Rheumatoid ArthritisPhase 3NCT01215942
An Open Label Study for Participants With Rheumatoid Arthritis
A Phase 3 study testing LY2127399 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 327 sites in 27 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- LY2127399
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,086 participants
- Where
- 327 sitesin 27 countries
- Study dates
- Jun 2011to Feb 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current presence of a serious disorder or illness
Trial locations and contacts
327 sites in 27 countries.
327 sites in 27 countries
United States127 sites
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Albuquerque, New Mexico, 87108
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Atlanta, Georgia, 30342
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Austin, Texas, 78731
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Aventura, Florida, 33180
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Bend, Oregon, 97701
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Berkeley Heights, New Jersey, 07922
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Bethlehem, Pennsylvania, 18017
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Bingham Farms, Michigan, 48025
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Birmingham, Alabama, 35216
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Bismarck, North Dakota, 58502
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Boca Raton, Florida, 33486
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Bowling Green, Kentucky, 42101
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Boynton Beach, Florida, 33472
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Brooklyn, New York, 11201
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Brownsburg, Indiana, 46112
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Burlington, Vermont, 05401
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Charlotte, North Carolina, 28210
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Cincinnati, Ohio, 45242
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Clarksburg, West Virginia, 26301
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Clifton, New Jersey, 07012
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Colorado Springs, Colorado, 80910
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Columbia, South Carolina, 29204
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Cumberland, Maryland, 21502
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Dallas, Texas, 75231
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DeBary, Florida, 32713
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Decatur, Georgia, 30033
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Denver, Colorado, 80209
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Dunwoody, Georgia, 30338
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Eagle, Idaho, 83616
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Erie, Pennsylvania, 16508
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Escondido, California, 92027
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Evansville, Indiana, 47714
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Florissant, Missouri, 63031
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Flowood, Mississippi, 39232
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Fresno, California, 93720
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Gainesville, Georgia, 30501
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Greenville, South Carolina, 29601
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Greer, South Carolina, 29650
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Haverhill, Massachusetts, 01830
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Hemet, California, 92543
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Hickory, North Carolina, 28601
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77090
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Huntington Beach, California, 92646
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Huntsville, Alabama, 35810
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Idaho Falls, Idaho, 83404
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Indianapolis, Indiana, 46227
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Jackson, Mississippi, 39202
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Jonesboro, Arkansas, 72401
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Kalispell, Montana, 59901
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Kansas City, Kansas, 66160
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Knoxville, Tennessee, 37909
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La Jolla, California, 92037
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La Mesa, California, 91942
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Lake Jackson, Texas, 77566
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Las Vegas, Nevada, 89128
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Lawrenceville, Georgia, 30045
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Lewes, Delaware, 19958
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Limerick, Pennsylvania, 19468
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Lincoln, Nebraska, 68516
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Little Rock, Arkansas, 72205
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Loma Linda, California, 92354
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Long Beach, California, 90808
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Los Angeles, California, 90022
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Lubbock, Texas, 79424
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Marietta, Georgia, 30060
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Memphis, Tennessee, 38119
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Mesquite, Texas, 75150
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Miami, Florida, 33173
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Milwaukee, Wisconsin, 53226
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Monroe, Louisiana, 71203
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Morton Grove, Illinois, 60053
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Myrtle Beach, South Carolina, 29572
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Nashua, New Hampshire, 03060
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Nashville, Tennessee, 37205
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Nassau Bay, Texas, 77058
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New Port Richey, Florida, 34652
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North Charleston, South Carolina, 29406
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North Richland Hills, Texas, 76180
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Oklahoma City, Oklahoma, 73104
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Omaha, Nebraska, 68134
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Owensboro, Kentucky, 42303
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Palm Harbor, Florida, 34684
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Peoria, Arizona, 85381
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Peoria, Illinois, 61636
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Philadelphia, Pennsylvania, 19152
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Phoenix, Arizona, 85032
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Pinellas Park, Florida, 33781
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Pottstown, Pennsylvania, 19464
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Racine, Wisconsin, 53406
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Raleigh, North Carolina, 27609
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Richmond, Virginia, 23225
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Rockford, Illinois, 61103
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Roslyn, New York, 11576
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Sacramento, California, 95825
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Saint Clair Shores, Michigan, 48081
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San Antonio, Texas, 78217
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San Diego, California, 92108
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Sanford, North Carolina, 27330
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Santa Monica, California, 90404
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Savannah, Georgia, 31405
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Scottsdale, Arizona, 85251
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Shawnee Mission, Kansas, 66218
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Spokane, Washington, 99204
