A Moderate to Severe Rheumatoid Arthritis Study (RA-BEACON)
9 сентября 2019 г. обновлено: Eli Lilly and Company
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors
The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic drugs (cDMARDs).
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
527
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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New South Wales
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Kogarah, New South Wales, Австралия, 04266-010
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Queensland
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Maroochydore, Queensland, Австралия, 4558
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Victoria
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Fitzroy, Victoria, Австралия, 3065
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Graz, Австрия, 8036
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Vienna, Австрия, 1100
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Buenos Aires, Аргентина, C1015ABO
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Rosario, Аргентина, 2000
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San Miguel De Tucuman, Аргентина, T4000AXL
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Brussels, Бельгия, 1000
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Mons, Бельгия, 7000
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Dresden, Германия, 01067
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Hamburg, Германия, 22081
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Heidelberg, Германия, 69120
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Würzburg, Германия, 97080
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Athens, Греция, 11527
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Heraklion, Греция, 71110
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Kifissia, Греция, 14561
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Larissa, Греция, 411 10
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Frederiksberg, Дания, 2000
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Glostrup, Дания, 2600
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Odense, Дания, 5000
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Ashkelon, Израиль, 78278
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Beer Yaakov, Израиль, 70300
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Haifa, Израиль, 34362
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Jerusalem, Израиль, 91120
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Kfar Saba, Израиль, 44281
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Petah Tikva, Израиль, 49100
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Tel Aviv, Израиль, 64239
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La Vila Joiosa, Испания, 03570
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Santander, Испания, 39008
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Sevilla, Испания, 41010
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Valencia, Испания, 46026
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Firenze, Италия, 50134
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Pisa, Италия, 56100
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Rome, Италия, 00100
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Ontario
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Toronto, Ontario, Канада, M5T 3L9
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Seoul, Корея, Республика, 110-744
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Guadalajara, Мексика, 44650
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Mexico City, Мексика, 06090
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Monterrey, Мексика, 64040
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San Luis Potosi, Мексика, 78213
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Ubbergen, Нидерланды, 6574 NA
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Gdansk, Польша, 80-546
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Nadarzyn, Польша, 05-830
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Warsaw, Польша, 02-507
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Caguas, Пуэрто-Рико, 00725
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San Juan, Пуэрто-Рико, 00927
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Santurce, Пуэрто-Рико, 00909
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Tyneside
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North Shields, Tyneside, Соединенное Королевство, NE29 8NH
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West Yorkshire
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Bradford, West Yorkshire, Соединенное Королевство, BD5 0NA
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Arizona
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Glendale, Arizona, Соединенные Штаты, 85304
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Phoenix, Arizona, Соединенные Штаты, 85023
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Tucson, Arizona, Соединенные Штаты, 85724
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California
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Palo Alto, California, Соединенные Штаты, 94304
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Upland, California, Соединенные Штаты, 91786
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Connecticut
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Danbury, Connecticut, Соединенные Штаты, 06810
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Trumbull, Connecticut, Соединенные Штаты, 06611
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Delaware
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Lewes, Delaware, Соединенные Штаты, 19958
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Florida
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Boynton Beach, Florida, Соединенные Штаты, 33472
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Orlando, Florida, Соединенные Штаты, 32806
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Tamarac, Florida, Соединенные Штаты, 33321
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Tampa, Florida, Соединенные Штаты, 33613
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Idaho
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Boise, Idaho, Соединенные Штаты, 83702
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Indiana
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Indianapolis, Indiana, Соединенные Штаты, 46260
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Michigan
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Lansing, Michigan, Соединенные Штаты, 48910
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Missouri
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Saint Louis, Missouri, Соединенные Штаты, 63117
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New Jersey
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Freehold, New Jersey, Соединенные Штаты, 07728
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New York
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Albany, New York, Соединенные Штаты, 12206
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Hartsdale, New York, Соединенные Штаты, 10530
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Rochester, New York, Соединенные Штаты, 14618
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты, 73103
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Tulsa, Oklahoma, Соединенные Штаты, 74135
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Pennsylvania
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Bethlehem, Pennsylvania, Соединенные Штаты, 18017
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Philadelphia, Pennsylvania, Соединенные Штаты, 19152
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Wyomissing, Pennsylvania, Соединенные Штаты, 19610
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South Carolina
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Myrtle Beach, South Carolina, Соединенные Штаты, 29572
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Texas
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Nassau Bay, Texas, Соединенные Штаты, 77058
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Webster, Texas, Соединенные Штаты, 77508
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Virginia
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Chesapeake, Virginia, Соединенные Штаты, 23320
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Washington
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Kennewick, Washington, Соединенные Штаты, 99336
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Vancouver, Washington, Соединенные Штаты, 98664
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Wisconsin
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Franklin, Wisconsin, Соединенные Штаты, 53132
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Edirne, Турция, 22030
- 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.
