DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Remitting Multiple Sclerosis

Intervention: Glatiramer acetate (GA) (Drug); Placebo (Other)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Teva Pharmaceutical Industries

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The total number of confirmed relapses during the 12 month PC phase

Secondary outcome:

The number of new T2 lesions at month 12 (end of PC phase) as compared to baseline scan.

The cumulative number of enhancing lesions on T1-weighted images taken at months 6 and 12 (end of PC phase).

Status of Gd-enhancing T1 activity at baseline

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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. 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.

Locations and Contacts

Teva Investigational Site 5940, Blagoevgrad, Bulgaria

Teva Investigational Site 5931, Pleven, Bulgaria

Teva Investigational Site 5932, Pleven, Bulgaria

Teva Investigational Site 5933, Plovdiv, Bulgaria

Teva Investigational Site 5936, Ruse, Bulgaria

Teva Investigational Site 5935, Shumen, Bulgaria

Teva Investigational Site 5921, Sofia, Bulgaria

Teva Investigational Site 5922, Sofia, Bulgaria

Teva Investigational Site 5923, Sofia, Bulgaria

Teva Investigational Site 5924, Sofia, Bulgaria

Teva Investigational Site 5925, Sofia, Bulgaria

Teva Investigational Site 5926, Sofia, Bulgaria

Teva Investigational Site 5927, Sofia, Bulgaria

Teva Investigational Site 5928, Sofia, Bulgaria

Teva Investigational Site 5929, Sofia, Bulgaria

Teva Investigational Site 5938, Sofia, Bulgaria

Teva Investigational Site 5939, Sofia, Bulgaria

Teva Investigational Site 5934, Stara Zagora, Bulgaria

Teva Investigational Site 5930, Varna, Bulgaria

Teva Investigational Site 5937, Veliko Tarnovo, Bulgaria

Teva Investigational Site 6011, Osijek, Croatia

Teva Investigational Site 6009, Zagreb, Croatia

Teva Investigational Site 6010, Zagreb, Croatia

Teva Investigational Site 6012, Zagreb, Croatia

Teva Investigational Site 6013, Zagreb, Croatia

Teva Investigational Site 5433, Olomouc, Czech Republic

Teva Investigational Site 5434, Ostrava - poruba, Czech Republic

Teva Investigational Site 5435, Teplice, Czech Republic

Teva Investigational Site 5513, Kohtla-Jaerve, Estonia

Teva Investigational Site 5510, Tallinn, Estonia

Teva Investigational Site 5512, Tartu, Estonia

Teva Investigational Site 8110, Tbilisi, Georgia

Teva Investigational Site 8111, Tbilisi, Georgia

Teva Investigational Site 3268, Bad Wildbad, Germany

Teva Investigational Site 3272, Bayreuth, Germany

Teva Investigational Site 3262, Berlin, Germany

Teva Investigational Site 3276, Berlin, Germany

Teva Investigational Site 3265, Dresden, Germany

Teva Investigational Site 3263, Erbach, Germany

Teva Investigational Site 3266, Hannover, Germany

Teva Investigational Site 3270, Herborn, Germany

Teva Investigational Site 3275, Marburg, Germany

Teva Investigational Site 3264, Ulm, Germany

Teva Investigational Site 5127, Budapest, Hungary

Teva Investigational Site 5129, Debrecen, Hungary

Teva Investigational Site 5130, Eger, Hungary

Teva Investigational Site 5132, Esztergom, Hungary

Teva Investigational Site 5131, Gyor, Hungary

Teva Investigational Site 5128, Kaposvar, Hungary

Teva Investigational Site 5133, Veszprem, Hungary

Teva Investigational Site 3089, Bologna, Italy

Teva Investigational Site 3084, Cefalù (Palermo), Italy

Teva Investigational Site 3080, Milano, Italy

Teva Investigational Site 3086, Roma, Italy

Teva Investigational Site 5710, Kaunas, Lithuania

Teva Investigational Site 5712, Siauliai, Lithuania

Teva Investigational Site 5711, Vilnius, Lithuania

Teva Investigational Site 5374, Czestochowa, Poland

Teva Investigational Site 5377, Elblag, Poland

Teva Investigational Site 5380, Gdansk, Poland

Teva Investigational Site 5381, Gdansk, Poland

Teva Investigational Site 5376, Gorzow Wielkopolski, Poland

Teva Investigational Site 5372, Grodzisk Mazowiecki, Poland

Teva Investigational Site 5368, Katowice, Poland

Teva Investigational Site 5375, Katowice, Poland

Teva Investigational Site 5379, Kielce, Poland

Teva Investigational Site 5382, Konskie, Poland

Teva Investigational Site 5369, Koscierzyna, Poland

Teva Investigational Site 5378, Krakow, Poland

Teva Investigational Site 5366, Lodz, Poland

Teva Investigational Site 5373, Olsztyn, Poland

Teva Investigational Site 5384, Poznan, Poland

Teva Investigational Site 5371, Szczecin, Poland

Teva Investigational Site 5367, Warszawa, Poland

Teva Investigational Site 5370, Wroclaw, Poland

Teva Investigational Site 5233, Balotesti, Romania

Teva Investigational Site 5220, Bucuresti, Romania

Teva Investigational Site 5221, Bucuresti, Romania

Teva Investigational Site 5227, Cluj-Napoca, Romania

Teva Investigational Site 5230, Cluj-Napoca, Romania

Teva Investigational Site 5225, Constanta, Romania

