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