An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

NCT01578785 | Terminated Phase 3 Results DMC

• 2 other identifiers: GA-MS-3022011-005550-57
• Study Type: interventional
• Target: 178
• Locations: 18 countries
• Sites: 168

Brief Summary

This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).

Conditions

Relapsing-Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• The Annualized Relapse Rate During the Placebo Controlled Period

  The total number of confirmed relapses during the placebo-controlled phase is divided by the sum of the number of days on study in the placebo-controlled phase and then multiplied by the number of days in the year to calculate the annualized relapse rate.

  Day 1 up to Month 12

Secondary Outcomes (3)

• The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period)

  Day 1 up to Month 12

• The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period)

  Day 1 up to Month 12

• Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume

  Day 1 up to Month 12

Study Arms (2)

Glatiramer Acetate

EXPERIMENTAL

Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.

Drug: Glatiramer Acetate

Placebo

PLACEBO COMPARATOR

Placebo solution in prefilled syringe for subcutaneous injection once daily.

Drug: Placebo

Interventions

Glatiramer Acetate DRUG

Glatiramer acetate 20mg in 0.5ml for subcutaneous injection in a pre-filled syringe (PFS) is administered daily. Each PFS also contains 20mg mannitol dissolved in water for injection.

Also known as: Copaxone®

Glatiramer Acetate

Placebo DRUG

Matching placebo injection; 20 mg mannitol dissolved in 0.5 mL water for subcutaneous injection in a PFS is administered daily.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must have a confirmed and documented multiple sclerosis (MS) diagnosis as defined by the 2010 Revised McDonald criteria \[Ann Neurol 2011: 69:292-302\], with a relapsing-remitting disease course.
• Subjects must be ambulatory with a Kurtzke's Expanded Disability Status Scale (EDSS) score of 0-5.5 in both screening and baseline visits.
• Subjects must be in a relapse-free, stable neurological condition and free of corticosteroid treatment \[intravenous (IV), intramuscular (IM) and/or by mouth (PO)\] or ACTH (adrenocorticotropic hormone) 30 days prior to screening (Month-1) and between screening and baseline (Month 0) visits.
• Subjects must have experienced one of the following:
• At least one documented relapse in the 12 months prior to screening,
• At least two documented relapses in the 24 months prior to screening,
• One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in a magnetic resonance imaging (MRI) performed within 12 months prior to screening.
• Subjects must be between 18 and 55 years of age, inclusive.
• Women of child-bearing potential must practice an acceptable method of birth control \[acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or a double-barrier method (condom or diaphragm with spermicide)\].
• Subjects must be able to sign and date a written informed consent prior to entering the study.
• Subjects must be willing and able to comply with the protocol requirements for the duration of the study.

You may not qualify if:

• Any of the following conditions will exclude the subject from entering the study:
• Subjects with progressive forms of MS.
• Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
• Use of immunosuppressive agents (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit.
• Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening.
• Use of cladribine within 2 years prior to screening.
• Previous treatment with immunomodulators \[including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg)\] within 2 months prior to screening.
• Previous use of glatiramer acetate (GA) or any other glatiramoid.
• Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
• Previous total body irradiation or total lymphoid irradiation.
• Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
• Pregnancy or breastfeeding.
• 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.
• A known history of sensitivity to Gadolinium.
• Glomerular filtration rate (GFR) ≤ 60 mL/minute at the screening visit

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (169)

