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Atacicept in Multiple Sclerosis Extension Study, Phase II (ATAMS ext)

This study has been terminated.
(EMD Serono voluntarily decided to terminate this trial after observing increased MS disease activity in trial 28063 ATAMS [Please refer to ATAMS])
Sponsor:
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00853762
First received: February 26, 2009
Last updated: April 15, 2016
Last verified: April 2016
History of Changes
Results First Received: April 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Relapsing Multiple Sclerosis
Intervention: Drug: Atacicept

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First/last participant (informed consent): 03 March 2009/13 August 2009. Last participant completed: 09 September 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 324 subjects were screened and 255 were enrolled in ATAMS (28063; NCT00642902). Overall, 75 subjects randomized and treated in ATAMS were eligible to enter ATAMS Extension. However, 74 subjects were included in ATAMS Extension and 1 subject could not enter due to the premature termination of the trial.

Reporting Groups
  Description
Atacicept 25 mg (With Loading) Subjects who received atacicept 25 milligram (mg) subcutaneously (SC) as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
Atacicept 75 mg (With Loading) Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
Atacicept 150 mg (With Loading) Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
Atacicept 150 mg (Without Loading) Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.

Participant Flow:   Overall Study
    Atacicept 25 mg (With Loading)     Atacicept 75 mg (With Loading)     Atacicept 150 mg (With Loading)     Atacicept 150 mg (Without Loading)  
STARTED     16     19     17     22  
COMPLETED     0     0     0     0  
NOT COMPLETED     16     19     17     22  
Premature Termination                 16                 15                 14                 21  
Protocol Violation                 0                 0                 0                 1  
Withdrawal by Subject                 0                 0                 1                 0  
Unspecified                 0                 2                 0                 0  
Randomised but not Treated                 0                 2                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) population included all randomized subjects.

Reporting Groups
  Description
Atacicept 25 mg (With Loading) Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
Atacicept 75 mg (With Loading) Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
Atacicept 150 mg (With Loading) Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
Atacicept 150 mg (Without Loading) Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
Total Total of all reporting groups

Baseline Measures
    Atacicept 25 mg (With Loading)     Atacicept 75 mg (With Loading)     Atacicept 150 mg (With Loading)     Atacicept 150 mg (Without Loading)     Total  
Number of Participants  
[units: participants]
 		  16     19     17     22     74  
Age  
[units: years]
Mean (Standard Deviation) 		  39.4  (8.4)     36.8  (9.1)     37.4  (11.2)     34.4  (8.6)     36.8  (9.3)  
Gender  
[units: participants]
 		         
Female     8     12     8     16     44  
Male     8     7     9     6     30  



  Outcome Measures
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1.  Primary:   Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity   [ Time Frame: From the first dose of study drug administration up to Week 24 ]
  Show Outcome Measure 1

2.  Primary:   Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36 ]
  Show Outcome Measure 2

3.  Primary:   Change From Baseline in Vital Signs: Pulse Rate   [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36 ]
  Show Outcome Measure 3

4.  Primary:   Change From Baseline in Vital Signs: Temperature   [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36 ]
  Show Outcome Measure 4

5.  Primary:   Change From Baseline in Electrocardiogram (ECGs)   [ Time Frame: Baseline, Week 12 and 36 ]
  Show Outcome Measure 5

6.  Primary:   Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels   [ Time Frame: Baseline up to Week 36 ]
  Show Outcome Measure 6

7.  Primary:   Number of Subjects With Positive Neutralizing Antibody (NAb)   [ Time Frame: Baseline, Week 12 and 36 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Subjects With Clinical Attacks/Relapses   [ Time Frame: Baseline up to Week 24 ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12   [ Time Frame: Baseline, Week 12 ]
  Show Outcome Measure 9

10.  Secondary:   Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 10

11.  Secondary:   Magnetic Resonance Imaging (MRI) Parameters: Number of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject   [ Time Frame: Baseline, Week 12 and 24 ]
  Show Outcome Measure 11

12.  Secondary:   Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions (New or Enlarging T2 Lesions) Per Subject   [ Time Frame: Baseline, Week 12 and Week 24 ]
  Show Outcome Measure 12

13.  Secondary:   Concentrations of Free and Total Atacicept   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 13

14.  Secondary:   Free B-Lymphocyte Stimulator (BLyS) and Free A Proliferation-Inducing Ligand (APRIL) Serum Concentrations.   [ Time Frame: Baseline, Week 12 and 36 ]
  Show Outcome Measure 14

15.  Secondary:   Pharmacogenetics/Pharmacogenomics Analysis   [ Time Frame: Day 1 and Week 36 ]
  Show Outcome Measure 15


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
EMD Serono voluntarily decided to terminate this trial after observing increased MS disease activity in trial 28063 ATAMS.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


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


Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00853762     History of Changes
Other Study ID Numbers: 28851
Study First Received: February 26, 2009
Results First Received: April 15, 2016
Last Updated: April 15, 2016
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency