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Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 (SIRROUND-LTE)

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sirukumab 100 mg
Sirukumab 50 mg
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid Arthritis, Sirukumab, CNTO 136, CNTO136ARA3002, SIRROUND-D, CNTO136ARA3003, SIRROUND-T, SIRROUND-LTE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sirukumab 100 mg

Sirukumab 50 mg / placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
Percentage of Participants With Malignancies
Percentage of participants with one or more malignancy was reported.
Percentage of Participants With Serious Infections
Percentage of participants with one or more serious infections was reported.
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.
Percentage of Participants With Hepatobiliary Abnormalities
Percentage of participants with hepatobiliary abnormalities was reported.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 15, 2013
Last Updated
April 12, 2019
Sponsor
Janssen Research & Development, LLC
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01856309
Brief Title
Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003
Acronym
SIRROUND-LTE
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 7, 2013 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a multicenter, long-term study of sirukumab (CNTO 136) that will be conducted in two groups of participants at the same time (parallel-group study). The maximum duration of participation in this study is 208 weeks, followed by approximately 16 weeks of safety and efficacy follow-up after the administration of the final study agent injection of sirukumab. Participant safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Rheumatoid Arthritis, Sirukumab, CNTO 136, CNTO136ARA3002, SIRROUND-D, CNTO136ARA3003, SIRROUND-T, SIRROUND-LTE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1820 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sirukumab 100 mg
Arm Type
Experimental
Arm Title
Sirukumab 50 mg / placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sirukumab 100 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sirukumab 50 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Serious Adverse Events (SAEs)
Description
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.
Time Frame
From baseline of this LTE study up to 4.3 years
Title
Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
Description
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.
Time Frame
From baseline of this LTE study up to 4.3 years
Title
Percentage of Participants With Malignancies
Description
Percentage of participants with one or more malignancy was reported.
Time Frame
From baseline of this LTE study up to 4.3 years
Title
Percentage of Participants With Serious Infections
Description
Percentage of participants with one or more serious infections was reported.
Time Frame
From baseline of this LTE study up to 4.3 years
Title
Percentage of Participants With Gastrointestinal (GI) Perforations
Description
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.
Time Frame
From baseline of this LTE study up to 4.3 years
Title
Percentage of Participants With Hepatobiliary Abnormalities
Description
Percentage of participants with hepatobiliary abnormalities was reported.
Time Frame
From baseline of this LTE study up to 4.3 years
Title
Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events
Description
Percentage of participants with serious or moderate/severe systemic hypersensitivity reactions, or serum sickness adverse events (AEs) was reported.
Time Frame
From baseline of this LTE study up to 4.3 years
Secondary Outcome Measure Information:
Title
Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils
Description
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.
Time Frame
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Title
Percentage of Participants With Toxicity Grade 4 Decrease in Platelets
Description
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.
Time Frame
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Title
Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN
Description
Percentage of participants with Alanine Aminotranserase (ALT) >= 3*Upper Limit of Normal (ULN), ALT >= 5*ULN or ALT >= 8*ULN was reported.
Time Frame
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Title
Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN
Description
Percentage of participants with Aspartate Aminotransferase (AST) >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN was reported.
Time Frame
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Title
Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN
Description
Percentage of participants with either ALT >= 3*ULN or AST >= 3*ULN and total bilirubin >= 2*ULN was reported.