Teva Investigational Site 10192

Cullman, Alabama, United States

Location

Teva Investigational Site 10204

Fresno, California, United States

Location

Teva Investigational Site 10201

La Jolla, California, United States

Location

Teva Investigational Site 10196

Centennial, Colorado, United States

Location

Teva Investigational Site 10184

Miami, Florida, United States

Location

Teva Investigational Site 10180

Sarasota, Florida, United States

Location

Teva Investigational Site 10197

Sarasota, Florida, United States

Location

Teva Investigational Site 10190

Tampa, Florida, United States

Location

Teva Investigational Site 10207

Tampa, Florida, United States

Location

Teva Investigational Site 10199

Vero Beach, Florida, United States

Location

Teva Investigational Site 10181

Chicago, Illinois, United States

Location

Teva Investigational Site 10202

Northbrook, Illinois, United States

Location

Teva Investigational Site 10188

Patchogue, New York, United States

Location

Teva Investigational Site 10198

Charlotte, North Carolina, United States

Location

Teva Investigational Site 10203

Hickory, North Carolina, United States

Location

Teva Investigational Site 10209

Hickory, North Carolina, United States

Location

Teva Investigational Site 10212

Raleigh, North Carolina, United States

Location

Teva Investigational Site 10213

Winston-Salem, North Carolina, United States

Location

Teva Investigational Site 10215

Winston-Salem, North Carolina, United States

Location

Teva Investigational Site 10194

Akron, Ohio, United States

Location

Teva Investigational Site 10191

Dayton, Ohio, United States

Location

Teva Investigational Site 10200

Uniontown, Ohio, United States

Location

Teva Investigational Site 10206

Cordova, Tennessee, United States

Location

Teva Investigational Site 10214

Cordova, Tennessee, United States

Location

Teva Investigational Site 10186

Nashville, Tennessee, United States

Location

Teva Investigational Site 67001

Tirana, Albania

Location

Teva Investigational Site 68004

Grodno, Belarus

Location

Teva Investigational Site 68007

Homyel, Belarus

Location

Teva Investigational Site 68003

Minsk, Belarus

Location

Teva Investigational Site 68005

Minsk, Belarus

Location

Teva Investigational Site 68006

Minsk, Belarus

Location

Teva Investigational Site 68001

Vitebsk, Belarus

Location

Teva Investigational Site 68002

Vitebsk, Belarus

Location

Teva Investigational Site 69004

Bihać, Bosnia and Herzegovina

Location

Teva Investigational Site 69002

Mostar, Bosnia and Herzegovina

Location

Teva Investigational Site 69001

Sarajevo, Bosnia and Herzegovina

Location

Teva Investigational Site 69003

Tuzla, Bosnia and Herzegovina

Location

Teva Investigational Site 59020

Blagoevgrad, Bulgaria

Location

Teva Investigational Site 59018

Pleven, Bulgaria

Location

Teva Investigational Site 59019

Pleven, Bulgaria

Location

Teva Investigational Site 59025

Pleven, Bulgaria

Location

Teva Investigational Site 59024

Rousse, Bulgaria

Location

Teva Investigational Site 59023

Shumen, Bulgaria

Location

Teva Investigational Site 59006

Sofia, Bulgaria

Location

Teva Investigational Site 59007

Sofia, Bulgaria

Location

Teva Investigational Site 59008

Sofia, Bulgaria

Location

Teva Investigational Site 59009

Sofia, Bulgaria

Location

Teva Investigational Site 59010

Sofia, Bulgaria

Location

Teva Investigational Site 59011

Sofia, Bulgaria

Location

Teva Investigational Site 59012

Sofia, Bulgaria

Location

Teva Investigational Site 59014

Sofia, Bulgaria

Location

Teva Investigational Site 59015

Sofia, Bulgaria

Location

Teva Investigational Site 59016

Sofia, Bulgaria

Location

Teva Investigational Site 59017

Sofia, Bulgaria

Location

Teva Investigational Site 59021

Sofia, Bulgaria

Location

Teva Investigational Site 59026

Sofia, Bulgaria

Location

Teva Investigational Site 59022

Stara Zagora, Bulgaria

Location

Teva Investigational Site 59013

Varna, Bulgaria

Location

Teva Investigational Site 59027

Veliko Tarnovo, Bulgaria

Location

Teva Investigational Site 59028

Veliko Tarnovo, Bulgaria

Location

Teva Investigational Site 60003

Osijek, Croatia

Location

Teva Investigational Site 60005

Varaždin, Croatia

Location

Teva Investigational Site 60001

Zagreb, Croatia

Location

Teva Investigational Site 60002

Zagreb, Croatia

Location

Teva Investigational Site 60004

Zagreb, Croatia

Location

Teva Investigational Site 60006

Zagreb, Croatia

Location

Teva Investigational Site 60007

Zagreb, Croatia

Location

Teva Investigational Site 55004

Pärnu, Estonia

Location

Teva Investigational Site 55003

Tallinn, Estonia

Location

Teva Investigational Site 81001

Tbilisi, Georgia

Location

Teva Investigational Site 81002

Tbilisi, Georgia

Location

Teva Investigational Site 81003

Tbilisi, Georgia

Location

Teva Investigational Site 81004

Tbilisi, Georgia

Location

Teva Investigational Site 81005

Tbilisi, Georgia

Location

Teva Investigational Site 63017

Athens, Greece

Location

Teva Investigational Site 63021

Athens, Greece

Location

Teva Investigational Site 63020

Melíssia, Greece

Location

Teva Investigational Site 63018

Thessaloniki, Greece

Location

Teva Investigational Site 63019

Thessaloniki, Greece

Location

Teva Investigational Site 56004

Riga, Latvia

Location

Teva Investigational Site 21023

Estado de México, Mexico

Location

Teva Investigational Site 21021

Guadalajara, Jalisco, Mexico

Location

Teva Investigational Site 21022

Mexico City, Distrito Federal, Mexico

Location

Teva Investigational Site 21025

Monterrey, Mexico

Location

Teva Investigational Site 21020

Morelia, Michoacan, Mexico

Location

Teva Investigational Site 21024

San Luís Potosí, Mexico

Location

Teva Investigational Site 70001

Chisinau, Moldova

Location

Teva Investigational Site 70002

Chisinau, Moldova

Location

Teva Investigational Site 70003

Chisinau, Moldova

Location

Teva Investigational Site 70004

Chisinau, Moldova

Location

Teva Investigational Site 66001

Podgorica, Montenegro

Location

Teva Investigational Site 65005

Shtip, North Macedonia

Location

Teva Investigational Site 65001

Skopje, North Macedonia

Location

Teva Investigational Site 65002

Skopje, North Macedonia

Location

Teva Investigational Site 65003

Skopje, North Macedonia

Location

Teva Investigational Site 65006

Strumica, North Macedonia

Location

Teva Investigational Site 65004

Tetovo, North Macedonia

Location

Teva Investigational Site 53033

Bialystok, Poland

Location

Teva Investigational Site 53020

Częstochowa, Poland

Location

Teva Investigational Site 53023

Gdansk, Poland

Location

Teva Investigational Site 53024

Gdansk, Poland

Location

Teva Investigational Site 53031

Grodzisk Mazowiecki, Poland

Location

Teva Investigational Site 53032

Grodzisk Mazowiecki, Poland

Location

Teva Investigational Site 53021

Katowice, Poland

Location

Teva Investigational Site 53019

Kielce, Poland

Location

Teva Investigational Site 53028

Konstancin-Jeziorna, Poland

Location

Teva Investigational Site 53037

Kościerzyna, Poland

Location

Teva Investigational Site 53018

Lodz, Poland

Location

Teva Investigational Site 53027

Lublin, Poland

Location

Teva Investigational Site 53036

Olsztyn, Poland

Location

Teva Investigational Site 53034

Poznan, Poland

Location

Teva Investigational Site 53030

Poznan / Plewiska, Poland

Location

Teva Investigational Site 53025

Szczecin, Poland

Location

Teva Investigational Site 53026

Szczecin, Poland

Location

Teva Investigational Site 53022

Warsaw, Poland

