Trial Outcomes & Findings for Atacicept in Subjects With Optic Neuritis (NCT NCT00624468)

Last Updated: 2016-02-17

Results Overview

The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and were then averaged over 12 sectors. The change in RNFL thickness at LOV visit was calculated as RNFL thickness at LOV minus RNFL thickness at baseline.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Baseline, LOV (Week 48)

Results posted on

2016-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo: Double-blind Period Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.	Placebo: SFU Period Subjects who received placebo matched to atacicept in double-blind period were included in safety follow-up (SFU) period (60 weeks) following premature termination of the trial.	Atacicept: SFU Period Subjects who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
Double-blind Period STARTED	17	17	0	0
Double-blind Period COMPLETED	3	4	0	0
Double-blind Period NOT COMPLETED	14	13	0	0
Safety Follow-up (SFU) Period STARTED	0	0	13	14
Safety Follow-up (SFU) Period COMPLETED	0	0	11	11
Safety Follow-up (SFU) Period NOT COMPLETED	0	0	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo: Double-blind Period Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.	Placebo: SFU Period Subjects who received placebo matched to atacicept in double-blind period were included in safety follow-up (SFU) period (60 weeks) following premature termination of the trial.	Atacicept: SFU Period Subjects who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
Double-blind Period Early Termination Initiated by Sponsor	13	12	0	0
Double-blind Period Withdrew Prematurely	1	1	0	0
Safety Follow-up (SFU) Period Lost to Follow-up	0	0	1	2
Safety Follow-up (SFU) Period Other	0	0	1	1

Baseline Characteristics

Atacicept in Subjects With Optic Neuritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo: Double-blind Period n=17 Participants Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period n=17 Participants Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.	Total n=34 Participants Total of all reporting groups
Age, Continuous	32.3 years STANDARD_DEVIATION 7.1 • n=5 Participants	30.6 years STANDARD_DEVIATION 10.2 • n=7 Participants	31.4 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, LOV (Week 48)

Population: ITT population included all randomized participants. Here, "n" signifies those participants who were evaluable for the specified category.

Outcome measures

Outcome measures
Measure	Placebo: Double-blind Period n=17 Participants Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period n=17 Participants Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV) Baseline (n = 17, 17)	103.893 micrometer Standard Deviation 17.271	104.170 micrometer Standard Deviation 8.832
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV) Change at LOV (n = 16, 15)	-17.317 micrometer Standard Deviation 15.158	-8.636 micrometer Standard Deviation 10.056

SECONDARY outcome

Timeframe: Weeks 12, 24 and 36

Population: ITT population included all randomized participants. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and "n" signifies those participants who were evaluable for the specified category.

The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and was then averaged over 12 sectors. Difference was calculated as RNFL thickness in affected eye minus RNFL thickness in fellow eye.

Outcome measures

Outcome measures
Measure	Placebo: Double-blind Period n=13 Participants Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period n=13 Participants Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye Change at Week 12 (n = 13, 13)	-14 micrometer Standard Error 4	-7.9 micrometer Standard Error 1.5
Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye Change at Week 24 (n = 4, 5)	-7 micrometer Standard Error 6.9	-10.6 micrometer Standard Error 3.7
Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye Change at Week 36 (n = 3, 4)	-7.5 micrometer Standard Error 8.8	-9.4 micrometer Standard Error 6.6

SECONDARY outcome

Timeframe: Baseline, Weeks 12 and 24

The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by OCT measurements and was then averaged over 12 sectors. The change in RNFL thickness at Weeks 12 and 24 was calculated as RNFL thickness at Weeks 12 and 24 minus RNFL thickness at baseline, respectively.

Outcome measures

Outcome measures
Measure	Placebo: Double-blind Period n=13 Participants Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period n=13 Participants Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24 Baseline (n=17, 17)	103.893 micrometer Standard Deviation 17.271	104.170 micrometer Standard Deviation 8.832
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24 Change at Week 12 (n = 13, 13)	-17.036 micrometer Standard Deviation 13.919	-9.356 micrometer Standard Deviation 9.532
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24 Change at Week 24 (n = 4, 5)	-17.815 micrometer Standard Deviation 16.505	-11.234 micrometer Standard Deviation 14.230

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24 and 36

Population: ITT population included all randomized participants. Here, "n" signifies those participants who were evaluable for the specified category.

The change in macular thickness at 3 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 3 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 3 mm in the affected eye at baseline, respectively.

Outcome measures

Outcome measures
Measure	Placebo: Double-blind Period n=17 Participants Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period n=17 Participants Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 Change at Week 24 (n = 4, 5)	-72.5 micrometer Standard Deviation 47.0	-50.4 micrometer Standard Deviation 47.7
Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 Change at Week 36 (n = 3, 4)	-32.7 micrometer Standard Deviation 30.7	-40.0 micrometer Standard Deviation 51.3
Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 Baseline (n = 17, 17)	1054.4 micrometer Standard Deviation 76.5	1070.6 micrometer Standard Deviation 72.7
Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 Change at Week 12 (n = 13, 13)	-29.3 micrometer Standard Deviation 34.4	-34.0 micrometer Standard Deviation 21.8

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24 and 36

Population: ITT population included all randomized participants. Here, "n" signifies those participants who were evaluable for the specified category.

The change in macular thickness at 6 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 6 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 6 mm in the affected eye at baseline, respectively.

Outcome measures

Outcome measures
Measure	Placebo: Double-blind Period n=17 Participants Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period n=17 Participants Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 Baseline (n = 17, 17)	954.4 micrometer Standard Deviation 57.4	947.5 micrometer Standard Deviation 61.3
Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 Change at Week 12 (n = 13, 13)	-36.1 micrometer Standard Deviation 28.4	-32.8 micrometer Standard Deviation 25.2
Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 Change at Week 24 (n = 4, 5)	-63.8 micrometer Standard Deviation 32.7	-46.2 micrometer Standard Deviation 36.5
Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 Change at Week 36 (n = 3, 4)	-33.3 micrometer Standard Deviation 33.7	-34.8 micrometer Standard Deviation 46.0

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24 and 36

Population: ITT population included all randomized participants. Here, "n" signifies those participants who were evaluable for the specified category.

The change in macular volume in the affected eye at Weeks 12, 24 and 36 was calculated as macular volume in the affected eye at Weeks 12, 24 and 36 minus macular volume in the affected eye at baseline, respectively.

Outcome measures

Outcome measures
Measure	Placebo: Double-blind Period n=17 Participants Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period n=17 Participants Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36 Baseline (n = 17, 17)	6.8865 cubic micrometer Standard Deviation 0.4199	6.8794 cubic micrometer Standard Deviation 0.4372
Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36 Change at Week 12 (n = 13, 13)	-0.2389 cubic micrometer Standard Deviation 0.1991	-0.2301 cubic micrometer Standard Deviation 0.1612
Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36 Change at Week 24 (n = 4, 5)	-0.4630 cubic micrometer Standard Deviation 0.2466	-0.3292 cubic micrometer Standard Deviation 0.2674
Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36 Change at Week 36 (n = 3, 4)	-0.2353 cubic micrometer Standard Deviation 0.2253	-0.2533 cubic micrometer Standard Deviation 0.3205

SECONDARY outcome

Timeframe: Weeks 12, 24 and 36

Low-contrast letter acuity was measured by using the Sloan Charts at 1.25 fraction (%) and 2.5%. Sloan letters are a set of optotypes used to test visual acuity. Total number of letters correctly identified in the affected and fellow eye were reported. The possible Sloan Chart range is 0 to 70. More the number of letters identified, better is the visual acuity.

