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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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) - An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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) - MACE was defined as a composite of Myocardial Infarction (MI), stroke, death, hospitalization for unstable angina, and hospitalization for Transient Ischemic Attack (TIA). Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion.
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 - Percentage of participants with one or more malignancy was reported.
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 - Percentage of participants with one or more serious infections was reported.
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 - Percentage of participants with one or more GI perforations was reported. GI perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.
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 - Percentage of participants with hepatobiliary abnormalities was reported.
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 - Percentage of participants with serious or moderate/severe systemic hypersensitivity reactions, or serum sickness adverse events (AEs) was reported.
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 - Percentage of participants with toxicity grade 4 decrease in neutrophils was reported. As per National Cancer Institute's Common Terminology Criteria for Adverse Events, toxicity grade 4 was defined as decrease in neutrophils less than (<) 500 per Cubic Millimeter (mm^3) or < 0.5 * 10^9 per liter.
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 - Percentage of participants with toxicity grade 4 decrease in platelets was reported. As per National Cancer Institute's Common Terminology Criteria for Adverse Events, toxicity grade 4 was defined as decreased in platelets <25000/mm^3 or < 25.0 * 10^9 per liter.
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 - Percentage of participants with Alanine Aminotranserase (ALT) >= 3*Upper Limit of Normal (ULN), ALT >= 5*ULN or ALT >= 8*ULN was reported.
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 - Percentage of participants with Aspartate Aminotransferase (AST) >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN was reported.
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 - Percentage of participants with either ALT >= 3*ULN or AST >= 3*ULN and total bilirubin >= 2*ULN was reported.
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 - Percentage of participants with normal total cholesterol value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal total cholesterol value was defined as total cholesterol value more than (>) 200 milligrams per deciliter (mg/dL).
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 - Percentage of participants with normal LDL value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal LDL value was defined as LDL value > 130 mg/dL.
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 - Percentage of participants with normal HDL value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal HDL value was defined as HDL value < 40 mg/dL.
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 - Percentage of participants with normal triglyceride value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal triglyceride value was defined as triglyceride value > 250 mg/dL.
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 - ACR 50 response is greater than or equal to (>=) 50 percent (%) improvement in both tender joint count (68) and swollen joint count (66) and >= 50% 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 for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.
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 - Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) <=1 on a 0 (very well ) to 10 (extremely bad) scale. Higher scores indicates worst health condition. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received.
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 - 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. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received.
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 - The CDAI score is a derived score of 4 components: tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received.
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 - Participant having SDAI-based ACR/EULAR remission at a visit if SDAI score is of <= 3.3. SDAI derived by combining 5 disease assessments: tender joint (28), swollen joint (28) counts, participants global assessment of disease activity using VAS (scale ranges from 0 to 10 [0 =very well to 10 = very poor]), physicians global assessment of disease activity using VAS (scale ranges from 0 to 10 [0=no arthritis to 10=extremely active arthritis]) and CRP. 28 joints evaluated for swelling and tenderness are same set of 28 joints used in DAS28 includes shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of upper right and left extremities and knee joints of lower right and left extremities. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.
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 - The Health Assessment Questionnaire-Disability Index (HAQ-DI) score is an evaluation of the functional status for a participant. The 20-question instrument 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, indicating no difficulty, to 3, indicating 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. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.
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 - HAQ-DI response was defined as change of less than -0.22 from baseline in HAQ-DI score. The HAQ-DI score is an evaluation of the functional status for a participant. The 20-question instrument 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, indicating no difficulty, to 3, indicating 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. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Victoria Park
Recruitment postcode(s) [1] 0 0
- Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
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Florida
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United States of America
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Iowa
Country [7] 0 0
United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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Minnesota
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Mississippi
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United States of America
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Missouri
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Nebraska
Country [14] 0 0
United States of America
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Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
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New York
Country [18] 0 0
United States of America
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North Carolina
Country [19] 0 0
United States of America
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Texas
Country [24] 0 0
United States of America
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West Virginia
Country [25] 0 0
Argentina
State/province [25] 0 0
Ciudad Autónoma de Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Rosario
Country [27] 0 0
Argentina
State/province [27] 0 0
San Miguel De Tucuman
Country [28] 0 0
Austria
State/province [28] 0 0
Wien
Country [29] 0 0
Belgium
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Liège
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Plovdiv
Country [31] 0 0
Bulgaria
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Sofia
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Edmonton
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Chile
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Rancagua
Country [36] 0 0
Chile
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Santiago
Country [37] 0 0
Chile
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Valdivia
Country [38] 0 0
Colombia
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Bogotá
Country [39] 0 0
Colombia
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Chia
Country [40] 0 0
Colombia
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Medellín
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Croatia
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Osijek
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Croatia
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Rijeka
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Croatia
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Zagreb
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France
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Toulouse
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Germany
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Berlin
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Germany
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Frankfurt/Main
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Germany
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Göttingen
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Germany
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Hamburg
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Germany
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Köln
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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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Japan
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Ayauta
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Japan
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Bunkyo-ku
Country [54] 0 0
Japan
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Fukuoka
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Japan
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Higashihiroshima
Country [56] 0 0
Japan
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Hiroshima
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Japan
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Izumo
Country [58] 0 0
Japan
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Kagoshima
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Japan
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Kato
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Japan
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Kawagoe
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Japan
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Kita-Gun
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Japan
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Kumamoto
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Japan
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Kurume
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Japan
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Matsuyama
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Japan
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Miyazaki
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Japan
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Nagano
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Japan
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Nagasaki
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Japan
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Nagoya
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Japan
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Nishimuro-gun
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Japan
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Nishinomiya
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Sapporo
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Japan
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Sasebo
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Japan
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Shibata
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Japan
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Shimonoseki
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Japan
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Shimotsuke
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Japan
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Shinjuku-ku
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Japan
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Sumida-ku
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Japan
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Takaoka,Toyama
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Japan
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Takasaki
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Japan
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Tokorozawa
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Japan
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Tokushima
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Japan
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Tomishiro
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Japan
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Tonami
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Japan
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Tsu
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Japan
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Ureshino
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Japan
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Yokohama
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Korea, Republic of
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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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Korea, Republic of
State/province [93] 0 0
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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Namdong-Gu
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Korea, Republic of
State/province [96] 0 0
Seongnam-si
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Korea, Republic of
State/province [97] 0 0
Seoul
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Korea, Republic of
State/province [98] 0 0
Suwon
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Lithuania
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Alytus
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Lithuania
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Kaunas
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Lithuania
State/province [101] 0 0
Klaipeda
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Lithuania
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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
State/province [107] 0 0
Merida
Country [108] 0 0
Mexico
State/province [108] 0 0
Mexicali
Country [109] 0 0
Mexico
State/province [109] 0 0
Morelia
Country [110] 0 0
Mexico
State/province [110] 0 0
México
Country [111] 0 0
Mexico
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San Luis De Potosi
Country [112] 0 0
Netherlands
State/province [112] 0 0
Sneek
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Poland
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Bialystok
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Poland
State/province [114] 0 0
Bydgoszcz
Country [115] 0 0
Poland
State/province [115] 0 0
Elblag
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Poland
State/province [116] 0 0
Lublin
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Poland
State/province [117] 0 0
Poznan
Country [118] 0 0
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
State/province [132] 0 0
Ryazan
Country [133] 0 0
Russian Federation
State/province [133] 0 0
Saint Petersburg
Country [134] 0 0
Russian Federation
State/province [134] 0 0
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/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
Other publications