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CompletedNCT01606761Updated Mar 23, 2018Results posted

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 Phase 3 interventional study of Placebo and Placebo in Arthritis, Rheumatoid, sponsored by Janssen Research & Development, LLC. Completed at 205 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-23.

Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
878
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Patients will be randomly assigned to treatment groups, and they and study personnel will not know the identity of the treatments given. Some patients will receive a placebo, which resembles a medication, but does not contain an active substance. This helps to determine if the study agent is effective. Patients will receive placebo or sirukumab by injection under the skin. The expected duration of the study is 68 weeks, which includes 52 weeks of treatment. Participants who complete participation in the study will be eligible for inclusion into the long term extension study if enrollment at a participating site is available to them. If they do not participate in the long-term study, they will continue into the safety follow-up for approximately 16 weeks. The placebo-controlled portion of the study is through Week 24, when placebo patients will cross over to one of two sirukumab dose regimens. Patient safety will be monitored throughout the study.

02

Conditions studied

  • Arthritis, Rheumatoid

Keywords

  • Arthritis, Rheumatoid
  • Active rheumatoid arthritis despite anti-TNF-alpha therapy
  • Sirukumab
  • Human Anti-IL-6 monoclonal antibody
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 878 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
878 participants (actual)

Study arms

  • 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.

    Drug: Placebo · Drug: Sirukumab

  • Experimental
    Group 2

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

    Drug: Sirukumab

  • 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.

    Drug: Placebo · Drug: Sirukumab

Interventions

  • DrugPlacebo

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

  • DrugPlacebo

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

  • DrugSirukumab

    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.

  • DrugSirukumab

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

  • DrugSirukumab

    Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 52.

06

What researchers measure

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).

    Time frame: Week 16

Secondary outcomes

  1. Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24

    The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

    Time frame: Baseline and Week 24

  2. Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24

    The ACR 50 Response is defined as \>= 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using 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 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).

    Time frame: Week 24

  3. Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24

    The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (\<) 2.6 at any study visit.

    Time frame: Week 24

07

Results

Posted Feb 5, 2018

Participant flow

Prior to Week 24
Participant flow — Prior to Week 24
MilestonePlaceboSirukumab 50 mg q4wSirukumab 100 mg q2wPlacebo to 50 mg q4w Due to EE or COPlacebo to 100 mg q2w Due to EE or CO
Started29429229200
Participants re-randomized at week 18940000
Completed25223724500
Not completed42554700
Withdrew: Lost to follow-up03200
Withdrew: Withdrawal by subject1210900
Withdrew: Adverse event11182200
Withdrew: Lack of efficacy1514800
Withdrew: Physician decision03100
Withdrew: Other47500
Week 24 to Week 52
Participant flow — Week 24 to Week 52
MilestonePlaceboSirukumab 50 mg q4wSirukumab 100 mg q2wPlacebo to 50 mg q4w Due to EE or COPlacebo to 100 mg q2w Due to EE or CO
Started0237245126126
Treated0237245124126
Completed0204212109106
Not completed033331720
Withdrew: Lost to follow-up01110
Withdrew: Withdrawal by subject06300
Withdrew: Adverse event01114315
Withdrew: Death00210
Withdrew: Lack of efficacy0137103
Withdrew: Physician decision01100
Withdrew: Other01522
Safety Follow-up Period (Week 52-68)
Participant flow — Safety Follow-up Period (Week 52-68)
MilestonePlaceboSirukumab 50 mg q4wSirukumab 100 mg q2wPlacebo to 50 mg q4w Due to EE or COPlacebo to 100 mg q2w Due to EE or CO
Started286562919
Safety population286562719
Completed245545711
Not completed4101728
Withdrew: Lost to follow-up01201
Withdrew: Withdrawal by subject46613
Withdrew: Death00001
Withdrew: Other03913

Outcome measures

PrimaryPercentage 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).

Time frame:
Week 16
Reported as:
Number · Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16
Percentage of ParticipantsPlaceboSirukumab 50 mgSirukumab 100 mg
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 1624.140.145.2
Statistical analysis
  • Placebo vs Sirukumab 50 mg · Cochran-Mantel-Haenszel · p = < 0.001 · Percentage difference: 15.9 · 95% CI 8.5 to 23.2
  • Placebo vs Sirukumab 100 mg · Cochran-Mantel-Haenszel · p = < 0.001 · Percentage difference: 21.0 · 95% CI 13.6 to 28.5
SecondaryChange From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24

The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame:
Baseline and Week 24
Reported as:
Mean · Units on a scale
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24
Units on a scalePlaceboSirukumab 50 mgSirukumab 100 mg
Baseline1.5663 ± 0.652231.6499 ± 0.597431.6122 ± 0.61320
Change at Week 24-0.12 ± 0.491-0.31 ± 0.543-0.33 ± 0.526
Statistical analysis
  • Placebo vs Sirukumab 50 mg · ANCOVA · p = < 0.001 · Least square (ls) mean difference: -0.17 · 95% CI -0.251 to -0.088
  • Placebo vs Sirukumab 100 mg · ANCOVA · p = < 0.001 · Ls mean difference: -0.194 · 95% CI -0.275 to -0.112
SecondaryPercentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24

The ACR 50 Response is defined as \>= 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using 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 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).

Time frame:
Week 24
Reported as:
Number · Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24
Percentage of ParticipantsPlaceboSirukumab 50 mgSirukumab 100 mg
Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 248.820.921.6
Statistical analysis
  • Placebo vs Sirukumab 50 mg · Cochran-Mantel-Haenszel · p = < 0.001 · Percentage difference: 12.0 · 95% CI 6.4 to 17.7
  • Placebo vs Sirukumab 100 mg · Cochran-Mantel-Haenszel · p = < 0.001 · Percentage difference: 12.7 · 95% CI 7.0 to 18.4
SecondaryPercentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24

The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (\<) 2.6 at any study visit.

Time frame:
Week 24
Reported as:
Number · Percentage of Participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24
Percentage of ParticipantsPlaceboSirukumab 50 mgSirukumab 100 mg
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 248.219.221.6
Statistical analysis
  • Placebo vs Sirukumab 50 mg · Cochran-Mantel-Haenszel · p = < 0.001 · Percentage difference: 11.0 · 95% CI 5.5 to 16.5
  • Placebo vs Sirukumab 100 mg · Cochran-Mantel-Haenszel · p = < 0.001 · Percentage difference: 13.4 · 95% CI 7.8 to 19.1

Adverse events

Collected over Up to Week 68. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Week (W) 24-Placebo—15/294 (5.1%)106/294 (36.1%)
W24 to W52-Placebo to 50 mg q4w Due to EE or CO—8/124 (6.5%)50/124 (40.3%)
W52-Sirukumab 50 mg q4w—51/292 (17.5%)152/292 (52.1%)
W24 to W52-Placebo to 100 mg q2w Due to EE or CO—18/126 (14.3%)63/126 (50%)
W52-Sirukumab 100 mg q2w—37/292 (12.7%)169/292 (57.9%)
W52 to W68-Placebo—0/28 (0%)0/28 (0%)
W52 to W68-Placebo to 50 mg q4w Due to EE or CO—0/7 (0%)1/7 (14.3%)
W52 to W68-Sirukumab 50 mg q4w—1/65 (1.5%)2/65 (3.1%)
W52 to W68-Placebo to 100 mg q2w Due to EE or CO—2/19 (10.5%)3/19 (15.8%)
W52 to W68-Sirukumab 100 mg q2w—0/62 (0%)4/62 (6.5%)
Most frequent serious events
Showing 10 of 123
Most frequent serious events
EventWeek (W) 24-PlaceboW24 to W52-Placebo to 50 mg q4w Due to EE or COW52-Sirukumab 50 mg q4wW24 to W52-Placebo to 100 mg q2w Due to EE or COW52-Sirukumab 100 mg q2wW52 to W68-PlaceboW52 to W68-Placebo to 50 mg q4w Due to EE or COW52 to W68-Sirukumab 50 mg q4wW52 to W68-Placebo to 100 mg q2w Due to EE or COW52 to W68-Sirukumab 100 mg q2w
Diverticular PerforationGastrointestinal disorders0/2940/1241/2920/1261/2920/280/70/651/190/62
ErysipelasInfections and infestations0/2940/1240/2922/1260/2920/280/70/651/190/62
PneumoniaInfections and infestations1/2940/1245/2920/1265/2920/280/70/650/190/62
Rheumatoid ArthritisMusculoskeletal and connective tissue disorders2/2942/1243/2920/1261/2920/280/71/650/190/62
CellulitisInfections and infestations0/2940/1243/2922/1262/2920/280/70/650/190/62
Angina UnstableCardiac disorders0/2940/1243/2920/1260/2920/280/70/650/190/62
OsteoarthritisMusculoskeletal and connective tissue disorders0/2941/1243/2921/1261/2920/280/70/650/190/62
GoitreEndocrine disorders0/2941/1240/2920/1260/2920/280/70/650/190/62
Anal FissureGastrointestinal disorders0/2941/1240/2920/1260/2920/280/70/650/190/62
Chest PainGeneral disorders1/2941/1241/2920/1262/2920/280/70/650/190/62
Most frequent other events
Showing 10 of 30
Most frequent other events
EventWeek (W) 24-PlaceboW24 to W52-Placebo to 50 mg q4w Due to EE or COW52-Sirukumab 50 mg q4wW24 to W52-Placebo to 100 mg q2w Due to EE or COW52-Sirukumab 100 mg q2wW52 to W68-PlaceboW52 to W68-Placebo to 50 mg q4w Due to EE or COW52 to W68-Sirukumab 50 mg q4wW52 to W68-Placebo to 100 mg q2w Due to EE or COW52 to W68-Sirukumab 100 mg q2w
Injection Site ErythemaGeneral disorders4/2945/12428/29219/12647/2920/280/70/650/190/62
BronchitisInfections and infestations5/2947/12413/2924/12622/2920/281/70/650/190/62
PneumoniaInfections and infestations0/2941/1243/2922/1265/2920/281/70/650/190/62
Lymphocyte Count IncreasedInvestigations0/2940/1240/2920/1260/2920/281/70/650/190/62
Neutrophil Count IncreasedInvestigations2/2941/1240/2920/1260/2920/281/70/650/190/62
White Blood Cell Count IncreasedInvestigations2/2941/1240/2920/1260/2920/281/70/650/190/62
HyperglycaemiaMetabolism and nutrition disorders3/2942/1243/2920/1261/2920/281/70/650/190/62
Back PainMusculoskeletal and connective tissue disorders2/2940/1247/2921/1269/2920/281/70/650/190/62
Muscle SpasmsMusculoskeletal and connective tissue disorders2/2942/1245/2921/1267/2920/281/70/650/191/62
CoughRespiratory, thoracic and mediastinal disorders2/2944/12413/2924/12622/2920/281/70/650/190/62

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PlaceboSirukumab 50 mg q4wSirukumab 100 mg q2wTotal
<=18 years0 ± 12.190 ± 11.890 ± 12.280
Between 18 and 65 years228225230683
>=65 years666762195
Age, Continuous
Age, Continuous(years)PlaceboSirukumab 50 mg q4wSirukumab 100 mg q2wTotal
Mean55.4 ± 12.1955.8 ± 11.8955 ± 12.2855.4 ± 12.11
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboSirukumab 50 mg q4wSirukumab 100 mg q2wTotal
Female240232240712
Male546052166
Region of Enrollment
Region of Enrollment(Participants)PlaceboSirukumab 50 mg q4wSirukumab 100 mg q2wTotal
Argentina106319
Australia1203
Austria2002
Belgium1001
Canada27110
France0101
Germany713727
Italy5049
Japan373544116
Lithuania47516
Mexico74617
Netherlands4116
Poland21292676
Portugal34411
Puerto Rico1618
Republic of Korea57517
Russian Federation18112150
Spain88723
Taiwan, Province of China82212
United Kingdom2439
United States148145152445
08

Study locations

205 sites
  • Birmingham, Alabama, United States
  • Glendale, Arizona, United States
  • Mesa, Arizona, United States
  • Phoenix, Arizona, United States
  • Covina, California, United States
  • El Cajon, California, United States
  • Hemet, California, United States
  • Huntington Beach, California, United States
  • La Jolla, California, United States
  • La Palma, California, United States
  • Placentia, California, United States
  • Santa Monica, California, United States
  • Tustin, California, United States
  • Upland, California, United States
  • Victorville, California, United States
  • Whittier, California, United States
  • Hamden, Connecticut, United States
  • Aventura, Florida, United States
  • Boca Raton, Florida, United States
  • Brandon, Florida, United States
  • Daytona Beach, Florida, United States
  • Lake Mary, Florida, United States
  • Miami, Florida, United States
  • Naples, Florida, United States
  • Orlando, Florida, United States
  • Palm Harbor, Florida, United States
  • Plantation, Florida, United States
  • Sarasota, Florida, United States
  • Tampa, Florida, United States
  • Zephyrhills, Florida, United States
  • Boise, Idaho, United States
  • Idaho Falls, Idaho, United States
  • Indianapolis, Indiana, United States
  • Cedar Rapids, Iowa, United States
  • Bowling Green, Kentucky, United States
  • Monroe, Louisiana, United States
  • Shreveport, Louisiana, United States
  • Cumberland, Maryland, United States
  • Frederick, Maryland, United States
  • Hagerstown, Maryland, United States
  • Eagan, Minnesota, United States
  • Rochester, Minnesota, United States
  • Flowood, Mississippi, United States
  • Tupelo, Mississippi, United States
  • Saint Louis, Missouri, United States
  • Springfield, Missouri, United States
  • Omaha, Nebraska, United States
  • Las Vegas, Nevada, United States
  • Freehold, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • Brooklyn, New York, United States
  • Lake Success, New York, United States
  • Plainview, New York, United States
  • Charlotte, North Carolina, United States
  • Hickory, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Columbus, Ohio, United States
  • Dayton, Ohio, United States
  • Middleburg Heights, Ohio, United States
  • Edmond, Oklahoma, United States
  • Tulsa, Oklahoma, United States
  • Erie, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Wyomissing, Pennsylvania, United States
  • East Greenwich, Rhode Island, United States
  • Charleston, South Carolina, United States
  • Austin, Texas, United States
  • Carrollton, Texas, United States
  • Corpus Christi, Texas, United States
  • Cypress, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Katy, Texas, United States
  • Lubbock, Texas, United States
  • Mesquite, Texas, United States
  • Richmond, Texas, United States
  • Victoria, Texas, United States
  • Kennewick, Washington, United States
  • Seattle, Washington, United States
  • Beckley, West Virginia, United States
  • Clarksburg, West Virginia, United States
  • Ciudad Autónoma De Buenos Aires, Argentina
  • Rosario, Argentina
  • San Miguel De Tucuman, Argentina
  • Campbelltown, Australia
  • Victoria Park, Australia
  • Vienna, Austria
  • Wien, Austria
  • Liège, Belgium
  • Victoria, British Columbia, Canada
  • Winnipeg, Manitoba, Canada
  • St. John'S, Newfoundland and Labrador, Canada
  • Kitchener, Ontario, Canada
  • Burlington, Canada
  • Saint-John'S, Canada
  • Toronto N/A, Canada
  • Zagreb, Croatia
  • Paris, France
  • Toulouse Cedex 9, France
  • Berlin, Germany

Showing the first 100 of 205 sites across 22 countries.

09

References and documents

Publications

  • 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. Erratum In: Lancet. 2017 May 20;389(10083):1980. doi: 10.1016/S0140-6736(17)31299-0. PubMed 28215362 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01606761
Lead sponsor
Janssen Research & Development, LLC
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
May 28, 2012
Start date
Aug 6, 2012
Primary completion
Mar 17, 2015
Completion
Jan 12, 2016
Results posted
Feb 5, 2018
Last update
Mar 23, 2018

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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