A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy
4 other identifiers
interventional
878
21 countries
199
Brief Summary
The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2012
Typical duration for phase_3
199 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2012
CompletedFirst Posted
Study publicly available on registry
May 28, 2012
CompletedStudy Start
First participant enrolled
August 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2016
CompletedResults Posted
Study results publicly available
February 5, 2018
CompletedMarch 23, 2018
February 1, 2018
2.6 years
May 24, 2012
November 24, 2017
February 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16
The ACR 20 Response is defined as greater than or equal to (\>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \[0 =no pain to 10 =worst possible pain\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Week 16
Secondary Outcomes (3)
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24
Baseline and Week 24
Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24
Week 24
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24
Week 24
Study Arms (3)
Group 1
EXPERIMENTALPatients will receive placebo every 2 weeks from Week 0 through Week 22, followed by a subcutaneous (SC) sirukumab dose regimen every 2 weeks through Week 52.
Group 2
EXPERIMENTALPatients will receive sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks through Week 52.
Group 3
EXPERIMENTALPatients will receive sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52. Between sirukumab injections, placebo SC administrations will be made at Weeks 2, 6, and every 4 weeks through Week 52.
Interventions
Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 22.
Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 23 through Week 52.
Eligibility Criteria
You may qualify if:
- Have a diagnosis of rheumatoid arthritis (RA) for at least 3 months before screening
- Have moderately to severely active RA with at least 4 of 68 tender joints and 4 of 66 swollen joints, at screening and at baseline
- Have had anti-tumor necrosis factor (TNF)-alpha therapy and were unresponsive by 1 of the following 2 reasons: Lack of benefit to at least 1 anti-TNF-alpha biologic therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, yisaipu, adalimumab, golimumab, or certolizumab pegol therapy and/or at least a 14-week dosage regimen (ie, at least 4 doses) of infliximab; Intolerance to at least 2 anti-TNF-alpha biologic therapies, as assessed by the treating physician, to etanercept, yisaipu, adalimumab, golimumab, certolizumab pegol, or infliximab or have documented intolerance to an anti-TNF-alpha agent as described above that precludes further administration of anti-TNF-alpha agents
- If using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 10 mg/day of prednisone for at least 2 weeks prior to the first administration of study agent. If currently not using corticosteroids, must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent
- If using non nonsteroidal anti-inflammatory drug (NSAIDs) or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent
- If using non-biologic disease modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX), sulfasalazine (SSZ), hydroxychloroquine, chloroquine, or bucillamine, must be on a stable dose for at least 4 weeks prior to the first administration of study agent and should have no serious toxic side effects attributable to the DMARD
- C-reactive protein (CRP) 8.00 mg/L or more or erythrocyte sedimentation rate (ESR) 28 mm/hr or more at screening
You may not qualify if:
- Has received infliximab, infliximab biosimilar, or golimumab intravenous (IV) within 8 weeks of the first study agent administration
- Has received subcutaneously (SC) golimumab, adalimumab, or certolizumab pegol within 6 weeks of the first study agent administration
- Has received etanercept or yisaipu within 4 weeks of the first study agent administration
- Has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy. Has used tocilizumab within 8 weeks of the first study agent administration
- Has used B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent administration or have evidence during screening of abnormally low B-cell level caused by previous B-cell depletion therapy
- Has used anakinra within 1 week of first study agent administration
- Has used abatacept or any other biologic therapy for the treatment of RA within 8 weeks of the first study agent administration
- Has received intra-articular (IA), intramuscular (IM), 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
- Has a history of cyclophosphamide or cytotoxic agent use
- Has received cyclosporine A, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or D-penicillamine within 4 weeks of the first study agent administration
- Has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half-lives, whichever is longer, before the first study agent administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- GlaxoSmithKlinecollaborator
Study Sites (201)
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Birmingham, Alabama, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Covina, California, United States
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El Cajon, California, United States
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Hemet, California, United States
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Huntington Beach, California, United States
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La Jolla, California, United States
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La Palma, California, United States
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Placentia, California, United States
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Santa Monica, California, United States
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Tustin, California, United States
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Upland, California, United States
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Victorville, California, United States
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Whittier, California, United States
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Hamden, Connecticut, United States
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Aventura, Florida, United States
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Boca Raton, Florida, United States
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Brandon, Florida, United States
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Daytona Beach, Florida, United States
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Lake Mary, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Plantation, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Zephyrhills, Florida, United States
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Indianapolis, Indiana, United States
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Cedar Rapids, Iowa, United States
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Bowling Green, Kentucky, United States
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Monroe, Louisiana, United States
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Shreveport, Louisiana, United States
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Cumberland, Maryland, United States
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Frederick, Maryland, United States
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Hagerstown, Maryland, United States
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Eagan, Minnesota, United States
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Rochester, Minnesota, United States
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Flowood, Mississippi, United States
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Tupelo, Mississippi, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Freehold, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Lake Success, New York, United States
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Plainview, New York, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Middleburg Heights, Ohio, United States
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Edmond, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Erie, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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East Greenwich, Rhode Island, United States
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Charleston, South Carolina, United States
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Austin, Texas, United States
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Carrollton, Texas, United States
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Corpus Christi, Texas, United States
