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 One or More TNF-α Inhibitors (FLEX V)
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 One or More TNF-α Inhibitors (FLEX V)
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors.
This study is comprised of 2 periods:
Period 1: 24-week blinded treatment
Period 2: 48-week post-treatment follow-up
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35216, United States
Huntsville, Alabama 35810, United States
Paradise Valley, Arizona 85253, United States
Phoenix, Arizona 85018, United States
Scottsdale, Arizona 85251, United States
Jonesboro, Arkansas 72401, United States
Little Rock, Arkansas 72205, United States
Escondido, California 92027, United States
Fresno, California 93720, United States
Hemet, California 92543, United States
Huntington Beach, California 92646, United States
La Mesa, California 91942, United States
Loma Linda, California 92354, United States
Long Beach, California 90808, United States
Los Angeles, California 90022, United States
San Diego, California 92108, United States
Santa Monica, California 90404, United States
Torrance, California 90505, United States
Tustin, California 92780, United States
Upland, California 91786, United States
Whittier, California 90606, United States
Wildomar, California 92595, United States
Colorado Springs, Colorado 80910, United States
Denver, Colorado 80209, United States
Lewes, Delaware 19958, United States
Aventura, Florida 33180, United States
Boca Raton, Florida 33486, United States
Boynton Beach, Florida 33472, United States
DeBary, Florida 32713, United States
Miami, Florida 33173, United States
New Port Richey, Florida 34652, United States
Palm Harbor, Florida 34684, United States
Pinellas Park, Florida 33781, United States
Tamarac, Florida 33321, United States
Tampa, Florida 33609, United States
Venice, Florida 34292, United States
Vero Beach, Florida 32960, United States
West Palm Beach, Florida 33401, United States
Atlanta, Georgia 30342, United States
Decatur, Georgia 30033, United States
Dunwoody, Georgia 30338, 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 61636, United States
Rock Island, Illinois 61201, United States
Brownsburg, Indiana 46112, United States
Evansville, Indiana 47714, United States
Indianapolis, Indiana 46227, United States
Kansas City, Kansas 66160, United States
Bowling Green, Kentucky 42101, United States
Lexington, Kentucky 40504, United States
Owensboro, Kentucky 42303, United States
Monroe, Louisiana 71203, United States
Wheaton, Maryland 20902, United States
Haverhill, Massachusetts 01830, United States
Worcester, Massachusetts 01605, United States
Saint Clair Shores, Michigan 48081, United States
Edina, Minnesota 55435, United States
Flowood, Mississippi 39232, United States
Jackson, Mississippi 39202, United States
Cape Girardeau, Missouri 63703, United States
Florissant, Missouri 63031, United States
St Louis, Missouri 63131, United States
Kalispell, Montana 59901, United States
Las Vegas, Nevada 89128, United States
Nashua, New Hampshire 03060, United States
Berkeley Heights, New Jersey 07922, United States
Clifton, New Jersey 07012, United States
Albuquerque, New Mexico 87108, United States
Brooklyn, New York 11201, United States
Charlotte, North Carolina 28210, United States
Greensboro, North Carolina 27408, United States
Hickory, North Carolina 28601, United States
Sanford, North Carolina 27330, United States
Bismarck, North Dakota 58502, United States
Cincinnati, Ohio 45242, United States