Time Frame
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Title
Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline
Description
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).
Time Frame
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Title
Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline
Description
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.
Time Frame
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Title
Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline
Description
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.
Time Frame
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Title
Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline
Description
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.
Time Frame
From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Title
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260
Description
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.
Time Frame
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
Title
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260
Description
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.
Time Frame
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
Title
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260
Description
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.
Time Frame
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
Title
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260
Description
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.
Time Frame
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
Title
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
Description
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.
Time Frame
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
Title
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260
Description
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.
Time Frame
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
Title
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Glendale
State/Province
Arizona
Country
United States
City
Mesa
State/Province
Arizona
Country
United States
City
Peoria
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Covina
State/Province
California
Country
United States
City
El Cajon
State/Province
California
Country
United States
City
Glendale
State/Province
California
Country
United States
City
Hemet
State/Province
California
Country
United States
City
Huntington Beach
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
La Palma
State/Province
California
Country
United States
City
Placentia
State/Province
California
Country
United States
City
Upland
State/Province
California
Country
United States
City
Victorville
State/Province
California
Country
United States
City
Whittier
State/Province
California
Country
United States
City
Hamden
State/Province
Connecticut
Country
United States
City
Aventura
State/Province
Florida
Country
United States
City
Boca Raton
State/Province
Florida
Country
United States
City
Brandon
State/Province
Florida
Country
United States
City
Daytona Beach
State/Province
Florida
Country
United States
City
DeBary
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Palm Harbor
State/Province
Florida
Country
United States
City
Plantation
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Zephyrhills
State/Province
Florida
Country
United States
City
Cedar Rapids
State/Province
Iowa
Country
United States
City
Bowling Green
State/Province
Kentucky
Country
United States
City
Monroe
State/Province
Louisiana
Country
United States
City
Cumberland
State/Province
Maryland
Country
United States
City
Hagerstown
State/Province
Maryland
Country
United States
City
Wheaton
State/Province
Maryland
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
Flowood
State/Province
Mississippi
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Springfield
State/Province
Missouri
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Freehold
State/Province
New Jersey
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Brooklyn
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Middleburg Heights
State/Province
Ohio
Country
United States
City
Edmond
State/Province
Oklahoma
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Wyomissing
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Carrollton
State/Province
Texas
Country
United States
City
Corpus Christi
State/Province
Texas
Country
United States
City
Cypress
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Katy
State/Province
Texas
Country
United States
City
Lubbock
State/Province
Texas
Country
United States
City
Mesquite
State/Province
Texas
Country
United States
City
Victoria
State/Province
Texas
Country
United States
City
Beckley
State/Province
West Virginia
Country
United States
City
Clarksburg
State/Province
West Virginia
Country
United States
City
Ciudad Autónoma de Buenos Aires
Country
Argentina
City
Rosario
Country
Argentina
City
San Miguel De Tucuman
Country
Argentina
City
Victoria Park
Country
Australia
City
Wien
Country
Austria
City
Liège
Country
Belgium
City
Plovdiv
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Victoria
State/Province
British Columbia
Country
Canada
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
Edmonton
Country
Canada
City
Rancagua
Country
Chile
City
Santiago
Country
Chile
City
Valdivia
Country
Chile
City
Bogotá
Country
Colombia
City
Chia
Country
Colombia
City
Medellín
Country
Colombia
City
Osijek
Country
Croatia
City
Rijeka
Country
Croatia
City
Zagreb
Country
Croatia
City
Toulouse
Country
France
City
Berlin
Country
Germany
City
Frankfurt/Main
Country
Germany
City
Göttingen
Country
Germany
City
Hamburg
Country
Germany
City
Köln
Country
Germany
City
Vogelsang-Gommern
Country
Germany
City
Würzburg
Country
Germany
City
Ayauta
Country
Japan
City
Bunkyo-ku
Country
Japan
City
Fukuoka
Country
Japan
City
Higashihiroshima
Country
Japan
City
Hiroshima
Country
Japan
City
Izumo
Country
Japan
City
Kagoshima
Country
Japan
City
Kato
Country
Japan
City
Kawagoe
Country
Japan
City
Kita-Gun
Country
Japan
City
Kumamoto
Country
Japan
City
Kurume
Country
Japan
City
Matsuyama
Country
Japan
City
Miyazaki
Country
Japan
City
Nagano
Country
Japan
City
Nagasaki
Country
Japan
City
Nagoya
Country
Japan
City
Nishimuro-gun
Country
Japan
City
Nishinomiya
Country
Japan
City
Okayama
Country
Japan
City
Osaka
Country
Japan
City
Sapporo
Country
Japan
City
Sasebo
Country
Japan
City
Shibata
Country
Japan
City
Shimonoseki
Country
Japan
City
Shimotsuke
Country
Japan
City
Shinjuku-ku
Country
Japan
City
Sumida-ku
Country
Japan
City
Takaoka,Toyama
Country
Japan
City
Takasaki
Country
Japan
City
Tokorozawa
Country
Japan
City
Tokushima
Country
Japan
City
Tomishiro
Country
Japan
City
Tonami
Country
Japan
City
Tsu
Country
Japan
City
Ureshino
Country
Japan
City
Yokohama
Country
Japan
City
Busan
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Daejeon
Country
Korea, Republic of
City
Gwangju
Country
Korea, Republic of
City
Incheon
Country
Korea, Republic of
City
Jeonju-si
Country
Korea, Republic of
City
Namdong-Gu
Country
Korea, Republic of
City
Seongnam-si
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Suwon
Country
Korea, Republic of
City
Alytus
Country
Lithuania
City
Kaunas
Country
Lithuania
City
Klaipeda
Country
Lithuania
City
Siauliai
Country
Lithuania
City
Kuala Lumpur
Country
Malaysia
City
Kuching
Country
Malaysia
City
Cuernavaca
Country
Mexico
City
Guadalajara
Country
Mexico
City
Merida
Country
Mexico
City
Mexicali
Country
Mexico
City
Morelia
Country
Mexico
City
México
Country
Mexico
City
San Luis De Potosi
Country
Mexico
City
Sneek
Country
Netherlands
City
Bialystok
Country
Poland
City
Bydgoszcz
Country
Poland
City
Elblag
Country
Poland
City
Lublin
Country
Poland
City
Poznan
Country
Poland
City
Ustron
Country
Poland
City
Warszawa N/a
Country
Poland
City
Warszawa
Country
Poland
City
Lisboa
Country
Portugal
City
San Juan
Country
Puerto Rico
City
Bucharest
Country
Romania
City
Bucuresti
Country
Romania
City
Iasi
Country
Romania
City
Barnaul
Country
Russian Federation
City
Moscow N/a
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Omsk
Country
Russian Federation
City
Orenburg
Country
Russian Federation
City
Ryazan
Country
Russian Federation
City
Saint Petersburg
Country
Russian Federation
City
Saratov
Country
Russian Federation
City
Smolensk
Country
Russian Federation
City
Ulyanovsk
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
Belgrade
Country
Serbia
City
Kragujevac
Country
Serbia
City
Niska Banja
Country
Serbia
City
Cape Town
Country
South Africa
City
Port Elizabeth
Country
South Africa
City
Pretoria
Country
South Africa
City
Barakaldo
Country
Spain
City
Coruña
Country
Spain
City
Santander
Country
Spain
City
Santiago de Compostela
Country
Spain
City
Kaohsiung
Country
Taiwan
City
Taichung City
Country
Taiwan
City
Taichung
Country
Taiwan
City
Taipei
Country
Taiwan
City
Kharkiv
Country
Ukraine
City
Kyiv
Country
Ukraine
City
Odesa
Country
Ukraine
City
Vinnytsia
Country
Ukraine
City
Zaporizhzhia
Country
Ukraine
City
London
Country
United Kingdom
City
Wigan
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33526709
Citation
Aletaha D, Bingham CO, Karpouzas GA, Takeuchi T, Thorne C, Bili A, Agarwal P, Hsu B, Rao R, Brown K, Tanaka Y. Long-term safety and efficacy of sirukumab for patients with rheumatoid arthritis who previously received sirukumab in randomised controlled trials (SIRROUND-LTE). RMD Open. 2021 Jan;7(1):e001465. doi: 10.1136/rmdopen-2020-001465.
Results Reference
derived

Learn more about this trial

Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

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