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An Open Label Study for Parti...

An Open Label Study for Participants With Rheumatoid Arthritis

Last Updated: 2018-06-11

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1086 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-02-28

Brief Summary

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The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in participants with Rheumatoid Arthritis.

This study is comprised of 2 periods:

Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).

Period 2: 48-week post-treatment follow-up

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Detailed Description

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Week 16 non-responders (NR) are participants with \<20% improvement from baseline in both tender and swollen joint counts when assessed at Week 16 of Studies BCDO, BCDV and BCDM.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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120 milligrams (mg) of LY2127399

Given every 4 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 240 mg loading dose when initiating treatment.

Or

Given every 4 weeks for 168 weeks for those participants from Study BCDM.

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

Administered Subcutaneously

90 mg LY2127399

Given every 2 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 180 mg loading dose when initiating treatment.

Or

Given every 2 weeks for 168 weeks for those participants from Study BCDM.

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

Administered Subcutaneously

Interventions

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LY2127399

Administered Subcutaneously

Intervention Type DRUG

Other Intervention Names

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Tabalumab

Eligibility Criteria

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Inclusion Criteria

* Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM
* Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion Criteria

* Current presence of a serious disorder or illness

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UCT/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Escondido, California, United States

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Fresno, California, United States

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Hemet, California, United States

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Huntington Beach, California, United States

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La Jolla, California, United States

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La Mesa, California, United States

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Loma Linda, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Torrance, California, United States

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Tustin, California, United States

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Upland, California, United States

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Wildomar, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Lewes, Delaware, United States

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Aventura, Florida, United States

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Boca Raton, Florida, United States

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Boynton Beach, Florida, United States

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DeBary, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Palm Harbor, Florida, United States

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Pinellas Park, Florida, United States

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St. Petersburg, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Venice, Florida, United States

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Vero Beach, Florida, United States

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West Palm Beach, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Dunwoody, Georgia, United States

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Gainesville, Georgia, United States

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Lawrenceville, Georgia, United States

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Marietta, Georgia, United States

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Savannah, Georgia, United States

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Stockbridge, Georgia, United States

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Eagle, Idaho, United States

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Idaho Falls, Idaho, United States

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Morton Grove, Illinois, United States

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Peoria, Illinois, United States

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Rockford, Illinois, United States

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Brownsburg, Indiana, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Kansas City, Kansas, United States

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Shawnee Mission, Kansas, United States

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Wichita, Kansas, United States

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Bowling Green, Kentucky, United States

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Owensboro, Kentucky, United States

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Monroe, Louisiana, United States

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Cumberland, Maryland, United States

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Wheaton, Maryland, United States

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Haverhill, Massachusetts, United States

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Worcester, Massachusetts, United States

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Bingham Farms, Michigan, United States

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Saint Clair Shores, Michigan, United States

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Flowood, Mississippi, United States

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Jackson, Mississippi, United States

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Florissant, Missouri, United States

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St Louis, Missouri, United States

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Kalispell, Montana, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Nashua, New Hampshire, United States

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Berkeley Heights, New Jersey, United States

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Clifton, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Roslyn, New York, United States

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Syracuse, New York, United States

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Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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Raleigh, North Carolina, United States

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Sanford, North Carolina, United States

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Bismarck, North Dakota, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Bend, Oregon, United States

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Bethlehem, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Limerick, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pottstown, Pennsylvania, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Greer, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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North Charleston, South Carolina, United States

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Taylors, South Carolina, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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Lubbock, Texas, United States

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Mesquite, Texas, United States

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Nassau Bay, Texas, United States

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North Richland Hills, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Burlington, Vermont, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Wenatchee, Washington, United States

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Clarksburg, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Racine, Wisconsin, United States

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Luján, , Argentina

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Mar del Plata, , Argentina

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Quilmes, , Argentina

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Rosario, , Argentina

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San Juan, , Argentina

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San Miguel de Tucumán, , Argentina

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Campbelltown, New South Wales, Australia

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Kogarah, New South Wales, Australia

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Herston, Queensland, Australia

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Malvern East, , Australia

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Campinas, , Brazil

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Caxias do Sul, , Brazil

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Curitiba, , Brazil

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Fortaleza, , Brazil

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Juiz de Fora, , Brazil

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Rio de Janeiro, , Brazil

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São Paulo, , Brazil

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Setor Oeste/Goiania, , Brazil

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Burgas, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sevlievo, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Bogotá, , Colombia

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Medellín, , Colombia

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Opatija, , Croatia

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Osijek, , Croatia

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Rijeka, , Croatia

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Montpellier, , France

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Nice, , France

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Orléans, , France

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Paris, , France

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Saint-Etienne, , France

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Strasbourg, , France

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Toulouse, , France

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Bad Doberan, , Germany

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Bad Nauheim, , Germany

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Baden-Baden, , Germany

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Berlin, , Germany

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Cologne, , Germany

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Dresden, , Germany

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Erlangen, , Germany

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Frankfurt, , Germany

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Göttingen, , Germany

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Munich, , Germany

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Haidari/Athens, , Greece

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Heraklion, , Greece

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Larissa, , Greece

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Thessaloniki, , Greece

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Baja, , Hungary

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Balassagyarmat, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Esztergom, , Hungary

