A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis
NCT ID: NCT02019472
Last Updated: 2017-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
559 participants
INTERVENTIONAL
2014-04-04
2016-08-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1 (adalimumab 40 mg)
Adalimumab 40 mg SC at Weeks 0, 2, and every 2 weeks through Week 52. At Week 16, subjects who have \< 20% improvement from baseline in both swollen and tender joint counts will early escape in a blinded fashion and receive adalimumab 40 mg every week through Week 52.
adalimumab 40 mg
SC injections
Group 2 (sirukumab 100 mg)
Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks through Week 52. Subjects may meet the early escape criteria at Week 16 (\< 20% improvement from baseline in both swollen and tender joint counts) but no sirukumab dose adjustments will made for these subjects. However, these subjects will receive placebo injections every 2 weeks between the sirukumab injections (ie, subjects that early escape will receive a weekly injection of alternating sirukumab and placebo, to preserve the blind).
sirukumab 100 mg
SC injections
Placebo
SC injections
Group 3 (sirukumab 50 mg)
Sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52. Between sirukumab injections, placebo SC injections will be administered at Weeks 2, 6, and every 4 weeks through Week 50. At Week 16, subjects who have \< 20% improvement from baseline in both swollen and tender joint counts will early escape in a blinded fashion and receive sirukumab 100 mg every 2 weeks through Week 52 and placebo injections every 2 weeks between the sirukumab injections (ie, subjects that early escape will receive a weekly injection of alternating sirukumab and placebo, to preserve the blind).
sirukumab 50 mg
SC injections
Placebo
SC injections
Interventions
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adalimumab 40 mg
SC injections
sirukumab 100 mg
SC injections
sirukumab 50 mg
SC injections
Placebo
SC injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline
* Have previous or current treatment with methotrexate (MTX) and are considered intolerant to MTX, and/or are considered inappropriate for treatment with MTX, (including MTX-naïve subjects for whom it is inappropriate to administer MTX) and/or an inadequate responder to methotrexate
* Must not have received MTX or any other non-biologic DMARD including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent
* C-reactive protein \>= 10.00 mg/L or erythrocyte sedimentation rate \>=28 mm/hr at screening
Exclusion Criteria
* Has ever received biologic therapy for RA, including but not limited to the following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept
* Has ever used tofacitinib therapy or any other JAK inhibitor
* Has received intra-articular, intramuscular, or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration
* Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable
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
Phoenix, Arizona, United States
Arvin, California, United States
El Cajon, California, United States
Huntington Beach, California, United States
Pleasanton, California, United States
Thousand Oaks, California, United States
Tustin, California, United States
Whittier, California, United States
Newark, Delaware, United States
Aventura, Florida, United States
Dunedin, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Palm Harbor, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Kansas City, Kansas, United States
Elizabethtown, Kentucky, United States
Paducah, Kentucky, United States
Frederick, Maryland, United States
Wheaton, Maryland, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Dayton, Ohio, United States
Portland, Oregon, United States
Duncansville, Pennsylvania, United States
Wexford, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Jackson, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Carrollton, Texas, United States
Corpus Christi, Texas, United States
Cypress, Texas, United States
Lubbock, Texas, United States
McKinney, Texas, United States
Mesquite, Texas, United States
Chesapeake, Virginia, United States
Clarksburg, West Virginia, United States
Rousse, , Bulgaria
Sofia, , Bulgaria
Port Montt, , Chile
Temuco, , Chile
Barranquilla, , Colombia
Bogotá, , Colombia
Bucaramanga, , Colombia
Bad Doberan, , Germany
Berlin, , Germany
Cologne, , Germany
Ratingen, , Germany
Vogelsang-Gommern, , Germany
Debrecen, , Hungary
Gödöllő, , Hungary
Klaipėda, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Chihuahua City, , Mexico
Guadalajara, , Mexico
Jalisco, , Mexico
Mexicali, , Mexico
Chisinau, , Moldova
Bydgoszcz, , Poland
Bytom, , Poland
Krakow, , Poland
Lublin, , Poland
Nadarzyn, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bucharest, , Romania
Constanța, , Romania
Ploieşti, , Romania
Arkhangelsk, , Russia
Kazan', , Russia
Kemerovo, , Russia
Kursk, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Petrozavodsk, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Tomsk, , Russia
Tver', , Russia
Vladimir, , Russia
Yaroslavl, , Russia
Belgrade, , Serbia
Novi Sad, , Serbia
Zemun, , Serbia
Cape Town, , South Africa
Durban, , South Africa
Kempton Park, , South Africa
Stellenbosch, , South Africa
A Coruña, , Spain
Madrid, , Spain
Chernihiv, , Ukraine
Kryvyi Rih, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Poltava, , Ukraine
Sumy, , Ukraine
Ternopil, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhia, , Ukraine
Countries
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References
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Taylor PC, Schiff MH, Wang Q, Jiang Y, Zhuang Y, Kurrasch R, Daga S, Rao R, Tak PP, Hsu B. Efficacy and safety of monotherapy with sirukumab compared with adalimumab monotherapy in biologic-naive patients with active rheumatoid arthritis (SIRROUND-H): a randomised, double-blind, parallel-group, multinational, 52-week, phase 3 study. Ann Rheum Dis. 2018 May;77(5):658-666. doi: 10.1136/annrheumdis-2017-212496. Epub 2018 Feb 26.
Other Identifiers
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CNTO136ARA3005
Identifier Type: OTHER
Identifier Source: secondary_id
2013-001417-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR103111
Identifier Type: -
Identifier Source: org_study_id