COMPLETED

A Study of Baricitinib in Participants With Rheumatoid Arthritis

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Conditions

Rheumatoid Arthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

Quick Facts

Study Start:2020-02-14
Study Completion:2025-05-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04086745

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have at least one of the following characteristics:
  2. * Documented evidence of a VTE prior to this study
  3. * At least 60 years of age
  4. * A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²), or
  5. * Age 50 to less than 60 years and BMI 25 to less than 30 kg/m²
  6. * Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic)
  1. * Participant must not have prior use of a Janus kinase (JAK) inhibitor or have received more than 1 prior TNF inhibitor that was:
  2. * discontinued for IR (lack or loss of efficacy) for RA, or
  3. * discontinued for intolerance (AE) when used for any indication
  4. * Participants must not be pregnant or breastfeeding
  5. * Participants must not have had more than one VTE
  6. * Participants must not have cancer
  7. * Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness
  8. * Participants must not have had a live vaccine within four weeks of study start
  9. * Participants must not have participated in any other clinical trial within four weeks of study start
  10. * Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year

Contacts and Locations

Principal Investigator

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)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Arizona Research Clinic PLLC
Chandler, Arizona, 85225
United States
Arizona Arthritis & Rheumatology Associates, P. C.
Mesa, Arizona, 85202
United States
Arizona Arthritis & Rheumatology Research
Paradise Valley, Arizona, 85253
United States
Sun Valley Arthritis Center, LTD
Peoria, Arizona, 85381
United States
Arizona Arthritis & Rheumatology Associates
Phoenix, Arizona, 85037
United States
Arthritis and Rheumatism Associates
Jonesboro, Arkansas, 72401
United States
Providence St. Joseph's Medical Center
Burbank, California, 91505
United States
Hope Clinical Research, Inc.
Canoga Park, California, 91303
United States
Medvin Clinical Research - Covina
Covina, California, 91722
United States
TriWest Research Associates LLC
El Cajon, California, 92020
United States
Newport Huntington Med Grp
Huntington Beach, California, 92648
United States
BioSolutions Clinical Research Center
La Mesa, California, 91942
United States
Valerius Medical Group and Research Center of Greater Long Beach
Los Alamitos, California, 90720
United States
R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center
Monterey Park, California, 91754
United States
ACRC Studies
Poway, California, 92064
United States
Desert Medical Advances
Rancho Mirage, California, 92270
United States
Purushotham & Akther Kotha MD Inc
San Diego, California, 92120
United States
East Bay Rheumatology Medical Group, Inc
San Leandro, California, 94578
United States
Providence Medical Foundation
Santa Rosa, California, 95403
United States
Dan La, MD Inc
Tujunga, California, 91042
United States
Office: Dr Robin K Dore
Tustin, California, 92780
United States
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, 91786
United States
Nazanin Firooz, MD Inc.
West Hills, California, 91307
United States
Medvin Clinical Research - Whittier
Whittier, California, 90602
United States
Danbury Clinical Research, LLC
Danbury, Connecticut, 06810
United States
Delaware Arthritis
Lewes, Delaware, 19958
United States
Omega Research Debary, LLC
DeBary, Florida, 32713
United States
Cria Center for Rheumatology
Fort Lauderdale, Florida, 33334
United States
SIMED Health
Gainesville, Florida, 32607
United States
GNP Research at Mark Jaffe, MD
Hollywood, Florida, 33024
United States
Rheumatology Center Of Palm Beach, Pllc
Lake Worth, Florida, 33467 2991
United States
Arthritis and Rheumatology Center of South Florida
Margate, Florida, 33063
United States
Miami Clinical Reserach
Miami, Florida, 33155
United States
Felicidad Medical Research
Miami, Florida, 33185
United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806
United States
Heuer MD Research
Orlando, Florida, 32819
United States
UCF Health Lake Nona Orlando
Orlando, Florida, 32827
United States
IRIS Research and Development, LLC
Plantation, Florida, 33324
United States
BayCare Health System Inc
Saint Petersburg, Florida, 33705
United States
West Broward Rheumatology Associates
Tamarac, Florida, 33321
United States
Avita Clinical Research
Tampa, Florida, 33613
United States
Tampa Medical Group, P.A.
Tampa, Florida, 33614
United States
Florida Medical Clinic LLC
Zephyrhills, Florida, 33542-7505
United States
Arthritis & Rheumatology of Georgia
Atlanta, Georgia, 30342
United States
Arthritis Center of North Georgia
Gainesville, Georgia, 30501
United States
St Luke's Clinic - Intermountain Orthopaedics
Boise, Idaho, 83702
United States
Hinsdale Orthopaedics, Illinois Bone and Joint
Hinsdale, Illinois, 60521
United States
Rockford Orthopedic Associates
Rockford, Illinois, 61107
United States
Orthoillinois
Rockford, Illinois, 61114
United States
Greater Chicago Specialty Physicians, LLC
Schaumburg, Illinois, 60195
United States
