Clinical trial NCT01856309: Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
Sirukumab
CNTO 136
CNTO136ARA3002
SIRROUND-D
CNTO136ARA3003
SIRROUND-T
SIRROUND-LTE
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2013-05-17
Enrollment: 1820
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: From baseline of this LTE study up to 4.3 years
measure: Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
timeFrame: From baseline of this LTE study up to 4.3 years
measure: Percentage of Participants With Malignancies
timeFrame: From baseline of this LTE study up to 4.3 years
measure: Percentage of Participants With Serious Infections
timeFrame: From baseline of this LTE study up to 4.3 years
measure: Percentage of Participants With Gastrointestinal (GI) Perforations
timeFrame: From baseline of this LTE study up to 4.3 years
measure: Percentage of Participants With Hepatobiliary Abnormalities
timeFrame: From baseline of this LTE study up to 4.3 years
measure: Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events
timeFrame: From baseline of this LTE study up to 4.3 years
Secondary outcomes:
measure: Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils
timeFrame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
measure: Percentage of Participants With Toxicity Grade 4 Decrease in Platelets
timeFrame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
measure: Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN
timeFrame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
measure: Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN
timeFrame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
measure: Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN
timeFrame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
measure: Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline
timeFrame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
measure: Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline
timeFrame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
measure: Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline
timeFrame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
measure: Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline
timeFrame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
measure: Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260
timeFrame: 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
measure: Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260
timeFrame: 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
measure: Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260
timeFrame: 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
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260
timeFrame: 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
measure: 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
timeFrame: 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
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260
timeFrame: 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
measure: Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260
timeFrame: 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
Other outcomes:
Locations:
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city: Peoria
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state: California
city: El Cajon
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state: California
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city: Hemet
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state: California
city: Huntington Beach
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city: La Jolla
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city: Orlando
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city: Tampa
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city: Cedar Rapids
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state: Iowa
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state: Maryland
city: Hagerstown
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state: Mississippi
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city: Ayauta
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city: Bunkyo-ku
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city: Higashihiroshima
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city: Nagasaki
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city: Shimonoseki
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city: Takaoka,Toyama
country: Japan
city: Takasaki
country: Japan
city: Tokorozawa
country: Japan
city: Tokushima
country: Japan
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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
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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
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country: Mexico
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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
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
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.