NCT04086745CompletedPhase 4
A Study of Baricitinib in Participants With Rheumatoid Arthritis
A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1050 (actual)
- First submitted
- 10 Sept 2019
- Start date
- 14 Feb 2020
- Primary completion date
- 19 May 2025
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04086745
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 1050
- From 14 Feb 2020 to the primary completion date, 19 May 2025
- 119 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 lack or loss of efficacy for RA, or
- discontinued for intolerance (AE) when used for any indication
- Participants must not have had a live vaccine within four weeks of study start
Other illness
- 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 a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year
Other
- Participants must not be pregnant or breastfeeding
- Participants must not have had more than one VTE
- Participants must not have participated in any other clinical trial within four weeks of study start
Who the study is looking for
- 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 drug (DMARD) (synthetic or biologic)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (119)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Accent Clinical Research Professionals, LLC Coordinator of this site? Confirm its status | Allen | United States | Unknown status |
| Amarillo Center For Clinical Research Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Arthritis & Rheumatology of Georgia Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Rheumatology & Pulmonary Clinic Coordinator of this site? Confirm its status | Beckley | United States | Unknown status |
| St Luke's Clinic - Intermountain Orthopaedics Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Graves Gilbert Clinic Coordinator of this site? Confirm its status | Bowling Green | United States | Unknown status |
| Providence St. Joseph's Medical Center Coordinator of this site? Confirm its status | Burbank | United States | Unknown status |
| Hope Clinical Research, Inc. Coordinator of this site? Confirm its status | Canoga Park | United States | Unknown status |
| Arizona Research Clinic PLLC Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Center for Arthritis and Rheumatic Diseases, PC Coordinator of this site? Confirm its status | Chesapeake | United States | Unknown status |
| Cincinnati Arthritis Associates Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Arthritis & Osteoporosis Clinic of Brazos Valley Coordinator of this site? Confirm its status | College Station | United States | Unknown status |
| Good Samaritan Hospital Corvallis Coordinator of this site? Confirm its status | Corvallis | United States | Unknown status |
| Medvin Clinical Research - Covina Coordinator of this site? Confirm its status | Covina | United States | Unknown status |
| Advanced Rheumatology and Arthritis Research Center, PC Coordinator of this site? Confirm its status | Cranberry Township | United States | Unknown status |
| Cumberland Rheumatology Coordinator of this site? Confirm its status | Crossville | United States | Unknown status |
| Klein and Associates MD, PA Coordinator of this site? Confirm its status | Cumberland | United States | Unknown status |
| Metroplex Clinical Research Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Danbury Clinical Research, LLC Coordinator of this site? Confirm its status | Danbury | United States | Unknown status |
| Spectrum Medical, Inc. Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Omega Research Debary, LLC Coordinator of this site? Confirm its status | DeBary | United States | Unknown status |
| Altoona Center For Clinical Research Coordinator of this site? Confirm its status | Duncansville | United States | Unknown status |
| TriWest Research Associates LLC Coordinator of this site? Confirm its status | El Cajon | United States | Unknown status |
| El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| NECCR PrimaCare Research Coordinator of this site? Confirm its status | Fall River | United States | Unknown status |
| Cria Center for Rheumatology Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Arthritis Center of North Georgia Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| SIMED Health Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Michigan Rheumatology Group Coordinator of this site? Confirm its status | Grand Blanc | United States | Unknown status |
| Medication Management Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Lovelace Scientific Resources Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| PMG Research of Hickory, LLC Coordinator of this site? Confirm its status | Hickory | United States | Unknown status |
| Hinsdale Orthopaedics, Illinois Bone and Joint Coordinator of this site? Confirm its status | Hinsdale | United States | Unknown status |
| GNP Research at Mark Jaffe, MD Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Western KY Rheumatology PLLC Coordinator of this site? Confirm its status | Hopkinsville | United States | Unknown status |
| Pioneer Research Solutions Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Accurate Clinical Management - Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Biopharma Informatic, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| UDL Clinical Research, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Newport Huntington Med Grp Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| West Tennessee Research Institute Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Jefferson City Medical Group Coordinator of this site? Confirm its status | Jefferson City | United States | Unknown status |
| Arthritis and Rheumatism Associates Coordinator of this site? Confirm its status | Jonesboro | United States | Unknown status |
| Synergy Group US Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| Houston Rheumatology & Arthritis Specialists Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| R and H Clinical Research Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| Accurate Clinical Research Coordinator of this site? Confirm its status | Lake Charles | United States | Unknown status |
| Rheumatology Center Of Palm Beach, Pllc Coordinator of this site? Confirm its status | Lake Worth | United States | Unknown status |
| Biosolutions Clinical Research Center Coordinator of this site? Confirm its status | La Mesa | United States | Unknown status |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| Cape Fear Arthritis Care Coordinator of this site? Confirm its status | Leland | United States | Unknown status |
| Delaware Arthritis Coordinator of this site? Confirm its status | Lewes | United States | Unknown status |
