Clinical trial NCT04086745: A Study of Baricitinib in Participants With Rheumatoid Arthritis
Official title: A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Incyte Corporation
First posted: 2019-09-12
Enrollment: 1300
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: This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis (RA).


Eligibility criteria: Inclusion Criteria:

* Participants must have at least one of the following characteristics:

  * Documented evidence of a VTE prior to this study
  * At least 60 years of age
  * A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²), or
  * Age 50 to less than 60 years and BMI 25 to less than 30 kg/m²
* Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic)

Exclusion Criteria:

* Participant must not have prior use of a Janus kinase (JAK) inhibitor or have received more than 1 prior TNF inhibitor that was:

  * discontinued for IR (lack or loss of efficacy) for RA, or
  * discontinued for intolerance (AE) when used for any indication
* Participants must not be pregnant or breastfeeding
* Participants must not have had more than one VTE
* Participants must not have cancer
* Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness
* Participants must not have had a live vaccine within four weeks of study start
* Participants must not have participated in any other clinical trial within four weeks of study start
* Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year

Primary outcomes:
measure: Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE)
timeFrame: Baseline through Study Completion (Approximately 5.5 Years)
Secondary outcomes:
measure: Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE)
timeFrame: Baseline through Study Completion (Approximately 5.5 Years)
measure: Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE)
timeFrame: Baseline through Study Completion (Approximately 5.5 Years)
measure: Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC])
timeFrame: Baseline through Study Completion (Approximately 5.5 Years)
measure: Time from First Dose of Study Treatment to First Opportunistic Infection
timeFrame: Baseline through Study Completion (Approximately 5.5 Years)
measure: Time from First Dose of Study Treatment to First Serious Infection
timeFrame: Baseline through Study Completion (Approximately 5.5 Years)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Research Clinic PLLC
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P. C.
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P. C.
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P. C.
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P. C.
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P. C.
state: Arizona
city: Paradise Valley
country: United States
facility: Arizona Arthritis & Rheumatology Research
state: Arizona
city: Paradise Valley
country: United States
facility: Arizona Arthritis & Rheumatology Research
state: Arizona
city: Peoria
country: United States
facility: Sun Valley Arthritis Center, LTD
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates
state: Arizona
city: Jonesboro
country: United States
facility: Arthritis and Rheumatism Associates
state: Arkansas
city: Anaheim
country: United States
facility: Smart Cures Clinical Research
state: California
city: Beverly Hills
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Burbank
country: United States
facility: Providence St. Joseph's Medical Center
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Covina
country: United States
facility: Medvin Clinical Research - Covina
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates LLC
state: California
city: Huntington Beach
country: United States
facility: Newport Huntington Med Grp
state: California
city: La Mesa
country: United States
facility: BioSolutions Clinical Research Center
state: California
city: Los Alamitos
country: United States
facility: Valerius Medical Group and Research Center of Greater Long Beach
state: California
city: Los Angeles
country: United States
facility: Soha Dolatabadi, MD
state: California
city: Monterey Park
country: United States
facility: R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center
state: California
city: Poway
country: United States
facility: ACRC Studies
state: California
city: Rancho Mirage
country: United States
facility: Desert Medical Advances
state: California
city: San Diego
country: United States
facility: Purushotham & Akther Kotha MD Inc
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group, Inc
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Foundation
state: California
city: Tujunga
country: United States
facility: Dan La, MD Inc
state: California
city: Tustin
country: United States
facility: Office: Dr Robin K Dore
state: California
city: Upland
country: United States
facility: Inland Rheumatology & Osteoporosis Medical Group
state: California
city: West Hills
country: United States
facility: Nazanin Firooz, MD Inc.
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research - Whittier
state: California
city: Danbury
country: United States
facility: Danbury Clinical Research, LLC
state: Connecticut
city: Lewes
country: United States
facility: Delaware Arthritis
state: Delaware
city: DeBary
country: United States
facility: Omega Research Debary, LLC
state: Florida
city: Doral
country: United States
facility: Unique Clinical Trials
state: Florida
city: Fort Lauderdale
country: United States
facility: Cria Center for Rheumatology
state: Florida
city: Gainesville
country: United States
facility: SIMED Health
state: Florida
city: Hollywood
country: United States
facility: GNP Research at Mark Jaffe, MD
state: Florida
city: Lake Worth
country: United States
facility: Rheumatology Center Of Palm Beach, Pllc
state: Florida
city: Margate
country: United States
facility: Arthritis and Rheumatology Center of South Florida
state: Florida
city: Miami
country: United States
facility: Oceane7 Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Miami Clinical Reserach
state: Florida
city: Miami
country: United States
facility: Felicidad Medical Research
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida
state: Florida
city: Orlando
country: United States
facility: Heuer MD Research
state: Florida
city: Orlando
country: United States
facility: UCF Health Lake Nona Orlando
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: BayCare Health System Inc
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates
state: Florida
city: Tampa
country: United States
facility: Avita Clinical Research
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group, P.A.
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic LLC
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Atlanta
country: United States
facility: Arthritis & Rheumatology of Georgia
