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A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS) (ATAMS)

This study has been terminated.
(Sponsor voluntarily decided to terminate trial due to increased MS disease activity in atacicept arms as compared to placebo during a routine IDMC review.)
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00642902
First received: March 21, 2008
Last updated: April 15, 2016
Last verified: April 2016
Results First Received: April 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Relapsing Multiple Sclerosis
Interventions: Drug: Atacicept
Drug: Placebo matched to 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
Atacicept 25 mg Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
Atacicept 75 mg Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
Atacicept 150 mg 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.

Participant Flow:   Overall Study
    Placebo     Atacicept 25 mg     Atacicept 75 mg     Atacicept 150 mg  
STARTED     63     63     64     65  
Treated     63     63     63     65  
COMPLETED     23     21     21     25  
NOT COMPLETED     40     42     43     40  
Adverse Event                 0                 1                 3                 1  
Lost to Follow-up                 1                 1                 0                 0  
Lack of Efficacy                 0                 3                 3                 0  
Death                 1                 0                 0                 0  
Premature termination of clinical trial                 37                 32                 35                 35  
Randomized, but not treated                 0                 0                 1                 0  
Unspecified                 1                 5                 1                 4  



  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 participants.

Reporting Groups
  Description
Placebo Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
Atacicept 25 mg Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
Atacicept 75 mg Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
Atacicept 150 mg 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.
Total Total of all reporting groups

Baseline Measures
    Placebo     Atacicept 25 mg     Atacicept 75 mg     Atacicept 150 mg     Total  
Number of Participants  
[units: participants]
  63     63     64     65     255  
Age  
[units: years]
Mean (Standard Deviation)
  37.7  (10.5)     37.5  (8.5)     38.0  (10.1)     37.5  (10.5)     37.7  (9.9)  
Gender  
[units: participants]
         
Female     45     34     44     46     169  
Male     18     29     20     19     86  



  Outcome Measures
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1.  Primary:   Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan   [ Time Frame: Weeks 12 to 36 ]

2.  Secondary:   Number of New T1 Gd-enhancing Lesions Per Participant   [ Time Frame: Weeks 12, 24, 36 ]

3.  Secondary:   Percentage of Participants Free From Relapses   [ Time Frame: Baseline up to Week 36 ]

4.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs   [ Time Frame: From the first dose of study drug administration up to 12 weeks after the last dose of the study drug ]


  Serious Adverse Events


  Other Adverse Events


  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
Sponsor voluntarily decided to prematurely terminate this trial due to an increase in multiple sclerosis (MS) disease activity observed in atacicept arms as compared to placebo during a routine independent data monitoring committee (IDMC) review.


  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: NCT00642902     History of Changes
Other Study ID Numbers: 28063
Study First Received: March 21, 2008
Results First Received: April 15, 2016
Last Updated: April 15, 2016
Health Authority: United States: Food and Drug Administration