A Study in Moderate to Severe Rheumatoid Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.

Key facts

Study ID: NCT01710358
Run by: Eli Lilly and Company
People needed: 1307
Starts: 2012-10-01
Expected to finish: 2015-09-01
Last updated by the study team: 2019-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥6 milligram per Liter (mg/L)
Have had regular use of methotrexate (MTX) for at least the 12 weeks prior to study entry at a dose that is considered acceptable to adequately assess clinical response.
Have at least 1 joint erosion in hand, wrist, or foot joints based on radiographic interpretation by the central reader and be rheumatoid factor or anticyclic citrullinated peptide (anti-CCP) antibody positive; or have at least 3 joint erosions in hand, wrist, or foot joints based on radiographic interpretation by the central reader regardless of rheumatoid factor or anti-CCP antibody status

You may not qualify if…

Are currently receiving corticosteroids at doses >10 mg of prednisone per day (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine or combination of any 3 conventional disease-modifying antirheumatic drugs (cDMARDs)
Are currently receiving or have received cDMARDs (eg, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 4 weeks prior to study entry
Have received leflunomide in the 12 weeks prior to study entry
Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry
Have ever received any biologic disease-modifying antirheumatic drugs (DMARD)
Have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study
Have received any parenteral corticosteroid administered by intramuscular or intravenous injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization
Have any condition or contraindication for adalimumab that would preclude the participant from participating in this protocol
Have active fibromyalgia that would make it difficult to appropriately assess RA activity for the purposes of this study
Have a diagnosis of any systemic inflammatory condition other than RA such as, but not limited to, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout(participants with secondary Sjögren's syndrome are not excluded)
Have a diagnosis of Felty's syndrome
Have had any major surgery within 8 weeks prior to study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant
Have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data
Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden or confined to a wheelchair
have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years
Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination)
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection
Have had symptomatic herpes zoster infection within 12 weeks prior to study entry
Have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, or postherpetic neuralgia)
Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)

Where it is running

Sun Valley Arthritis Center, LTD — Peoria, Arizona, United States
Valley Arthritis Care, LLC — Phoenix, Arizona, United States
University of Boards Regent — Tucson, Arizona, United States
Valley Endocrine, Fresno — Fresno, California, United States
Desert Medical Advances — Palm Desert, California, United States
Pacific Arthritis Center — Santa Maria, California, United States
Inlande Rheumatology Clinical Trials — Upland, California, United States
Boulder Medical Center — Boulder, Colorado, United States
Clinical Research Center of CT/NY — Danbury, Connecticut, United States
New England Research Associates — Trumbull, Connecticut, United States
Delaware Arthritis — Lewes, Delaware, United States
Orthopedic Research Institute — Boynton Beach, Florida, United States
Jeffrey Alper, M.D. — Naples, Florida, United States
Sun Coast Clinical Research, Inc — New Port Richey, Florida, United States
Rheumatology Associates of Central Florida — Orlando, Florida, United States
Integral Rheumatology & Immunology Specialists — Plantation, Florida, United States
McIlwain Medical Group — Tampa, Florida, United States
Indiana University Health — Indianapolis, Indiana, United States
Diagnostic Rheumatology and Research — Indianapolis, Indiana, United States
Goldpoint Clinical Research LLC — Indianapolis, Indiana, United States
West Michigan Rheumatology — Grand Rapids, Michigan, United States
University of Missouri — Columbia, Missouri, United States
Dr. George Timothy Kelly — Las Vegas, Nevada, United States
(AOA) Arthritis & Osteoporosis Associates — Freehold, New Jersey, United States
Arizona Arthritis & Rheumatology Research — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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