A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate Therapy (FLEX M)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate Therapy (FLEX M)
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate.
This study is comprised of 3 periods:
Period 1: 52-week blinded treatment
Period 2: additional 48-week unblinded treatment
Period 3: 48-week post-treatment follow-up
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35216, United States
Huntsville, Alabama 35801, United States
Paradise Valley, Arizona 85253, United States
Peoria, Arizona 85381, United States
Phoenix, Arizona 85018, United States
Scottsdale, Arizona 85251, United States
Hot Springs, Arkansas 71913, United States
Little Rock, Arkansas 72205, United States
Escondido, California 92027, United States
Fresno, California 93720, United States
Hemet, California 92543, United States
La Jolla, California 92037, United States
La Mesa, California 91942, United States
Sacramento, California 95825, United States
Torrance, California 90505, United States
Tustin, California 92780, United States
Upland, California 91786, United States
Wildomar, California 92595, United States
Colorado Springs, Colorado 80910, United States
Denver, Colorado 80209, United States
Danbury, Connecticut 06810, United States
Lewes, Delaware 19958, United States
Aventura, Florida 33180, United States
Boynton Beach, Florida 33472, United States
DeBary, Florida 32713, United States
Palm Harbor, Florida 34684, United States
Pinellas Park, Florida 33781, United States
Tampa, Florida 33609, United States
Venice, Florida 34292, United States
Vero Beach, Florida 32960, United States
Atlanta, Georgia 30342, United States
Decatur, Georgia 30033, United States
Duluth, Georgia 30096, United States
Gainesville, Georgia 30501, United States
Marietta, Georgia 30060, United States
Stockbridge, Georgia 30281, United States
Eagle, Idaho 83616, United States
Idaho Falls, Idaho 83404, United States
Peoria, Illinois 61602, United States
Evansville, Indiana 47714, United States
Indianapolis, Indiana 46227, United States
Shawnee Mission, Kansas 66218, United States
Owensboro, Kentucky 42303, United States
Worcester, Massachusetts 01605, United States
Bingham Farms, Michigan 48025, United States
Flowood, Mississippi 39232, United States
Jackson, Mississippi 39202, United States
St Louis, Missouri 63141, United States
Omaha, Nebraska 68134, United States
Las Vegas, Nevada 89123, United States
Albuquerque, New Mexico 87108, United States
Brooklyn, New York 11201, United States
Syracuse, New York 13210, United States
Charlotte, North Carolina 28210, United States
Sanford, North Carolina 27330, United States
Cincinnati, Ohio 45242, United States
Cleveland, Ohio 44109, United States
Tulsa, Oklahoma 74135, United States
Erie, Pennsylvania 16508, United States
Phoenixville, Pennsylvania 19460, United States
Pottstown, Pennsylvania 19464, United States
Columbia, South Carolina 29204, United States
Greenville, South Carolina 29601, United States
Myrtle Beach, South Carolina 29572, United States
Watertown, South Dakota 57201, United States
Memphis, Tennessee 38119, United States
Austin, Texas 78731, United States
Houston, Texas 77090, United States
Lubbock, Texas 79424, United States
Mesquite, Texas 75150, United States
Nassau Bay, Texas 77058, United States
North Richland Hills, Texas 76180, United States
San Antonio, Texas 78215, United States
Waco, Texas 76708, United States
Racine, Wisconsin 53406, United States
Buenos Aires, C1280AEB, Argentina
Córdoba, X5016KEH, Argentina
Luján, 6700, Argentina
Mar del Plata, B7600FZN, Argentina
Quilmes, B1878DVC, Argentina
San Juan, 5400, Argentina
San Miguel de Tucumán, 4000, Argentina
Campbelltown, New South Wales 2560, Australia
Herston, Queensland 4029, Australia
Malvern East, 3145, Australia
Campinas, 13059-000, Brazil
Caxias do Sul, 95070-560, Brazil
Curitiba, 80060-240, Brazil
Fortaleza, 60150-170, Brazil
Goiânia, 74110-120, Brazil
Juiz de Fora, 36010-570, Brazil
Rio de Janeiro, 20551-030, Brazil
São Paulo, 09090780, Brazil
Burgas, 8000, Bulgaria
Pleven, 5800, Bulgaria
Plovdiv, 4003, Bulgaria
Rousse, 7002, Bulgaria
Sevlievo, 5400, Bulgaria
Sofia, 1784, Bulgaria
Varna, 9000, Bulgaria
Bogotá, Colombia
Medellín, Colombia
Opatija, 51410, Croatia
Osijek, 31000, Croatia
Rijeka, 51 000, Croatia
Baja, 6500, Hungary
Balassagyarmat, 2660, Hungary
Budapest, 1095, Hungary
Debrecen, 4012, Hungary
Esztergom, 2500, Hungary
Kiskunhalas, 6400, Hungary
Sátoraljaújhely, 3980, Hungary
Szikszó, 3800, Hungary
Veszprém, 8200, Hungary
Ahmedabad, 3800015, India
Bangalore, 5600092, India
Chennai, 600100, India
Hyderabaad, 500082, India
Jaipur, 302019, India
Lucknow, 226 014, India
Mysore, 570023, India
Nellore, 524003, India
New Delhi, 110 076, India
Secunderabad, 500 003, India
Surat, 395003, India
Aichi, 460-0001, Japan
Chiba, 284-0003, Japan
Fukuoka, 807-8555, Japan
Gunma, 370-0053, Japan
Hokkaido, 060-8604, Japan
Hyōgo, 650-0017, Japan
Ibaraki, 305-8576, Japan
Ibaraki, 316-0035, Japan
Japan, 104-8560, Japan
Kagoshima, 891-0133, Japan
Kanagawa, 252-0392, Japan
Kumamoto, 861-8520, Japan
Mie, 514-1101, Japan
Miyagi, 982-0032, Japan
Miyazaki, 880-0122, Japan
Nagano, 380-8582, Japan
Nagasaki, 857-1195, Japan
Nara, 634-0007, Japan
Ohita, 874-0011, Japan
Okayama, 710-0016, Japan
Osaka, 586-8521, Japan
Saga, 843-0393, Japan
Saitama, 337-0012, Japan
Sapporo, 060-8648, Japan
Tokushima, 770-8503, Japan
Tokyo, 185-0012, Japan
Toyama, 933-0874, Japan
Klaipedos, 92288, Lithuania
Vilnius, LT-08661, Lithuania
Kota Bharu, 15586, Malaysia
Perak, 30990, Malaysia
Putrajaya, 62250, Malaysia
Sarawak, 93586, Malaysia
Aguascalientes, 20203, Mexico
Barrio San Mateo, 52140, Mexico
Chihuahua City, 31000, Mexico
Guadalajara, 44690, Mexico
Mexicali, 21100, Mexico
Mexico City, 14050, Mexico
Monterrey, 64460, Mexico
Morelia, 58070, Mexico
Querétaro, 76000, Mexico
San Luis Potosí City, 78200, Mexico
Tijuana, 22010, Mexico
Hamilton, 3204, New Zealand
Rotorua, 3010, New Zealand
Tauranga, 3140, New Zealand
Timaru, New Zealand
Bydgoszcz, 85-168, Poland
Działdowo, 13-200, Poland
Elblag, 82-300, Poland
Gdynia, 81-384, Poland
Lublin, 20-607, Poland
Płock, 09-400, Poland
Torun, 87-100, Poland
Warsaw, 01-192, Poland
Włoszczowa, 29-100, Poland
Brasov, 500365, Romania
Cluj-Napoca, 400130, Romania
Iași, 700656, Romania
Ploieşti, 100337, Romania
Barnaul, 656038, Russia
Kazan', 420029, Russia
Kemerovo, 650066, Russia
Khanty-Mansiysk, 628012, Russia
Moscow, 125299, Russia
Novosibirsk, 630047, Russia
Petrozavodsk, 185019, Russia
Ryazan, 390026, Russia
Saint Petersburg, 194291, Russia
Saratov, 410002, Russia
Stavropol, 355017, Russia
Voronezh, 394066, Russia
Yaroslavl, 150062, Russia
Bratislava, 84231, Slovakia
Dunajská Streda, 929 01, Slovakia
Piešťany, 921 12, Slovakia
Benoni, 1500, South Africa
Bloemfontein, 9301, South Africa
Cape Town, 7925, South Africa
Durban, 4001, South Africa
Limpopo, 0380, South Africa
Pretoria, 0084, South Africa
Somerset West, 7130, South Africa
Stellenbosch, 7600, South Africa
Busan, 602-715, South Korea
Daegu, 700-721, South Korea
Daejeon, 301-721, South Korea
Incheon, 400-711, South Korea
Seongnam-si, 463-707, South Korea
Seoul, 143-729, South Korea
Suwon, 442-721, South Korea
Colombo, Sri Lanka
Galle, Sri Lanka
Kalubowila, Sri Lanka
Nugegoda, Sri Lanka
Chiayi City, 613, Taiwan
Keelung, 204, Taiwan
Kuei Shan Hsiang, 33305, Taiwan
Niao Sung Hsiang, 833, Taiwan
Taichung, 404, Taiwan
Taipei, 112, Taiwan
Dnipropetrovsk, 49008, Ukraine
Donetsk, 83045, Ukraine
Kharkiv, 61178, Ukraine
Kyiv, 03151, Ukraine
Odesa, 65026, Ukraine
Poltava, 36038, Ukraine