Clinical trial NCT01373151: Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
Official title: A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2011-06-14
Enrollment: 418
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 purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.


Eligibility criteria: Inclusion Criteria:

* Inadequate response to Methotrexate
* Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of at least 15 mg and stable dose for 4 weeks prior to randomization
* American College of Rheumatology (ACR) global function status class 1-3
* Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist
* High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL

Exclusion Criteria:

* Previously received or currently receiving concomitant biologic therapy

Primary outcomes:
measure: Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate
timeFrame: At 12 Weeks
Secondary outcomes:
measure: Percent of Participants With ACR 20 Response
timeFrame: At 24 weeks
measure: Percent of Participants Achieving ACR 50 Response Rate
timeFrame: At weeks 12 and 24
measure: Percent of Participants Achieving ACR 70 Response Rate
timeFrame: At weeks 12 and 24
measure: Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
timeFrame: Baseline, weeks 12 and 24
measure: Percent of Participants With Remission by DAS28-CRP
timeFrame: At weeks 12 and 24
measure: Mean Change From Baseline in Clinical Disease Activity Index (CDAI)
timeFrame: Baseline, weeks 12 and 24
measure: Percent of Participants With Remission by CDAI
timeFrame: At weeks 12 and 24
measure: Mean Change From Baseline in Simplified Disease Activity Index (SDAI)
timeFrame: Baseline, weeks 12 and 24
measure: Percent of Participants With Remission by SDAI
timeFrame: At weeks 12 and 24
measure: Percent of Participants With Remission Rate by Boolean Definition
timeFrame: At weeks 12 and 24
measure: Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index
timeFrame: Baseline, weeks 12 and 24
measure: Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components
timeFrame: Baseline, weeks 12 and 24
measure: Mean Change From Baseline in Fatigue Severity (VAS) Score
timeFrame: Baseline, weeks 12 and 24
measure: Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Scores
timeFrame: Baseline, weeks 12 and 24
measure: Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing)
timeFrame: Baseline and week 12
measure: Mean Change From Baseline in Radiographic (X-ray) Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijde Total Score
timeFrame: Baseline and week 24
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Sun Valley Arthritis Center, Ltd.
state: Arizona
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: Trumbull
country: United States
facility: New England Research Associates, Llc
state: Connecticut
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Rockford
country: United States
facility: Rockford Orthopedic Associates, Llc.
state: Illinois
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Jackson
country: United States
facility: Arthritis Associates Of Mississippi
state: Mississippi
city: Lincoln
country: United States
facility: Physician Research Collaboration, Llc
state: Nebraska
city: Charlotte
country: United States
facility: Box Arthritis And Rheumatology Of The Carolinas, Pllc
state: North Carolina
city: Oklahoma City
country: United States
facility: Health Research Of Oklahoma
state: Oklahoma
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, P.C.
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa FE
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: Cordoba
country: Argentina
facility: Local Institution
city: San Juan
country: Argentina
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Hasselt
country: Belgium
facility: Local Institution
city: Goiania
country: Brazil
facility: Local Institution
state: Goias
city: Juiz De Fora
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Trois-rivieres
country: Canada
facility: Centre De Recherche Musculo-Squelettique
state: Quebec
city: Quebec
country: Canada
facility: Local Institution
city: Praha 2
country: Czechia
facility: Local Institution
city: Praha 4
country: Czechia
facility: Local Institution
city: Bordeaux Cedex
country: France
facility: Local Institution
city: Chambray Les Tours
country: France
facility: Local Institution
city: Strasbourg Cedex
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Koeln
country: Germany
facility: Local Institution
city: Leipzig
country: Germany
facility: Local Institution
city: Wuerzburg
country: Germany
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Local Institution
city: Gyula
country: Hungary
facility: Local Institution
city: Veszprem
country: Hungary
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Reggio Emilia
country: Italy
facility: Local Institution
city: Chiba-shi
country: Japan
facility: Local Institution
state: Chiba
city: Kitakyushu-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Higashi-hiroshima-shi
country: Japan
facility: Local Institution
state: Hiroshima
city: Kato-shi
country: Japan
facility: Local Institution
state: Hyogo
city: Miyazaki-shi
country: Japan
facility: Local Institution
state: Miyazaki
city: Nagano-shi
country: Japan
facility: Local Institution
state: Nagano
city: Nagasaki-shi
country: Japan
facility: Local Institution
state: Nagasaki
city: Sasebo-shi
country: Japan
facility: Local Institution
state: Nagasaki
city: Tomigusuku-shi
country: Japan
facility: Local Institution
state: Okinawa
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Shizuoka-shi
country: Japan
facility: Local Institution
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Toshima-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Morelia
country: Mexico
facility: Local Institution
state: Michioacan
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Culiacan
country: Mexico
facility: Local Institution
state: Sinaloa
city: San Luis Potosi
country: Mexico
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Katowice
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Ekaterinburg
country: Russian Federation
facility: Local Institution
city: Kazan
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Novosibirsk
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Yaroslavl
country: Russian Federation
facility: Local Institution
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Durban
country: South Africa
facility: Local Institution
state: KWA ZULU Natal
city: Panorama
country: South Africa
facility: Local Institution
state: Western CAPE
city: Pinelands, Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Tygerberg
country: South Africa
facility: Local Institution
state: Western CAPE
city: A Coruna
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Santander
country: Spain
facility: Local Institution
city: Santiago De Compostela
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Changhua
country: Taiwan
facility: Local Institution
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taoyuan
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Weinblatt ME, Mease P, Mysler E, Takeuchi T, Drescher E, Berman A, Xing J, Zilberstein M, Banerjee S, Emery P. The efficacy and safety of subcutaneous clazakizumab in patients with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate: results from a multinational, phase IIb, randomized, double-blind, placebo/active-controlled, dose-ranging study. Arthritis Rheumatol. 2015 Oct;67(10):2591-600. doi: 10.1002/art.39249.