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

NCT01856309 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CR102023CNTO136ARA30042012-001176-10
• Study Type: interventional
• Target: 1,820
• Locations: 28 countries
• Sites: 196

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.

Conditions

Arthritis, Rheumatoid

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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.

  From baseline of this LTE study up to 4.3 years

• 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.

  From baseline of this LTE study up to 4.3 years

• Percentage of Participants With Malignancies

  Percentage of participants with one or more malignancy was reported.

  From baseline of this LTE study up to 4.3 years

• Percentage of Participants With Serious Infections

  Percentage of participants with one or more serious infections was reported.

  From baseline of this LTE study up to 4.3 years

• 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.

  From baseline of this LTE study up to 4.3 years

• Percentage of Participants With Hepatobiliary Abnormalities

  Percentage of participants with hepatobiliary abnormalities was reported.

  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

  Percentage of participants with serious or moderate/severe systemic hypersensitivity reactions, or serum sickness adverse events (AEs) was reported.

  From baseline of this LTE study up to 4.3 years

Secondary Outcomes (16)

• Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils

  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

  From baseline of primary studies through end of this LTE study (Approximately 5.3 years)

• Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN

  From baseline of primary studies through end of this LTE study (Approximately 5.3 years)

• Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN

  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

  From baseline of primary studies through end of this LTE study (Approximately 5.3 years)

Study Arms (2)

Sirukumab 100 mg

EXPERIMENTAL

Drug: Sirukumab 100 mg

Sirukumab 50 mg / placebo

EXPERIMENTAL

Drug: Sirukumab 50 mg; Drug: Placebo

Interventions

Sirukumab 100 mg DRUG

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.

Sirukumab 100 mg

Sirukumab 50 mg DRUG

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.

Sirukumab 50 mg / placebo

Placebo DRUG

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.

Sirukumab 50 mg / placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• GlaxoSmithKline: collaborator

Study Sites (197)

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Birmingham, Alabama, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Covina, California, United States

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El Cajon, California, United States

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Glendale, California, United States

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Hemet, California, United States

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Huntington Beach, California, United States

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La Jolla, California, United States

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La Palma, California, United States

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Placentia, California, United States

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Upland, California, United States

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Victorville, California, United States

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Whittier, California, United States

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Hamden, Connecticut, United States

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Aventura, Florida, United States

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Boca Raton, Florida, United States

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Brandon, Florida, United States

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Daytona Beach, Florida, United States

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DeBary, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Palm Harbor, Florida, United States

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Plantation, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Zephyrhills, Florida, United States

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Cedar Rapids, Iowa, United States

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Bowling Green, Kentucky, United States

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Monroe, Louisiana, United States

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Cumberland, Maryland, United States

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Hagerstown, Maryland, United States

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Wheaton, Maryland, United States

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Rochester, Minnesota, United States

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Flowood, Mississippi, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Freehold, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Middleburg Heights, Ohio, United States

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Edmond, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Carrollton, Texas, United States

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Corpus Christi, Texas, United States

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Cypress, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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Lubbock, Texas, United States

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Mesquite, Texas, United States

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Victoria, Texas, United States

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Beckley, West Virginia, United States

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Clarksburg, West Virginia, United States

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Buenos Aires, Argentina

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Rosario, Argentina

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San Miguel de Tucumán, Argentina

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Victoria Park, Australia

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Vienna, Austria

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Liège, Belgium

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Edmonton, Canada

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Rancagua, Chile

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Santiago, Chile

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Valdivia, Chile

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Bogotá, Colombia

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Chía, Colombia

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Medellín, Colombia

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Osijek, Croatia

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Rijeka, Croatia

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Zagreb, Croatia

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Toulouse, France

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Berlin, Germany

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Cologne, Germany

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Frankfurt am Main, Germany

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Göttingen, Germany

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Hamburg, Germany

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Vogelsang-Gommern, Germany

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Würzburg, Germany

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Ayauta, Japan

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Bunkyō City, Japan

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Fukuoka, Japan

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Higashihiroshima, Japan

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Hiroshima, Japan

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Izumo, Japan

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Kagoshima, Japan

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Katō, Japan

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Kawagoe, Japan

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Kita-Gun, Japan

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Kumamoto, Japan

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Kurume, Japan

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Matsuyama, Japan

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Miyazaki, Japan

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Nagano, Japan

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Nagasaki, Japan

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Nagoya, Japan

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Nishimuro-gun, Japan

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Nishinomiya, Japan

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Okayama, Japan

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Osaka, Japan

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Sapporo, Japan

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Sasebo, Japan

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Shibata, Japan

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Shimonoseki, Japan

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Shimotsuke, Japan

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Shinjuku-ku, Japan

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Sumida-ku, Japan

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Takaoka,Toyama, Japan

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Takasaki, Japan

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Tokorozawa, Japan

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Tokushima, Japan

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Tomishiro, Japan

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Tonami, Japan

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Tsu, Japan

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Ureshino, Japan

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Yokohama, Japan

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Alytus, Lithuania

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Kaunas, Lithuania

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Klaipėda, Lithuania

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Šiauliai, Lithuania

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Kuala Lumpur, Malaysia

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Kuching, Malaysia

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Cuernavaca, Mexico

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Guadalajara, Mexico

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Mexicali, Mexico

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Mérida, Mexico

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México, Mexico

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Morelia, Mexico

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San Luis de Potosi, Mexico

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Sneek, Netherlands

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Bialystok, Poland

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Bydgoszcz, Poland

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Elblag, Poland

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Lublin, Poland

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Poznan, Poland

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Ustroń, Poland

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Warsaw, Poland

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Lisbon, Portugal

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San Juan, Puerto Rico

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Bucharest, Romania

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Iași, Romania

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Barnaul, Russia

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Moscow, Russia

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Novosibirsk, Russia

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Omsk, Russia

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Orenburg, Russia

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Ryazan, Russia

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Saint Petersburg, Russia

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Saratov, Russia

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Smolensk, Russia

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Ulyanovsk, Russia

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Yaroslavl, Russia

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Belgrade, Serbia

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Kragujevac, Serbia

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Niška Banja, Serbia

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Cape Town, South Africa

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Port Elizabeth, South Africa

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Pretoria, South Africa

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Busan, South Korea

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Daegu, South Korea

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Daejeon, South Korea

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Gwangju, South Korea

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Incheon, South Korea

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Jeonju, South Korea

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Namdong-Gu, South Korea

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Seongnam-si, South Korea

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Seoul, South Korea

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Suwon, South Korea

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A Coruña, Spain

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Barakaldo, Spain

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Santander, Spain

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Santiago de Compostela, Spain

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Kharkiv, Ukraine

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Kyiv, Ukraine

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Odesa, Ukraine

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Vinnytsia, Ukraine

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Zaporizhzhia, Ukraine

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London, United Kingdom

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Wigan, United Kingdom

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Related Publications (1)

• 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.

  PMID: 33526709 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

sirukumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Due to early study termination, full intended length of observation and amount of safety, efficacy data collected for participants receiving sirukumab was not achieved and only statistical analysis plan dedicated to safety data(Week 28) was created.

Results Point of Contact

• Title: Associate Director, Clinical Development
• Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 17, 2013
• Study Start: August 7, 2013
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-04

Locations

CR (3); BE (1); BU (2); KR (10); CO (3); RO (2); CL (3); NL (1); UA (5); GB (2); LI (4); ES (4); CA (3); US (66); PT (1); AR (3); AU (1); PL (7); ZA (3); ME (7); SE (3); DE (7); RU (11); FR (1); TW (3); MY (2); JP (37); PR (1)