state: Georgia
city: Gainesville
country: United States
facility: Arthritis Center of North Georgia
state: Georgia
city: Boise
country: United States
facility: St Luke's Clinic - Intermountain Orthopaedics
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Hinsdale
country: United States
facility: Hinsdale Orthopaedics, Illinois Bone and Joint
state: Illinois
city: Rockford
country: United States
facility: Rockford Orthopedic Associates
state: Illinois
city: Rockford
country: United States
facility: Orthoillinois
state: Illinois
city: Schaumburg
country: United States
facility: Greater Chicago Specialty Physicians, LLC
state: Illinois
city: Skokie
country: United States
facility: Center of Robert Hozman
state: Illinois
city: South Bend
country: United States
facility: Beacon Medical Group Clinical Research
state: Indiana
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic
state: Kentucky
city: Hopkinsville
country: United States
facility: Western KY Rheumatology PLLC
state: Kentucky
city: Lake Charles
country: United States
facility: Accurate Clinical Research
state: Louisiana
city: Lake Charles
country: United States
facility: Accurate Clinical Research
state: Louisiana
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic, Inc.
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Cumberland
country: United States
facility: Klein and Associates MD, PA
state: Maryland
city: Cumberland
country: United States
facility: Klein and Associates MD, PA
state: Maryland
city: Fall River
country: United States
facility: NECCR PrimaCare Research
state: Massachusetts
city: Grand Blanc
country: United States
facility: Michigan Rheumatology Group
state: Michigan
city: Okemos
country: United States
facility: Pandit Rheumatology PC
state: Michigan
city: Jefferson City
country: United States
facility: Jefferson City Medical Group
state: Missouri
city: Saint Louis
country: United States
facility: West County Rheumatology
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Henderson
country: United States
facility: Lovelace Scientific Resources
state: Nevada
city: Reno
country: United States
facility: Allied Clinical Research
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Somerset
country: United States
facility: Arthritis Care Medical Center
state: New Jersey
city: Toms River
country: United States
facility: Atlantic Coastal Research
state: New Jersey
city: West Long Branch
country: United States
facility: Sahni Rheumatology & Therapy PC
state: New Jersey
city: New York
country: United States
facility: NYU Langone
state: New York
city: Greensboro
country: United States
facility: Medication Management
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Leland
country: United States
facility: Cape Fear Arthritis Care
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates
state: North Carolina
city: Minot
country: United States
facility: Trinity Medical Group
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati Arthritis Associates
state: Ohio
city: Marion
country: United States
facility: Craig S Thompson MD LLC
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Arthritis & Rheumatology Center of Oklahoma PLLC
state: Oklahoma
city: Corvallis
country: United States
facility: Good Samaritan Hospital Corvallis
state: Oregon
city: Cranberry Township
country: United States
facility: Advanced Rheumatology and Arthritis Research Center, PC
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pennsylvania Regional Center for Arthritis and Osteoporosis Research
state: Pennsylvania
city: North Charleston
country: United States
facility: Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health Rapid City Hospital
state: South Dakota
city: Crossville
country: United States
facility: Cumberland Rheumatology
state: Tennessee
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Nashville Arthritis and Rheumatology
state: Tennessee
city: Allen
country: United States
facility: Accent Clinical Research Professionals, LLC
state: Texas
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research
state: Texas
city: College Station
country: United States
facility: Arthritis & Osteoporosis Clinic of Brazos Valley
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: El Paso
country: United States
facility: El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization
state: Texas
city: Houston
country: United States
facility: UDL Clinical Research, LLC
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management - Houston
state: Texas
city: Katy
country: United States
facility: Synergy Group US
state: Texas
city: Katy
country: United States
facility: Houston Rheumatology & Arthritis Specialists
state: Texas
city: Katy
country: United States
facility: R and H Clinical Research
state: Texas
city: Mansfield
country: United States
facility: Prime Clinical Research
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology, P.A.
state: Texas
city: Pearland
country: United States
facility: Advanced Clinical Research Center of Houston
state: Texas
city: Plano
country: United States
facility: Clinrx Research Joseph INC.
state: Texas
city: Pleasanton
country: United States
facility: Violeta T. Baddour, MD
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research
state: Texas
city: San Antonio
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Sugar Land
country: United States
facility: Accurate Clinical Management
state: Texas
city: Sugar Land
country: United States
facility: Fort Bend Clinical Research, LLC
state: Texas
city: Sugar Land
country: United States
facility: Mt. Olympus Medical Research
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Health
state: Texas
city: The Woodlands
country: United States
facility: North Houston Rheumatology Associates
state: Texas
city: Tomball
country: United States
facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research
state: Texas
city: Tomball
country: United States
facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research
state: Texas
city: Murray
country: United States
facility: Epic Medical Research
state: Utah
city: Chesapeake
country: United States
facility: Center for Arthritis and Rheumatic Diseases, PC
state: Virginia
city: Danville
country: United States
facility: Spectrum Medical Inc.
state: Virginia
city: Manassas
country: United States
facility: Arthritis & Osteoporosis Center of Northern Virinia
state: Virginia
city: Newport News
country: United States
facility: TPMG Rheumatology/TPMG Clinical Research
state: Virginia
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
city: Beckley
country: United States
facility: Rheumatology & Pulmonary Clinic
state: West Virginia
city: Milwaukee
country: United States
facility: Rheumatic Disease Center
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: