Trial · NCT00853762

Atacicept in Multiple Sclerosis Extension Study, Phase II

NCT00853762, Phase 2, Terminated, EMD Serono; results first posted 2016-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Atacicept in Multiple Sclerosis Extension Study, Phase II. Trials, record NCT00853762. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00853762

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Atacicept in Multiple Sclerosis Extension Study, Phase II
NCT number: NCT00853762
Status: Terminated
Phases: Phase 2
Enrollment: 74 participants, actual
Lead sponsor: EMD Serono
Conditions: Relapsing Multiple Sclerosis
Interventions: Atacicept 25 mg, Atacicept 75 mg, Atacicept 150 mg, Atacicept 150 mg
First posted: 2009-03-02
Last updated: 2017-03-20
Results first posted: 2016-05-24
Limitations and caveats: Sponsor voluntarily decided to terminate this trial after observing increased MS disease activity in trial 28063 ATAMS.

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity	From the first dose of study drug administration up to Week 24	TEAEs were defined as AEs with a start date after or on the date of the first DB treatment injection in ATAMS Extension and that occurred anytime after treatment discontinuation, or up to the day before first Rebif® rescue medication injection in ATAMS Extension. A serious TEAE was an AE that resulted in any of the following: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE severity was graded as per Qualitative Toxicity Scale. Local injection site reactions (injection site: pain, redness, itching and swelling) throughout ATAMS Extension, starting after the first trial medication administration. If the subject experienced 1 or more of the above injection site symptoms, these were reported with the AE verbatim term "injection site reaction". For all randomized subjects, there was an option of rescue treatment with Rebif® for 1 year beginning with the first injection of Rebif®).
Primary	Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36	Blood pressure (systolic and diastolic) was measured after at least 3 minutes resting, with the subject in the seated position.
Primary	Change From Baseline in Vital Signs: Pulse Rate	Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36
Primary	Change From Baseline in Vital Signs: Temperature	Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36
Primary	Change From Baseline in Electrocardiogram (ECGs)	Baseline, Week 12 and 36
Primary	Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels	Baseline up to Week 36	Number of subjects with shifts from normal Grade (Grade 0) at Baseline to worse value at post-baseline (Grade 1 to Grade 4) according to the following criteria: IgA Grade 0: greater than or equal to (\>=) lower limit normal (LLN) 0.7 gram per liter (g/L); Grade 1: less than (\<) LLN - 0.5 g/L, Grade 2: \<0.5g/L -0.3 g/L, Grade 3: \<0.3 g/L -0.1 g/L, Grade 4: \< 0.1 g/L; IgG Grade 0: \>= LLN (7 g/L), Grade 1: \< LLN - 5 g/L, Grade 2: \<5g/L -4 g/L, Grade 3: \<4 g/L -3 g/L and Grade 4: \< 3 g/L; IgM Grade 0: \>= LLN (0.4 g/L), Grade 1: \< LLN - 0.3 g/L, Grade 2: \<0.3 g/L -0.2 g/L, Grade 3: \<0.2 g/L -0.1 g/L, and Grade 4: \< 0.1 g/L are presented in this outcome measure.
Primary	Number of Subjects With Positive Neutralizing Antibody (NAb)	Baseline, Week 12 and 36
Secondary	Number of Subjects With Clinical Attacks/Relapses	Baseline up to Week 24	A clinical attack/relapse was defined as the fulfillment of all the following criteria: 1. 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. 2. Absence of fever or known infection (fever with temperature (axillary, orally, or intra-auriculary) \> 37.5°C/99.5 °Fahrenheit). 3. Objective neurological impairment, correlating with the subject's reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. EDSS overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.
Secondary	Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12	Baseline, Week 12	EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.
Secondary	Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12	Week 12	The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity	From the first dose of study drug administration up to Week 24	Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study.	Subjects	NUMBER
PRIMARY	Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36	Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.	millimeter of mercury (mmHg)	MEAN
PRIMARY	Change From Baseline in Vital Signs: Pulse Rate	Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36	Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.	beats per minute (beats/min)	MEAN
PRIMARY	Change From Baseline in Vital Signs: Temperature	Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36	Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.	Degree Celsius	MEAN
PRIMARY	Change From Baseline in Electrocardiogram (ECGs)	Baseline, Week 12 and 36	No summary tables were prepared for ECG parameters, and ECG data were not formally analyzed. However, a qualitative assessment of ECG morphology and rhythm was made by the Investigator and recorded in the electronic case report form (eCRF). ECG abnormalities considered significant by the investigator were reported as AEs.
PRIMARY	Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels	Baseline up to Week 36	Intent-to-treat (ITT) population included all randomized subjects.	Subjects	NUMBER
SECONDARY	Number of Subjects With Clinical Attacks/Relapses	Baseline up to Week 24	Intent-to-treat (ITT) population included all randomized subjects.	Subjects	NUMBER
SECONDARY	Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12	Baseline, Week 12	Intent-to-treat (ITT) population included all randomized subjects. N signifies (total number of subjects analyzed) the number of evaluable subjects for this outcome measure.	Units on a scale	MEAN
SECONDARY	Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12	Week 12	Intent-to-treat (ITT) population included all randomized subjects. N signifies number of evaluable subjects for this outcome measure.	z-score	MEAN
SECONDARY	Magnetic Resonance Imaging (MRI) Parameters: Number of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject	Baseline, Week 12 and 24	Intent-to-treat (ITT) population included all randomized subjects. n signifies the number of evaluable subjects for this outcome measure.	Number of lesions per subject	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group252

