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A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis, Rheumatoid

Intervention: adalimumab 40 mg (Biological); sirukumab 100 mg (Biological); sirukumab 50 mg (Biological); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC

Summary

The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate.

Clinical Details

Official title: A Multicenter, Randomized, Double-blind, Parallel Group Study of Sirukumab Monotherapy Compared With HUMIRA Monotherapy Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change from baseline in Disease Activity Index Score 28 using erythrocyte sedimentation rate [DAS28 (ESR)]

Percentage of subjects with an American College of Rheumatology 50 (ACR 50) response

Secondary outcome:

Percentage of subjects with DAS28 (ESR) remission

Percentage of subjects with an ACR 20 response

Detailed description: This is a randomized, double-blind, parallel-group, global, multicenter study of subcutaneous (SC) sirukumab monotherapy compared with adalimumab monotherapy in subjects with active rheumatoid arthritis. Approximately 510 subjects will be randomly assigned in a 1: 1:1 ratio to receive treatment with adalimumab 40 mg SC every 2 weeks, sirukumab 100 mg SC every 2 weeks, or 50 mg SC every 4 weeks, with approximately 170 subjects per treatment group. At Week 16, subjects in all treatment groups who have < 20% improvement from baseline in both swollen and tender joint counts will qualify for early escape. The expected duration of the study is 68 weeks. This includes 52 weeks of treatment with study agent and 16 weeks of safety follow-up after the last study agent administration. The study will end when the last subject completes the last scheduled visit (Week 68 visit or completes the 16 week safety follow-up, whichever is later). Subject safety will be monitored through the end of the study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening

- Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66

swollen joints, at screening and at baseline

- Have previous or current treatment with methotrexate (MTX) and are considered

intolerant to MTX, and/or are considered inappropriate for treatment with MTX, (including MTX-naïve subjects for whom it is inappropriate to administer MTX) and/or an inadequate responder to methotrexate

- Must not have received MTX or any other non-biologic DMARD including but not limited

to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent

- C-reactive protein >= 10. 00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at

screening Exclusion Criteria:

- Has Functional Class IV as defined by the ACR Classification of Functional Status in

Rheumatoid Arthritis

- Has ever received biologic therapy for RA, including but not limited to the

following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept

- Has ever used tofacitinib therapy or any other JAK inhibitor

- Has received intra-articular, intramuscular, or IV corticosteroids for RA, including

adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration

- Has received leflunomide within 24 months before the first study agent administration

and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable

Locations and Contacts

Ruse, Bulgaria

Sofia, Bulgaria

Puerto Montt, Chile

Temuco, Chile

Barranquilla, Colombia

Bogota, Colombia

Bucaramanga, Colombia

Bad Doberan, Germany

Berlin, Germany

Köln, Germany

Ratingen, Germany

Vogelsang-Gommern, Germany

Debrecen, Hungary

Gödöllő, Hungary

Klaipeda, Lithuania

Siauliai, Lithuania

Vilnius, Lithuania

Chihuahua, Mexico

Guadalajara, Mexico

Jalisco, Mexico

Mexicali, Mexico

Chisinau, Moldova, Republic of

Bydgoszcz, Poland

Bytom, Poland

Krakow, Poland

Lublin, Poland

Nadarzyn, Poland

Poznan, Poland

Warszawa, Poland

Wroclaw, Poland

Bucharest, Romania

Constanta, Romania

Ploiesti, Romania

Arkhangelsk, Russian Federation

Kazan, Russian Federation

Kemerovo, Russian Federation

Kursk, Russian Federation

Moscow, Russian Federation

Novosibirsk, Russian Federation

Petrozavodsk, Russian Federation

Ryazan, Russian Federation

Saint Petersburg, Russian Federation

St Petersburg, Russian Federation

St-Petersburg, Russian Federation

Tomsk, Russian Federation

Tver, Russian Federation

Vladimir, Russian Federation

Yaroslavl, Russian Federation

Belgrade, Serbia

Novi Sad, Serbia

Zemun, Serbia

Cape Town, South Africa

Durban, South Africa

Kempton Park, South Africa

Stellenbosch, South Africa

Coruna, Spain

Madrid, Spain

Chernihiv, Ukraine

Kryvyi Rih, Ukraine

Kyiv, Ukraine

Lviv, Ukraine

Odessa, Ukraine

Poltava, Ukraine

Sumy, Ukraine

Ternopil, Ukraine

Vinnytsia, Ukraine

Zaporizhzhia, Ukraine

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Arvin, California, United States

El Cajon, California, United States

Huntington Beach, California, United States

Pleasanton, California, United States

Thousand Oaks, California, United States

Tustin, California, United States

Whittier, California, United States

Newark, Delaware, United States

Aventura, Florida, United States

Dunedin, Florida, United States

Miami, Florida, United States

New Port Richey, Florida, United States

Palm Harbor, Florida, United States

Plantation, Florida, United States

Tampa, Florida, United States

Kansas City, Kansas, United States

Elizabethtown, Kentucky, United States

Paducah, Kentucky, United States

Frederick, Maryland, United States

Wheaton, Maryland, United States

Saint Louis, Missouri, United States

Las Vegas, Nevada, United States

Salisbury, North Carolina, United States

Wilmington, North Carolina, United States

Dayton, Ohio, United States

Portland, Oregon, United States

Duncansville, Pennsylvania, United States

Wexford, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

Jakson, Tennessee, United States

Nashville, Tennessee, United States

Austin, Texas, United States

Carrollton, Texas, United States

Corpus Christi, Texas, United States

Cypress, Texas, United States

Lubbock, Texas, United States

Mckinney, Texas, United States

Mesquite, Texas, United States

Chesapeake, Virginia, United States

Clarksburg, West Virginia, United States

Additional Information

Starting date: April 2014
Last updated: June 29, 2015

Page last updated: August 23, 2015

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