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St Louis, Missouri, 63131
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St. Petersburg, Florida, 33716
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Stockbridge, Georgia, 30281
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Sugar Land, Texas, 77478
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Syracuse, New York, 13210
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Tacoma, Washington, 98405
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Tamarac, Florida, 33321
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Tampa, Florida, 33609
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Taylors, South Carolina, 29687
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Torrance, California, 90505
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Tucson, Arizona, 85704
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Tulsa, Oklahoma, 74135
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Tustin, California, 92780
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Upland, California, 91786
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Venice, Florida, 34292
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Vero Beach, Florida, 32960
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Wenatchee, Washington, 98801
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West Palm Beach, Florida, 33401
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Wheaton, Maryland, 20902
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Wichita, Kansas, 67208
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Wildomar, California, 92595
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Worcester, Massachusetts, 01605
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Zephyrhills, Florida, 33542
Japan28 sites
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Aichi, 460-0001
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Chiba, 260-8712
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Fukuoka, 807-8555
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Gunma, 370-0053
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Hokkaido, 063-0811
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Hyōgo, 650-0017
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Ibaraki, 305-8576
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Ibaraki, 316-0035
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Japan, 275-0006
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Kagoshima, 891-0133
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Kanagawa, 252-0392
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Kumamoto, 861-8520
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Mie, 514-1101
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Miyagi, 982-0032
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Miyazaki, 880-0122
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Nagano, 380-8582
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Nagasaki, 857-1195
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Nara, 634-0007
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Ohita, 874-0011
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Okayama, 710-0016
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Osaka, 586-8521
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Saga, 843-0393
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Saitama, 337-0012
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Sapporo, 060-8648
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Shizuoka, 420-8623
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Tokushima, 770-8503
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Tokyo, 113-0034
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Toyama, 933-0874
Russia15 sites
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Barnaul, 656038
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Kazan', 420029
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Kemerovo, 650066
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Khanty-Mansiysk, 628012
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Kursk, 305007
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Moscow, 125299
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Nizhny Novgorod, 603005
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Novosibirsk, 630047
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Petrozavodsk, 185019
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Ryazan, 390026
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Saint Petersburg, 197022
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Saratov, 410002
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Stavropol, 355017
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Voronezh, 394066
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Yaroslavl, 150062
India11 sites
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Ahmedabad, 3800015
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Bangalore, 5600092
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Chennai, 600100
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Hyderabaad, 500082
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Jaipur, 302023
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Lucknow, 226 014
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Mysore, 570023
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Nellore, 524003
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New Delhi, 110 076
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Secunderabad, 500 003
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Surat, 395003
Mexico11 sites
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Aguascalientes, 20000
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Barrio San Mateo, 52140
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Chihuahua City, 31000
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Guadalajara, 44690
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Mexicali, 21100
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Mexico City, 03720
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Monterrey, 64460
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Morelia, 58070
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Querétaro, 76000
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San Luis Potosí City, 78200
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Tijuana, 22010
Germany10 sites
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Bad Doberan, 18209
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Bad Nauheim, 61231
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Baden-Baden, 76530
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Berlin, 14059
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Cologne, 50924
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Dresden, 01307
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Erlangen, 91054
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Frankfurt, 60590
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Göttingen, 37075
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Munich, 80639
Hungary10 sites
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Baja, 6500
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Balassagyarmat, 2660
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Budapest, 1062
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Debrecen, 4032
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Esztergom, 2500
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Kiskunhalas, 6400
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Nyíregyháza, 4400
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Sátoraljaújhely, 3980
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Szikszó, 3800
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Veszprém, 8200
Poland10 sites
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Bydgoszcz, 85-168
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Działdowo, 13-200
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Elblag, 82-300
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Gdynia, 81-384
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Krakow, 30-510
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Lublin, 20-607
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Płock, 09-400
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Torun, 87-100
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Warsaw, 01-192
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Włoszczowa, 29-100
Ukraine10 sites
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Dnipropetrovsk, 49008
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Donetsk, 83114
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Kharkiv, 61178
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Kiev, 04114
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Kyiv, 03151
