Clinical trial NCT02019472: A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid arthritis
CNTO 136
Sirukumab
Adalimumab
HUMIRA®
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2013-12-24
Enrollment: 559
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 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.

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 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

Primary outcomes:
measure: Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission at Week 24
timeFrame: Week 24
measure: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Arvin
country: United States
state: California
city: El Cajon
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Pleasanton
country: United States
state: California
city: Thousand Oaks
country: United States
state: California
city: Tustin
country: United States
state: California
city: Whittier
country: United States
state: California
city: Newark
country: United States
state: Delaware
city: Aventura
country: United States
state: Florida
city: Dunedin
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Kansas City
country: United States
state: Kansas
city: Elizabethtown
country: United States
state: Kentucky
city: Paducah
country: United States
state: Kentucky
city: Frederick
country: United States
state: Maryland
city: Wheaton
country: United States
state: Maryland
city: Saint Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Salisbury
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Duncansville
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Jackson
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Cypress
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: McKinney
country: United States
state: Texas
city: Mesquite
country: United States
state: Texas
city: Chesapeake
country: United States
state: Virginia
city: Clarksburg
country: United States
state: West Virginia
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Puerto Montt
country: Chile
city: Temuco
country: Chile
city: Barranquilla
country: Colombia
city: Bogota
country: Colombia
city: Bucaramanga
country: Colombia
city: Bad Doberan
country: Germany
city: Berlin
country: Germany
city: Köln
country: Germany
city: Ratingen
country: Germany
city: Vogelsang-Gommern
country: Germany
city: Debrecen
country: Hungary
city: Gödöllő
country: Hungary
city: Klaipeda
country: Lithuania
city: Siauliai
country: Lithuania
city: Vilnius
country: Lithuania
city: Chihuahua
country: Mexico
city: Guadalajara
country: Mexico
city: Jalisco
country: Mexico
city: Mexicali
country: Mexico
city: Chisinau
country: Moldova, Republic of
city: Bydgoszcz
country: Poland
city: Bytom
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Nadarzyn
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Bucharest
country: Romania
city: Constanta
country: Romania
city: Ploiesti
country: Romania
city: Arkhangelsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Kursk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tver
country: Russian Federation
city: Vladimir
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Novi Sad
country: Serbia
city: Zemun
country: Serbia
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Kempton Park
country: South Africa
city: Stellenbosch
country: South Africa
city: Coruna
country: Spain
city: Madrid
country: Spain
city: Chernihiv
country: Ukraine
city: Kryvyi Rih
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Poltava
country: Ukraine
city: Sumy
country: Ukraine
city: Ternopil
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Taylor PC, Schiff MH, Wang Q, Jiang Y, Zhuang Y, Kurrasch R, Daga S, Rao R, Tak PP, Hsu B. Efficacy and safety of monotherapy with sirukumab compared with adalimumab monotherapy in biologic-naive patients with active rheumatoid arthritis (SIRROUND-H): a randomised, double-blind, parallel-group, multinational, 52-week, phase 3 study. Ann Rheum Dis. 2018 May;77(5):658-666. doi: 10.1136/annrheumdis-2017-212496. Epub 2018 Feb 26.