Clinical trial NCT02638948: Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis
Official title: Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-12-23
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
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 whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male and female age 18 and above
* Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III
* Have an inadequate response to methotrexate
* In addition to an inadequate response to methotrexate have an inadequate response or intolerance to 1 but not more than 2 TNF inhibitors
* Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count)
* Have hsCRP of ≥ 0.8 mg/dL (8mg/L) \[by central laboratory values\] or an ESR ≥ 28 mm/hr
* Willing to use effective birth control for the entire length of the study

Exclusion Criteria:

* Diagnosed with juvenile Rheumatoid Arthritis
* Have been treated with other biologic treatment than a TNF inhibitor
* Active systemic bacterial, viral or fungal infection or evidence of prior or current Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal infections
* Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4 weeks of randomization
* Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents)
* Have other autoimmune disease other than RA like lupus, multiple sclerosis
* Have significant concurrent medical condition at the time of screening or baseline visit

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% Response Over Time From Baseline to Week 12
timeFrame: Baseline, Day 15, Day 29, Day 57, Day 85
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Over Time From Baseline to Week 12
timeFrame: Baseline, Day 15, Day 29, Day 57, Day 85
measure: Percentage of Participants Achieving American College of Rheumatology 70% Response Over Time From Baseline to Week 12
timeFrame: Baseline, Day 15, Day 29, Day 57, Day 85
measure: Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints Erythrocyte Sedimentation Rate (DAS28--ESR) Score at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving <= 2.8 Response in Clinical Disease Activity Index (CDAI) Score at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving <= 3.3 Response in Simple Disease Activity Index (SDAI) Score at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving Boolean Remission Criteria at Week 12
timeFrame: Week 12
measure: Change From Baseline in DAS28-CRP Score Over Time up to Week 12
timeFrame: Baseline, Day 85 (Week 12)
measure: Change From Baseline in DAS28-ESR Score Over Time up to Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in CDAI Score Over Time up to Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in SDAI Score Over Time up to Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Adverse Events (AEs), and Serious AEs (SAEs)
timeFrame: Up to 30 days after treatment discontinuation
measure: Trough Observed Plasma Concentration (Ctrough) of BMS-986142
timeFrame: Week 4, 8, and 12
measure: Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Synovitis at Week 4 and 12
timeFrame: Week 4 and Week 12
measure: Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Osteitis at Week 4 and 12
timeFrame: Week 4, and Week 12
measure: Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Bone Erosion at Week 4 and 12
timeFrame: Week 4 and Week 12
measure: Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Cartilage Loss at Week 4 and 12
timeFrame: Week 4, and Week12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates Of North Alabama, P.C.
state: Alabama
city: Fullerton
country: United States
facility: St. Joseph Heritage Medical Group
state: California
city: Hemet
country: United States
facility: C.V Mehta M.D Medical Corp
state: California
city: Huntington Beach
country: United States
facility: HCP Clinical Research, LLC
state: California
city: Miami Lakes
country: United States
facility: Precision Research Organization
state: Florida
city: Miami
country: United States
facility: Leon Medical Research
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Coral Research Clinic Corp
state: Florida
city: Palm Harbor
country: United States
facility: The Arthritis Center
state: Florida
city: Pembroke Pines
country: United States
facility: Vizae Clinical Trials Management
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology & Immunology Specialists
state: Florida
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology Group
state: Georgia
city: Monroe
country: United States
facility: Arthritis And Diabetes Clinic
state: Louisiana
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Grand Blanc
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Albuquerque
country: United States
facility: Albuquerque Center For Rheumatology
state: New Mexico
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, Llc
state: Ohio
city: Bethlehem
country: United States
facility: East Penn Rheumatology
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Wexford
country: United States
facility: Advanced Rheumatology & Arthritis Research Center, P.C
state: Pennsylvania
city: Wyomissing
country: United States
facility: Local Institution
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Amarillo
country: United States
facility: Pharma Tex Research
state: Texas
city: Austin
country: United States
facility: Tekton Research Inc
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research LLC
state: Texas
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Aprillus Asistencia e Investigacion
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto De Rehabilitacion Psicofisica
city: Cordoba
country: Argentina
facility: Instituto Reumatologico Strusberg
city: Wien
country: Austria
facility: Universitaetsklinik Fuer Innere Medizin 3
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: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Santo Andre
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Brampton
country: Canada
facility: Aggarwal And Associates
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil K Gupta Med Prof Corp
state: Ontario
city: Corbeil Essonnes
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Orleans cedex 2
country: France
facility: Local Institution
city: Strasbourg Cedex
country: France
facility: Local Institution
city: Elmshorn
country: Germany
facility: Asklepios Gesundheitszentrum
city: Freiburg
country: Germany
facility: Medizinsche Universitaetsklinik Freiburg
city: Magdeburg
country: Germany
facility: Smo.Md Gmbh
city: Firenze
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Kato-shi
country: Japan
facility: Local Institution
state: Hyogo
city: Sagamihara-shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Local Institution
state: Kumamoto
city: Sendai-shi
country: Japan
facility: Local Institution
state: Miyagi
city: Sasebo-shi
country: Japan
facility: Local Institution
state: Nagasaki
city: Kawachinagano
country: Japan
facility: Local Institution
state: Osaka
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Iruma-gun
country: Japan
facility: Local Institution
state: Saitama
city: Kawagoe-shi
country: Japan
facility: Local Institution
state: Saitama
city: Hamamatsu-shi
country: Japan
facility: Local Institution
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Meguro-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Osaki-shi
country: Japan
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Mexico City
country: Mexico
facility: CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
state: Distrito Fededral
city: Guadalajara
country: Mexico
facility: Consultorio Privado de Especialidad
state: Jalisco
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo LEON
city: Villahermosa
country: Mexico
facility: Local Institution
state: Tabasco
city: Merida
country: Mexico
facility: Unidad Reumatologica Las Americas, S.C. P.
state: Yucatan
city: Distrito Federal
country: Mexico
facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis Rotterdam
city: Bialystok
country: Poland
facility: Nzoz Osteo-Medic S.C. A. Racewicz, J.Supronik
city: Bialystok
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Centrum Badan Klinicznych JCI Life Science Park
city: Lublin
country: Poland
facility: Local Institution
city: Nadarzyn
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
city: Warszawa
country: Poland
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: St Petersburg
country: Russian Federation
facility: Local Institution
city: Tolyatti
country: Russian Federation
facility: Local Institution
city: Benoni
country: South Africa
facility: Local Institution
state: Gauteng
city: Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: George
country: South Africa
facility: Local Institution
state: Western CAPE
city: Somerset West
country: South Africa
facility: Local Institution
state: Western CAPE
city: A Coruna
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Santiago Compostela
country: Spain
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: