A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic drug (DMARD) therapy.
This study is comprised of 2 periods:
Period 1 - 24-week blinded treatment
Period 2 - 48-week post-treatment follow-up
In consideration of disease severity, all participants were assessed for non-response at Week 16. A total of 66 joints were examined for swelling, and a total of 66 joint were examined for tenderness. For participants who had at least 5 swollen and 5 tender joints at baseline, Week 16 non-responders (NRs) were defined as participants with <20% improvement from baseline in both tender joint counts and swollen joint counts. For participants who did not have at least 5 swollen and 5 tender joints at baseline, Week 16 NRs were defined as participants who had at least 2 additional tender and 2 additional swollen joints from baseline. All Week 16 NRs and all participants who discontinued study treatment at any time, for any reason, were defined as NRs starting at that timepoint and going forward for all American College of Rheumatology (ACR) imputed analyses, including the Week 24 endpoint.
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35216, United States
Paradise Valley, Arizona 85253, United States
Peoria, Arizona 85381, United States
Phoenix, Arizona 85018, United States
Scottsdale, Arizona 85251, United States
Tucson, Arizona 85704, United States
Hot Springs, Arkansas 71913, United States
Little Rock, Arkansas 72205, United States
San Diego, California 92103, United States
Torrance, California 90505, United States
Tustin, California 92780, United States
Whittier, California 90606, United States
Wildomar, California 92595, United States
Colorado Springs, Colorado 80910, United States
Lewes, Delaware 19958, United States
Aventura, Florida 33180, United States
DeBary, Florida 32713, United States
Palm Harbor, Florida 34684, United States
Pinellas Park, Florida 33781, United States
St. Petersburg, Florida 33716, United States
Tamarac, Florida 33321, United States
Venice, Florida 34292, United States
Zephyrhills, Florida 33542, United States
Decatur, Georgia 30033, United States
Gainesville, Georgia 30501, United States
Lawrenceville, Georgia 30045, United States
Marietta, Georgia 30060, United States
Savannah, Georgia 31405, United States
Eagle, Idaho 83616, United States
Morton Grove, Illinois 60053, United States
Rockford, Illinois 61103, United States
Indianapolis, Indiana 46227, United States
Wichita, Kansas 67208, United States
Cumberland, Maryland 21502, United States
Hyannis, Massachusetts 02601, United States
Worcester, Massachusetts 01605, United States
Bingham Farms, Michigan 48025, United States
Saint Clair Shores, Michigan 48081, United States
Flowood, Mississippi 39232, United States
Jackson, Mississippi 39202, United States
St Louis, Missouri 63131, United States
Lincoln, Nebraska 68516, 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
Roslyn, New York 11576, United States
Syracuse, New York 13210, United States
Charlotte, North Carolina 28210, United States
Hickory, North Carolina 28601, United States
Raleigh, North Carolina 27609, United States
Cincinnati, Ohio 45242, United States
Oklahoma City, Oklahoma 73103, United States
Tulsa, Oklahoma 74135, United States
Bend, Oregon 97701, United States
Bethlehem, Pennsylvania 18017, United States
Limerick, Pennsylvania 19468, United States
Philadelphia, Pennsylvania 19152, United States
Pottstown, Pennsylvania 19464, United States
Columbia, South Carolina 29204, United States
Greenville, South Carolina 29601, United States
Greer, South Carolina 29650, United States
Myrtle Beach, South Carolina 29572, United States
North Charleston, South Carolina 29406, United States