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Odesa, 65026
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Poltava, 36038
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Simferopol, 95017
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Vinnitsa, 21000
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Vinnytsia, 21018
South Africa9 sites
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Benoni, 1500
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Bloemfontein, 9301
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Breyten, 2330
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Cape Town, 7925
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Durban, 4092
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Limpopo, 0380
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Pretoria, 0184
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Somerset West, 7130
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Stellenbosch, 7600
Argentina8 sites
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Buenos Aires, C1280AEB
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Córdoba, X5016KEH
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Luján, 6700
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Mar del Plata, B7600FZN
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Quilmes, B1878DVC
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Rosario, 2000
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San Juan, 5400
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San Miguel de Tucumán, 4000
Brazil8 sites
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Campinas, 13059-000
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Caxias do Sul, 95070-560
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Curitiba, 80060-240
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Fortaleza, 60150-170
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Juiz de Fora, 36010-570
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Rio de Janeiro, 20551-030
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São Paulo, 05403-000
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Setor Oeste/Goiania, 74110-129
Bulgaria7 sites
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Burgas, 8000
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Pleven, 5800
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Plovdiv, 4003
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Rousse, 7002
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Sevlievo, 5400
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Sofia, 1784
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Varna, 9000
France7 sites
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Montpellier, 34295
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Nice, 06202
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Orléans, 45000
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Paris, 75022
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Saint-Etienne, 42055
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Strasbourg, 67 098
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Toulouse, 31059
South Korea7 sites
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Busan, 602-715
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Daegu, 700-721
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Daejeon, 301-721
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Incheon, 400-711
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Seongnam-si, 463-707
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Seoul, 143-729
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Suwon, 442-721
Malaysia6 sites
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Batu Caves, 68100
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Kota Bharu, 15586
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Kuantan Pahang, 25100
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Perak, 30990
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Putrajaya, 62250
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Sarawak, 93586
Lithuania5 sites
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Alytus, 62114
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Kaunas, 49475
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Klaipedos, 92288
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Šiauliai, 73231
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Vilnius, LT-08661
Spain5 sites
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A Coruña, 15006
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Barcelona, 08034
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Bilboa, 48013
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Donostia / San Sebastian, 20014
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Madrid, 28046
Taiwan5 sites
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Keelung, 204
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Kuei Shan Hsiang, 33305
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Niao Sung Hsiang, 833
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Taichung, 40705
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Taipei, 112
Australia4 sites
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Campbelltown, New South Wales, 2560
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Herston, Queensland, 4029
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Kogarah, New South Wales, 04266-010
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Malvern East, 3145
Greece4 sites
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Haidari/Athens, 12462
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Heraklion, 71110
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Larissa, 411 10
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Thessaloniki, 54636
New Zealand4 sites
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Hamilton, 3204
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Rotorua, 3010
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Tauranga, 3140
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Timaru
Romania4 sites
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Brasov, 500365
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Cluj-Napoca, 400130
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Iași, 700656
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Ploieşti, 100337
Sri Lanka4 sites
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Colombo
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Galle
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Kalubowila
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Nugegoda
Croatia3 sites
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Opatija, 51410
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Osijek, 31000
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Rijeka, HR-51000
Slovakia3 sites
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Bratislava, 84231
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Dunajská Streda, 929 01
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Piešťany, 921 12
Colombia2 sites
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Bogotá
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Medellín
About this study
Official title: A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)
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
Read the detailed description
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
- Rheumatoid Arthritis
- Being tested
- LY2127399
- Keywords
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2127399Drug
Also called Tabalumab
Administered Subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| 120 milligrams (mg) of LY2127399 | Experimental | 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. Receives: Drug: LY2127399 |
| 90 mg LY2127399 | Experimental | 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. Receives: Drug: LY2127399 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure, peripheral revascularization procedure, cardiogenic shock due to MI, resuscitated sudden death, serious arrhythmia, hospitalization for hypertension, peripheral arterial event. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Measured: up to 84.4 weeks during treatment period
Percentage of Participants Developing Anti-LY2127399 Antibodies
Participants with treatment-emergent anti-LY2127399 antibodies were participants who had any samples from baseline up to and through Week 72 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants with anti-LY2127399 antibodies=(number of participants with treatment-emergent anti-LY2127399 antibodies / number of participants assessed)*100.
Measured: Baseline through Weeks 4, 24, 48 and 72
Change From Baseline in Absolute B Cell Counts
Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment in preceding studies, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively, in B cell count.
