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An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00930553
First Posted: June 30, 2009
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
Results First Submitted: February 16, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Multiple Sclerosis, Relapsing-Remitting
Intervention: Biological: alemtuzumab

  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
This extension study enrolled participants from previous 3 studies: CAMMS223 (NCT00050778), CAMMS323 (NCT00530348), and CAMMS324 (NCT00548405). Participants were enrolled in this study only after their Month 24 visit in CAMMS323 and CAMMS324. CAMMS223 participants were enrolled within 6 months once their site received approval of extension study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Efficacy outcome data was analyzed only on CAMMS323 and CAMMS324 participants; safety data was analyzed on all participants, as pre-specified in protocol.

Reporting Groups
  Description
Alemtuzumab Participants enrolled from any of the prior studies received long-term follow-up in this study. Participants randomized to receive interferon beta-1a (IFNB-1a) in prior studies received alemtuzumab 12 mg/day infusion intravenously (IV) once daily (QD) for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on magnetic resonance imaging [MRI]), unless they met safety-related retreatment disqualifying criteria.

Participant Flow:   Overall Study
    Alemtuzumab
STARTED   1314 
Participants Entered From CAMMS223   141 
Participants Entered From CAMMS323   488 
Participants Entered From CAMMS324   685 
COMPLETED   1091 
NOT COMPLETED   223 
Adverse Event                1 
Lack of Efficacy                7 
Physician Decision                39 
Protocol Violation                1 
Pregnancy                1 
Withdrawal by Subject                88 
Lost to Follow-up                25 
Death                9 
Study terminated by sponsor                24 
Other than specified above                28 



  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.
No text entered.

Reporting Groups
  Description
Alemtuzumab Participants enrolled from any of the previous studies received long-term follow-up in this study. Participants randomized to receive IFNB-1a in any of the previous studies received alemtuzumab 12 mg/day infusion IV, QD for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on MRI), unless they met safety-related retreatment disqualifying criteria.

Baseline Measures
   Alemtuzumab 
Overall Participants Analyzed 
[Units: Participants]
 1314 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.7  (8.51) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      857  65.2% 
Male      457  34.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Annualized Relapse Rate (ARR)   [ Time Frame: Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension" group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively) ]

2.  Primary:   Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab   [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]

3.  Primary:   Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment   [ Time Frame: Year 1 prior to retreatment, Year 1, 2, 3 after retreatment ]

4.  Primary:   Number of Participants With Sustained Accumulation of Disability (SAD)   [ Time Frame: Baseline (Year 0) up to Year 6 ]

5.  Primary:   Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison   [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]

6.  Secondary:   Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6   [ Time Frame: Baseline (Year 0) up to Year 6 ]

7.  Secondary:   Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study   [ Time Frame: Extension study (CAMMS03409) baseline up to Extension Year 2 ]

8.  Secondary:   Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6   [ Time Frame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension" group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5, 6 ]

9.  Secondary:   Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison   [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]

10.  Secondary:   Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment   [ Time Frame: Retreatment baseline, Year 1, 2 and 3 after retreatment baseline ]

11.  Secondary:   Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity   [ Time Frame: Year 3, 4, 5 and 6 ]

12.  Secondary:   Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment   [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]

13.  Secondary:   Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment   [ Time Frame: Retreatment Baseline, Year 1, 2 and 3 after retreatment ]

14.  Secondary:   Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6   [ Time Frame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension" group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5, 6 ]

15.  Secondary:   Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity   [ Time Frame: Year 3, 4, 5 and 6 ]

16.  Secondary:   Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6   [ Time Frame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension" group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5 and 6 ]

17.  Secondary:   Percentage of Relapse Free Participants   [ Time Frame: Year 3, 4, 5 and 6 ]

18.  Secondary:   Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6   [ Time Frame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “alemtuzumab treatment CAMMS323 extension group”, “alemtuzumab Treatment CAMMS324 Extension” group, respectively),Year 3, 4, 5 and 6 ]

19.  Secondary:   Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison   [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]

20.  Secondary:   Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6   [ Time Frame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension" group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5 and 6 ]

21.  Secondary:   Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison   [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]

22.  Secondary:   Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score at Year 3, 4, 5 and 6   [ Time Frame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension" group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5, 6 ]

23.  Secondary:   Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score Before and After Alemtuzumab Treatment: 2 Year Comparison   [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]

24.  Secondary:   Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6   [ Time Frame: Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension" group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5 and 6 ]

25.  Secondary:   Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison   [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]


  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
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  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: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-US@sanofi.com


Publications:

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00930553     History of Changes
Other Study ID Numbers: CAMMS03409
2009-010788-18 ( EudraCT Number )
LTE12824 ( Other Identifier: Sanofi )
First Submitted: June 26, 2009
First Posted: June 30, 2009
Results First Submitted: February 16, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017