Rheumatoid ArthritisPhase 3RA-BEACONNCT01721044

A Moderate to Severe Rheumatoid Arthritis Study

A Phase 3 study testing Baricitinib and cDMARD in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 103 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, despite ongoing treatment with… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Baricitinib and cDMARD
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 527 participants
Where: 103 sitesin 22 countries
Study dates: Jan 2013to Sep 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 ≥ (greater than or equal to) 1 times the upper limit of normal (ULN)
Have been treated at approved doses with at least 1 biologic tumor necrosis factor (TNF)- alpha inhibitor for at least 3 months and either:
experienced insufficient efficacy or loss of efficacy
experienced intolerance of such treatment
Have had regular use of at least 1 conventional disease-modifying antirheumatic drugs (cDMARD) for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry

Who cannot join

Have received a biologic treatment for RA within 28 days of planned randomization; have received rituximab within 6 months of planned randomization
Are currently receiving corticosteroids at doses > (greater than) 10 mg per day of prednisone (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 methotrexate (MTX), hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs
Have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) 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

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Have active fibromyalgia that, in the investigator's opinion, 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 Sjogren's syndrome are not excluded.)
Have a diagnosis of Felty's syndrome
Have had any major surgery within 8 weeks of 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 have 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 an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of < (less than) 40 milliliter per minute per 1.73 m^2 (mL/min/1.73 m^2)
Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN
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, 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)
Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the participant's participation in the study
Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the participant's participation in the study (e.g. Fridericia's corrected QT interval >500 millisecond [msec])
Have symptomatic herpes simplex at the time of study enrollment
Have evidence of active or latent tuberculosis (TB)

Trial locations and contacts

103 sites in 22 countries.

Country

City, postcode or hospital

103 sites in 22 countries

United States32 sites

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Albany, New York, 12206
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Bethlehem, Pennsylvania, 18017
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Boise, Idaho, 83702
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Boynton Beach, Florida, 33472
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Chesapeake, Virginia, 23320
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Danbury, Connecticut, 06810
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Franklin, Wisconsin, 53132
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Freehold, New Jersey, 07728
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Glendale, Arizona, 85304
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Hartsdale, New York, 10530
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Indianapolis, Indiana, 46260
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Kennewick, Washington, 99336
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Lansing, Michigan, 48910
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Lewes, Delaware, 19958
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Myrtle Beach, South Carolina, 29572
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Nassau Bay, Texas, 77058
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Oklahoma City, Oklahoma, 73103
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Orlando, Florida, 32806
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Palo Alto, California, 94304
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Philadelphia, Pennsylvania, 19152
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Phoenix, Arizona, 85023
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Rochester, New York, 14618
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St Louis, Missouri, 63117
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Tamarac, Florida, 33321
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Tampa, Florida, 33613
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Trumbull, Connecticut, 06611
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Tucson, Arizona, 85724
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Tulsa, Oklahoma, 74135
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Upland, California, 91786
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Vancouver, Washington, 98664
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Webster, Texas, 77508
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Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan11 sites

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Chiba, 284-0003
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Fukuoka, 810-8563
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Hiroshima, 730-0017
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Hokkaido, 060-8648
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Japan, 275-8580
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Kagawa, 761-0793
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Kumamoto, 861-1196
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Nagasaki, 856-8562
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Okayama, 700-8607
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Saitama, 359-1111
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Tokyo, 104-8560

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Israel7 sites

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Ashkelon, 78278
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Beer Yaakov, 70300
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Haifa, 34362
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Jerusalem, 91120
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Kfar Saba, 44281
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Petah Tikva, 49100
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Tel Aviv, 64239

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France5 sites

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Montpellier, 34295
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Orléans, 45032
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Paris, 75679
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Rennes, 35056
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Tours, 3700

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Germany4 sites

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Dresden, 01067
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Hamburg, 22081
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Heidelberg, 69120
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Würzburg, 97080

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Greece4 sites

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Athens, 11527
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Heraklion, 71110
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Kifissia, 14561
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Larissa, 411 10

