A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis
SIRROUND-H
A Multicenter, Randomized, Double-blind, Parallel Group Study of Sirukumab Monotherapy Compared With HUMIRA® Monotherapy Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis
3 other identifiers
interventional
559
16 countries
107
Brief Summary
The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2014
107 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
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedStudy Start
First participant enrolled
April 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2016
CompletedResults Posted
Study results publicly available
September 14, 2017
CompletedOctober 26, 2017
September 1, 2017
2.4 years
December 18, 2013
August 16, 2017
September 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24
The Disease Activity Index Score 28 using ESR \[DAS28 (ESR)\] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of "0-10", with the minimum score= 0 (best) to maximum score= 10 (worst).
Baseline and Week 24
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24
The ACR 50 Response is defined as greater than or equal to (\>=) 50 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>= 50% improvement in 3 of following 5 assessments: subject's assessment of pain using Visual Analog Scale (VAS) (0-10 millimeter \[mm\], 0 mm=no pain and 10 mm=worst possible pain), subject's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, \[0 mm=no pain to 100 mm=worst possible pain\]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, \[0=no arthritis activity to 10=extremely active arthritis\]), participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Week 24
Secondary Outcomes (2)
Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission at Week 24
Week 24
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24
Week 24
Study Arms (3)
Group 1 (adalimumab 40 mg)
EXPERIMENTALAdalimumab 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.
Group 2 (sirukumab 100 mg)
EXPERIMENTALSirukumab 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).
Group 3 (sirukumab 50 mg)
EXPERIMENTALSirukumab 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).
Interventions
Eligibility Criteria
You may qualify if:
- Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening
- 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
You may not qualify if:
- Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- GlaxoSmithKlinecollaborator
Study Sites (107)
Unknown Facility
Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Arvin, California, United States
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El Cajon, California, United States
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Huntington Beach, California, United States
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Pleasanton, California, United States
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Thousand Oaks, California, United States
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Tustin, California, United States
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Whittier, California, United States
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Newark, Delaware, United States
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Aventura, Florida, United States
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Dunedin, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Palm Harbor, Florida, United States
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Plantation, Florida, United States
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Tampa, Florida, United States
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Kansas City, Kansas, United States
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Elizabethtown, Kentucky, United States
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Paducah, Kentucky, United States
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Frederick, Maryland, United States
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Wheaton, Maryland, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Dayton, Ohio, United States
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Portland, Oregon, United States
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Duncansville, Pennsylvania, United States
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Wexford, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Jackson, Tennessee, United States
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Nashville, Tennessee, 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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Lubbock, Texas, United States
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McKinney, Texas, United States
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Mesquite, Texas, United States
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Chesapeake, Virginia, United States
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Clarksburg, West Virginia, United States
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Rousse, Bulgaria
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Sofia, Bulgaria
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Port Montt, Chile
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Temuco, Chile
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Barranquilla, Colombia
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Bogotá, Colombia
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Bucaramanga, Colombia
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Bad Doberan, Germany
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Berlin, Germany
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Cologne, Germany
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Ratingen, Germany
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Vogelsang-Gommern, Germany
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Debrecen, Hungary
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Gödöllő, Hungary
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Klaipėda, Lithuania
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Šiauliai, Lithuania
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Vilnius, Lithuania
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Chihuahua City, Mexico
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Guadalajara, Mexico
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Jalisco, Mexico
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Mexicali, Mexico
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Chisinau, Moldova
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Bydgoszcz, Poland
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Bytom, Poland
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Krakow, Poland
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Lublin, Poland
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Nadarzyn, Poland
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Poznan, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Bucharest, Romania
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Constanța, Romania
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Ploieşti, Romania
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Arkhangelsk, Russia
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Kazan', Russia
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Kemerovo, Russia
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Kursk, Russia
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Moscow, Russia
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Novosibirsk, Russia
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Petrozavodsk, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Tomsk, Russia
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Tver', Russia
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Vladimir, Russia
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Yaroslavl, Russia
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Belgrade, Serbia
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Novi Sad, Serbia
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Zemun, Serbia
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Cape Town, South Africa
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Durban, South Africa
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Kempton Park, South Africa
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Stellenbosch, South Africa
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A Coruña, Spain
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Madrid, Spain
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Chernihiv, Ukraine
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Kryvyi Rih, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Sumy, Ukraine
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Ternopil, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhia, Ukraine
Related Publications (1)
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.
PMID: 29483080DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director
- Organization
- Janssen-Cilag International N.V.
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2013
First Posted
December 24, 2013
Study Start
April 4, 2014
Primary Completion
August 17, 2016
Study Completion
August 17, 2016
Last Updated
October 26, 2017
Results First Posted
September 14, 2017
Record last verified: 2017-09