Center of Robert Hozman
Skokie, Illinois, 60076
United States
Beacon Medical Group Clinical Research
South Bend, Indiana, 46617
United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101
United States
Western KY Rheumatology PLLC
Hopkinsville, Kentucky, 42240
United States
Accurate Clinical Research
Lake Charles, Louisiana, 70605
United States
Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, 71203
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Klein and Associates MD, PA
Cumberland, Maryland, 21502
United States
NECCR PrimaCare Research
Fall River, Massachusetts, 02721
United States
Michigan Rheumatology Group
Grand Blanc, Michigan, 48439
United States
Pandit Rheumatology PC
Okemos, Michigan, 48864
United States
Jefferson City Medical Group
Jefferson City, Missouri, 65109
United States
West County Rheumatology
Saint Louis, Missouri, 63131
United States
Clinvest Research LLC
Springfield, Missouri, 65807
United States
Lovelace Scientific Resources
Henderson, Nevada, 89104
United States
Allied Clinical Research
Reno, Nevada, 89519
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Arthritis Care Medical Center
Somerset, New Jersey, 08873
United States
Atlantic Coastal Research
Toms River, New Jersey, 08757
United States
Sahni Rheumatology & Therapy PC
West Long Branch, New Jersey, 07764
United States
NYU Langone
New York, New York, 10016
United States
Medication Management
Greensboro, North Carolina, 27408
United States
PMG Research of Hickory, LLC
Hickory, North Carolina, 28601
United States
Cape Fear Arthritis Care
Leland, North Carolina, 28451
United States
Carolina Arthritis Associates
Wilmington, North Carolina, 28401
United States
Cincinnati Arthritis Associates
Cincinnati, Ohio, 45242
United States
Craig S Thompson MD LLC
Marion, Ohio, 43302
United States
Paramount Medical Research
Middleburg Heights, Ohio, 44130
United States
Arthritis & Rheumatology Center of Oklahoma PLLC
Oklahoma City, Oklahoma, 73103
United States
Good Samaritan Hospital Corvallis
Corvallis, Oregon, 97330
United States
Advanced Rheumatology and Arthritis Research Center, PC
Cranberry Township, Pennsylvania, 15090
United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
United States
Pennsylvania Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, 19610
United States
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
North Charleston, South Carolina, 29406
United States
Monument Health Rapid City Hospital
Rapid City, South Dakota, 57701
United States
Cumberland Rheumatology
Crossville, Tennessee, 38555
United States
West Tennessee Research Institute
Jackson, Tennessee, 38305
United States
Nashville Arthritis and Rheumatology
Nashville, Tennessee, 37203
United States
Accent Clinical Research Professionals, LLC
Allen, Texas, 75013
United States
Amarillo Center for Clinical Research
Amarillo, Texas, 79124
United States
Arthritis & Osteoporosis Clinic of Brazos Valley
College Station, Texas, 77845
United States
Metroplex Clinical Research Center
Dallas, Texas, 75235
United States
El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization
El Paso, Texas, 79912
United States
UDL Clinical Research, LLC
Houston, Texas, 77002
United States
Pioneer Research Solutions
Houston, Texas, 77008
United States
Biopharma Informatic, LLC
Houston, Texas, 77043
United States
Accurate Clinical Management - Houston
Houston, Texas, 77084
United States
Synergy Group US
Katy, Texas, 77450
United States
Houston Rheumatology & Arthritis Specialists
Katy, Texas, 77494
United States
R and H Clinical Research
Katy, Texas, 77494
United States
Prime Clinical Research
Mansfield, Texas, 76063
United States
Southwest Rheumatology, P.A.
Mesquite, Texas, 75150
United States
Advanced Clinical Research Center of Houston
Pearland, Texas, 77584
United States
Clinrx Research Joseph INC.
Plano, Texas, 75007
United States
Violeta T. Baddour, MD
Pleasanton, Texas, 78064
United States
Accurate Clinical Research, Inc.
San Antonio, Texas, 78229
United States
Accurate Clinical Management
Sugar Land, Texas, 77479
United States
Fort Bend Clinical Research, LLC
Sugar Land, Texas, 77479
United States
Mt. Olympus Medical Research
Sugar Land, Texas, 77479
United States
Baylor Scott & White Health
Temple, Texas, 76508
United States
North Houston Rheumatology Associates
The Woodlands, Texas, 77380
United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, 77375
United States
Center for Arthritis and Rheumatic Diseases, PC
Chesapeake, Virginia, 23320
United States
Spectrum Medical Inc.
Danville, Virginia, 24541
United States
Arthritis & Osteoporosis Center of Northern Virinia
Manassas, Virginia, 20109
United States
TPMG Rheumatology/TPMG Clinical Research
Newport News, Virginia, 23606
United States
Arthritis Northwest, PLLC
Spokane, Washington, 99204
United States
Rheumatology & Pulmonary Clinic
Beckley, West Virginia, 25801
United States
Rheumatic Disease Center
Milwaukee, Wisconsin, 53211
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • 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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-14
Study Completion Date2025-05-19

Study Record Updates

Study Start Date2020-02-14
Study Completion Date2025-05-19

Terms related to this study

Additional Relevant MeSH Terms

  • Rheumatoid Arthritis