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Mexico4 sites

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Guadalajara, 44650
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Mexico City, 06090
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Monterrey, 64040
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San Luis Potosí City, 78213

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Spain4 sites

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Santander, 39008
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Seville, 41010
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Valencia, 46026
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Villajoyosa, 03570

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Argentina3 sites

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Buenos Aires, C1015ABO
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Rosario, 2000
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San Miguel de Tucumán, T4000AXL

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Australia3 sites

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Fitzroy, Victoria, 3065
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Kogarah, New South Wales, 04266-010
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Maroochydore, Queensland, 4558

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Denmark3 sites

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Frederiksberg, 2000
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Glostrup Municipality, 2600
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Odense, 5000

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Italy3 sites

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Florence, 50134
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Pisa, 56100
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Rome, 00100

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Poland3 sites

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Gdansk, 80-546
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Nadarzyn, 05-830
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Warsaw, 02-507

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Puerto Rico3 sites

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Caguas, 00725
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San Juan, 00927
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Santurce, 00909

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Switzerland3 sites

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Fribourg, 1708
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Lausanne, CH-1011
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Zurich, 8091

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Austria2 sites

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Graz, 8036
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Vienna, 1100

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Belgium2 sites

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Brussels, 1000
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Mons, 7000

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Turkey (Türkiye)2 sites

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Edirne, 22030
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Gaziantep, 27310

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United Kingdom2 sites

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Bradford, West Yorkshire, BD5 0NA
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North Shields, Tyneside, NE29 8NH

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Canada1 site

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Toronto, Ontario, M5T 3L9

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Netherlands1 site

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Ubbergen, 6574 NA

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South Korea1 site

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Seoul, 110-744

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About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors

Conditions: Rheumatoid Arthritis
Being tested: Placebo, Baricitinib, cDMARD
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Administered orally
BaricitinibDrug
Also called LY 3009104, INCB 028050
Administered orally
cDMARDDrug
Participants will continue to take background cDMARD therapy throughout study.

Study groups in NCT01721044
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 milligram (mg) orally once daily through Week 24. Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study. Receives: Drug: Placebo; Drug: cDMARD
Baricitinib 2 mg	Experimental	Baricitinib 2 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. Receives: Drug: Baricitinib; Drug: cDMARD
Baricitinib 4 mg	Experimental	Baricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. Receives: Drug: Baricitinib; Drug: cDMARD

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
Measured: Week 12

Secondary outcomes (23)

Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Measured: Baseline, Week 12
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg
DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Measured: Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg
The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.
Measured: Week 12
Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Measured: Week 12
Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score. Total scores ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Measured: Baseline, Week 12
Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg
DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Measured: Baseline, Week 12
Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg
The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.
Measured: Week 12
Percentage of Participants Achieving ACR20 Response
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Measured: Week 24
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Measured: Week 12 and Week 24
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Measured: Week 12 and Week 24
Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Measured: Baseline, Week 12
Change From Baseline in Clinical Disease Activity Index Score
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Measured: Baseline, Week 24
Change From Baseline in Measures of SDAI Score
The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.
Measured: Baseline, Week 24
Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission
The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.
Measured: Week 24
Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Measured: Baseline, Week 24
Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine). Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours. Total scores ranged from 0-10.
Measured: Baseline, Week 24
Change From Baseline in Worst Joint Pain NRS
Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine). Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours. Total scores ranged from 0-10.
Measured: Baseline, Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.
Measured: Baseline, Week 12, Week 24
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status.
Measured: Baseline, Week 12, Week 24
Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Measured: Baseline, Week 12, Week 24
Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
The WPAI-RA participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)*100, Percentage impairment while working presenteeism: Q5/10*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]*100; Percentage activity impairment activity impairment: Q6/10*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.
Measured: Baseline, Week 12, Week 24
Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib
Measured: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.
Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib
Measured: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Sep 2014

First posted2 Nov 2012 (estimated)
Study startJan 2013
Primary completionJun 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 527 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01721044
Sponsor's protocol ID: 14058
Other IDs: I4V-MC-JADW
Acronym: RA-BEACON
Status last verified: Sep 2019
First submitted: 1 Nov 2012
Last updated: 18 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.
PubMed 34706874
Wells AF, Jia B, Xie L, Valenzuela GJ, Keystone EC, Li Z, Quebe AK, Griffing K, Otawa S, Haraoui B. Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study. Rheumatol Ther. 2021 Jun;8(2):987-1001. doi: 10.1007/s40744-021-00317-9. Epub 2021 May 24.
PubMed 34028703
Emery P, Tanaka Y, Cardillo T, Schlichting D, Rooney T, Beattie S, Helt C, Smolen JS. Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 May 15;22(1):115. doi: 10.1186/s13075-020-02199-8.
PubMed 32414425
Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15.
PubMed 30219772
Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.
PubMed 30058112
Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
PubMed 29463520
Genovese MC, Kremer JM, Kartman CE, Schlichting DE, Xie L, Carmack T, Pantojas C, Sanchez Burson J, Tony HP, Macias WL, Rooney TP, Smolen JS. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis. Rheumatology (Oxford). 2018 May 1;57(5):900-908. doi: 10.1093/rheumatology/kex489.
PubMed 29415145
Smolen JS, Kremer JM, Gaich CL, DeLozier AM, Schlichting DE, Xie L, Stoykov I, Rooney T, Bird P, Sanchez Burson JM, Genovese MC, Combe B. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). Ann Rheum Dis. 2017 Apr;76(4):694-700. doi: 10.1136/annrheumdis-2016-209821. Epub 2016 Oct 31.
PubMed 27799159
Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, Beattie SD, Koch AE, Cardillo TE, Rooney TP, Macias WL, de Bono S, Schlichting DE, Smolen JS. Baricitinib in Patients with Refractory Rheumatoid Arthritis. N Engl J Med. 2016 Mar 31;374(13):1243-52. doi: 10.1056/NEJMoa1507247.
PubMed 27028914

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Questions to ask the study team

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors
ClinicalTrials.gov ID: NCT01721044
Acronym / sponsor ID: RA-BEACON / 14058
Conditions: Rheumatoid Arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 527 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Jun 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 2 Nov 2012 (estimated)
Results: Posted 18 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo, Drug: cDMARDPlacebo administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 milligram (mg) orally once daily through Week 24. Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
Baricitinib 2 mg	Experimental	Drug: Baricitinib, Drug: cDMARDBaricitinib 2 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Baricitinib 4 mg	Experimental	Drug: Baricitinib, Drug: cDMARDBaricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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 ≥ (greater than or equal to) 1 times the upper limit of normal (ULN)
Have been treated at approved doses with at least 1 biologic tumor necrosis factor (TNF)- alpha inhibitor for at least 3 months and either:
Have had regular use of at least 1 conventional disease-modifying antirheumatic drugs (cDMARD) for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry

Key exclusion criteria (26 listed)

Have received a biologic treatment for RA within 28 days of planned randomization; have received rituximab within 6 months of planned randomization
Are currently receiving corticosteroids at doses > (greater than) 10 mg per day of prednisone (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 methotrexate (MTX), hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs
Have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) 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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboAdministered orally	Drug	Placebo
BaricitinibAlso: LY 3009104, INCB 028050Administered orally	Drug	Baricitinib 2 mg, Baricitinib 4 mg
cDMARDParticipants will continue to take background cDMARD therapy throughout study.	Drug	Baricitinib 2 mg, Baricitinib 4 mg, Placebo

Primary outcome

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg
Time frame: Week 12
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.

23 secondary outcomes

Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg
Time frame: Baseline, Week 12
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg
Time frame: Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg
Time frame: Week 12
Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg
Time frame: Week 12
Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg
Time frame: Baseline, Week 12
Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg
Time frame: Baseline, Week 12
Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg
Time frame: Week 12
Percentage of Participants Achieving ACR20 Response
Time frame: Week 24
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Time frame: Week 12 and Week 24
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Time frame: Week 12 and Week 24
Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline, Week 12
Change From Baseline in Clinical Disease Activity Index Score
Time frame: Baseline, Week 24
Change From Baseline in Measures of SDAI Score
Time frame: Baseline, Week 24
Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission
Time frame: Week 24
Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness
Time frame: Baseline, Week 24
Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
Time frame: Baseline, Week 24
Change From Baseline in Worst Joint Pain NRS
Time frame: Baseline, Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
Time frame: Baseline, Week 12, Week 24
Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores
Time frame: Baseline, Week 12, Week 24
Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Time frame: Baseline, Week 12, Week 24
Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib
Time frame: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.
Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib
Time frame: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.

Results and safety

Results posted to the registry on 18 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	176	144
Baricitinib 2 mg	174	157
Baricitinib 4 mg	177	158

Primary outcome: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg

Time frame: Week 12. Number. Unit: Percentage of Participants

Measure	Placebo n = 176	Baricitinib 4 mg n = 177
Value	27.3	55.4

Placebo vs Baricitinib 4 mg: p = 0.001, Regression, Logistic

Population analysed: Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).

23 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo -Treatment Period	14 of 176 (8%)	79 of 176 (44.9%)	Not reported
Baricitinib 2 mg - Treatment Period	8 of 174 (4.6%)	105 of 174 (60.3%)	Not reported
Baricitinib 4 mg - Treatment Period	19 of 177 (10.7%)	102 of 177 (57.6%)	Not reported
Rescue Period	2 of 127 (1.6%)	6 of 127 (4.7%)	Not reported
Placebo - Follow Up Period	1 of 19 (5.3%)	2 of 19 (10.5%)	Not reported
Baricitinib 2 mg - Follow Up Period	1 of 9 (11.1%)	4 of 9 (44.4%)	Not reported
Baricitinib 4 mg - Follow Up Period	0 of 20 (0%)	1 of 20 (5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34706874Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.
Derived from this study: PubMed 34028703Wells AF, Jia B, Xie L, Valenzuela GJ, Keystone EC, Li Z, Quebe AK, Griffing K, Otawa S, Haraoui B. Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study. Rheumatol Ther. 2021 Jun;8(2):987-1001. doi: 10.1007/s40744-021-00317-9. Epub 2021 May 24.
Derived from this study: PubMed 32414425Emery P, Tanaka Y, Cardillo T, Schlichting D, Rooney T, Beattie S, Helt C, Smolen JS. Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 May 15;22(1):115. doi: 10.1186/s13075-020-02199-8.
Derived from this study: PubMed 30219772Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15.
Derived from this study: PubMed 30058112Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.
Derived from this study: PubMed 29463520Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
Derived from this study: PubMed 29415145Genovese MC, Kremer JM, Kartman CE, Schlichting DE, Xie L, Carmack T, Pantojas C, Sanchez Burson J, Tony HP, Macias WL, Rooney TP, Smolen JS. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis. Rheumatology (Oxford). 2018 May 1;57(5):900-908. doi: 10.1093/rheumatology/kex489.
Derived from this study: PubMed 27799159Smolen JS, Kremer JM, Gaich CL, DeLozier AM, Schlichting DE, Xie L, Stoykov I, Rooney T, Bird P, Sanchez Burson JM, Genovese MC, Combe B. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). Ann Rheum Dis. 2017 Apr;76(4):694-700. doi: 10.1136/annrheumdis-2016-209821. Epub 2016 Oct 31.
Derived from this study: PubMed 27028914Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, Beattie SD, Koch AE, Cardillo TE, Rooney TP, Macias WL, de Bono S, Schlichting DE, Smolen JS. Baricitinib in Patients with Refractory Rheumatoid Arthritis. N Engl J Med. 2016 Mar 31;374(13):1243-52. doi: 10.1056/NEJMoa1507247.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

103 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baricitinib and cDMARD in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 103 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Japan, Israel, France, Germany and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01721044, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.