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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01606761




Registration number
NCT01606761
Ethics application status
Date submitted
24/05/2012
Date registered
28/05/2012
Date last updated
23/03/2018

Titles & IDs
Public title
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)
Scientific title
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
Secondary ID [1] 0 0
CNTO136ARA3003
Secondary ID [2] 0 0
CR100864
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Sirukumab
Treatment: Drugs - Sirukumab
Treatment: Drugs - Sirukumab

Experimental: Group 1 - Patients 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.

Experimental: Group 2 - Patients will receive sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks through Week 52.

Experimental: Group 3 - Patients 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.


Treatment: Drugs: Placebo
Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 22.

Treatment: Drugs: Placebo
Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 52.

Treatment: Drugs: Sirukumab
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.

Treatment: Drugs: Sirukumab
Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 52.

Treatment: Drugs: Sirukumab
Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 52.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24
Timepoint [3] 0 0
Week 24

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/01/2016
Sample size
Target
Accrual to date
Final
878
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Campbelltown
Recruitment hospital [2] 0 0
- Victoria Park
Recruitment postcode(s) [1] 0 0
- Campbelltown
Recruitment postcode(s) [2] 0 0
- Victoria Park
Recruitment outside Australia
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Alabama
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Nebraska
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New York
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North Carolina
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Washington
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West Virginia
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Rosario
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Argentina
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San Miguel De Tucuman
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Austria
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Vienna
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Austria
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Wien
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Belgium
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Liège
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British Columbia
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Canada
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Manitoba
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Newfoundland and Labrador
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Ontario
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Canada
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Burlington
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Canada
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Saint-John'S
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Canada
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Toronto N/A
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Croatia
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Zagreb
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France
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Paris
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France
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Toulouse Cedex 9
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Erfurt
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Germany
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Frankfurt/Main
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Germany
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Gÿttingen N/A
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Germany
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Hamburg
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Germany
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Herne
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Germany
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Kiel Kronshagen
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Germany
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Köln
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Germany
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Schwerin
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Germany
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Vogelsang-Gommern
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Germany
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Würzburg
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Germany
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Zerbst
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Japan
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Ayauta
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Japan
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Bunkyo-Ku
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Japan
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Fukuoka
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Japan
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Fukuyama
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Higashihiroshima
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Hiroshima
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Izumo
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Kagoshima
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Kato
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Kawagoe
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Kumamoto
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Miyazaki
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Nagano
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Nagasaki
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Nagoya
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Nishimuro-Gun
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Nishinomiya
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Okayama
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Osaka
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Sapporo
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Shimotsuke
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Shinjuku-Ku
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Sumida-Ku
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Takaoka,Toyama
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Takasaki
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Tokorozawa
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Tokushima
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Tomakomai
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Tomishiro
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Tonami
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Tsu
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Ureshino
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Yokohama
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Korea, Republic of
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Busan
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jeonju-Si
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Korea, Republic of
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Seongnam-Si
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Mexico
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Guadalajara
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Mexico
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Merida
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Mexico
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San Luis Potosí
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Netherlands
State/province [111] 0 0
Sneek
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New Zealand
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Christchurch
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New Zealand
State/province [113] 0 0
Hamilton
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New Zealand
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Wellington
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Poland
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Bydgoszcz
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Poland
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Elblag
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Poland
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Lublin
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Poland
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Poznan
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Poland
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Ustron
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Poland
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Warszawa
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Lisbon
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Puerto Rico
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San Juan
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Russian Federation
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Barnaul
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Russian Federation
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Moscow N/A
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Orenburg
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Ulyanovsk
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Spain
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Bilbao
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Spain
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Coruña
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Spain
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La Laguna
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Spain
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Madrid
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Spain
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Mérida
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Spain
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Santander
Country [141] 0 0
Spain
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Santiago De Compostela
Country [142] 0 0
Taiwan
State/province [142] 0 0
Kaohsiung
Country [143] 0 0
Taiwan
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Taichung City
Country [144] 0 0
Taiwan
State/province [144] 0 0
Taichung
Country [145] 0 0
Taiwan
State/province [145] 0 0
Taipei
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Barnsley
Country [147] 0 0
United Kingdom
State/province [147] 0 0
London
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Middlesbrough
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Sheffield
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Wigan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01606761