| Valerius Medical Group and Research Center of Greater Long Beach Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| Arthritis & Osteoporosis Center of Northern Virinia Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| Prime Clinical Research Coordinator of this site? Confirm its status | Mansfield | United States | Unknown status |
| Arthritis and Rheumatology Center of South Florida Coordinator of this site? Confirm its status | Margate | United States | Unknown status |
| Craig S Thompson MD LLC Coordinator of this site? Confirm its status | Marion | United States | Unknown status |
| Arizona Arthritis & Rheumatology Associates, P. C. Coordinator of this site? Confirm its status | Mesa | United States | Unknown status |
| Southwest Rheumatology, P.A. Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| Felicidad Medical Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Miami Clinical Reserach Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Paramount Medical Research Coordinator of this site? Confirm its status | Middleburg Heights | United States | Unknown status |
| Rheumatic Disease Center Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Arthritis And Diabetes Clinic, Inc. Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center Coordinator of this site? Confirm its status | Monterey Park | United States | Unknown status |
| Nashville Arthritis and Rheumatology Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Ochsner Clinic Foundation Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| TPMG Rheumatology/TPMG Clinical Research Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| NYU Langone Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Articularis Healthcare d/b/a/ Low Country Rheumatology, PA Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| Pandit Rheumatology PC Coordinator of this site? Confirm its status | Okemos | United States | Unknown status |
| Arthritis & Rheumatology Center of Oklahoma PLLC Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Heuer MD Research Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Rheumatology Associates of Central Florida Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| UCF Health Lake Nona Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Arizona Arthritis & Rheumatology Research Coordinator of this site? Confirm its status | Paradise Valley | United States | Unknown status |
| Advanced Clinical Research Center of Houston Coordinator of this site? Confirm its status | Pearland | United States | Unknown status |
| Sun Valley Arthritis Center Ltd Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Arizona Arthritis & Rheumatology Associates Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Clinrx Research Joseph INC. Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| IRIS Research and Development LLC Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Violeta T. Baddour, MD Coordinator of this site? Confirm its status | Pleasanton | United States | Unknown status |
| ACRC Studies Coordinator of this site? Confirm its status | Poway | United States | Unknown status |
| Desert Medical Advances Coordinator of this site? Confirm its status | Rancho Mirage | United States | Unknown status |
| Monument Health Rapid City Hospital Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
| Allied Clinical Research Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| OrthoIllinois Coordinator of this site? Confirm its status | Rockford | United States | Unknown status |
| Rockford Orthopedic Associates Coordinator of this site? Confirm its status | Rockford | United States | Unknown status |
| Accurate Clinical Research, Inc. Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Purushotham & Akther Kotha MD Inc Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| East Bay Rheumatology Medical Group, Inc Coordinator of this site? Confirm its status | San Leandro | United States | Unknown status |
| Providence Medical Foundation Coordinator of this site? Confirm its status | Santa Rosa | United States | Unknown status |
| Greater Chicago Specialty Physicians, LLC Coordinator of this site? Confirm its status | Schaumburg | United States | Unknown status |
| Center of Robert Hozman Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| Arthritis Care Medical Center Coordinator of this site? Confirm its status | Somerset | United States | Unknown status |
| Beacon Medical Group Clinical Research Coordinator of this site? Confirm its status | South Bend | United States | Unknown status |
| Arthritis Northwest, PLLC Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Clinvest Research, LLC Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| West County Rheumatology Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| BayCare Health System Inc Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Mt. Olympus Medical Research Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Fort Bend Clinical Research, LLC Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Accurate Clinical Management Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| West Broward Rheumatology Associates Coordinator of this site? Confirm its status | Tamarac | United States | Unknown status |
| Tampa Medical Group, P.A. Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Avita Clinical Research Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Baylor Scott & White Health Coordinator of this site? Confirm its status | Temple | United States | Unknown status |
| North Houston Rheumatology Associates Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Dynamed Clinical Research, LP d/b/a DM Clinical Research Coordinator of this site? Confirm its status | Tomball | United States | Unknown status |
| Atlantic Coastal Research Coordinator of this site? Confirm its status | Toms River | United States | Unknown status |
| Dan La, MD Inc Coordinator of this site? Confirm its status | Tujunga | United States | Unknown status |
| Office: Dr Robin K Dore Coordinator of this site? Confirm its status | Tustin | United States | Unknown status |
| Inland Rheumatology & Osteoporosis Medical Group Coordinator of this site? Confirm its status | Upland | United States | Unknown status |
| Nazanin Firooz, MD Inc. Coordinator of this site? Confirm its status | West Hills | United States | Unknown status |
| Sahni Rheumatology & Therapy PC Coordinator of this site? Confirm its status | West Long Branch | United States | Unknown status |
| Medvin Clinical Research - Whittier Coordinator of this site? Confirm its status | Whittier | United States | Unknown status |
| Carolina Arthritis Associates Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Pennsylvania Regional Center for Arthritis and Osteoporosis Research Coordinator of this site? Confirm its status | Wyomissing | United States | Unknown status |
| Florida Medical Clinic, LLC Coordinator of this site? Confirm its status | Zephyrhills | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.