Site Status

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Kiskunhalas, , Hungary

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Nyíregyháza, , Hungary

Site Status

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Sátoraljaújhely, , Hungary

Site Status

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Szikszó, , Hungary

Site Status

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Veszprém, , Hungary

Site Status

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Ahmedabad, , India

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Bangalore, , India

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Chennai, , India

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Hyderabaad, , India

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Jaipur, , India

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Lucknow, , India

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Mysore, , India

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Nellore, , India

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New Delhi, , India

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Secunderabad, , India

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Surat, , India

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Aichi, , Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Gunma, , Japan

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Hokkaido, , Japan

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Hyōgo, , Japan

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Ibaraki, , Japan

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Ibaraki, , Japan

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Japan, , Japan

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Kagoshima, , Japan

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Kanagawa, , Japan

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Kumamoto, , Japan

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Mie, , Japan

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Miyagi, , Japan

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Miyazaki, , Japan

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Nagano, , Japan

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Nagasaki, , Japan

Site Status

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Nara, , Japan

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Ohita, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Saga, , Japan

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Saitama, , Japan

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Sapporo, , Japan

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Shizuoka, , Japan

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Tokushima, , Japan

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Tokyo, , Japan

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Toyama, , Japan

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Alytus, , Lithuania

Site Status

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Kaunas, , Lithuania

Site Status

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Klaipedos, , Lithuania

Site Status

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Šiauliai, , Lithuania

Site Status

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Vilnius, , Lithuania

Site Status

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Batu Caves, , Malaysia

Site Status

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Kota Bharu, , Malaysia

Site Status

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Kuantan Pahang, , Malaysia

Site Status

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Perak, , Malaysia

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Putrajaya, , Malaysia

Site Status

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Sarawak, , Malaysia

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Aguascalientes, , Mexico

Site Status

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Barrio San Mateo, , Mexico

Site Status

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Chihuahua City, , Mexico

Site Status

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Guadalajara, , Mexico

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Mexicali, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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Morelia, , Mexico

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Querétaro, , Mexico

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San Luis Potosí City, , Mexico

Site Status

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Tijuana, , Mexico

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Hamilton, , New Zealand

Site Status

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Rotorua, , New Zealand

Site Status

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Tauranga, , New Zealand

Site Status

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Timaru, , New Zealand

Site Status

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Bydgoszcz, , Poland

Site Status

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Działdowo, , Poland

Site Status

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Elblag, , Poland

Site Status

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Gdynia, , Poland

Site Status

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Krakow, , Poland

Site Status

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Lublin, , Poland

Site Status

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Płock, , Poland

Site Status

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Torun, , Poland

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Warsaw, , Poland

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Włoszczowa, , Poland

Site Status

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Brasov, , Romania

Site Status

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Cluj-Napoca, , Romania

Site Status

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Iași, , Romania

Site Status

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Ploieşti, , Romania

Site Status

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Barnaul, , Russia

Site Status

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Kazan', , Russia

Site Status

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Kemerovo, , Russia

Site Status

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Khanty-Mansiysk, , Russia

Site Status

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Kursk, , Russia

Site Status

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Moscow, , Russia

Site Status

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Nizhny Novgorod, , Russia

Site Status

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Novosibirsk, , Russia

Site Status

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Petrozavodsk, , Russia

Site Status

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Ryazan, , Russia

Site Status

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Saint Petersburg, , Russia

Site Status

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Saratov, , Russia

Site Status

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Stavropol, , Russia

Site Status

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Voronezh, , Russia

Site Status

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Yaroslavl, , Russia

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Bratislava, , Slovakia

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Dunajská Streda, , Slovakia

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Piešťany, , Slovakia

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Benoni, , South Africa

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Bloemfontein, , South Africa

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Breyten, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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Limpopo, , South Africa

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Pretoria, , South Africa

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Somerset West, , South Africa

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Stellenbosch, , South Africa

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Busan, , South Korea

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Daegu, , South Korea

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Daejeon, , South Korea

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Incheon, , South Korea

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Seongnam-si, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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A Coruña, , Spain

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Barcelona, , Spain

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Bilboa, , Spain

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Donostia / San Sebastian, , Spain

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Madrid, , Spain

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Colombo, , Sri Lanka

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Galle, , Sri Lanka

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Kalubowila, , Sri Lanka

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Nugegoda, , Sri Lanka

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Keelung, , Taiwan

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Kuei Shan Hsiang, , Taiwan

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Niao Sung Hsiang, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Odesa, , Ukraine

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Poltava, , Ukraine

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Simferopol, , Ukraine

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Vinnitsa, , Ukraine

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Vinnytsia, , Ukraine

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Countries

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United States Argentina Australia Brazil Bulgaria Colombia Croatia France Germany Greece Hungary India Japan Lithuania Malaysia Mexico New Zealand Poland Romania Russia Slovakia South Africa South Korea Spain Sri Lanka Taiwan Ukraine

Other Identifiers

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H9B-MC-BCDP

Identifier Type: OTHER

Identifier Source: secondary_id

13419

Identifier Type: -

Identifier Source: org_study_id

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Study Results

Basic Information

Brief Summary

Related Clinical Trials

A Study of LY2127399 in Rheumatoid Arthritis

A Rheumatoid Arthritis Study in Participants

An Open Label Extension Study in Participants With Rheumatoid Arthritis

A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate

Detailed Description

Conditions

Study Design

Study Groups

120 milligrams (mg) of LY2127399

LY2127399

90 mg LY2127399

LY2127399

Interventions

LY2127399

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Eli Lilly and Company

Responsible Party

Principal Investigators

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.