A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)
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 DMARD Therapy
4 other identifiers
interventional
1,670
18 countries
156
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) and inhibition of radiographic progression in patients with active RA who are unresponsive to treatment with disease-modifying antirheumatic drugs (DMARD).
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
156 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedStudy Start
First participant enrolled
August 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2016
CompletedResults Posted
Study results publicly available
January 11, 2018
CompletedJanuary 11, 2018
December 1, 2017
3 years
May 21, 2012
October 17, 2017
December 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 16
ACR 20 response is greater than or equal to (\>=) 20 percent (%) improvement in both tender joint count (68) and swollen joint count (66) and \>= 20% improvement in 3 of following 5 assessments:Participant's assessment of pain using visual analog scale (VAS) (0-10 scale, 0=no pain and 10=worst possible pain),Participant's global assessment of disease activity by using VAS (scale ranges from 0 to 10, \[0 = very well to 10 = very poor\]), Physician's global assessment of disease activity using VAS (scale ranges from 0 to 10, \[0=no arthritis activity to 10=extremely active arthritis\]), Participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (scale ranges from 0= no difficulty to 3= inability to perform a task in that area), and Serum C-reactive protein (CRP). Participants were analyzed according to randomized treatment groups they were assigned, regardless of treatments they actually received. Here, TF= treatment failure.
Week 16
Change From Baseline in Van Der Heijde-modified Sharpe (vdH-S) Score at Week 52
The van der Heijde-modified Sharpe (vdH-S) score is defined as a measurement of progression in structural damage. It is the sum of joint erosion (32 joints of the hands and 12 joints of the feet) score and joint space narrowing (JSN) (30 joints of the hands and 12 joints of the feet) score. The joint erosion assessment is scored according to the surface area involved, from 0 to 5, with 0 indicating no erosion and 5 indicating complete collapse of bone whereas the JSN assessment including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received. Here, EE= early escape.
Baseline, Week 52
Secondary Outcomes (32)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
Baseline, Week 24
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24
Week 24
Percentage of Participants With Disease Activity Index Score 28 (DAS28) (C-reactive Protein (CRP) Remission at Week 24
Week 24
Percentage of Participants With Major Clinical Response (MCR) at Week 52
Week 52
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response Through Week 52
Week 2, 4, 6, 8, 12, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52
- +27 more secondary outcomes
Study Arms (3)
Placebo then Sirukumab 50 mg or Sirukumab 100 mg
EXPERIMENTALSirukumab 100 mg
EXPERIMENTALSirukumab 50 mg + Placebo
EXPERIMENTALInterventions
Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 50.
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 52 through Week 104.
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 6 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline
- Have been unresponsive to single-agent or combination disease-modifying antirheumatic drugs (DMARD) therapy that includes methotrexate (MTX) or sulfasalazine (SSZ) due to lack of benefit after at least 12 weeks of DMARD, as assessed by the treating physician
- 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 DMARD such as MTX, 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
You may not qualify if:
- Has a history of intolerance to at least 2 or inadequate response to at least 1 anti-tumor necrosis factor alpha agent after 3 months of therapy
- Has received infliximab, golimumab, adalimumab, or certolizumab pegol within 3 months of the first study agent administration
- Has received etanercept or yisaipu within 6 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 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 4 weeks of first study agent administration
- Has used any other biologic therapy for the treatment of RA within 3 months of the first study agent administration
- Has received intra-articular (IA), intramuscular (IM), or intravenous (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 have not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable. If a drug elimination procedure is performed during screening, the M1 metabolite should be measured and found to be 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 (156)
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Peoria, 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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Glendale, 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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Whittier, California, United States
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Aventura, 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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Naples, Florida, United States
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Palm Harbor, Florida, United States
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Tampa, Florida, United States
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Zephyrhills, Florida, 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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Wheaton, Maryland, United States
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Eagan, Minnesota, 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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Albuquerque, New Mexico, United States
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Brooklyn, 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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Cincinnati, 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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Duncansville, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Carrollton, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Mesquite, Texas, United States
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Kennewick, 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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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Ottawa, Ontario, Canada
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Burlington, Canada
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Edmonton, Canada
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Rancagua, Chile
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Santiago, Chile
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Valdivia, Chile
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Bogotá, Colombia
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Chía, Colombia
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Medellín, Colombia
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Osijek, Croatia
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Rijeka, Croatia
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Zagreb, Croatia
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Ayauta-Gun, Japan
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Bunkyō City, Japan
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Fukuoka, Japan
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Higashihiroshima, 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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Miyazaki, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Osaka, Japan
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Sapporo, Japan
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Sasebo, 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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Tomishiro, Japan
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Tsu, Japan
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Ureshino, Japan
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Yokohama, Japan
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Alytus, Lithuania
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Šiauliai, Lithuania
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Cuernavaca, Mexico
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Guadalajara, Mexico
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Juárez, Mexico
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Mexicali, Mexico
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Mexico City, Mexico
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Mérida, Mexico
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México, Mexico
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Morelia, Mexico
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San Luis de Potosi, Mexico
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Bialystok, Poland
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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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Bucharest, Romania
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Cluj-Napoca, Romania
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Iași, Romania
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Kemerovo, Russia
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Moscow, Russia
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Novosibirsk, 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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Smolensk, Russia
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Ulyanovsk, Russia
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Yaroslavl, Russia
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Belgrade, Serbia
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Kragujevac, Serbia
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Niška Banja, Serbia
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Cape Town, South Africa
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Port Elizabeth, South Africa
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Pretoria, South Africa
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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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Namdong-Gu, 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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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Kyiv, Ukraine
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Odesa, Ukraine
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Sympheropol, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhia, Ukraine
Related Publications (1)
Takeuchi T, Thorne C, Karpouzas G, Sheng S, Xu W, Rao R, Fei K, Hsu B, Tak PP. Sirukumab for rheumatoid arthritis: the phase III SIRROUND-D study. Ann Rheum Dis. 2017 Dec;76(12):2001-2008. doi: 10.1136/annrheumdis-2017-211328. Epub 2017 Aug 30.
PMID: 28855173DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The short pure placebo-controlled period (through Week 18) and the EE at Week 18 and LE at Week 40 for participants in the placebo group might have affected the ability to directly compare safety between sirukumab and placebo groups through Week 52.
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 21, 2012
First Posted
May 23, 2012
Study Start
August 15, 2012
Primary Completion
September 2, 2015
Study Completion
December 6, 2016
Last Updated
January 11, 2018
Results First Posted
January 11, 2018
Record last verified: 2017-12