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Gaziantep, Турция, 27310
- 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.
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Montpellier, Франция, 34295
- 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.
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Orleans, Франция, 45032
- 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.
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Paris, Франция, 75679
- 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.
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Rennes, Франция, 35056
- 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.
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Tours, Франция, 3700
- 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.
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Fribourg, Швейцария, 1708
- 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.
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Lausanne, Швейцария, CH-1011
- 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.
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Zürich, Швейцария, 8091
- 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.
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Chiba, Япония, 284-0003
- 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.
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Fukuoka, Япония, 810-8563
- 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.
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Hiroshima, Япония, 730-0017
- 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.
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Hokkaido, Япония, 060-8648
- 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.
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Japan, Япония, 275-8580
- 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.
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Kagawa, Япония, 761-0793
- 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.
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Kumamoto, Япония, 861-1196
- 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.
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Nagasaki, Япония, 856-8562
- 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.
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Okayama, Япония, 700-8607
- 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.
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Saitama, Япония, 359-1111
- 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.
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Tokyo, Япония, 104-8560
- 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.
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
- Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
- Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥ (greater than or equal to) 1 times the upper limit of normal (ULN)
Have been treated at approved doses with at least 1 biologic tumor necrosis factor (TNF)- alpha inhibitor for at least 3 months and either:
- experienced insufficient efficacy or loss of efficacy
- experienced intolerance of such treatment
- Have had regular use of at least 1 conventional disease-modifying antirheumatic drugs (cDMARD) for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry
Exclusion Criteria:
- Have received a biologic treatment for RA within 28 days of planned randomization; have received rituximab within 6 months of planned randomization
- Are currently receiving corticosteroids at doses > (greater than) 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
- Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
- Are currently receiving concomitant treatment with methotrexate (MTX), hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs
- Have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
- Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization
- Have active fibromyalgia that, in the investigator's opinion, would make it difficult to appropriately assess RA activity for the purposes of this study
- Have a diagnosis of any systemic inflammatory condition other than RA, such as, but not limited to juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout (participants with secondary Sjogren's syndrome are not excluded.)
- Have a diagnosis of Felty's syndrome
- Have had any major surgery within 8 weeks of study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant
- Have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or have New York Heart Association stage IV heart failure
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data
- Are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair
- Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of < (less than) 40 milliliter per minute per 1.73 m^2 (mL/min/1.73 m^2)
- Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN
- Have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years
- Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination)
- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection
- Have had symptomatic herpes zoster infection within 12 weeks prior to study entry
- Have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, postherpetic neuralgia)
- Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
- Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the participant's participation in the study
- Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the participant's participation in the study (e.g. Fridericia's corrected QT interval >500 millisecond [msec])
- Have symptomatic herpes simplex at the time of study enrollment
- Have evidence of active or latent tuberculosis (TB)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Плацебо Компаратор: Плацебо
Плацебо вводили перорально один раз в день в течение недели 24. Начиная с 16-й недели, участники, не ответившие на лечение, будут получать барицитиниб в дозе 4 миллиграмма (мг) перорально один раз в день в течение 24-й недели. Участники будут продолжать принимать фоновую терапию обычными противоревматическими препаратами, модифицирующими заболевание (cDMARD), на протяжении всего исследования. |
Вводится перорально
Participants will continue to take background cDMARD therapy throughout study.
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Экспериментальный: Барицитиниб 2 мг
Барицитиниб 2 мг перорально один раз в день до 24 недели. Начиная с 16-й недели, участники, не ответившие на лечение, будут получать барицитиниб в дозе 4 мг перорально один раз в день до 24-й недели. Участники будут продолжать принимать фоновую терапию cDMARD на протяжении всего исследования. |
Вводится перорально
Другие имена:
Participants will continue to take background cDMARD therapy throughout study.
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Экспериментальный: Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. |
Вводится перорально
Другие имена:
Participants will continue to take background cDMARD therapy throughout study.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg
Временное ограничение: Week 12
|
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis.
ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP).
Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
|
Week 12
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg
Временное ограничение: Baseline, Week 12
|
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities.
Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability).
A decrease in HAQ-DI score indicated an improvement in the participant's condition.
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Baseline, Week 12
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Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg
Временное ограничение: Baseline, Week 12
|
DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity.
DAS28 was calculated using following formula: DAS28-hsCRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural
log(CRP+1)+0.014*Patient's
Global VAS+0.96.
Total scores ranged from 1.0-9.4,
where lower scores indicated less disease activity.
|
Baseline, Week 12
|
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Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg
Временное ограничение: Week 12
|
The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition.
The index-based definition of remission occurs with a SDAI score ≤3.3.
The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm).
Lower scores indicated less disease activity.
|
Week 12
|
|
Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg
Временное ограничение: Week 12
|
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis.
ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP.
Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
|
Week 12
|
|
Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg
Временное ограничение: Baseline, Week 12
|
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities.
Scores for each functional area were averaged to calculate the HAQ-DI score.
Total scores ranged from 0 (no disability) to 3 (worst disability).
A decrease in HAQ-DI score indicated an improvement in the participant's condition.
|
Baseline, Week 12
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|
Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg
Временное ограничение: Baseline, Week 12
|
DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity.
DAS28 was calculated using following formula: DAS28-CRP=0.56*square
root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural
log(CRP+1)+0.014*Patient's
Global VAS+0.96.
Total scores ranged from 1.0-9.4,
where lower scores indicated less disease activity.
|
Baseline, Week 12
|
|
Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg
Временное ограничение: Week 12
|
The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition.
The index-based definition of remission occurs with a SDAI score ≤3.3.
The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm).
Lower scores indicated less disease activity.
|
Week 12
|
|
Percentage of Participants Achieving ACR20 Response
Временное ограничение: Week 24
|
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis.
ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP.
Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
|
Week 24
|
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Временное ограничение: Week 12 and Week 24
|
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA.
ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.
Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
|
Week 12 and Week 24
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Временное ограничение: Week 12 and Week 24
|
ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA.
ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.
Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
|
Week 12 and Week 24
|
|
Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)
Временное ограничение: Baseline, Week 12
|
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity.
DAS28 was calculated using following formula: DAS28-ESR=0.56*square
root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural
log(ESR)+0.014*Patient's
Global VAS.
Total scores ranged from 1.0-9.4,
where lower scores indicated less disease activity.
|
Baseline, Week 12
|
|
Change From Baseline in Clinical Disease Activity Index Score
Временное ограничение: Baseline, Week 24
|
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site.
It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity).
The CDAI is calculated by summing the values of the 4 components.
CDAI scores range from 0 to 76; lower scores indicated lower disease activity.
A negative change from baseline indicates improvement in condition.
|
Baseline, Week 24
|
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Change From Baseline in Measures of SDAI Score
Временное ограничение: Baseline, Week 24
|
The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement. |
Baseline, Week 24
|
|
Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission
Временное ограничение: Week 24
|
The ACR/EULAR definitions of RA remission includes a Boolean-based definition.
The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.
|
Week 24
|
|
Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness
Временное ограничение: Baseline, Week 24
|
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes.
The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day.
If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.