Cleveland, Ohio 44109, United States
Oklahoma City, Oklahoma 73104, United States
Tulsa, Oklahoma 74104, United States
Bethlehem, Pennsylvania 18017, United States
Erie, Pennsylvania 16508, United States
Limerick, Pennsylvania 19468, United States
Wexford, Pennsylvania 15090, United States
Columbia, South Carolina 29204, United States
Greenville, South Carolina 29601, United States
Greer, South Carolina 29651, United States
Myrtle Beach, South Carolina 29572, United States
Taylors, South Carolina 29687, United States
Knoxville, Tennessee 37909, United States
Memphis, Tennessee 38119, United States
Nashville, Tennessee 37205, United States
Austin, Texas 78731, United States
Houston, Texas 77008, United States
Lubbock, Texas 79424, United States
Mesquite, Texas 75150, United States
San Antonio, Texas 78217, United States
Sugar Land, Texas 77478, United States
Burlington, Vermont 05401, United States
Chesapeake, Virginia 23320, United States
Danville, Virginia 24541, United States
Richmond, Virginia 23225, United States
Spokane, Washington 99204, United States
Tacoma, Washington 98405, United States
Wenatchee, Washington 98801, United States
Clarksburg, West Virginia 26301, United States
Milwaukee, Wisconsin 53226, United States
Racine, Wisconsin 53406, United States
Buenos Aires, C1280AEB, Argentina
CĂłrdoba, X5016KEH, Argentina
Luján, 6700, Argentina
Mar del Plata, B7600FZN, Argentina
Quilmes, B1878DVC, Argentina
San Isidro, B1642AKG, Argentina
San Miguel de Tucumán, 4000, Argentina
Kogarah, New South Wales 04266-010, Australia
Herston, Queensland 4029, Australia
Malvern East, 3145, Australia
Campinas, 13059-000, Brazil
Goiânia, 74110-120, Brazil
Juiz de Fora, 36010-570, Brazil
SĂŁo Paulo, 04266-010, Brazil
Bogotá, Colombia
MedellĂn, Colombia
Montpellier, 34295, France
Nice, 06202, France
Orléans, 45000, France
Paris, 75018, France
Saint-Etienne, 42055, France
Strasbourg, 67 098, France
Toulouse, 31059, France
Bad Doberan, 18209, Germany
Bad Nauheim, 61231, Germany
Baden-Baden, 76530, Germany
Berlin, 14059, Germany
Cologne, 50924, Germany
Dresden, 01307, Germany
Erlangen, 91054, Germany
Frankfurt, 60590, Germany
Göttingen, 37075, Germany
Munich, 80639, Germany
Haidari/Athens, 12462, Greece
Heraklion, 71110, Greece
Larissa, 411 10, Greece
Thessaloniki, 54642, Greece
Arenzano, 16011, Italy
Fukuoka, 807-8555, Japan
Gunma, 370-0053, Japan
HyĹŤgo, 673-1462, Japan
Kanagawa, 216-8511, Japan
Miyazaki, 880-0122, Japan
Nagasaki, 852-8501, Japan
Okayama, 700-8558, Japan
Tokyo, 162, Japan
Perak, 30990, Malaysia
Putrajaya, 62250, Malaysia
Sarawak, 93586, Malaysia
Chihuahua City, 31000, Mexico
Col Centro, 80000, Mexico
Guadalajara, 44620, Mexico
Mexico City, 03720, Mexico
Monterrey, 64000, Mexico
Querétaro, 76000, Mexico
San Luis PotosĂ City, 78200, 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
Lublin, 20-607, Poland
Płock, 09-400, Poland
Torun, 87-100, Poland
Warsaw, 02-118, Poland
Kazan', 420029, Russia
Khanty-Mansiysk, 628012, Russia
Kursk, 305007, Russia
Moscow, 115093, Russia
Nizhny Novgorod, 603005, Russia
Petrozavodsk, 185019, Russia
Saint Petersburg, 191104, Russia
Stavropol, 355017, Russia
Voronezh, 394066, Russia
Benoni, 1500, South Africa
Bloemfontein, 9301, South Africa
Limpopo, 0380, South Africa
Incheon, 400-711, South Korea
Seoul, 150-713, South Korea
Suwon, 442-721, South Korea
A Coruña, 15006, Spain
Barcelona, 08034, Spain
Bilboa, 48013, Spain
Madrid, 28046, Spain
Manises, 46940, Spain
Santiago de Compostela, 15706, Spain
Keelung, 204, Taiwan
Taichung, 40705, Taiwan