Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial (REGARD-PGx)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01034579
First received: December 16, 2009
Last updated: January 27, 2014
Last verified: January 2014
Results First Received: January 27, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Relapsing Multiple Sclerosis
Intervention: Other: Blood sampling

  Participant Flow
  Hide Participant Flow

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
Of the 758 participants randomized and treated in study 24735 (NCT00078338), 326 were enrolled in EMR200136_023 (NCT01034579) out of which 2 participants, who had participated in initial pharmacogenetics (PGx) sub-study, were found to be ineligible and therefore, evaluable population for EMR200136_023 (NCT01034579) comprised of 324 participants.

Reporting Groups
  Description
Rebif® Cohort Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
Copaxone® Cohort Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.

Participant Flow:   Overall Study
    Rebif® Cohort     Copaxone® Cohort  
STARTED     158     166  
COMPLETED     158     166  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Evaluable population included all randomized participants who had received at least 1 dose of Rebif® or Copaxone® in 24735 (NCT00078338) and not participated in the initial PGx sub-study and provided consent to take part in this EMR200136_023 study (NCT01034579).

Reporting Groups
  Description
Rebif® Cohort Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
Copaxone® Cohort Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
Total Total of all reporting groups

Baseline Measures
    Rebif® Cohort     Copaxone® Cohort     Total  
Number of Participants  
[units: participants]
  158     166     324  
Age  
[units: years]
Mean ± Standard Deviation
  36.4  ± 9.5     37.4  ± 9.5     36.9  ± 9.5  
Gender  
[units: participants]
     
Female     99     119     218  
Male     59     47     106  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers   [ Time Frame: Day 1 of EMR200136_023 study ]

2.  Secondary:   Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker   [ Time Frame: Day 1 of EMR200136_023 study ]

3.  Secondary:   Change in Time Constant 1 Gadolinium (T1 Gd) Enhancing Lesion Volume as Defined by SNP3 and SNP4 Markers   [ Time Frame: Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study ]

4.  Secondary:   Change in Brain Volume as Defined by SNP2 Marker   [ Time Frame: Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study ]

5.  Secondary:   Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker   [ Time Frame: Day 1 of EMR200136_023 study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided


Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01034579     History of Changes
Other Study ID Numbers: EMR200136_023
Study First Received: December 16, 2009
Results First Received: January 27, 2014
Last Updated: January 27, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation