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

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ClinicalTrials.gov Identifier: NCT01034579
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Relapsing Multiple Sclerosis
Intervention Other: Blood sampling
Enrollment 324
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Rebif® Cohort Copaxone® Cohort
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 158 166
Completed 158 166
Not Completed 0 0
Arm/Group Title Rebif® Cohort Copaxone® Cohort Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 158 166 324
Hide Baseline Analysis Population Description
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).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 158 participants 166 participants 324 participants
36.4  (9.5) 37.4  (9.5) 36.9  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 166 participants 324 participants
Female
99
  62.7%
119
  71.7%
218
  67.3%
Male
59
  37.3%
47
  28.3%
106
  32.7%
1.Primary Outcome
Title Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers
Hide Description A responder was defined as a participant with no multiple sclerosis (MS) relapse and no Expanded Disability Status Scale (EDSS) progression during 96 weeks in 24735 (NCT00078338). All responders were categorized on the basis of following six SNP markers: SNP1, SNP2, SNP3, SNP4, SNP5, and SNP6. Two types of variables were possible for each SNP marker: two-level genotype-based or three-level allele-based association variables. For the two-level genotype-based SNP markers (SNP2, SNP4, and SNP6), the absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). For the three-level allele-based association SNP markers (SNP1, SNP3, and SNP5), the analysis was based on the number of copies of the allele (0, 1 and 2). Percentage of responders segregated on the basis of SNP marker variable were reported.
Time Frame Day 1 of EMR200136_023 study
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.
Arm/Group Title Rebif® Cohort Copaxone® Cohort
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 135 149
Measure Type: Number
Unit of Measure: percentage of participants
SNP1: 0 copy (n=63, 61) 63.5 63.9
SNP1: 1 copy (n=61, 73) 65.6 60.3
SNP1: 2 copies (n=11, 15) 72.7 73.3
SNP2: Present (n=106, 121) 61.3 64.5
SNP2: Absent (n=29, 28) 79.3 57.1
SNP3: 0 copy (n=62, 72) 67.7 65.3
SNP3: 1 copy (n=64, 62) 60.9 56.5
SNP3: 2 copies (n=9, 15) 77.8 80.0
SNP4: Present (n=73, 77) 63.0 61.0
SNP4: Absent (n=62, 72) 67.7 65.3
SNP5: 0 copy (n=58, 66) 65.5 60.6
SNP5: 1 copy (n=54, 67) 64.8 67.2
SNP5: 2 copies (n=23, 16) 65.2 56.3
SNP6: Present (n=18, 27) 55.6 63.0
SNP6: Absent (n=117, 122) 66.7 63.1
2.Secondary Outcome
Title Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker
Hide Description EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5, and by at least 0.5 points if last EDSS was more than 5.5. SNP2 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). Number of responders segregated on the basis of SNP2 marker variable were reported.
Time Frame Day 1 of EMR200136_023 study
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.
Arm/Group Title Rebif® Cohort Copaxone® Cohort
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 135 151
Measure Type: Number
Unit of Measure: participants
SNP2: Present (n=106, 123) 16 16
SNP2: Absent (n=29, 28) 3 0
3.Secondary Outcome
Title Change in Time Constant 1 Gadolinium (T1 Gd) Enhancing Lesion Volume as Defined by SNP3 and SNP4 Markers
Hide Description Change in T1 Gd enhancing lesion volume was measured by using magnetic resonance imaging (MRI) scans. SNP4 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). SNP3 is a three-level allele-based association SNP markers. The analysis was based on the number of copies of the allele (0, 1 and 2). Change in T1 Gd enhancing lesion volume segregated on the basis of SNP3 and SNP4 marker variables were reported.
Time Frame Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study
Hide Outcome Measure Data
Hide Analysis Population Description
MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.
Arm/Group Title Rebif® Cohort Copaxone® Cohort
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 65 69
Mean (Standard Deviation)
Unit of Measure: cubic millimeter (mm^3)
SNP3: 0 copy (n=30, 42) -524.23  (1481.03) -203.71  (687.59)
SNP3: 1 copy (n=31, 22) -106.97  (152.22) -61.95  (232.25)
SNP3: 2 copies (n=4, 5) -26.50  (53.00) -22.80  (34.27)
SNP4: Present (n=35, 27) -97.77  (146.18) -54.70  (209.73)
SNP4: Absent (n=30, 42) -524.23  (1481.03) -203.71  (687.59)
4.Secondary Outcome
Title Change in Brain Volume as Defined by SNP2 Marker
Hide Description Change in brain volume was measured as the brain parenchymal fraction using MRI scans. SNP2 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). Change in brain volume segregated on the basis of SNP2 marker variables were reported.
Time Frame Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study
Hide Outcome Measure Data
Hide Analysis Population Description
MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.
Arm/Group Title Rebif® Cohort Copaxone® Cohort
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 44 44
Mean (Standard Deviation)
Unit of Measure: cubic millimeter (mm^3)
SNP2: Present (n=33, 38) -1.51  (1.60) -1.10  (1.16)
SNP2: Absent (n=11, 6) -0.57  (1.25) -0.48  (0.41)
5.Secondary Outcome
Title Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker
Hide Description Mean number of T2 active lesions was measured by using MRI scans. SNP5 is a three-level allele-based association SNP markers. The analysis was based on the number of copies of the allele (0, 1 and 2). Mean number of T2 active lesions segregated on the basis of SNP5 marker variables were reported.
Time Frame Day 1 of EMR200136_023 study
Hide Outcome Measure Data
Hide Analysis Population Description
MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.
Arm/Group Title Rebif® Cohort Copaxone® Cohort
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 78 83
Mean (Standard Deviation)
Unit of Measure: T2 lesions
SNP5: 0 copy (n=31, 42) 0.72  (1.50) 1.05  (1.32)
SNP5: 1 copy (n=36, 34) 0.53  (1.41) 0.55  (1.19)
SNP5: 2 copies (n=11, 7) 0.30  (0.40) 0.18  (0.37)
Time Frame [Not Specified]
Adverse Event Reporting Description As it is a retrospective study, only serious adverse events which were considered by the investigator to be at least possibly related to the conduct of the trial, that is, the trial procedure (blood sampling), were collected.
 
Arm/Group Title Rebif® Cohort Copaxone® Cohort
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Rebif® Cohort Copaxone® Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rebif® Cohort Copaxone® Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/158 (0.00%)   0/166 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rebif® Cohort Copaxone® Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
PIs have to submit any publication for internal review and approval by EMD Serono before it can be publicly disclosed.
Results Point of Contact
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01034579     History of Changes
Other Study ID Numbers: EMR200136_023
First Submitted: December 16, 2009
First Posted: December 17, 2009
Results First Submitted: January 27, 2014
Results First Posted: March 10, 2014
Last Update Posted: March 10, 2014