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity	Atacicept 25 mg (With Loading)	Mild TEAEs	5	Subjects
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity	Atacicept 75 mg (With Loading)	Mild TEAEs	8	Subjects
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity	Atacicept 150 mg (With Loading)	Mild TEAEs	8	Subjects
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity	Atacicept 150 mg (Without Loading)	Mild TEAEs	13	Subjects
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity	Atacicept 25 mg (With Loading)	Moderate TEAEs	2	Subjects
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity	Atacicept 75 mg (With Loading)	Moderate TEAEs	4	Subjects
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity	Atacicept 150 mg (With Loading)	Moderate TEAEs	6	Subjects
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity	Atacicept 150 mg (Without Loading)	Moderate TEAEs	4	Subjects
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity	Atacicept 25 mg (With Loading)	Severe TEAEs	0	Subjects
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity	Atacicept 75 mg (With Loading)	Severe TEAEs	0	Subjects

1 to 10 of 252Source ClinicalTrials.gov

See all 252 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Atacicept 25 mg (With Loading)	16
Overall Study	STARTED	Atacicept 75 mg (With Loading)	19
Overall Study	STARTED	Atacicept 150 mg (With Loading)	17
Overall Study	STARTED	Atacicept 150 mg (Without Loading)	22
Overall Study	COMPLETED	Atacicept 25 mg (With Loading)	0
Overall Study	COMPLETED	Atacicept 75 mg (With Loading)	0
Overall Study	COMPLETED	Atacicept 150 mg (With Loading)	0
Overall Study	COMPLETED	Atacicept 150 mg (Without Loading)	0
Overall Study	NOT COMPLETED	Atacicept 25 mg (With Loading)	16
Overall Study	NOT COMPLETED	Atacicept 75 mg (With Loading)	19

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events224

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Injection site reaction	General disorders	Atacicept 25 mg (With Loading)	2	16
other	Injection site reaction	General disorders	Atacicept 75 mg (With Loading)	2	17
other	Injection site reaction	General disorders	Atacicept 150 mg (With Loading)	5	15
other	Injection site reaction	General disorders	Atacicept 150 mg (Without Loading)	7	22
other	Fatigue	General disorders	Atacicept 25 mg (With Loading)	0	16
other	Fatigue	General disorders	Atacicept 75 mg (With Loading)	2	17
other	Fatigue	General disorders	Atacicept 150 mg (With Loading)	0	15
other	Fatigue	General disorders	Atacicept 150 mg (Without Loading)	0	22
other	Nasopharyngitis	Infections and infestations	Atacicept 25 mg (With Loading)	0	16
other	Nasopharyngitis	Infections and infestations	Atacicept 75 mg (With Loading)	1	17

1 to 10 of 224Source ClinicalTrials.gov

See all 224 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Atacicept 25 mg (With Loading)
Total, all-cause mortality	Atacicept 75 mg (With Loading)
Total, all-cause mortality	Atacicept 150 mg (With Loading)
Total, all-cause mortality	Atacicept 150 mg (Without Loading)
Total, other adverse events	Atacicept 25 mg (With Loading)	6	16
Total, other adverse events	Atacicept 75 mg (With Loading)	9	17
Total, other adverse events	Atacicept 150 mg (With Loading)	8	15
Total, other adverse events	Atacicept 150 mg (Without Loading)	12	22
Total, serious adverse events	Atacicept 25 mg (With Loading)	0	16
Total, serious adverse events	Atacicept 75 mg (With Loading)	1	17

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24613349	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Paced Visual Serial Addition Test	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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