AzTrials
AzTrials

Rheumatoid ArthritisPhase 3RA-BEGINNCT01711359

A Study in Participants With Moderate to Severe Rheumatoid Arthritis

A Phase 3 study testing Baricitinib, Methotrexate and Folic Acid in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 154 sites in 19 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 therapy alone is noninferior to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other conventional or biologic disease-modifying… 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, Methotrexate and Folic Acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
588 participants
Where
154 sitesin 19 countries
Study dates
Nov 2012to Aug 2015
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 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
  • Have documented history of positive rheumatoid factor and/or cyclic citrullinated peptide (CCP) antibody test
  • 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 ≥1.2 times the upper limit of normal (ULN)
  • Have had limited or no treatment with methotrexate (MTX)

Who cannot join

  • Have received conventional disease-modifying antirheumatic drugs (DMARDs) other than MTX (eg, gold salts, cyclosporine, leflunomide, azathioprine, hydroxychloroquine, sulfasalazine or any other immunosuppressives)
  • Are currently receiving corticosteroids at doses >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
  • Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry
  • Have ever received any biologic DMARD
  • Have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study
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  • 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 a 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 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 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 <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
  • Have symptomatic herpes simplex at the time of study enrollment
  • Have evidence of active or latent tuberculosis (TB)

Trial locations and contacts

154 sites in 19 countries.

154 sites in 19 countries

United States47 sites

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Albuquerque, New Mexico, 87102

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    Boulder, Colorado, 80304

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    Boynton Beach, Florida, 33472

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    Chesapeake, Virginia, 23320

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    Clarksburg, West Virginia, 26301

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    Cumberland, Maryland, 21502

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    Dallas, Texas, 75231

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    Duncansville, Pennsylvania, 16635

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    El Cajon, California, 92020

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    Flowood, Mississippi, 39232

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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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    Grand Rapids, Michigan, 49546

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    Grapevine, Texas, 76051

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    Hartsdale, New York, 10530

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    Houston, Texas, 77084

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    Indianapolis, Indiana, 46260

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    Jackson, Tennessee, 38305

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    Kennewick, Washington, 99336

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    Lakewood, California, 90712

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    Lansing, Michigan, 48910

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    Lewes, Delaware, 19958

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    Lubbock, Texas, 79424

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    Mesa, Arizona, 85202

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    Middleburg Heights, Ohio, 44130

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    Naples, Florida, 34102

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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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    Palm Desert, California, 92260

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    Palm Harbor, Florida, 34684

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    Peoria, Arizona, 85381

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    Phoenix, Arizona, 85037

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    Plantation, Florida, 33324

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    Portland, Oregon, 97239

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    St Louis, Missouri, 63141

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    Tampa, Florida, 33614

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    Toms River, New Jersey, 08755

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    Trumbull, Connecticut, 06611

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    Tulsa, Oklahoma, 74135

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    Tustin, California, 92780

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    Upland, California, 91786

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    Vancouver, Washington, 98664

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    Venice, Florida, 34292

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    Vernon Hills, Illinois, 60061

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    Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan23 sites

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Aichi, 466-8560

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    Chiba, 284-0003

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    Fukuoka, 807-8556

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    Hiroshima, 733-0032

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    Hokkaido, 063-0811

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    Hyōgo, 665-0827

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    Ibaraki, 316-0015

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    Japan, 275-8580

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    Kagawa, 761-0793

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    Kagoshima, 899-5117

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    Kanagawa, 236-0004

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    Kumamoto, 861-1196

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    Mie, 510-0016

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    Nagano, 380-8582

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    Nagasaki, 857-1195

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    Niigata, 940-2085

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    Numakunai, 020-0015

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    Okayama, 700-8607

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    Okinawa, 901-0243

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    Saitama, 359-1111

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    Shizuoka, 430-8558

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    Tokyo, 160-8582

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    Toyama, 933-0874

Other trials in Japan

Argentina11 sites

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Buenos Aires, C1128AAF

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    Caba, C1440AAD

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Córdoba, 5000

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    La Plata, B1902COS

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    Mar del Plata, B7600FZN

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    Quilmes, 1878

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    Rosario, 2000

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    San Fernando, 1646

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    San Juan, 5400

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    San Miguel de Tucumán, 4000

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    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

India10 sites

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    Ahmedabad, 532004

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    Attavar, Mangalore, 575001

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    Bangalore, 560 054

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    Belagavi, 590 010

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    Hyderabaad, 500072

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    Jaipur, 302006

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    Kolkata, 700 020

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    Lucknow, 226 014

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    Mumbai, 400053

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    New Delhi, 110 076

Other trials in India

Canada8 sites

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    Edmonton, Alberta, T5M 0H4

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    Kitchener, Ontario, N2M 5N6

