A Study of Baricitinib in Participants With Rheumatoid Arthritis

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04086745
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Baricitinib Low Dose

Baricitinib administered orally.

Experimental: Baricitinib High Dose

Baricitinib administered orally.

Active Comparator: TNF Inhibitor

Adalimumab or etanercept administered subcutaneously (SC) per standard of care.

Interventions

Drug: - Baricitinib

Administered orally.

Drug: - TNF Inhibitor

Administered SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Flagstaff, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Research, PLLC

Flagstaff, Arizona, 86001

Gilbert, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Associates, P. C.

Gilbert, Arizona, 85704

Glendale, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Research

Glendale, Arizona, 85306

Mesa, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Associates, P. C.

Mesa, Arizona, 85210

Sun Valley Arthritis Center, LTD, Peoria, Arizona

Status

Recruiting

Address

Sun Valley Arthritis Center, LTD

Peoria, Arizona, 85381

Phoenix, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Research

Phoenix, Arizona, 85032

Phoenix, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Associates, P. C.

Phoenix, Arizona, 85037

Sun City, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Associates, P. C.

Sun City, Arizona, 85351

Tucson, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Associates, P. C.

Tucson, Arizona, 85704

Arthritis and Rheumatism Associates, Jonesboro, Arkansas

Status

Recruiting

Address

Arthritis and Rheumatism Associates

Jonesboro, Arkansas, 72401

Hope Clinical Research, Canoga Park, California

Status

Recruiting

Address

Hope Clinical Research

Canoga Park, California, 91303

Medvin Clinical Research - Weidmann, Covina, California

Status

Recruiting

Address

Medvin Clinical Research - Weidmann

Covina, California, 91722

TriWest Research Associates LLC, El Cajon, California

Status

Recruiting

Address

TriWest Research Associates LLC

El Cajon, California, 92020

St. Joseph Heritage Medical Group, Fullerton, California

Status

Recruiting

Address

St. Joseph Heritage Medical Group

Fullerton, California, 92835

MD Medical Corporation, Hemet, California

Status

Recruiting

Address

MD Medical Corporation

Hemet, California, 92543

Newport Huntington Med Grp, Huntington Beach, California

Status

Recruiting

Address

Newport Huntington Med Grp

Huntington Beach, California, 92648

BioSolutions Clinical Research Center, La Mesa, California

Status

Recruiting

Address

BioSolutions Clinical Research Center

La Mesa, California, 91942

Purushotham & Akther Kotha MD Inc, La Mesa, California

Status

Not yet recruiting

Address

Purushotham & Akther Kotha MD Inc

La Mesa, California, 91942

Los Alamitos, California

Status

Recruiting

Address

Valerius Medical Group and Research Center of Greater Long Beach

Los Alamitos, California, 90720

Soha Dolatabadi, MD, Los Angeles, California

Status

Recruiting

Address

Soha Dolatabadi, MD

Los Angeles, California, 90017

Providence St. Joseph's Medical Center, Mission Hills, California

Status

Recruiting

Address

Providence St. Joseph's Medical Center

Mission Hills, California, 91345

Desert Medical Advances, Palm Desert, California

Status

Recruiting

Address

Desert Medical Advances

Palm Desert, California, 92260

ACRC Studies, Poway, California

Status

Recruiting

Address

ACRC Studies

Poway, California, 92064

East Bay Rheumatology Medical Group, Inc, San Leandro, California

Status

Recruiting

Address

East Bay Rheumatology Medical Group, Inc

San Leandro, California, 94578

Dan La, MD Inc, Tujunga, California

Status

Recruiting

Address

Dan La, MD Inc

Tujunga, California, 91042

Office: Dr Robin K Dore, Tustin, California

Status

Recruiting

Address

Office: Dr Robin K Dore

Tustin, California, 92780

Upland, California

Status

Recruiting

Address

Inland Rheumatology & Osteoporosis Medical Group

Upland, California, 91786

Nazanin Firooz, MD Inc., West Hills, California

Status

Recruiting

Address

Nazanin Firooz, MD Inc.

