Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01856309




Registration number
NCT01856309
Ethics application status
Date submitted
15/05/2013
Date registered
17/05/2013
Date last updated
6/05/2019

Titles & IDs
Public title
Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003
Scientific title
A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (Sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)
Secondary ID [1] 0 0
CNTO136ARA3004
Secondary ID [2] 0 0
CR102023
Universal Trial Number (UTN)
Trial acronym
SIRROUND-LTE
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 - Sirukumab 100 mg
Treatment: Drugs - Sirukumab 50 mg
Treatment: Drugs - Placebo

Experimental: Sirukumab 100 mg -

Experimental: Sirukumab 50 mg / placebo -


Treatment: Drugs: Sirukumab 100 mg
Sirukumab 100 mg subcutaneously (SC) at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 2, and every 2 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.

Treatment: Drugs: Sirukumab 50 mg
Sirukumab 50 mg SC at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 4, and every 4 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.

Treatment: Drugs: Placebo
Between sirukumab 50 mg injections, placebo SC injections will be administered at Weeks 2, 6, and every 4 weeks until the study becomes open-label, and placebo injections are discontinued.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Serious Adverse Events (SAEs)
Timepoint [1] 0 0
From baseline of this LTE study up to 4.3 years
Primary outcome [2] 0 0
Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
Timepoint [2] 0 0
From baseline of this LTE study up to 4.3 years
Primary outcome [3] 0 0
Percentage of Participants With Malignancies
Timepoint [3] 0 0
From baseline of this LTE study up to 4.3 years
Primary outcome [4] 0 0
Percentage of Participants With Serious Infections
Timepoint [4] 0 0
From baseline of this LTE study up to 4.3 years
Primary outcome [5] 0 0
Percentage of Participants With Gastrointestinal (GI) Perforations
Timepoint [5] 0 0
From baseline of this LTE study up to 4.3 years
Primary outcome [6] 0 0
Percentage of Participants With Hepatobiliary Abnormalities
Timepoint [6] 0 0
From baseline of this LTE study up to 4.3 years
Primary outcome [7] 0 0
Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events
Timepoint [7] 0 0
From baseline of this LTE study up to 4.3 years
Secondary outcome [1] 0 0
Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils
Timepoint [1] 0 0
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Secondary outcome [2] 0 0
Percentage of Participants With Toxicity Grade 4 Decrease in Platelets
Timepoint [2] 0 0
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Secondary outcome [3] 0 0
Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN
Timepoint [3] 0 0
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Secondary outcome [4] 0 0
Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN
Timepoint [4] 0 0
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Secondary outcome [5] 0 0
Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN
Timepoint [5] 0 0
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Secondary outcome [6] 0 0
Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline
Timepoint [6] 0 0
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Secondary outcome [7] 0 0
Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline
Timepoint [7] 0 0
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Secondary outcome [8] 0 0
Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline
Timepoint [8] 0 0
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Secondary outcome [9] 0 0
Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline
Timepoint [9] 0 0
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Secondary outcome [10] 0 0
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260
Timepoint [10] 0 0
Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Secondary outcome [11] 0 0
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260
Timepoint [11] 0 0
Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Secondary outcome [12] 0 0
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260
Timepoint [12] 0 0
Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Secondary outcome [13] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260
Timepoint [13] 0 0
Baseline (Week 0 of primary studies), Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Secondary outcome [14] 0 0
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260
Timepoint [14] 0 0
Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Secondary outcome [15] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260
Timepoint [15] 0 0
Baseline (Week 0 of primary studies), Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Secondary outcome [16] 0 0
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260
Timepoint [16] 0 0
Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260

Eligibility
Key inclusion criteria
- Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003

- Signed an informed consent form (ICF) indicating that they understand the purpose of
and procedures required for the study and are willing to participate in the study

- Signed an informed consent form (ICF) for pharmacogenetics research (how a person's
genes may affect a drug's effects) in order to participate in the optional
pharmacogenetics component of this study. Refusal to give consent for this component
does not exclude a participant from participation in this clinical study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or
CNTO136ARA3003

- Is pregnant

- Has active diverticulitis

- Has any condition that, in the opinion of the investigator, would make participation
not be in the best interest (eg, compromise the well-being) of the participant or that
could prevent, limit, or confound the protocol-specified assessments

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
7/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2018
Sample size
Target
Accrual to date
Final
1820
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Victoria Park
Recruitment postcode(s) [1] 0 0
- Victoria Park
Recruitment outside Australia
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United States of America
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West Virginia
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Argentina
State/province [25] 0 0
Ciudad Autónoma de Buenos Aires
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Argentina
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Rosario
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Argentina
State/province [27] 0 0
San Miguel De Tucuman
Country [28] 0 0
Austria
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Wien
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Liège
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Chia
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Ayauta
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Fukuoka
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Izumo
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Kato
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Tsu
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Ureshino
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Yokohama
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Korea, Republic of
State/province [89] 0 0
Busan
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Korea, Republic of
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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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Incheon
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Korea, Republic of
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Jeonju-si
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Korea, Republic of
State/province [95] 0 0
Namdong-Gu
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Korea, Republic of
State/province [96] 0 0
Seongnam-si
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Seoul
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Suwon
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Lithuania
State/province [99] 0 0
Alytus
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Lithuania
State/province [100] 0 0
Kaunas
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Lithuania
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Klaipeda
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Lithuania
State/province [102] 0 0
Siauliai
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Malaysia
State/province [103] 0 0
Kuala Lumpur
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Malaysia
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Kuching
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Mexico
State/province [105] 0 0
Cuernavaca
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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
State/province [108] 0 0
Mexicali
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Mexico
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Morelia
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Mexico
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México
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Mexico
State/province [111] 0 0
San Luis De Potosi
Country [112] 0 0
Netherlands
State/province [112] 0 0
Sneek
Country [113] 0 0
Poland
State/province [113] 0 0
Bialystok
Country [114] 0 0
Poland
State/province [114] 0 0
Bydgoszcz
Country [115] 0 0
Poland
State/province [115] 0 0
Elblag
Country [116] 0 0
Poland
State/province [116] 0 0
Lublin
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Poland
State/province [117] 0 0
Poznan
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Poland
State/province [118] 0 0
Ustron
Country [119] 0 0
Poland
State/province [119] 0 0
Warszawa N/a
Country [120] 0 0
Poland
State/province [120] 0 0
Warszawa
Country [121] 0 0
Portugal
State/province [121] 0 0
Lisboa
Country [122] 0 0
Puerto Rico
State/province [122] 0 0
San Juan
Country [123] 0 0
Romania
State/province [123] 0 0
Bucharest
Country [124] 0 0
Romania
State/province [124] 0 0
Bucuresti
Country [125] 0 0
Romania
State/province [125] 0 0
Iasi
Country [126] 0 0
Russian Federation
State/province [126] 0 0
Barnaul
Country [127] 0 0
Russian Federation
State/province [127] 0 0
Moscow N/a
Country [128] 0 0
Russian Federation
State/province [128] 0 0
Moscow
Country [129] 0 0
Russian Federation
State/province [129] 0 0
Novosibirsk
Country [130] 0 0
Russian Federation
State/province [130] 0 0
Omsk
Country [131] 0 0
Russian Federation
State/province [131] 0 0
Orenburg
Country [132] 0 0
Russian Federation
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Ryazan
Country [133] 0 0
Russian Federation
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Saint Petersburg
Country [134] 0 0
Russian Federation
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Saratov
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Smolensk
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Ulyanovsk
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Yaroslavl
Country [138] 0 0
Serbia
State/province [138] 0 0
Belgrade
Country [139] 0 0
Serbia
State/province [139] 0 0
Kragujevac
Country [140] 0 0
Serbia
State/province [140] 0 0
Niska Banja
Country [141] 0 0
South Africa
State/province [141] 0 0
Cape Town
Country [142] 0 0
South Africa
State/province [142] 0 0
Port Elizabeth
Country [143] 0 0
South Africa
State/province [143] 0 0
Pretoria
Country [144] 0 0
Spain
State/province [144] 0 0
Barakaldo
Country [145] 0 0
Spain
State/province [145] 0 0
Coruña
Country [146] 0 0
Spain
State/province [146] 0 0
Santander
Country [147] 0 0
Spain
State/province [147] 0 0
Santiago de Compostela
Country [148] 0 0
Taiwan
State/province [148] 0 0
Kaohsiung
Country [149] 0 0
Taiwan
State/province [149] 0 0
Taichung City
Country [150] 0 0
Taiwan
State/province [150] 0 0
Taichung
Country [151] 0 0
Taiwan
State/province [151] 0 0
Taipei
Country [152] 0 0
Ukraine
State/province [152] 0 0
Kharkiv
Country [153] 0 0
Ukraine
State/province [153] 0 0
Kyiv
Country [154] 0 0
Ukraine
State/province [154] 0 0
Odesa
Country [155] 0 0
Ukraine
State/province [155] 0 0
Vinnytsia
Country [156] 0 0
Ukraine
State/province [156] 0 0
Zaporizhzhia
Country [157] 0 0
United Kingdom
State/province [157] 0 0
London
Country [158] 0 0
United Kingdom
State/province [158] 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
The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136
(sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment
with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01856309
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01856309