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

• ClinicalTrials.gov Identifier: NCT01856309
• Recruitment Status: Completed
• First Posted: May 17, 2013
• Results First Posted: May 6, 2019
• Last Update Posted: May 6, 2019
• Sponsor: Janssen Research & Development, LLC
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): Janssen Research & Development, LLC

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.

Condition or disease	Intervention/treatment	Phase
Arthritis, Rheumatoid	Drug: Sirukumab 100 mg; Drug: Sirukumab 50 mg; Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1820 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: August 7, 2013
• Actual Primary Completion Date: April 30, 2018
• Actual Study Completion Date: April 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sirukumab 100 mg	Drug: 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.
Experimental: Sirukumab 50 mg / placebo	Drug: 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.; Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: From baseline of this LTE study up to 4.3 years ]
   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.
2. Percentage of Participants With Major Adverse Cardiovascular Events (MACE) [ Time Frame: From baseline of this LTE study up to 4.3 years ]
   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.
3. Percentage of Participants With Malignancies [ Time Frame: From baseline of this LTE study up to 4.3 years ]
   Percentage of participants with one or more malignancy was reported.
4. Percentage of Participants With Serious Infections [ Time Frame: From baseline of this LTE study up to 4.3 years ]
   Percentage of participants with one or more serious infections was reported.
5. Percentage of Participants With Gastrointestinal (GI) Perforations [ Time Frame: From baseline of this LTE study up to 4.3 years ]
   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.
6. Percentage of Participants With Hepatobiliary Abnormalities [ Time Frame: From baseline of this LTE study up to 4.3 years ]
   Percentage of participants with hepatobiliary abnormalities was reported.
7. Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events [ Time Frame: From baseline of this LTE study up to 4.3 years ]
   Percentage of participants with serious or moderate/severe systemic hypersensitivity reactions, or serum sickness adverse events (AEs) was reported.

Secondary Outcome Measures :

1. Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils [ Time Frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years) ]
   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.
2. Percentage of Participants With Toxicity Grade 4 Decrease in Platelets [ Time Frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years) ]
   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.
3. Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN [ Time Frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years) ]
   Percentage of participants with Alanine Aminotranserase (ALT) >= 3*Upper Limit of Normal (ULN), ALT >= 5*ULN or ALT >= 8*ULN was reported.
4. Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN [ Time Frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years) ]
   Percentage of participants with Aspartate Aminotransferase (AST) >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN was reported.
5. Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN [ Time Frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years) ]
   Percentage of participants with either ALT >= 3*ULN or AST >= 3*ULN and total bilirubin >= 2*ULN was reported.
6. Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline [ Time Frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years) ]
   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).
7. Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline [ Time Frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years) ]
   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.
8. Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline [ Time Frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years) ]
   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.
9. Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline [ Time Frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years) ]
   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.
10. Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 [ 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 ]
    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.
11. Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 [ 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 ]
    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.
12. Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 [ 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 ]
    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.
13. Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 [ 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 ]
    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.
14. 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 [ 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 ]
    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.
15. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 [ 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 ]
    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.
16. Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 [ 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 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

Birmingham, Alabama, United States

United States, Arizona

Glendale, Arizona, United States

Mesa, Arizona, United States

Peoria, Arizona, United States

Phoenix, Arizona, United States

United States, California

Covina, California, United States

El Cajon, California, United States

Glendale, California, United States

Hemet, California, United States

Huntington Beach, California, United States

La Jolla, California, United States

La Palma, California, United States

Placentia, California, United States

Upland, California, United States

Victorville, California, United States

Whittier, California, United States

United States, Connecticut

Hamden, Connecticut, United States

United States, Florida

Aventura, Florida, United States

Boca Raton, Florida, United States

Brandon, Florida, United States

Daytona Beach, Florida, United States

DeBary, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Palm Harbor, Florida, United States

Plantation, Florida, United States

Sarasota, Florida, United States

Tampa, Florida, United States

Zephyrhills, Florida, United States

United States, Iowa

Cedar Rapids, Iowa, United States

United States, Kentucky

Bowling Green, Kentucky, United States

United States, Louisiana

Monroe, Louisiana, United States

United States, Maryland

Cumberland, Maryland, United States

Hagerstown, Maryland, United States

Wheaton, Maryland, United States

United States, Minnesota

Rochester, Minnesota, United States

United States, Mississippi

Flowood, Mississippi, United States

United States, Missouri

Saint Louis, Missouri, United States

Springfield, Missouri, United States

United States, Nebraska

Omaha, Nebraska, United States

United States, Nevada

Las Vegas, Nevada, United States

United States, New Jersey

Freehold, New Jersey, United States

United States, New Mexico

Albuquerque, New Mexico, United States

United States, New York

Brooklyn, New York, United States

United States, North Carolina

Charlotte, North Carolina, United States

United States, Ohio

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Middleburg Heights, Ohio, United States

United States, Oklahoma

Edmond, Oklahoma, United States

Tulsa, Oklahoma, United States

United States, Pennsylvania

Duncansville, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

United States, South Carolina

Charleston, South Carolina, United States

United States, Texas

Austin, Texas, United States

Carrollton, Texas, United States

Corpus Christi, Texas, United States

Cypress, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

Katy, Texas, United States

Lubbock, Texas, United States

Mesquite, Texas, United States

Victoria, Texas, United States

United States, West Virginia

Beckley, West Virginia, United States

Clarksburg, West Virginia, United States

Argentina

Ciudad Autónoma de Buenos Aires, Argentina

Rosario, Argentina

San Miguel De Tucuman, Argentina

Australia

Victoria Park, Australia

Austria

Wien, Austria

Belgium

Liège, Belgium

Bulgaria

Plovdiv, Bulgaria

Sofia, Bulgaria

Canada, British Columbia

Victoria, British Columbia, Canada

Canada, Manitoba

Winnipeg, Manitoba, Canada

Canada

Edmonton, Canada

Chile

Rancagua, Chile

Santiago, Chile

Valdivia, Chile

Colombia

Bogotá, Colombia

Chia, Colombia

Medellín, Colombia

Croatia

Osijek, Croatia

Rijeka, Croatia

Zagreb, Croatia

France

Toulouse, France

Germany

Berlin, Germany

Frankfurt/Main, Germany

Göttingen, Germany

Hamburg, Germany

Köln, Germany

Vogelsang-Gommern, Germany

Würzburg, Germany

Japan

Ayauta, Japan

Bunkyo-ku, Japan

Fukuoka, Japan

Higashihiroshima, Japan

Hiroshima, Japan

Izumo, Japan

Kagoshima, Japan

Kato, Japan

Kawagoe, Japan

Kita-Gun, Japan

Kumamoto, Japan

Kurume, Japan

Matsuyama, Japan

Miyazaki, Japan

Nagano, Japan

Nagasaki, Japan

Nagoya, Japan

Nishimuro-gun, Japan

Nishinomiya, Japan

Okayama, Japan

Osaka, Japan

Sapporo, Japan

Sasebo, Japan

Shibata, Japan

Shimonoseki, Japan

Shimotsuke, Japan

Shinjuku-ku, Japan

Sumida-ku, Japan

Takaoka,Toyama, Japan

Takasaki, Japan

Tokorozawa, Japan

Tokushima, Japan

Tomishiro, Japan

Tonami, Japan

Tsu, Japan

Ureshino, Japan

Yokohama, Japan

Korea, Republic of

Busan, Korea, Republic of

Daegu, Korea, Republic of

Daejeon, Korea, Republic of

Gwangju, Korea, Republic of

Incheon, Korea, Republic of

Jeonju-si, Korea, Republic of

Namdong-Gu, Korea, Republic of

Seongnam-si, Korea, Republic of

Seoul, Korea, Republic of

Suwon, Korea, Republic of

Lithuania

Alytus, Lithuania

Kaunas, Lithuania

Klaipeda, Lithuania

Siauliai, Lithuania

Malaysia

Kuala Lumpur, Malaysia

Kuching, Malaysia

Mexico

Cuernavaca, Mexico

Guadalajara, Mexico

Merida, Mexico

Mexicali, Mexico

Morelia, Mexico

México, Mexico

San Luis De Potosi, Mexico

Netherlands

Sneek, Netherlands

Poland

Bialystok, Poland

Bydgoszcz, Poland

Elblag, Poland

Lublin, Poland

Poznan, Poland

Ustron, Poland

Warszawa N/a, Poland

Warszawa, Poland

Portugal

Lisboa, Portugal

Puerto Rico

San Juan, Puerto Rico

Romania

Bucharest, Romania

Bucuresti, Romania

Iasi, Romania

Russian Federation

Barnaul, Russian Federation

Moscow N/a, Russian Federation

Moscow, Russian Federation

Novosibirsk, Russian Federation

Omsk, Russian Federation

Orenburg, Russian Federation

Ryazan, Russian Federation

Saint Petersburg, Russian Federation

Saratov, Russian Federation

Smolensk, Russian Federation

Ulyanovsk, Russian Federation

Yaroslavl, Russian Federation

Serbia

Belgrade, Serbia

Kragujevac, Serbia

Niska Banja, Serbia

South Africa

Cape Town, South Africa

Port Elizabeth, South Africa

Pretoria, South Africa

Spain

Barakaldo, Spain

Coruña, Spain

Santander, Spain

Santiago de Compostela, Spain

Taiwan

Kaohsiung, Taiwan

Taichung City, Taiwan

Taichung, Taiwan

Taipei, Taiwan

Ukraine

Kharkiv, Ukraine

Kyiv, Ukraine

Odesa, Ukraine

Vinnytsia, Ukraine

Zaporizhzhia, Ukraine

United Kingdom

London, United Kingdom

Wigan, United Kingdom

Sponsors and Collaborators

Janssen Research & Development, LLC

GlaxoSmithKline

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:

Study Protocol  [PDF] October 6, 2016

Statistical Analysis Plan  [PDF] April 9, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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). pii: e001465. doi: 10.1136/rmdopen-2020-001465.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT01856309
• Other Study ID Numbers: CR102023; CNTO136ARA3004 ( Other Identifier: Janssen Research & Development, LLC ); 2012-001176-10 ( EudraCT Number )
• First Posted: May 17, 2013
• Results First Posted: May 6, 2019
• Last Update Posted: May 6, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:

Rheumatoid Arthritis; Sirukumab; CNTO 136; CNTO136ARA3002; SIRROUND-D; CNTO136ARA3003; SIRROUND-T; SIRROUND-LTE

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs