Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003
NCT ID: NCT01856309
Last Updated: 2019-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1820 participants
INTERVENTIONAL
2013-08-07
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sirukumab 100 mg
Sirukumab 100 mg
Sirukumab 100 mg subcutaneously (SC) at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 2, and every 2 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.
Sirukumab 50 mg / placebo
Sirukumab 50 mg
Sirukumab 50 mg SC at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 4, and every 4 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.
Placebo
Between sirukumab 50 mg injections, placebo SC injections will be administered at Weeks 2, 6, and every 4 weeks until the study becomes open-label, and placebo injections are discontinued.
Interventions
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Sirukumab 100 mg
Sirukumab 100 mg subcutaneously (SC) at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 2, and every 2 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.
Sirukumab 50 mg
Sirukumab 50 mg SC at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 4, and every 4 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.
Placebo
Between sirukumab 50 mg injections, placebo SC injections will be administered at Weeks 2, 6, and every 4 weeks until the study becomes open-label, and placebo injections are discontinued.
Eligibility Criteria
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Inclusion Criteria
* Signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
* Signed an informed consent form (ICF) for pharmacogenetics research (how a person's genes may affect a drug's effects) in order to participate in the optional pharmacogenetics component of this study. Refusal to give consent for this component does not exclude a participant from participation in this clinical study
Exclusion Criteria
* Is pregnant
* Has active diverticulitis
* Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Birmingham, Alabama, United States
Glendale, Arizona, United States
Mesa, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Covina, California, United States
El Cajon, California, United States
Glendale, California, United States
Hemet, California, United States
Huntington Beach, California, United States
La Jolla, California, United States
La Palma, California, United States
Placentia, California, United States
Upland, California, United States
Victorville, California, United States
Whittier, California, United States
Hamden, Connecticut, United States
Aventura, Florida, United States
Boca Raton, Florida, United States
Brandon, Florida, United States
Daytona Beach, Florida, United States
DeBary, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Plantation, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Zephyrhills, Florida, United States
Cedar Rapids, Iowa, United States
Bowling Green, Kentucky, United States
Monroe, Louisiana, United States
Cumberland, Maryland, United States
Hagerstown, Maryland, United States
Wheaton, Maryland, United States
Rochester, Minnesota, United States
Flowood, Mississippi, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Freehold, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Middleburg Heights, Ohio, United States
Edmond, Oklahoma, United States
Tulsa, Oklahoma, United States
Duncansville, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Charleston, South Carolina, United States
Austin, Texas, United States
Carrollton, Texas, United States
Corpus Christi, Texas, United States
Cypress, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Katy, Texas, United States
Lubbock, Texas, United States
Mesquite, Texas, United States
Victoria, Texas, United States
Beckley, West Virginia, United States
Clarksburg, West Virginia, United States
Buenos Aires, , Argentina
Rosario, , Argentina
San Miguel de Tucumán, , Argentina
Victoria Park, , Australia
Vienna, , Austria
Liège, , Belgium
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Edmonton, , Canada
Rancagua, , Chile
Santiago, , Chile
Valdivia, , Chile
Bogotá, , Colombia
Chía, , Colombia
Medellín, , Colombia
Osijek, , Croatia
Rijeka, , Croatia
Zagreb, , Croatia
Toulouse, , France
Berlin, , Germany
Cologne, , Germany
Frankfurt am Main, , Germany
Göttingen, , Germany
Hamburg, , Germany
Vogelsang-Gommern, , Germany
Würzburg, , Germany
Ayauta, , Japan
Bunkyō City, , Japan
Fukuoka, , Japan
Higashihiroshima, , Japan
Hiroshima, , Japan
Izumo, , Japan
Kagoshima, , Japan
Katō, , Japan
Kawagoe, , Japan
Kita-Gun, , Japan
Kumamoto, , Japan
Kurume, , Japan
Matsuyama, , Japan
Miyazaki, , Japan
Nagano, , Japan
Nagasaki, , Japan
Nagoya, , Japan
Nishimuro-gun, , Japan
Nishinomiya, , Japan
Okayama, , Japan
Osaka, , Japan
Sapporo, , Japan
Sasebo, , Japan
Shibata, , Japan
Shimonoseki, , Japan
Shimotsuke, , Japan
Shinjuku-ku, , Japan
Sumida-ku, , Japan
Takaoka,Toyama, , Japan
Takasaki, , Japan
Tokorozawa, , Japan
Tokushima, , Japan
Tomishiro, , Japan
Tonami, , Japan
Tsu, , Japan
Ureshino, , Japan
Yokohama, , Japan
Alytus, , Lithuania
Kaunas, , Lithuania
Klaipėda, , Lithuania
Šiauliai, , Lithuania
Kuala Lumpur, , Malaysia
Kuching, , Malaysia
Cuernavaca, , Mexico
Guadalajara, , Mexico
Mexicali, , Mexico
Mérida, , Mexico
México, , Mexico
Morelia, , Mexico
San Luis de Potosi, , Mexico
Sneek, , Netherlands
Bialystok, , Poland
Bydgoszcz, , Poland
Elblag, , Poland
Lublin, , Poland
Poznan, , Poland
Ustroń, , Poland
Warsaw, , Poland
Lisbon, , Portugal
San Juan, , Puerto Rico
Bucharest, , Romania
Iași, , Romania
Barnaul, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Orenburg, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Smolensk, , Russia
Ulyanovsk, , Russia
Yaroslavl, , Russia
Belgrade, , Serbia
Kragujevac, , Serbia
Niška Banja, , Serbia
Cape Town, , South Africa
Port Elizabeth, , South Africa
Pretoria, , South Africa
Busan, , South Korea
Daegu, , South Korea
Daejeon, , South Korea
Gwangju, , South Korea
Incheon, , South Korea
Jeonju, , South Korea
Namdong-Gu, , South Korea
Seongnam-si, , South Korea
Seoul, , South Korea
Suwon, , South Korea
A Coruña, , Spain
Barakaldo, , Spain
Santander, , Spain
Santiago de Compostela, , Spain
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Kharkiv, , Ukraine
Kyiv, , Ukraine
Odesa, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhia, , Ukraine
London, , United Kingdom
Wigan, , United Kingdom
Countries
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References
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Aletaha D, Bingham CO, Karpouzas GA, Takeuchi T, Thorne C, Bili A, Agarwal P, Hsu B, Rao R, Brown K, Tanaka Y. Long-term safety and efficacy of sirukumab for patients with rheumatoid arthritis who previously received sirukumab in randomised controlled trials (SIRROUND-LTE). RMD Open. 2021 Jan;7(1):e001465. doi: 10.1136/rmdopen-2020-001465.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CNTO136ARA3004
Identifier Type: OTHER
Identifier Source: secondary_id
2012-001176-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR102023
Identifier Type: -
Identifier Source: org_study_id
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