Measured: Baseline, Week 48
Change From Baseline in Serum Immunoglobulin (Ig) Levels
Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP.
Measured: Baseline, Week 48
Secondary outcomes (12)
Percentage of Participants With American College of Rheumatology 20% Response (ACR20)
ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants achieving ACR20 response=(number of ACR20 responders / number of participants treated) * 100. All participants who discontinue study treatment for any reason were defined as NR at that time point and going forward.
Measured: Baseline through Weeks 12, 24 and 48
Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)
Measured: Baseline, 240 weeks
Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR-28) Response
Measured: Baseline through 240 weeks
Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores
Measured: Baseline, 240 weeks
Change From Baseline in Tender Joint Count (68 Joint Count)
Measured: Baseline, 240 weeks
Change From Baseline in Swollen Joint Count (66 Joint Count)
Measured: Baseline, 240 weeks
Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
Measured: Baseline, 240 weeks
Change From Baseline in Participants Global Assessment of Disease Activity (VAS)
Measured: Baseline, 240 weeks
Change From Baseline in Physicians Global Assessment of Disease Activity (VAS)
Measured: Baseline, 240 weeks
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Measured: Baseline, 240 weeks
Change From Baseline in CRP
Measured: Baseline, 240 weeks
American College of Rheumatology Percent Improvement (ACR-N)
Measured: Baseline through 240 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startJun 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Insufficient efficacy observed in study BCDM (NCT01198002) and BCDV (NCT01202773).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,086 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UCT/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215942
- Sponsor's protocol ID
- 13419
- Other IDs
- H9B-MC-BCDP
- Status last verified
- May 2018
- First submitted
- 5 Oct 2010
- Last updated
- 11 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT01215942
- Acronym / sponsor ID
- 13419
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient efficacy observed in study BCDM (NCT01198002) and BCDV (NCT01202773).
- Enrolment
- 1,086 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Posted 11 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 120 milligrams (mg) of LY2127399 | Experimental | Drug: LY2127399Given 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. |
| 90 mg LY2127399 | Experimental | Drug: LY2127399Given 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Current presence of a serious disorder or illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2127399Also: TabalumabAdministered Subcutaneously | Drug | 120 milligrams (mg) of LY2127399, 90 mg LY2127399 |
Primary outcome
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
Time frame: up to 84.4 weeks during treatment period
A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure, peripheral revascularization procedure, cardiogenic shock due to MI, resuscitated sudden death, serious arrhythmia, hospitalization for hypertension, peripheral arterial event. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Percentage of Participants Developing Anti-LY2127399 Antibodies
Time frame: Baseline through Weeks 4, 24, 48 and 72
Participants with treatment-emergent anti-LY2127399 antibodies were participants who had any samples from baseline up to and through Week 72 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants with anti-LY2127399 antibodies=(number of participants with treatment-emergent anti-LY2127399 antibodies / number of participants assessed)*100.
Change From Baseline in Absolute B Cell Counts
Time frame: Baseline, Week 48
Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment in preceding studies, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively, in B cell count.
Change From Baseline in Serum Immunoglobulin (Ig) Levels
Time frame: Baseline, Week 48
Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP.
12 secondary outcomes
Percentage of Participants With American College of Rheumatology 20% Response (ACR20)
Time frame: Baseline through Weeks 12, 24 and 48
Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)
Time frame: Baseline, 240 weeks
Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR-28) Response
Time frame: Baseline through 240 weeks
Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores
Time frame: Baseline, 240 weeks
Change From Baseline in Tender Joint Count (68 Joint Count)
Time frame: Baseline, 240 weeks
Change From Baseline in Swollen Joint Count (66 Joint Count)
Time frame: Baseline, 240 weeks
Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
Time frame: Baseline, 240 weeks
Change From Baseline in Participants Global Assessment of Disease Activity (VAS)
Time frame: Baseline, 240 weeks
Change From Baseline in Physicians Global Assessment of Disease Activity (VAS)
Time frame: Baseline, 240 weeks
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time frame: Baseline, 240 weeks
Change From Baseline in CRP
Time frame: Baseline, 240 weeks
American College of Rheumatology Percent Improvement (ACR-N)
Time frame: Baseline through 240 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UCT/GMT - 5 hours, EST) study director
Eli Lilly and Company
327 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY2127399 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 327 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 327 sites in United States, Japan, Russia, India, Mexico and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period (time frame: up to 84.4 weeks during treatment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.