The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial

NCT01034579 | Completed Phase 4 Results

• 1 other identifier: EMR200136_023
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief Summary

This study, REbif® vs Glatiramer acetate in relapsing multiple sclerosis (MS) disease - pharmacogenetic(s) (REGARD-PGx) is a single blood sampling exploratory pharmacogenetic study of the REGARD trial. The aim of this trial is to provide additional data on the factors influencing interferon (IFN) beta response. This is a Phase 4 trial involving subjects who previously participated in the REGARD trial. To address the trial objectives, a single visit follow-up trial will be performed during which a blood sample will be collected.

Conditions

Relapsing Multiple Sclerosis

Keywords

Biomarkers; Genetic markers

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers

  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.

  Day 1 of EMR200136_023 study

Secondary Outcomes (4)

• Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker

  Day 1 of EMR200136_023 study

• Change in Time Constant 1 Gadolinium (T1 Gd) Enhancing Lesion Volume as Defined by SNP3 and SNP4 Markers

  Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study

• Change in Brain Volume as Defined by SNP2 Marker

  Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study

• Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker

  Day 1 of EMR200136_023 study

Study Arms (2)

Rebif® Cohort

OTHER

Other: Blood sampling

Copaxone® Cohort

OTHER

Other: Blood sampling

Interventions

Blood sampling OTHER

Subjects 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 will be enrolled in this retrospective cohort study wherein single blood sampling will be performed for pharmacogenetic markers analysis.

Rebif® Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Was randomized in the REGARD 24735 study
• Is willing and able to comply with the protocol
• Has given written informed consent before performing any trial-related activities

You may not qualify if:

• Is unwilling or unable to participate in the study
• Is already included in the initial REGARD 24735 PGx sub-study

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (1)

Please Contact U.S. Medical Information Located in

Rockland, Massachusetts, United States

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Elisabetta Verdun di Cantogno, MD

  Merck Serono S.A., Geneva

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: February 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 10, 2014
• Results First Posted: March 10, 2014

Record last verified: 2014-01

Locations

US (1)