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Cypress, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Katy, Texas, United States
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Lubbock, Texas, United States
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Mesquite, Texas, United States
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Richmond, Texas, United States
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Victoria, Texas, United States
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Kennewick, Washington, United States
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Seattle, Washington, United States
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Beckley, West Virginia, United States
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Clarksburg, West Virginia, United States
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Buenos Aires, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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Campbelltown, Australia
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Victoria Park, Australia
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Vienna, Austria
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Liège, Belgium
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Kitchener, Ontario, Canada
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Burlington, Canada
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St. John's, Canada
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Toronto, Canada
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Zagreb, Croatia
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Paris, France
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Toulouse, France
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Berlin, Germany
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Cologne, Germany
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Dresden, Germany
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Erfurt, Germany
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Frankfurt am Main, Germany
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Gÿttingen N/A, Germany
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Hamburg, Germany
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Herne, Germany
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Kiel Kronshagen, Germany
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Schwerin, Germany
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Vogelsang-Gommern, Germany
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Würzburg, Germany
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Zerbst, Germany
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Ayauta, Japan
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Bunkyō City, Japan
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Fukuoka, Japan
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Fukuyama, Japan
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Higashihiroshima, Japan
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Hiroshima, Japan
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Izumo, Japan
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Kagoshima, Japan
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Katō, Japan
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Kawagoe, Japan
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Kita-Gun, Japan
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Kumamoto, Japan
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Kurume, Japan
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Matsuyama, Japan
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Miyazaki, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Nishimuro-Gun, Japan
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Nishinomiya, Japan
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Okayama, Japan
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Osaka, Japan
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Sapporo, Japan
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Sasebo, Japan
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Shibata, Japan
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Shimonoseki, Japan
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Shimotsuke, Japan
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Shinjuku-Ku, Japan
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Sumida-Ku, Japan
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Takaoka,Toyama, Japan
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Takasaki, Japan
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Tokorozawa, Japan
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Tokushima, Japan
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Tomakomai, Japan
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Tomishiro, Japan
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Tonami, Japan
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Tsu, Japan
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Ureshino, Japan
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Yokohama, Japan
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Guadalajara, Mexico
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Mérida, Mexico
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San Luis Potosí City, Mexico
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Sneek, Netherlands
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Christchurch, New Zealand
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Hamilton, New Zealand
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Wellington, New Zealand
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Bydgoszcz, Poland
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Elblag, Poland
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Lublin, Poland
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Poznan, Poland
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Ustroń, Poland
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Warsaw, Poland
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Coimbra, Portugal
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Lisbon, Portugal
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San Juan, Puerto Rico
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Barnaul, Russia
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Moscow, Russia
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Novosibirsk, Russia
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Omsk, Russia
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Orenburg, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Ulyanovsk, Russia
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Busan, South Korea
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Daegu, South Korea
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Daejeon, South Korea
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Gwangju, South Korea
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Incheon, South Korea
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Jeonju, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Suwon, South Korea
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A Coruña, Spain
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Bilbao, Spain
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Madrid, Spain
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Mérida, Spain
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San Cristóbal de La Laguna, Spain
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Santander, Spain
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Santiago de Compostela, Spain
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Barnsley, United Kingdom
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London, United Kingdom
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Middlesbrough, United Kingdom
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Sheffield, United Kingdom
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Wigan, United Kingdom
Related Publications (1)
Aletaha D, Bingham CO 3rd, Tanaka Y, Agarwal P, Kurrasch R, Tak PP, Popik S. Efficacy and safety of sirukumab in patients with active rheumatoid arthritis refractory to anti-TNF therapy (SIRROUND-T): a randomised, double-blind, placebo-controlled, parallel-group, multinational, phase 3 study. Lancet. 2017 Mar 25;389(10075):1206-1217. doi: 10.1016/S0140-6736(17)30401-4. Epub 2017 Feb 16.
PMID: 28215362DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2012
First Posted
May 28, 2012
Study Start
August 6, 2012
Primary Completion
March 17, 2015
Study Completion
January 12, 2016
Last Updated
March 23, 2018
Results First Posted
February 5, 2018
Record last verified: 2018-02