Teva Investigational Site 5226, Constanta, Romania

Teva Investigational Site 5232, Craiova, Romania

Teva Investigational Site 5231, Iasi, Romania

Teva Investigational Site 5223, Piatra-Neamt, Romania

Teva Investigational Site 5228, Sibiu, Romania

Teva Investigational Site 5229, Targu-Mures, Romania

Teva Investigational Site 5224, Timisoara, Romania

Teva Investigational Site 5063, Barnaul, Russian Federation

Teva Investigational Site 5059, Ekaterinburg, Russian Federation

Teva Investigational Site 5068, Irkutsk, Russian Federation

Teva Investigational Site 5067, Krasnoyarsk, Russian Federation

Teva Investigational Site 5052, Moscow, Russian Federation

Teva Investigational Site 5057, Nizhny Novgorod, Russian Federation

Teva Investigational Site 5062, Novosibirsk, Russian Federation

Teva Investigational Site 5060, Perm, Russian Federation

Teva Investigational Site 5053, Saint Petersburg, Russian Federation

Teva Investigational Site 5058, Samara, Russian Federation

Teva Investigational Site 5838, Simferopol, AR Crimea, Russian Federation

Teva Investigational Site 5064, Smolensk, Russian Federation

Teva Investigational Site 5054, St. Petersburg, Russian Federation

Teva Investigational Site 5055, St. Petersburg, Russian Federation

Teva Investigational Site 5056, St. Petersburg, Russian Federation

Teva Investigational Site 5066, Tomsk, Russian Federation

Teva Investigational Site 5061, Ufa, Russian Federation

Teva Investigational Site 5065, Yaroslavl, Russian Federation

Teva Investigational Site 9020, Johannesburg, South Africa

Teva Investigational Site 9022, Pietermaritzburg, South Africa

Teva Investigational Site 9018, Pretoria, South Africa

Teva Investigational Site 9021, Rosebank, South Africa

Teva Investigational Site 5835, Chernihiv, Ukraine

Teva Investigational Site 5834, Chernivtsi, Ukraine

Teva Investigational Site 5827, Dnipropetrovsk, Ukraine

Teva Investigational Site 5828, Donetsk, Ukraine

Teva Investigational Site 5829, Ivano-Frankivsk, Ukraine

Teva Investigational Site 5830, Kharkiv, Ukraine

Teva Investigational Site 5833, Kyiv, Ukraine

Teva Investigational Site 5836, Kyiv, Ukraine

Teva Investigational Site 5825, Lviv, Ukraine

Teva Investigational Site 5839, Odesa, Ukraine

Teva Investigational Site 5832, Poltava, Ukraine

Teva Investigational Site 5837, Uzhgorod, Ukraine

Teva Investigational Site 5826, Vinnytsya, Ukraine

Teva Investigational Site 5831, Zaporizhzhya, Ukraine

Teva Investigational Site 3438, Salford, United Kingdom

Teva Investigational Site 3440, Sheffield, United Kingdom

Teva Investigational Site 1327, Gilbert, Arizona, United States

Teva Investigational Site 1311, Phoenix, Arizona, United States

Teva Investigational Site 1326, Fullerton, California, United States

Teva Investigational Site 1335, La Jolla, California, United States

Teva Investigational Site 1297, Aurora, Colorado, United States

Teva Investigational Site 1344, Boulder, Colorado, United States

Teva Investigational Site 1315, Centennial, Colorado, United States

Teva Investigational Site 1345, Miami, Florida, United States

Teva Investigational Site 1336, Naples, Florida, United States

Teva Investigational Site 1347, Pompano Beach, Florida, United States

Teva Investigational Site 1298, Sarasota, Florida, United States

Teva Investigational Site 1316, Sarasota, Florida, United States

Teva Investigational Site 1340, Tampa, Florida, United States

Teva Investigational Site 1317, Vero Beach, Florida, United States

Teva Investigational Site 8052, Tel Hashomer, IL, Israel

Teva Investigational Site 1303, Northbrook, Illinois, United States

Teva Investigational Site 1302, Lexington, Kentucky, United States

Teva Investigational Site 1322, Shreveport, Louisiana, United States

Teva Investigational Site 1306, Detroit, Michigan, United States

Teva Investigational Site 1329, Akron, Ohio, United States

Teva Investigational Site 1349, Columbus, Ohio, United States

Teva Investigational Site 1313, Dayton, Ohio, United States

Teva Investigational Site 1318, Uniontown, Ohio, United States

Teva Investigational Site 1341, Oklahoma City, Oklahoma, United States

Teva Investigational Site 1310, Nashville, Tennessee, United States

Teva Investigational Site 1321, Lubbock, Texas, United States

Teva Investigational Site 1301, San Antonio, Texas, United States

Teva Investigational Site 1346, San Antonio, Texas, United States

Teva Investigational Site 1343, Salt Lake City, Utah, United States

Teva Investigational Site 1338, Richmond, Virginia, United States

Teva Investigational Site 1339, Roanoke, Virginia, United States

Teva Investigational Site 1300, Vienna, Virginia, United States

Teva Investigational Site 1323, Kirkland, Washington, United States

Additional Information

Starting date: May 2010
Last updated: July 9, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017