Location

Teva Investigational Site 53029

Warsaw, Poland

Location

Teva Investigational Site 52010

Bucharest, Romania

Location

Teva Investigational Site 52012

Bucharest, Romania

Location

Teva Investigational Site 52015

Cluj-Napoca, Romania

Location

Teva Investigational Site 52016

Cluj-Napoca, Romania

Location

Teva Investigational Site 52017

Constanța, Romania

Location

Teva Investigational Site 52018

Constanța, Romania

Location

Teva Investigational Site 52014

Iași, Romania

Location

Teva Investigational Site 52021

Oradea, Romania

Location

Teva Investigational Site 52011

Piatra Neamţ, Romania

Location

Teva Investigational Site 52013

Sibiu, Romania

Location

Teva Investigational Site 52020

Târgu Mureş, Romania

Location

Teva Investigational Site 52019

Timișoara, Romania

Location

Teva Investigational Site 50023

Barnaul, Russia

Location

Teva Investigational Site 50021

Chelyabinsk, Russia

Location

Teva Investigational Site 50025

Kazan', Russia

Location

Teva Investigational Site 50039

Krasnodar, Russia

Location

Teva Investigational Site 50022

Moscow, Russia

Location

Teva Investigational Site 50034

Moscow, Russia

Location

Teva Investigational Site 50035

Moscow, Russia

Location

Teva Investigational Site 50036

Moscow, Russia

Location

Teva Investigational Site 50020

Nizhny Novgorod, Russia

Location

Teva Investigational Site 50024

Nizhny Novgorod, Russia

Location

Teva Investigational Site 50123

Nizhny Novgorod, Russia

Location

Teva Investigational Site 50027

Novosibirsk, Russia

Location

Teva Investigational Site 50019

Perm, Russia

Location

Teva Investigational Site 50038

Rostov-on-Don, Russia

Location

Teva Investigational Site 50029

Saint Petersburg, Russia

Location

Teva Investigational Site 50032

Saint Petersburg, Russia

Location

Teva Investigational Site 50030

Samara, Russia

Location

Teva Investigational Site 50037

Saratov, Russia

Location

Teva Investigational Site 50028

Smolensk, Russia

Location

Teva Investigational Site 50031

Tyumen, Russia

Location

Teva Investigational Site 50026

Ufa, Russia

Location

Teva Investigational Site 50040

Volgograd, Russia

Location

Teva Investigational Site 50033

Yaroslavl, Russia

Location

Teva Investigational Site 61002

Belgrade, Serbia

Location

Teva Investigational Site 61005

Belgrade, Serbia

Location

Teva Investigational Site 61001

Kragujevac, Serbia

Location

Teva Investigational Site 61003

Niš, Serbia

Location

Teva Investigational Site 58022

Chernihiv, Ukraine

Location

Teva Investigational Site 58030

Donetsk, Ukraine

Location

Teva Investigational Site 58020

Ivano-Frankivsk, Ukraine

Location

Teva Investigational Site 58028

Kharkiv, Ukraine

Location

Teva Investigational Site 58023

Kyiv, Ukraine

Location

Teva Investigational Site 58025

Kyiv, Ukraine

Location

Teva Investigational Site 58018

Lviv, Ukraine

Location

Teva Investigational Site 58021

Odesa, Ukraine

Location

Teva Investigational Site 58029

Poltava, Ukraine

Location

Teva Investigational Site 58032

Simferopol, AR Crimea, Ukraine

Location

Teva Investigational Site 58031

Uzhhorod, Ukraine

Location

Teva Investigational Site 58027

Vinnytsia, Ukraine

Location

Teva Investigational Site 58019

Zaporizhzhya, Ukraine

Location

Teva Investigational Site 58024

Zaporizhzhya, Ukraine

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Alexey Boyko, MD

  Department of Neurology, Russian State Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: April 17, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 2, 2014
• Results First Posted: April 2, 2014

Record last verified: 2014-02

Locations

ES (2); AL (1); GR (5); GE (5); SE (4); MO (4); NO (6); BE (7); ME (6); BO (4); LA (1); CR (7); UA (14); RO (12); PL (19); RU (23); US (25); BU (23)