Outcome measures

Outcome measures
Measure	Placebo: Double-blind Period n=15 Participants Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period n=14 Participants Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified Sloan chart 1.25%, affected eye: Week 12 (n=15,14)	14.7 letters Standard Deviation 14.7	15.7 letters Standard Deviation 19.0
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified Sloan chart 1.25%, affected eye: Week 24 (n = 5,5)	16.2 letters Standard Deviation 13.6	13.4 letters Standard Deviation 18.4
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified Sloan chart 1.25%, affected eye: Week 36 (n = 3,4)	24.7 letters Standard Deviation 8.1	9.8 letters Standard Deviation 18.8
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified Sloan chart 2.5%, affected eye: Week 12 (n=15, 14)	25.6 letters Standard Deviation 16.7	22.1 letters Standard Deviation 19.5
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified Sloan chart 2.5%, affected eye: Week 24 (n = 5, 5)	26.8 letters Standard Deviation 15.2	21.4 letters Standard Deviation 19.3
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified Sloan chart 2.5%, affected eye: Week 36 (n = 3, 4)	38.7 letters Standard Deviation 4.7	20.3 letters Standard Deviation 18.7
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified Sloan chart 1.25%, fellow eye: Week 12 (n=15,14)	25.7 letters Standard Deviation 13.1	25.9 letters Standard Deviation 16.5
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified Sloan chart 1.25%, fellow eye: Week 24 (n = 5,5)	22.2 letters Standard Deviation 16.1	24.6 letters Standard Deviation 18.4
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified Sloan chart 1.25%, fellow eye: Week 36 (n = 3,4)	35.3 letters Standard Deviation 4.2	19.8 letters Standard Deviation 20.6
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified Sloan chart 2.5%, fellow eye: Week 12 (n=15, 14)	35.3 letters Standard Deviation 13.4	36.4 letters Standard Deviation 12.7
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified Sloan chart 2.5%, fellow eye: Week 24 (n = 5, 5)	33.6 letters Standard Deviation 18.2	35.8 letters Standard Deviation 15.4
Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified Sloan chart 2.5%, fellow eye: Week 36 (n = 3, 4)	45.7 letters Standard Deviation 4.5	32.5 letters Standard Deviation 19.1

SECONDARY outcome

Timeframe: Weeks 12, 24 and 36

Contrast Sensitivity was measured using the Pelli-Robson Charts. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. Total number of letters correctly identified in the affected and fellow eye were reported. The total possible range is 0 to 48. More the number of letters identified, better is the contrast sensitivity.

Outcome measures

Outcome measures
Measure	Placebo: Double-blind Period n=15 Participants Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period n=14 Participants Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Contrast Sensitivity: Total Number of Letters Correctly Identified Affected eye: Week 12 (n = 15, 14)	35.4 letters Standard Deviation 5.9	32.4 letters Standard Deviation 8.8
Contrast Sensitivity: Total Number of Letters Correctly Identified Affected eye: Week 24 (n = 5, 5)	34.2 letters Standard Deviation 6.9	33.0 letters Standard Deviation 4.7
Contrast Sensitivity: Total Number of Letters Correctly Identified Affected eye: Week 36 (n = 3, 3)	37.0 letters Standard Deviation 5.3	34.7 letters Standard Deviation 3.2
Contrast Sensitivity: Total Number of Letters Correctly Identified Fellow eye: Week 12 (n = 15, 14)	38.3 letters Standard Deviation 4.1	37.6 letters Standard Deviation 3.3
Contrast Sensitivity: Total Number of Letters Correctly Identified Fellow eye: Week 24 (n = 5, 5)	36.2 letters Standard Deviation 9.4	37.4 letters Standard Deviation 2.4
Contrast Sensitivity: Total Number of Letters Correctly Identified Fellow eye: Week 36 (n = 3, 3)	39.7 letters Standard Deviation 4.0	40.0 letters Standard Deviation 1.0

SECONDARY outcome

Timeframe: Weeks 12, 24 and 36

Contrast sensitivity was measured using the Pelli-Robson charts with letters arranged in groups of 3. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. The possible score line range is 0 (visual disability) to 16 (normal contrast sensitivity).