A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
|
Baseline, Week 24
|
|
Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
Временное ограничение: Baseline, Week 24
|
A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine).
Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours.
Total scores ranged from 0-10.
|
Baseline, Week 24
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|
Change From Baseline in Worst Joint Pain NRS
Временное ограничение: Baseline, Week 24
|
Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine).
Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours.
Total scores ranged from 0-10.
|
Baseline, Week 24
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores
Временное ограничение: Baseline, Week 12, Week 24
|
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning.
The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days.
Total scores range from 0 to 52, with higher scores indicating less fatigue.
|
Baseline, Week 12, Week 24
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Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
Временное ограничение: Baseline, Week 12, Week 24
|
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]).
MCS consisted of social functioning, vitality, mental health, and role-emotional scales.
PCS consisted of physical functioning, bodily pain, role-physical, and general health scales.
Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status.
|
Baseline, Week 12, Week 24
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Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores
Временное ограничение: Baseline, Week 12, Week 24
|
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant.
The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1.
A higher score indicates better health state.
The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
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Baseline, Week 12, Week 24
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Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Временное ограничение: Baseline, Week 12, Week 24
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The WPAI-RA participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit.
Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages.
Percentage work time missed absenteeism: Q2/(Q2+Q4)*100, Percentage impairment while working presenteeism: Q5/10*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]*100; Percentage activity impairment activity impairment: Q6/10*100.
Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.
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Baseline, Week 12, Week 24
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Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib
Временное ограничение: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.
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Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.
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Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib
Временное ограничение: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.
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Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.
- Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
- Emery P, Tanaka Y, Cardillo T, Schlichting D, Rooney T, Beattie S, Helt C, Smolen JS. Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 May 15;22(1):115. doi: 10.1186/s13075-020-02199-8. Erratum In: Arthritis Res Ther. 2020 Jul 2;22(1):166.
- Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15. Erratum In: J Rheumatol. 2019 Dec;46(12):1648-1649.
- Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.
- Wells AF, Jia B, Xie L, Valenzuela GJ, Keystone EC, Li Z, Quebe AK, Griffing K, Otawa S, Haraoui B. Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study. Rheumatol Ther. 2021 Jun;8(2):987-1001. doi: 10.1007/s40744-021-00317-9. Epub 2021 May 24.
- Genovese MC, Kremer JM, Kartman CE, Schlichting DE, Xie L, Carmack T, Pantojas C, Sanchez Burson J, Tony HP, Macias WL, Rooney TP, Smolen JS. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis. Rheumatology (Oxford). 2018 May 1;57(5):900-908. doi: 10.1093/rheumatology/kex489.
- Smolen JS, Kremer JM, Gaich CL, DeLozier AM, Schlichting DE, Xie L, Stoykov I, Rooney T, Bird P, Sanchez Burson JM, Genovese MC, Combe B. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). Ann Rheum Dis. 2017 Apr;76(4):694-700. doi: 10.1136/annrheumdis-2016-209821. Epub 2016 Oct 31.
- Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, Beattie SD, Koch AE, Cardillo TE, Rooney TP, Macias WL, de Bono S, Schlichting DE, Smolen JS. Baricitinib in Patients with Refractory Rheumatoid Arthritis. N Engl J Med. 2016 Mar 31;374(13):1243-52. doi: 10.1056/NEJMoa1507247.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 января 2013 г.
Первичное завершение (Действительный)
1 июня 2014 г.
Завершение исследования (Действительный)
1 сентября 2014 г.
Даты регистрации исследования
Первый отправленный
1 ноября 2012 г.
Впервые представлено, что соответствует критериям контроля качества
1 ноября 2012 г.
Первый опубликованный (Оценивать)
2 ноября 2012 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
18 сентября 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 сентября 2019 г.
Последняя проверка
1 сентября 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 14058
- I4V-MC-JADW (Другой идентификатор: Eli Lilly and Company)
Планирование данных отдельных участников (IPD)
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ДА
Описание плана IPD
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Сроки обмена IPD
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
Критерии совместного доступа к IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- КСО
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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