A Study of Baricitinib in Participants With Rheumatoid Arthritis
- Registration Number
- NCT04086745
- Lead Sponsor
- Eli Lilly and Company
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1300
-
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)
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Baricitinib High Dose Baricitinib Baricitinib administered orally. TNF Inhibitor TNF Inhibitor Adalimumab or etanercept administered subcutaneously (SC) per standard of care. Baricitinib Low Dose Baricitinib Baricitinib administered orally.
- Primary Outcome Measures
Name Time Method Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) Baseline through Study Completion (Approximately 5.5 Years) Time from First Dose of Study Treatment to First Event of VTE
- Secondary Outcome Measures
Name Time Method Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE) Baseline through Study Completion (Approximately 5.5 Years) Time from First Dose of Study Treatment to First MACE
Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE) Baseline through Study Completion (Approximately 5.5 Years) Time from First Dose of Study Treatment to First ATE
Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC]) Baseline through Study Completion (Approximately 5.5 Years) Time from First Dose of Study Treatment to First Malignancy (excluding NMSC)
Time from First Dose of Study Treatment to First Opportunistic Infection Baseline through Study Completion (Approximately 5.5 Years) Time from First Dose of Study Treatment to First Opportunistic Infection
Time from First Dose of Study Treatment to First Serious Infection Baseline through Study Completion (Approximately 5.5 Years) Time from First Dose of Study Treatment to First Serious Infection
Trial Locations
- Locations (119)
Arizona Research Clinic PLLC
🇺🇸Chandler, Arizona, United States
Smart Cures Clinical Research
🇺🇸Anaheim, California, United States
Wallace Rheumatic Study Center
🇺🇸Beverly Hills, California, United States
BioSolutions Clinical Research Center
🇺🇸La Mesa, California, United States
R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center
🇺🇸Monterey Park, California, United States
ACRC Studies
🇺🇸Poway, California, United States
Purushotham & Akther Kotha MD Inc
🇺🇸San Diego, California, United States
Providence Medical Foundation
🇺🇸Santa Rosa, California, United States
Nazanin Firooz, MD Inc.
🇺🇸West Hills, California, United States
Danbury Clinical Research, LLC
🇺🇸Danbury, Connecticut, United States
Unique Clinical Trials
🇺🇸Doral, Florida, United States
Rheumatology Center Of Palm Beach, Pllc
🇺🇸Lake Worth, Florida, United States
Oceane7 Clinical Research, LLC
🇺🇸Miami, Florida, United States
Miami Clinical Reserach
🇺🇸Miami, Florida, United States
Felicidad Medical Research
🇺🇸Miami, Florida, United States
Heuer MD Research
🇺🇸Orlando, Florida, United States
UCF Health Lake Nona Orlando
🇺🇸Orlando, Florida, United States
BayCare Health System Inc
🇺🇸Saint Petersburg, Florida, United States
Avita Clinical Research
🇺🇸Tampa, Florida, United States
Tampa Medical Group, P.A.
🇺🇸Tampa, Florida, United States
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States
Arthritis & Rheumatology of Georgia
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Orthoillinois
🇺🇸Rockford, Illinois, United States
Michigan Rheumatology Group
🇺🇸Grand Blanc, Michigan, United States
West County Rheumatology
🇺🇸Saint Louis, Missouri, United States
Arthritis Care Medical Center
🇺🇸Somerset, New Jersey, United States
Trinity Medical Group
🇺🇸Minot, North Dakota, United States
Cincinnati Arthritis Associates
🇺🇸Cincinnati, Ohio, United States
Arthritis & Rheumatology Center of Oklahoma PLLC
🇺🇸Oklahoma City, Oklahoma, United States
Advanced Rheumatology and Arthritis Research Center, PC
🇺🇸Cranberry Township, Pennsylvania, United States
Clinical Research of Philadelphia, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Pennsylvania Regional Center for Arthritis and Osteoporosis Research
🇺🇸Wyomissing, Pennsylvania, United States
Accent Clinical Research Professionals, LLC
🇺🇸Allen, Texas, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Pioneer Research Solutions
🇺🇸Houston, Texas, United States
Accurate Clinical Management - Houston
🇺🇸Houston, Texas, United States
R and H Clinical Research
🇺🇸Katy, Texas, United States
Prime Clinical Research
🇺🇸Mansfield, Texas, United States
Advanced Clinical Research Center of Houston
🇺🇸Pearland, Texas, United States
Violeta T. Baddour, MD
🇺🇸Pleasanton, Texas, United States
Epic Medical Research
🇺🇸Murray, Utah, United States
Baylor Scott & White Health
🇺🇸Temple, Texas, United States
Arizona Arthritis & Rheumatology Associates, P. C.
