1/868 (0.12%)
Psychotic behaviour † 1	1/868 (0.12%)	0/868 (0.00%)
Psychotic disorder † 1	0/868 (0.00%)	1/868 (0.12%)
Psychotic disorder due to a general medical condition † 1	0/868 (0.00%)	1/868 (0.12%)
Stress † 1	1/868 (0.12%)	0/868 (0.00%)
Suicide attempt † 1	1/868 (0.12%)	0/868 (0.00%)
Renal and urinary disorders
Haematuria † 1	1/868 (0.12%)	0/868 (0.00%)
Hydronephrosis † 1	1/868 (0.12%)	1/868 (0.12%)
Nephrolithiasis † 1	1/868 (0.12%)	2/868 (0.23%)
Nephrotic syndrome † 1	1/868 (0.12%)	0/868 (0.00%)
Neurogenic bladder † 1	1/868 (0.12%)	0/868 (0.00%)
Renal failure acute † 1	1/868 (0.12%)	0/868 (0.00%)
Reproductive system and breast disorders
Breast necrosis † 1	1/868 (0.12%)	0/868 (0.00%)
Cervical dysplasia † 1	0/868 (0.00%)	2/868 (0.23%)
Cystocele † 1	1/868 (0.12%)	0/868 (0.00%)
Dysfunctional uterine bleeding † 1	1/868 (0.12%)	0/868 (0.00%)
Endometrial hyperplasia † 1	1/868 (0.12%)	0/868 (0.00%)
Endometriosis † 1	0/868 (0.00%)	3/868 (0.35%)
Fibrocystic breast disease † 1	1/868 (0.12%)	0/868 (0.00%)
Menorrhagia † 1	1/868 (0.12%)	2/868 (0.23%)
Metrorrhagia † 1	1/868 (0.12%)	3/868 (0.35%)
Ovarian cyst † 1	2/868 (0.23%)	1/868 (0.12%)
Ovarian cyst ruptured † 1	0/868 (0.00%)	1/868 (0.12%)
Pelvic adhesions † 1	0/868 (0.00%)	1/868 (0.12%)
Pelvic pain † 1	0/868 (0.00%)	1/868 (0.12%)
Uterine polyp † 1	1/868 (0.12%)	1/868 (0.12%)
Respiratory, thoracic and mediastinal disorders
Asthma † 1	1/868 (0.12%)	0/868 (0.00%)
Choking † 1	0/868 (0.00%)	1/868 (0.12%)
Chronic obstructive pulmonary disease † 1	2/868 (0.23%)	1/868 (0.12%)
Paranasal cyst † 1	0/868 (0.00%)	1/868 (0.12%)
Pleural effusion † 1	1/868 (0.12%)	0/868 (0.00%)
Pleurisy † 1	0/868 (0.00%)	1/868 (0.12%)
Pneumonia aspiration † 1	1/868 (0.12%)	0/868 (0.00%)
Pulmonary artery thrombosis † 1	1/868 (0.12%)	0/868 (0.00%)
Pulmonary embolism † 1	2/868 (0.23%)	1/868 (0.12%)
Pulmonary sarcoidosis † 1	0/868 (0.00%)	1/868 (0.12%)
Skin and subcutaneous tissue disorders
Decubitus ulcer † 1	1/868 (0.12%)	0/868 (0.00%)
Dermatitis allergic † 1	0/868 (0.00%)	1/868 (0.12%)
Skin ulcer † 1	1/868 (0.12%)	0/868 (0.00%)
Surgical and medical procedures
Abdominoplasty † 1	1/868 (0.12%)	0/868 (0.00%)
Aortic valve replacement † 1	1/868 (0.12%)	0/868 (0.00%)
Appendicectomy † 1	1/868 (0.12%)	0/868 (0.00%)
Bladder neck suspension † 1	0/868 (0.00%)	1/868 (0.12%)
Bunion operation † 1	0/868 (0.00%)	1/868 (0.12%)
Caesarean section † 1	0/868 (0.00%)	1/868 (0.12%)
Carpal tunnel decompression † 1	0/868 (0.00%)	1/868 (0.12%)
Cholecystectomy † 1	1/868 (0.12%)	0/868 (0.00%)
Cochlea implant † 1	0/868 (0.00%)	1/868 (0.12%)
Cystocele repair † 1	1/868 (0.12%)	0/868 (0.00%)
Female sterilisation † 1	1/868 (0.12%)	1/868 (0.12%)
Hip arthroplasty † 1	1/868 (0.12%)	0/868 (0.00%)
Hysterectomy † 1	0/868 (0.00%)	1/868 (0.12%)
Knee arthroplasty † 1	0/868 (0.00%)	1/868 (0.12%)
Mammoplasty † 1	1/868 (0.12%)	0/868 (0.00%)
Medical device change † 1	0/868 (0.00%)	1/868 (0.12%)
Medical device removal † 1	0/868 (0.00%)	1/868 (0.12%)
Ovarian cystectomy † 1	1/868 (0.12%)	0/868 (0.00%)
Percutaneous coronary intervention † 1	1/868 (0.12%)	0/868 (0.00%)
Postoperative care † 1	0/868 (0.00%)	1/868 (0.12%)
Surgery † 1	0/868 (0.00%)	1/868 (0.12%)
Thyroidectomy † 1	0/868 (0.00%)	1/868 (0.12%)
Umbilical hernia repair † 1	1/868 (0.12%)	0/868 (0.00%)
Varicose vein operation † 1	1/868 (0.12%)	0/868 (0.00%)
Vascular disorders
Circulatory collapse † 1	1/868 (0.12%)	0/868 (0.00%)
Deep vein thrombosis † 1	1/868 (0.12%)	1/868 (0.12%)
Hypertension † 1	1/868 (0.12%)	0/868 (0.00%)
Hypertensive crisis † 1	0/868 (0.00%)	1/868 (0.12%)
Venous thrombosis † 1	1/868 (0.12%)	0/868 (0.00%)
Venous thrombosis limb † 1	0/868 (0.00%)	1/868 (0.12%)
1 Term from vocabulary, MedDRA 13.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	BG00012 240 mg BID	BG00012 240 mg TID
	Affected / at Risk (%)	Affected / at Risk (%)
Total	779/868 (89.75%)	767/868 (88.36%)
Blood and lymphatic system disorders
Lymphopenia † 1	52/868 (5.99%)	42/868 (4.84%)
Gastrointestinal disorders
Abdominal pain † 1	50/868 (5.76%)	55/868 (6.34%)
Abdominal pain upper † 1	69/868 (7.95%)	76/868 (8.76%)
Diarrhoea † 1	111/868 (12.79%)	118/868 (13.59%)
Nausea † 1	56/868 (6.45%)	61/868 (7.03%)
Vomiting † 1	42/868 (4.84%)	45/868 (5.18%)
General disorders
Fatigue † 1	100/868 (11.52%)	102/868 (11.75%)
Pyrexia † 1	47/868 (5.41%)	43/868 (4.95%)
Infections and infestations
Bronchitis † 1	82/868 (9.45%)	98/868 (11.29%)
Gastroenteritis † 1	52/868 (5.99%)	33/868 (3.80%)
Herpes zoster † 1	47/868 (5.41%)	38/868 (4.38%)
Influenza † 1	87/868 (10.02%)	67/868 (7.72%)
Nasopharyngitis † 1	220/868 (25.35%)	226/868 (26.04%)
Pharyngitis † 1	44/868 (5.07%)	50/868 (5.76%)
Sinusitis † 1	65/868 (7.49%)	63/868 (7.26%)
Upper respiratory tract infection † 1	143/868 (16.47%)	136/868 (15.67%)
Urinary tract infection † 1	196/868 (22.58%)	164/868 (18.89%)
Injury, poisoning and procedural complications
Fall † 1	60/868 (6.91%)	63/868 (7.26%)
Investigations
Alanine aminotransferase increased † 1	53/868 (6.11%)	59/868 (6.80%)
Albumin urine present † 1	66/868 (7.60%)	62/868 (7.14%)
Lymphocyte count decreased † 1	56/868 (6.45%)	42/868 (4.84%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	97/868 (11.18%)	115/868 (13.25%)
Back pain † 1	125/868 (14.40%)	125/868 (14.40%)
Muscle spasms † 1	38/868 (4.38%)	49/868 (5.65%)
Musculoskeletal pain † 1	35/868 (4.03%)	49/868 (5.65%)
Pain in extremity † 1	102/868 (11.75%)	92/868 (10.60%)
Nervous system disorders
Dizziness † 1	60/868 (6.91%)	45/868 (5.18%)
Headache † 1	145/868 (16.71%)	131/868 (15.09%)
Hypoaesthesia † 1	64/868 (7.37%)	49/868 (5.65%)
Multiple sclerosis relapse † 1	324/868 (37.33%)	335/868 (38.59%)
Paraesthesia † 1	57/868 (6.57%)	59/868 (6.80%)
Psychiatric disorders
Anxiety † 1	31/868 (3.57%)	46/868 (5.30%)
Depression † 1	102/868 (11.75%)	87/868 (10.02%)
Insomnia † 1	52/868 (5.99%)	51/868 (5.88%)
Renal and urinary disorders
Haematuria † 1	49/868 (5.65%)	61/868 (7.03%)
Microalbuminuria † 1	55/868 (6.34%)	61/868 (7.03%)
Proteinuria † 1	76/868 (8.76%)	81/868 (9.33%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	54/868 (6.22%)	66/868 (7.60%)
Skin and subcutaneous tissue disorders
Erythema † 1	47/868 (5.41%)	32/868 (3.69%)
Pruritus † 1	50/868 (5.76%)	38/868 (4.38%)
Rash † 1	45/868 (5.18%)	40/868 (4.61%)
Vascular disorders
Flushing † 1	170/868 (19.59%)	165/868 (19.01%)
Hot flush † 1	44/868 (5.07%)	53/868 (6.11%)
Hypertension † 1	51/868 (5.88%)	43/868 (4.95%)
1 Term from vocabulary, MedDRA 13.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.

Results Point of Contact

• Name/Title: US Biogen Clinical Trial Center
• Organization: Biogen
• Phone: 866-633-4636
• EMail: clinicaltrials@biogen.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020. Erratum In: Ther Adv Neurol Disord. 2020 Oct 21;13:1756286420968357.

Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.

Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT00835770
• Other Study ID Numbers: 109MS303; 2008-004753-14 ( EudraCT Number )
• First Submitted: February 2, 2009
• First Posted: February 4, 2009
• Results First Submitted: October 20, 2020
• Results First Posted: December 31, 2020
• Last Update Posted: December 31, 2020