Knoxville, Tennessee 37909, United States
Memphis, Tennessee 38119, United States
Nashville, Tennessee 37205, United States
Austin, Texas 78731, United States
Dallas, Texas 75231, United States
Lake Jackson, Texas 77566, 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 78217, United States
Sugar Land, Texas 77478, United States
Spokane, Washington 99204, United States
Buenos Aires, C1280AEB, Argentina
Córdoba, X5016KEH, Argentina
Mar del Plata, B7600FZN, Argentina
Rosario, 2000, Argentina
San Juan, 5400, Argentina
San Miguel de Tucumán, 4000, Argentina
Kogarah, New South Wales 04266-010, Australia
Herston, Queensland 4029, Australia
Malvern East, 3145, Australia
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
Rijeka, HR-51000, Croatia
Split, 21000, Croatia
Budapest, 1036, Hungary
Debrecen, 4032, Hungary
Kiskunhalas, 6400, Hungary
Nyíregyháza, 4400, Hungary
Sátoraljaújhely, 3980, Hungary
Szikszó, 3800, Hungary
Veszprém, 8200, Hungary
Ahmedabad, 3800015, India
Bangalore, 5600092, India
Chennai, 600100, India
Hyderabaad, 500033, India
Jaipur, 302023, India
Mysore, 570023, India
Nellore, 524003, India
New Delhi, 110 076, India
Secunderabad, 500 003, India
Surat, 560092, India
Aichi, 460-0001, Japan
Fukuoka, 820-8505, Japan
Gunma, 370-0053, Japan
Hokkaido, 063-0811, Japan
Hyōgo, 650-0017, Japan
Ibaraki, 316-0035, Japan
Kanagawa, 252-0392, Japan
Kumamoto, 861-8520, Japan
Mie, 514-1101, Japan
Miyagi, 982-0032, Japan
Nagano, 390-8601, Japan
Nagasaki, 857-1195, Japan
Nara, 634-0007, Japan
Ohita, 874-0011, Japan
Okayama, 712-8044, Japan
Osaka, 586-8521, Japan
Saga, 843-0393, Japan
Saitama, 337-0012, Japan
Sapporo, 060-8648, Japan
Shizuoka, 420-8623, Japan
Tokyo, 185-0012, Japan
Tomakomai, 053-8567, Japan
Alytus, 62114, Lithuania
Kaunas, 49475, Lithuania
Klaipedos, 92288, Lithuania
Šiauliai, 73231, Lithuania
Vilnius, LT-08661, Lithuania
Batu Caves, 68100, Malaysia
Kuantan Pahang, 25100, Malaysia
Perak, 30990, Malaysia
Sarawak, 93586, Malaysia
Aguascalientes, 20203, Mexico
Chihuahua City, 31000, Mexico
Guadalajara, 44690, Mexico
Mexicali, 21100, Mexico
Mexico City, 06100, Mexico
Monterrey, 64000, Mexico
Morelia, 58070, Mexico
Querétaro, 76000, Mexico
San Luis Potosí City, 78200, Mexico
Tijuana, 22010, Mexico
Tlalpan, 14080, Mexico
Hamilton, 3204, New Zealand
Rotorua, 3010, New Zealand
Tauranga, 3140, New Zealand
Timaru, New Zealand
Bydgoszcz, 85-168, Poland
Elblag, 82-300, Poland
Gdynia, 81-384, Poland
Krakow, 30-510, Poland
Lublin, 20-607, Poland
Torun, 87-100, Poland
Warsaw, 01-192, Poland
Brasov, 500365, Romania
Cluj-Napoca, 400130, Romania
Iași, 700656, Romania
Ploieşti, 100337, Romania
Barnaul, 656038, Russia
Kemerovo, 650066, Russia
Kursk, 305007, Russia
Moscow, 111539, Russia
Nizhny Novgorod, 603005, Russia
Novosibirsk, 630047, Russia
Ryazan, 390026, Russia
Saint Petersburg, 197022, Russia
Stavropol, 355017, Russia
Bratislava, 84231, Slovakia
Piešťany, 921 12, Slovakia
Benoni, 1500, South Africa
Bloemfontein, 9301, South Africa
Breyten, 2330, South Africa
Cape Town, 7925, South Africa
Durban, 4092, South Africa
Limpopo, 0380, South Africa
Pretoria, 0184, South Africa
Somerset West, 7130, South Africa
Stellenbosch, 7600, South Africa
Westville, 3630, South Africa
Busan, 602-715, South Korea
Daegu, 700-721, South Korea
Seoul, 134-727, South Korea
Colombo, Sri Lanka
Galle, Sri Lanka
Kalubowila, Sri Lanka
Nugegoda, Sri Lanka
Keelong, 333, Taiwan
Kuei Shan Hsiang, 33305, Taiwan
Taichung, 407, Taiwan
Taipei, 112, Taiwan
Dnipropetrovsk, 49008, Ukraine
Donetsk, 83045, Ukraine
Kharkiv, 61178, Ukraine
Kiev, 04114, Ukraine
Kyiv, 03151, Ukraine
Odesa, 65026, Ukraine
Poltava, 36038, Ukraine
Simferopol, 95017, Ukraine