🇺🇸Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research
🇺🇸Paradise Valley, Arizona, United States
Sun Valley Arthritis Center, LTD
🇺🇸Peoria, Arizona, United States
Arizona Arthritis & Rheumatology Associates
🇺🇸Phoenix, Arizona, United States
Arthritis and Rheumatism Associates
🇺🇸Jonesboro, Arkansas, United States
Providence St. Joseph's Medical Center
🇺🇸Burbank, California, United States
Medvin Clinical Research - Covina
🇺🇸Covina, California, United States
TriWest Research Associates LLC
🇺🇸El Cajon, California, United States
Newport Huntington Med Grp
🇺🇸Huntington Beach, California, United States
Soha Dolatabadi, MD
🇺🇸Los Angeles, California, United States
Desert Medical Advances
🇺🇸Rancho Mirage, California, United States
East Bay Rheumatology Medical Group, Inc
🇺🇸San Leandro, California, United States
Dan La, MD Inc
🇺🇸Tujunga, California, United States
Office: Dr Robin K Dore
🇺🇸Tustin, California, United States
Inland Rheumatology & Osteoporosis Medical Group
🇺🇸Upland, California, United States
Medvin Clinical Research - Whittier
🇺🇸Whittier, California, United States
Delaware Arthritis
🇺🇸Lewes, Delaware, United States
Omega Research Debary, LLC
🇺🇸DeBary, Florida, United States
Cria Center for Rheumatology
🇺🇸Fort Lauderdale, Florida, United States
GNP Research at Mark Jaffe, MD
🇺🇸Hollywood, Florida, United States
Arthritis and Rheumatology Center of South Florida
🇺🇸Margate, Florida, United States
Rheumatology Associates of Central Florida
🇺🇸Orlando, Florida, United States
IRIS Research and Development, LLC
🇺🇸Plantation, Florida, United States
West Broward Rheumatology Associates
🇺🇸Tamarac, Florida, United States
Florida Medical Clinic LLC
🇺🇸Zephyrhills, Florida, United States
Arthritis Center of North Georgia
🇺🇸Gainesville, Georgia, United States
St Luke's Clinic - Intermountain Orthopaedics
🇺🇸Boise, Idaho, United States
Hinsdale Orthopaedics, Illinois Bone and Joint
🇺🇸Hinsdale, Illinois, United States
Rockford Orthopedic Associates
🇺🇸Rockford, Illinois, United States
Greater Chicago Specialty Physicians, LLC
🇺🇸Schaumburg, Illinois, United States
Center of Robert Hozman
🇺🇸Skokie, Illinois, United States
Graves-Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
Western KY Rheumatology PLLC
🇺🇸Hopkinsville, Kentucky, United States
Accurate Clinical Research
🇺🇸Lake Charles, Louisiana, United States
Arthritis and Diabetes Clinic, Inc.
🇺🇸Monroe, Louisiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Klein and Associates MD, PA
🇺🇸Cumberland, Maryland, United States
NECCR PrimaCare Research
🇺🇸Fall River, Massachusetts, United States
Pandit Rheumatology PC
🇺🇸Okemos, Michigan, United States
Jefferson City Medical Group
🇺🇸Jefferson City, Missouri, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Lovelace Scientific Resources
🇺🇸Henderson, Nevada, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Atlantic Coastal Research
🇺🇸Toms River, New Jersey, United States
Sahni Rheumatology & Therapy PC
🇺🇸West Long Branch, New Jersey, United States
NYU Langone
🇺🇸New York, New York, United States
Medication Management
🇺🇸Greensboro, North Carolina, United States
Cape Fear Arthritis Care
🇺🇸Leland, North Carolina, United States
Carolina Arthritis Associates
🇺🇸Wilmington, North Carolina, United States
Craig S Thompson MD LLC
🇺🇸Marion, Ohio, United States
Paramount Medical Research
🇺🇸Middleburg Heights, Ohio, United States
Good Samaritan Hospital Corvallis
🇺🇸Corvallis, Oregon, United States
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
🇺🇸North Charleston, South Carolina, United States
Monument Health Rapid City Hospital
🇺🇸Rapid City, South Dakota, United States
Cumberland Rheumatology
🇺🇸Crossville, Tennessee, United States
West Tennessee Research Institute
🇺🇸Jackson, Tennessee, United States
Amarillo Center for Clinical Research
🇺🇸Amarillo, Texas, United States
El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization
🇺🇸El Paso, Texas, United States
UDL Clinical Research, LLC
🇺🇸Houston, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Houston Rheumatology & Arthritis Specialists
🇺🇸Katy, Texas, United States
Southwest Rheumatology, P.A.
🇺🇸Mesquite, Texas, United States
Clinrx Research Joseph INC.
🇺🇸Plano, Texas, United States
Accurate Clinical Research, Inc.
🇺🇸San Antonio, Texas, United States
Accurate Clinical Management
🇺🇸Sugar Land, Texas, United States
Mt. Olympus Medical Research
🇺🇸Sugar Land, Texas, United States
North Houston Rheumatology Associates
🇺🇸The Woodlands, Texas, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
🇺🇸Tomball, Texas, United States
Center for Arthritis and Rheumatic Diseases, PC
🇺🇸Chesapeake, Virginia, United States
Spectrum Medical Inc.
🇺🇸Danville, Virginia, United States
Arthritis & Osteoporosis Center of Northern Virinia
🇺🇸Manassas, Virginia, United States
TPMG Rheumatology/TPMG Clinical Research
🇺🇸Newport News, Virginia, United States
Arthritis Northwest, PLLC
🇺🇸Spokane, Washington, United States
Rheumatology & Pulmonary Clinic
🇺🇸Beckley, West Virginia, United States
Rheumatic Disease Center
🇺🇸Milwaukee, Wisconsin, United States