West Hills, California, 91307

Medvin Clinical Research - Weidmann, Whittier, California

Status

Recruiting

Address

Medvin Clinical Research - Weidmann

Whittier, California, 90602

Danbury Clinical Research, LLC, Danbury, Connecticut

Status

Recruiting

Address

Danbury Clinical Research, LLC

Danbury, Connecticut, 06810

Delaware Arthritis, Lewes, Delaware

Status

Recruiting

Address

Delaware Arthritis

Lewes, Delaware, 19958

Omega Research Debary, LLC, DeBary, Florida

Status

Not yet recruiting

Address

Omega Research Debary, LLC

DeBary, Florida, 32713

SIMED Health, Gainesville, Florida

Status

Recruiting

Address

SIMED Health

Gainesville, Florida, 32607

GNP Research at Mark Jaffe, MD, Hollywood, Florida

Status

Recruiting

Address

GNP Research at Mark Jaffe, MD

Hollywood, Florida, 33024

Margate, Florida

Status

Recruiting

Address

Arthritis and Rheumatology Center of South Florida

Margate, Florida, 33063

Miami Clinical Reserach, Miami, Florida

Status

Recruiting

Address

Miami Clinical Reserach

Miami, Florida, 33155

Orlando, Florida

Status

Recruiting

Address

Rheumatology Associates of Central Florida

Orlando, Florida, 32806

Heuer MD Research, Orlando, Florida

Status

Recruiting

Address

Heuer MD Research

Orlando, Florida, 32819

IRIS Research and Development, LLC, Plantation, Florida

Status

Not yet recruiting

Address

IRIS Research and Development, LLC

Plantation, Florida, 33324

Lovelace Scientific Resources, Riverview, Florida

Status

Recruiting

Address

Lovelace Scientific Resources

Riverview, Florida, 33569

Tamarac, Florida

Status

Recruiting

Address

West Broward Rheumatology Associates, Inc

Tamarac, Florida, 33321

Avita Clinical Research, Tampa, Florida

Status

Recruiting

Address

Avita Clinical Research

Tampa, Florida, 33613

Florida Medical Clinic LLC, Zephyrhills, Florida

Status

Recruiting

Address

Florida Medical Clinic LLC

Zephyrhills, Florida, 33542-7505

Arthritis Center of North Georgia, Gainesville, Georgia

Status

Recruiting

Address

Arthritis Center of North Georgia

Gainesville, Georgia, 30501

Rockford Orthopedic Associates, Rockford, Illinois

Status

Recruiting

Address

Rockford Orthopedic Associates

Rockford, Illinois, 61114

Schaumburg, Illinois

Status

Recruiting

Address

Greater Chicago Specialty Physicians, LLC

Schaumburg, Illinois, 60195

Center of Robert Hozman, Skokie, Illinois

Status

Recruiting

Address

Center of Robert Hozman

Skokie, Illinois, 60076

Beacon Medical Group Clinical Research, South Bend, Indiana

Status

Recruiting

Address

Beacon Medical Group Clinical Research

South Bend, Indiana, 46617

Graves-Gilbert Clinic, Bowling Green, Kentucky

Status

Recruiting

Address

Graves-Gilbert Clinic

Bowling Green, Kentucky, 42101

Western KY Rheumatology PLLC, Hopkinsville, Kentucky

Status

Recruiting

Address

Western KY Rheumatology PLLC

Hopkinsville, Kentucky, 42240

Ochsner Clinic Foundation, Baton Rouge, Louisiana

Status

Not yet recruiting

Address

Ochsner Clinic Foundation

Baton Rouge, Louisiana, 70836

Klein and Associates MD, PA, Cumberland, Maryland

Status

Recruiting

Address

Klein and Associates MD, PA

Cumberland, Maryland, 21502

Klein & Associates, M.D., P.A, Hagerstown, Maryland

Status

Recruiting

Address

Klein & Associates, M.D., P.A

Hagerstown, Maryland, 21740

NECCR PrimaCare Research, Fall River, Massachusetts

Status

Recruiting

Address

NECCR PrimaCare Research

Fall River, Massachusetts, 02721

Pandit Rheumatology PC, Okemos, Michigan

Status

Recruiting

Address

Pandit Rheumatology PC

Okemos, Michigan, 48864

West County Rheumatology, Saint Louis, Missouri

Status

Recruiting

Address

West County Rheumatology

Saint Louis, Missouri, 63131

Clinvest Research LLC, Springfield, Missouri

Status

Recruiting

Address

Clinvest Research LLC

Springfield, Missouri, 65810

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0001

Atlantic Coastal Research, Toms River, New Jersey

Status

Recruiting

Address

Atlantic Coastal Research

Toms River, New Jersey, 08755

NYU Langone, New York, New York

Status

Recruiting

Address

NYU Langone

New York, New York, 11201

Medication Management, LLC, Greensboro, North Carolina

Status

Recruiting

Address

Medication Management, LLC

Greensboro, North Carolina, 27408

Cape Fear Arthritis Care, Leland, North Carolina

Status

Recruiting

Address

Cape Fear Arthritis Care

Leland, North Carolina, 28451

Carolina Arthritis Associates, Wilmington, North Carolina

Status

Recruiting

Address

Carolina Arthritis Associates

Wilmington, North Carolina, 28401

Cincinnati Arthritis Associates, Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Arthritis Associates

Cincinnati, Ohio, 45242

Craig S Thompson MD LLC, Marion, Ohio

Status

Recruiting

Address

Craig S Thompson MD LLC

Marion, Ohio, 43302

Paramount Medical Research, Middleburg Heights, Ohio

Status

Recruiting

Address

Paramount Medical Research

Middleburg Heights, Ohio, 44130

Oklahoma City, Oklahoma

Status

Recruiting

Address

Arthritis & Rheumatology Center of Oklahoma PLLC

Oklahoma City, Oklahoma, 73102

Good Samaritan Hospital Corvallis, Corvallis, Oregon

Status

Recruiting

Address

Good Samaritan Hospital Corvallis

Corvallis, Oregon, 97330

Altoona Center For Clinical Research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635

Wyomissing, Pennsylvania

Status

Recruiting

Address

Pennsylvania Regional Center for Arthritis and Osteoporosis Research

Wyomissing, Pennsylvania, 19610

Summerville, South Carolina

Status

Recruiting

Address

Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

Summerville, South Carolina, 29486

Rapid City, South Dakota

Status

Recruiting

Address

Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.

