NCT01721044

Brief 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 conventional disease-modifying antirheumatic drugs (cDMARDs).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
527

participants targeted

Target at P50-P75 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
21 countries

101 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

January 18, 2018

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

November 1, 2012

Results QC Date

March 10, 2017

Last Update Submit

September 9, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Week 12

Secondary Outcomes (23)

  • Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg

    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

    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

    Week 12

  • Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg

    Week 12

  • Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg

    Baseline, Week 12

  • +18 more secondary outcomes

Study Arms (3)

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.

Drug: PlaceboDrug: 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.

Drug: BaricitinibDrug: 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.

Drug: BaricitinibDrug: cDMARD

Interventions

PlaceboDRUG

Administered orally

Placebo
BaricitinibDRUG

Administered orally

Also known as: LY 3009104, INCB 028050
Baricitinib 2 mgBaricitinib 4 mg
cDMARDDRUG

Participants will continue to take background cDMARD therapy throughout study.

Baricitinib 2 mgBaricitinib 4 mgPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
  • Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
  • Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥ (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

You may not qualify if:

  • 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
  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (103)

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Glendale, Arizona, 85304, United States

Location

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Phoenix, Arizona, 85023, United States

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Tucson, Arizona, 85724, United States

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Palo Alto, California, 94304, United States

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Upland, California, 91786, United States

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Danbury, Connecticut, 06810, United States

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Trumbull, Connecticut, 06611, United States

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Lewes, Delaware, 19958, United States

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Boynton Beach, Florida, 33472, United States

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Orlando, Florida, 32806, United States

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Tamarac, Florida, 33321, United States

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Tampa, Florida, 33613, United States

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Boise, Idaho, 83702, United States

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Indianapolis, Indiana, 46260, United States

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Lansing, Michigan, 48910, United States

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St Louis, Missouri, 63117, United States

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Freehold, New Jersey, 07728, United States

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Albany, New York, 12206, United States

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Hartsdale, New York, 10530, United States

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Rochester, New York, 14618, United States

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Oklahoma City, Oklahoma, 73103, United States

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Tulsa, Oklahoma, 74135, United States

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Bethlehem, Pennsylvania, 18017, United States

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Philadelphia, Pennsylvania, 19152, United States

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Wyomissing, Pennsylvania, 19610, United States

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Myrtle Beach, South Carolina, 29572, United States

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Nassau Bay, Texas, 77058, United States

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Webster, Texas, 77508, United States

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Chesapeake, Virginia, 23320, United States

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Kennewick, Washington, 99336, United States

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Vancouver, Washington, 98664, United States

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Franklin, Wisconsin, 53132, United States

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Buenos Aires, C1015ABO, Argentina

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Rosario, 2000, Argentina

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San Miguel de Tucumán, T4000AXL, Argentina

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Kogarah, New South Wales, 04266-010, Australia

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Maroochydore, Queensland, 4558, Australia

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Fitzroy, Victoria, 3065, Australia

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Graz, 8036, Austria

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Vienna, 1100, Austria

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Brussels, 1000, Belgium

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Mons, 7000, Belgium

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Toronto, Ontario, M5T 3L9, Canada

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Frederiksberg, 2000, Denmark

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Glostrup Municipality, 2600, Denmark

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Odense, 5000, Denmark

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Montpellier, 34295, France

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Orléans, 45032, France

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Paris, 75679, France

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Rennes, 35056, France

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Tours, 3700, France

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Dresden, 01067, Germany

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Hamburg, 22081, Germany

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Heidelberg, 69120, Germany

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Würzburg, 97080, Germany

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Athens, 11527, Greece

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Heraklion, 71110, Greece

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Kifissia, 14561, Greece

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Larissa, 411 10, Greece

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Ashkelon, 78278, Israel

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Beer Yaakov, 70300, Israel

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Haifa, 34362, Israel

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Jerusalem, 91120, Israel

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Kfar Saba, 44281, Israel

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Petah Tikva, 49100, Israel

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Tel Aviv, 64239, Israel

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Florence, 50134, Italy

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Pisa, 56100, Italy

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Rome, 00100, Italy

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Chiba, 284-0003, Japan

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Fukuoka, 810-8563, Japan

Location

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Hiroshima, 730-0017, Japan

Location

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Hokkaido, 060-8648, Japan

Location

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Japan, 275-8580, Japan

Location

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Kagawa, 761-0793, Japan

Location

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Kumamoto, 861-1196, Japan

Location

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Nagasaki, 856-8562, Japan

Location

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Okayama, 700-8607, Japan

Location

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Saitama, 359-1111, Japan

Location

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Tokyo, 104-8560, Japan

Location

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Guadalajara, 44650, Mexico

Location

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Mexico City, 06090, Mexico

Location

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Monterrey, 64040, Mexico

Location

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San Luis Potosí City, 78213, Mexico

Location

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Ubbergen, 6574 NA, Netherlands

Location

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Gdansk, 80-546, Poland

Location

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Nadarzyn, 05-830, Poland

Location

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Warsaw, 02-507, Poland

Location

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Caguas, 00725, Puerto Rico

Location

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San Juan, 00927, Puerto Rico

Location

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Santurce, 00909, Puerto Rico

Location

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Seoul, 110-744, South Korea

Location

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Santander, 39008, Spain

Location

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Seville, 41010, Spain

Location

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Valencia, 46026, Spain

Location

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Villajoyosa, 03570, Spain

Location

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Fribourg, 1708, Switzerland

Location

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Lausanne, CH-1011, Switzerland

Location

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Zurich, 8091, Switzerland

Location

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Edirne, 22030, Turkey (Türkiye)

Location

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Gaziantep, 27310, Turkey (Türkiye)

Location

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North Shields, Tyneside, NE29 8NH, United Kingdom

Location

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Bradford, West Yorkshire, BD5 0NA, United Kingdom

Location

Related Publications (9)

  • 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.

    PMID: 34706874DERIVED

  • 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.

    PMID: 34028703DERIVED

  • 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.

    PMID: 32414425DERIVED

  • 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.

    PMID: 30219772DERIVED

  • 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.

    PMID: 30058112DERIVED

  • 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.

    PMID: 29463520DERIVED

  • 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.

    PMID: 29415145DERIVED

  • 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.

    PMID: 27799159DERIVED

  • 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.

    PMID: 27028914DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

baricitinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2012

First Posted

November 2, 2012

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

September 18, 2019

Results First Posted

January 18, 2018

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

ES(4)AU(3)BE(2)CA(1)CH(3)ME(4)IL(7)AR(3)NL(1)PL(3)TU(2)US(32)GR(4)DK(3)IT(3)KR(1)GB(2)DE(4)FR(5)JP(11)PR(3)