A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Wee...
`
`A service of the U.S. National Institutes of Health
`
`Example: "Heart attack" AND "Los Angeles"
` Search for studies:
`
`Advanced Search Help Studies by Topic Glossary
`
`Find Studies
`
`About Clinical Studies
`
`Submit Studies
`
`Resources
`
`About This Site
`
`Home
`
`Find Studies Study Record Detail
`
`Text Size
`
`A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety
` and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared
` to Placebo (GALA)
`
` This study is ongoing, but not recruiting
` participants.
`
`Sponsor:
` Teva Pharmaceutical Industries
`
`Information provided by (Responsible Party):
`Teva Pharmaceutical Industries
`
`ClinicalTrials.gov Identifier:
`NCT01067521
`First received: February 10, 2010
`Last updated: January 6, 2016
`Last verified: January 2016
`History of Changes
`
`Full Text View
`
`Tabular View
`
`No Study Results Posted
`
`Disclaimer
`
`How to Read a Study Record
`
` Purpose
`
`The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in
` subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled phase. The study has two phases:
`Placebo Controlled Phase: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo.
`Open Label Extension: All subjects will continue treatment with GA 40 mg administered three times a week, until this dose strength is
` commercially available for the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the development of this GA dose
` regimen is stopped by the Sponsor
`
`Condition
`
` Relapsing Remitting Multiple Sclerosis
`
`Intervention
`
` Drug: Glatiramer acetate (GA)
` Other: Placebo
`
`Phase
`
` Phase 3
`
` Interventional
`Study Type:
`Study Design: Allocation: Randomized
`Endpoint Classification: Safety/Efficacy Study
`Intervention Model: Parallel Assignment
`Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
`Primary Purpose: Treatment
`
`Official Title:
`
`A Multinational, Multicenter, Randomized, Parallel-group Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess
` Efficacy, Safety and Tolerability of Glatiramer Acetate Injection 40mg Compared to Placebo in a Double-blind Design
`
`Resource links provided by NLM:
`
`Genetics Home Reference related topics: multiple sclerosis
`
`MedlinePlus related topics: Multiple Sclerosis
`
`Drug Information available for: Glatiramer Glatiramer acetate
`
`https://clinicaltrials.gov/ct2/show/NCT01067521[2/5/2016 1:40:53 PM]
`
`Mylan Pharms. Inc. Exhibit 1004 Page 1
`
`

`
`A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Wee...
`
`U.S. FDA Resources
`
`Further study details as provided by Teva Pharmaceutical Industries:
`
`Primary Outcome Measures:
`The total number of confirmed relapses during the 12 month PC phase [ Time Frame: 12 months ] [ Designated as safety issue: No ]
`
`Secondary Outcome Measures:
`The number of new T2 lesions at month 12 (end of PC phase) as compared to baseline scan. [ Time Frame: 12 months ]
` [ Designated as safety issue: No ]
`The cumulative number of enhancing lesions on T1-weighted images taken at months 6 and 12 (end of PC phase). [ Time Frame: 12 months ]
` [ Designated as safety issue: No ]
`Status of Gd-enhancing T1 activity at baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
`=0 if the subject has no Gd-enhancing T1 lesions at baseline; =1 if the subject has at least one Gd-enhancing T1 lesion at baseline
`
`1404
` Enrollment:
`May 2010
` Study Start Date:
`August 2016
` Estimated Study Completion Date:
` Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
`
` Arms
`
` Assigned Interventions
`
` Experimental: GA 40 mg
`
` Drug: Glatiramer acetate (GA)
`GA 40 mg administered 3 times a week by subcutaneous injection for a period of 12 months
`
` Placebo Comparator: Placebo
`
` Other: Placebo
`Placebo comparator
`
` Eligibility
`
`18 Years to 55 Years
`Ages Eligible for Study:
`Genders Eligible for Study:
`Both
`Accepts Healthy Volunteers: No
`
`Criteria
`Inclusion Criteria:
`1. Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria with a relapsing-remitting
` disease course.
`2. Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline visits.
`3. Subjects must be in a relapse-free, stable neurological condition and free of corticosteroid treatment [intravenous (IV), intramuscular (IM)
` and/or per os (PO)] or ACTH 30 days prior to screening (month -1) and between screening and baseline (month 0) visits.
`4. Subjects must have experienced one of the following: At least one documented relapse in the 12 months prior to screening, or At least two
` documented relapses in the 24 months prior to screening, or One documented relapse between 12 and 24 months prior to screening with at
` least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.
`5. Subjects must be between 18 and 55 years of age, inclusive.
`6. Women of child-bearing potential must practice an acceptable method of birth control.
`7. Subjects must be able to sign and date a written informed consent prior to entering the study.
`8. Subjects must be willing and able to comply with the protocol requirements for the duration of the study
`Exclusion Criteria:
`1. Subjects with progressive forms of MS.
`2. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
`3. Use of immunosuppressive (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit.
`4. Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening.
`
`https://clinicaltrials.gov/ct2/show/NCT01067521[2/5/2016 1:40:53 PM]
`
`Mylan Pharms. Inc. Exhibit 1004 Page 2
`
`

`
`A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Wee...
`
`5. Use of cladribine within 2 years prior to screening.
`6. Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg) within 2 months prior to screening.
`7. Previous use of GA or any other glatiramoid.
`8. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
`9. Previous total body irradiation or total lymphoid irradiation.
`10. Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
`11. Pregnancy or breastfeeding.
`12. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as
` determined by medical history, physical exams, ECG, abnormal laboratory tests and chest X-ray. Such conditions may include hepatic, renal
` or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of malignancy, major psychiatric
` disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment.
`13. A known history of sensitivity to Gadolinium.
`14. Inability to successfully undergo MRI scanning.
`15. A known drug hypersensitivity to Mannitol.
`
` Contacts and Locations
`
` Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a
` study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general
` information, see Learn About Clinical Studies.
`
` Please refer to this study by its ClinicalTrials.gov identifier: NCT01067521
`
` Show 159 Study Locations
`
`Sponsors and Collaborators
`Teva Pharmaceutical Industries
`
` More Information
`
` No publications provided
`
`Teva Pharmaceutical Industries
`Responsible Party:
`ClinicalTrials.gov Identifier: NCT01067521 History of Changes
`Other Study ID Numbers:
` MS-GA-301
`Study First Received:
`February 10, 2010
`Last Updated:
`January 6, 2016
`Health Authority:
`United States: Food and Drug Administration
`
` Keywords provided by Teva Pharmaceutical Industries:
` Relapsing Remitting Multiple Sclerosis
` Glatiramer Acetate
`
` Additional relevant MeSH terms:
` Multiple Sclerosis
` Multiple Sclerosis, Relapsing-Remitting
` Sclerosis
` Autoimmune Diseases
` Autoimmune Diseases of the Nervous System
` Demyelinating Autoimmune Diseases, CNS
` Demyelinating Diseases
` Immune System Diseases
`
`ClinicalTrials.gov processed this record on February 04, 2016
`
`https://clinicaltrials.gov/ct2/show/NCT01067521[2/5/2016 1:40:53 PM]
`
` Nervous System Diseases
` Pathologic Processes
` Copolymer 1
` Adjuvants, Immunologic
` Immunologic Factors
` Immunosuppressive Agents
` Pharmacologic Actions
` Physiological Effects of Drugs
`
`TO TOP
`
`Mylan Pharms. Inc. Exhibit 1004 Page 3
`
`

`
`A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Wee...
`
`For Patients and Families
`
`
`
`For Researchers
`
`
`
`For Study Record Managers
`
`HOME
`
` RSS FEEDS
`
` SITE MAP
`
` TERMS AND CONDITIONS
`
` DISCLAIMER
`
` CONTACT NLM HELP DESK
`
` Privacy
`Copyright
`U.S. National Library of Medicine
`
` Viewers and Players
` Accessibility
` U.S. National Institutes of Health
`
` USA.gov
` Freedom of Information Act
` U.S. Department of Health and Human Services
`
`https://clinicaltrials.gov/ct2/show/NCT01067521[2/5/2016 1:40:53 PM]
`
`Mylan Pharms. Inc. Exhibit 1004 Page 4