Outcome measures

Outcome measures
Measure	Placebo: Double-blind Period n=15 Participants Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period n=14 Participants Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Contrast Sensitivity: Score Line Affected eye: Week 12 (n = 15, 14)	12.1 units on a scale Standard Deviation 1.5	10.9 units on a scale Standard Deviation 2.9
Contrast Sensitivity: Score Line Affected eye: Week 24 (n = 5, 5)	11.4 units on a scale Standard Deviation 2.6	11.2 units on a scale Standard Deviation 1.6
Contrast Sensitivity: Score Line Affected eye: Week 36 (n = 3, 3)	12.3 units on a scale Standard Deviation 2.1	11.7 units on a scale Standard Deviation 1.5
Contrast Sensitivity: Score Line Fellow eye: Week 12 (n = 15, 14)	12.9 units on a scale Standard Deviation 1.5	12.7 units on a scale Standard Deviation 1.1
Contrast Sensitivity: Score Line Fellow eye: Week 24 (n = 5, 5)	11.8 units on a scale Standard Deviation 3.3	12.4 units on a scale Standard Deviation 0.5
Contrast Sensitivity: Score Line Fellow eye: Week 36 (n = 3, 3)	13.3 units on a scale Standard Deviation 1.2	13.3 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: From baseline (Study Day 1) up to Week 36

Population: ITT population included all randomized participants.

Conversion to CDMS was defined as experiencing a second clinical attack meeting all of the following criteria: (a) Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both (i) Neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and (ii) Neurological abnormality lasting for at least 24 hours; (b) Absence of fever or known infection (fever with temperature \[axillary, orally or intraauricularly\] greater than 37.5 degree Celsius/99.5 degree Fahrenheit); (c) Objective neurological impairment, correlating with the participant's reported symptoms, defined as either (i) Increase in at least 1 of the functional systems of the Expanded Disability Status Score (EDSS), or (ii) Increase of the total EDSS score. EDSS assesses disability in 8 functional systems and total score ranges from 0 (normal) to 10 (death due to MS). Percentage of participants converting to CDMS (second clinical attack) was reported.

Outcome measures

Outcome measures
Measure	Placebo: Double-blind Period n=17 Participants Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period n=17 Participants Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack	17.6 percentage of participants	35.3 percentage of participants

Adverse Events

Placebo: Double-blind Period

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Atacicept: Double-blind Period

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo: SFU Period

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Atacicept: SFU Period

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo: Double-blind Period n=17 participants at risk Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	Atacicept: Double-blind Period n=17 participants at risk Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.	Placebo: SFU Period n=13 participants at risk Participants who received placebo matched to atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.	Atacicept: SFU Period n=14 participants at risk Participants who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
Infections and infestations Bacterial pyelonephritis	0.00% 0/17 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	0.00% 0/17 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	0.00% 0/13 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	7.1% 1/14 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).
Nervous system disorders Multiple sclerosis	0.00% 0/17 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	0.00% 0/17 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	0.00% 0/13 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	7.1% 1/14 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).
Nervous system disorders Myelitis transverse	0.00% 0/17 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	0.00% 0/17 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	0.00% 0/13 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	7.1% 1/14 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).
Nervous system disorders Myelitis	0.00% 0/17 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	0.00% 0/17 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	7.7% 1/13 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	0.00% 0/14 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).
General disorders Pyrexia	0.00% 0/17 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	0.00% 0/17 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	7.7% 1/13 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	0.00% 0/14 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).
Skin and subcutaneous tissue disorders Blister	0.00% 0/17 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	0.00% 0/17 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	7.7% 1/13 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).	0.00% 0/14 • Baseline up to Week 48 ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).

Other adverse events

Additional Information

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