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    Ottawa, Ontario, K1H 1A2

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    Saint Catherines, Ontario, L2N 7E4

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    Saskatoon, Saskatchewan, S7K 0H6

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    Trois-Rivières, Quebec, G8Z 1Y2

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    Victoria, British Columbia, V8V 3P9

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    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Germany6 sites

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    Bad Nauheim, 61231

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    Bayreuth, 95444

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    Berlin, 13125

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    Gommern, 39245

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    Hamburg, 22081

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    Munich, 80336

Other trials in Germany

Italy6 sites

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    Florence, 50139

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    Genova, 16132

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    Milan, 20157

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    Monza, 20900

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    Torino, 10154

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    Valeggio sul Mincio, 37067

Other trials in Italy

Belgium5 sites

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    Brussels, 1200

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    Genk, 3600

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    Ghent, 9000

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    Liège, 4000

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    Mons, 7000

Other trials in Belgium

Puerto Rico5 sites

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    Caguas, 00725

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    Carolina, 00983

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    San German, 00683

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    San Juan, 00927

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    Santurce, 00909

Other trials in Puerto Rico

South Africa5 sites

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    Bloemfontein, 9301

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    Durban, 4092

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    Greenacres, 6057

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    Somerset West, 7135

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    Stellenbosch, 7600

Other trials in South Africa

United Kingdom5 sites

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    Basingstoke, Hampshire, RG24 9NA

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    Cambridge, Cambridgeshire, CB2 0QQ

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    London, Greater London, SE1 9RT

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    North Shields, Tyneside, NE29 8NH

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    Southampton, Hants, SO16 6YD

Other trials in United Kingdom

Greece4 sites

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    Ampelokipoi, 11527

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Heraklion, 71110

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    Kifissia, 14561

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    Larissa, 41221

Other trials in Greece

Russia4 sites

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    Moscow, 115522

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    Ryazan, 390026

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    Ulyanovsk, 432063

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    Yaroslavl, 150003

Other trials in Russia

Brazil3 sites

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    Curitiba, 80030-110

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    Goiânia, 74110-120

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    São Paulo, 04266-010

Other trials in Brazil

Mexico3 sites

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    Guadalajara, 44620

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    Monterrey, 64040

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    San Luis Potosí City, 78213

Other trials in Mexico

South Korea3 sites

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    Daejeon, 301-721

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    Incheon, 405-760

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    Seoul, 134-727

Other trials in South Korea

Sweden3 sites

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    Gothenburg, SE 413 45

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    Huddinge, 141 87

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    Malmö, SE-20502

Other trials in Sweden

Portugal2 sites

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    Lisbon, 1050

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    Porto, 4200-319

Other trials in Portugal

Austria1 site

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    Vienna, 1100

Other trials in Austria

About this study

Official title: A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs

The purpose of this study is to determine whether baricitinib therapy alone is noninferior to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs).

Being tested
Baricitinib, Methotrexate, Baricitinib Placebo, MTX Placebo, Folic Acid
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • BaricitinibDrug

    Also called LY3009104

    Administered orally

  • MethotrexateDrug

    Administered orally

  • Baricitinib PlaceboDrug

    Baricitinib placebo administered orally once daily.

  • MTX PlaceboDrug

    MTX placebo administered orally once weekly.

  • Folic AcidDrug

    Administered orally every day

Study groups in NCT01711359
Study groupRoleWhat they receive
Baricitinib + MTXExperimentalBaricitinib 4 milligram (mg) administered orally once daily through Week 52. Participants received methotrexate (MTX) orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Receives: Drug: Baricitinib; Drug: Methotrexate; Drug: Folic Acid
BaricitinibExperimentalBaricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Receives: Drug: Baricitinib; Drug: MTX Placebo; Drug: Folic Acid
MTXActive comparatorMTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Receives: Drug: Methotrexate; Drug: Baricitinib Placebo; Drug: Folic Acid

What is being measured

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

  1. Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)

    ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "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 discontinued study or drug or were rescued before analysis time point were deemed non-responders.

    Measured: Week 24

Secondary outcomes (21)

  1. Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)

    ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "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 discontinued study or drug or were rescued before analysis time point were deemed non-responders.

    Measured: Week 52

  2. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

    HAQ-DI 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 are averaged to calculate the HAQ-DI score, which ranges from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicates an improvement in the participant's condition.

    Measured: Baseline, Week 24

  3. Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)

    Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the 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. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.

    Measured: Baseline, Week 24

  4. Change From Baseline in the Modified Total Sharp Score (mTSS)

    X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS (van der Heijde 2000). This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.

    The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448.

    Measured: Baseline, Week 24

  5. Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3

    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 VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.

    Measured: Week 24

  6. Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

    ACR50 Responder Index is 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 discontinued study or drug or were rescued before analysis time point were deemed non-responders.

    Measured: Week 12, Week 24, Week 52

  7. Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

    ACR70 Responder Index is 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 discontinued study or drug or were rescued before analysis timepoint were deemed non-responders.

    Measured: Week 12, Week 24, Week 52

  8. Change From Baseline in Clinical Disease Activity Index (CDAI) 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; Baseline, Week 52

  9. Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)

    DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the 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. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.

    Measured: Baseline, Week 24; Baseline, Week 52

  10. Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission

    The ACR/EULAR definitions of RA remission include 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 12, Week 24, Week 52

  11. Change From Baseline in Joint Space Narrowing and Bone Erosion Scores

    X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).

    Measured: Baseline, Week 24; Baseline, Week 52

  12. Change From Baseline in Duration of 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 the day of the study visit. 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 52

  13. Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)

    Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine".

    Measured: Baseline, Week 24; Baseline Week 52

  14. Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)

    Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine".

    Measured: Baseline, Week 24; Baseline Week 52

  15. Change From Baseline in Mental Component Score (MCS) and 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 (MCS and 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 or functioning.

    Measured: Baseline, Week 24; Baseline Week 52

  16. Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores

    European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of 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.

    Measured: Baseline, Week 24; Baseline Week 52

  17. Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)

    A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.

    Measured: Baseline, Week 24; Baseline Week 52

  18. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores

    The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-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 24; Baseline Week 52

  19. Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores

    The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) 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. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.

    Measured: Baseline, Week 24; Baseline Week 52

  20. Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib

    Measured: Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose

  21. Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib

    Measured: Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose

Timeline

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

  1. First posted22 Oct 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionFeb 2015
  4. Study completionAug 2015

Resources

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
588 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01711359
Sponsor's protocol ID
14062
Other IDs
I4V-MC-JADZ
Acronym
RA-BEGIN
Status last verified
Sep 2019
First submitted
18 Oct 2012
Last updated
19 Sep 2019
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

  • Landewe R, Sun L, Chen YF, Daojun M, van der Heijde D. Robust analyses for radiographic progression in rheumatoid arthritis. RMD Open. 2023 Apr;9(2):e002543. doi: 10.1136/rmdopen-2022-002543.

    PubMed 37015757

  • Taylor PC, Alten R, Alvaro Gracia JM, Kaneko Y, Walls C, Quebe A, Jia B, Bello N, Terres JR, Fleischmann R. Achieving pain control in early rheumatoid arthritis with baricitinib monotherapy or in combination with methotrexate versus methotrexate monotherapy. RMD Open. 2022 Mar;8(1):e001994. doi: 10.1136/rmdopen-2021-001994.

    PubMed 35264432

  • 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

  • van der Heijde D, Kartman CE, Xie L, Beattie S, Schlichting D, Mo D, Durez P, Tanaka Y, Fleischmann R. Radiographic Progression of Structural Joint Damage Over 5 Years of Baricitinib Treatment in Patients With Rheumatoid Arthritis: Results From RA-BEYOND. J Rheumatol. 2022 Feb;49(2):133-141. doi: 10.3899/jrheum.210346. Epub 2021 Sep 15.

    PubMed 34526397

  • 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

  • Fleischmann R, Takeuchi T, Schiff M, Schlichting D, Xie L, Issa M, Stoykov I, Lisse J, Martinez-Osuna P, Rooney T, Zerbini CAF. Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate. Arthritis Care Res (Hoboken). 2020 Aug;72(8):1112-1121. doi: 10.1002/acr.24007.

    PubMed 31233281

  • 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

  • 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

  • Schiff M, Takeuchi T, Fleischmann R, Gaich CL, DeLozier AM, Schlichting D, Kuo WL, Won JE, Carmack T, Rooney T, Durez P, Shaikh S, Hidalgo RP, van Vollenhoven R, Zerbini CAF. Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Res Ther. 2017 Sep 18;19(1):208. doi: 10.1186/s13075-017-1410-1.

    PubMed 28923098

  • Fleischmann R, Schiff M, van der Heijde D, Ramos-Remus C, Spindler A, Stanislav M, Zerbini CA, Gurbuz S, Dickson C, de Bono S, Schlichting D, Beattie S, Kuo WL, Rooney T, Macias W, Takeuchi T. Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment. Arthritis Rheumatol. 2017 Mar;69(3):506-517. doi: 10.1002/art.39953.

    PubMed 27723271

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baricitinib, Methotrexate and Folic Acid in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 154 sites in 19 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 5 inclusion and 28 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 19 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 154 sites in United States, Japan, Argentina, India, Canada and 14 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. 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 15 Aug 2017). 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% Improvement (ACR20) (time frame: Week 24). 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 NCT01711359, which also lists 10 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 19 Sep 2019.

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