Rapid City, South Dakota, 57701

Cumberland Rheumatology, Crossville, Tennessee

Status

Recruiting

Address

Cumberland Rheumatology

Crossville, Tennessee, 38555

Nashville Arthritis and Rheumatology, Nashville, Tennessee

Status

Recruiting

Address

Nashville Arthritis and Rheumatology

Nashville, Tennessee, 37203

Allen, Texas

Status

Recruiting

Address

Accent Clinical Research Professionals, LLC

Allen, Texas, 75013

Amarillo Center for Clinical Research, Amarillo, Texas

Status

Recruiting

Address

Amarillo Center for Clinical Research

Amarillo, Texas, 79124

Accurate Clinical Management, Baytown, Texas

Status

Recruiting

Address

Accurate Clinical Management

Baytown, Texas, 77521

College Station, Texas

Status

Recruiting

Address

Arthritis & Osteoporosis Clinic of Brazos Valley

College Station, Texas, 77845

Pioneer Research Solutions, Cypress, Texas

Status

Recruiting

Address

Pioneer Research Solutions

Cypress, Texas, 77429

Metroplex Clinical Research Center, Dallas, Texas

Status

Recruiting

Address

Metroplex Clinical Research Center

Dallas, Texas, 75231

El Paso, Texas

Status

Recruiting

Address

El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization

El Paso, Texas, 79912

Houston, Texas

Status

Recruiting

Address

DM Clinical Research/Rheumatology Clinic of Houston

Houston, Texas, 77065

Accurate Clinical Management, LLC., Houston, Texas

Status

Recruiting

Address

Accurate Clinical Management, LLC.

Houston, Texas, 77084

Biopharma Informatic, Inc., Houston, Texas

Status

Not yet recruiting

Address

Biopharma Informatic, Inc.

Houston, Texas, 77084

Accurate Clinical Research, Houston, Texas

Status

Recruiting

Address

Accurate Clinical Research

Houston, Texas, 77089

Biopharma Informatic, Inc., Houston, Texas

Status

Not yet recruiting

Address

Biopharma Informatic, Inc.

Houston, Texas, 77089

Accurate Clinical Research, League City, Texas

Status

Recruiting

Address

Accurate Clinical Research

League City, Texas, 77573

Southwest Rheumatology, P.A., Mesquite, Texas

Status

Recruiting

Address

Southwest Rheumatology, P.A.

Mesquite, Texas, 75150

Synergy Group US, Missouri City, Texas

Status

Recruiting

Address

Synergy Group US

Missouri City, Texas, 77459

Accurate Clinical Research, Inc., San Antonio, Texas

Status

Recruiting

Address

Accurate Clinical Research, Inc.

San Antonio, Texas, 78229

Accurate Clinical Management, Sugar Land, Texas

Status

Recruiting

Address

Accurate Clinical Management

Sugar Land, Texas, 77479

Mt. Olympus Medical Research, Sugar Land, Texas

Status

Recruiting

Address

Mt. Olympus Medical Research

Sugar Land, Texas, 77479

North Houston Rheumatology Associates, The Woodlands, Texas

Status

Recruiting

Address

North Houston Rheumatology Associates

The Woodlands, Texas, 77380

Tomball, Texas

Status

Recruiting

Address

Dynamed Clinical Research, LP d/b/a DM Clinical Research

Tomball, Texas, 77375

Chesapeake, Virginia

Status

Recruiting

Address

Center for Arthritis and Rheumatic Diseases, PC

Chesapeake, Virginia, 23320

Spectrum Medical Inc., Danville, Virginia

Status

Recruiting

Address

Spectrum Medical Inc.

Danville, Virginia, 24541

Manassas, Virginia

Status

Recruiting

Address

Arthritis & Osteoporosis Center of Northern Virinia

Manassas, Virginia, 20109

TPMG Rheumatology/TPMG Clinical Research, Newport News, Virginia

Status

Recruiting

Address

TPMG Rheumatology/TPMG Clinical Research

Newport News, Virginia, 23606

Arthritis Northwest, PLLC, Spokane, Washington

Status

Recruiting

Address

Arthritis Northwest, PLLC

Spokane, Washington, 99204

Rheumatology and Pulmonary Clinic, Beckley, West Virginia

Status

Recruiting

Address

Rheumatology and Pulmonary Clinic

Beckley, West Virginia, 25801

Rheumatic Disease Center, Glendale, Wisconsin

Status

Recruiting

Address

Rheumatic Disease Center

Glendale, Wisconsin, 53217