NCT01721057

Brief Summary

The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily (QD) is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR \[inadequate response\] participants) and who have not received a biologic disease-modifying antirheumatic drug (DMARD).

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
684

participants targeted

Target at P75+ for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Dec 2012

Geographic Reach
23 countries

147 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
29 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

June 12, 2017

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

November 1, 2012

Results QC Date

May 1, 2017

Last Update Submit

September 9, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (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 discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.

    Week 12

Secondary Outcomes (20)

  • Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

    Baseline, Week 12

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

    Baseline, Week 12

  • Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3

    Week 12

  • Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries

    Week 12

  • Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries

    Week 12

  • +15 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 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

Conventional disease-modifying anti-rheumatic drug as a background therapy

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) 1.2 times the upper limit of normal (ULN)
  • Have had an insufficient response or are intolerant to conventional disease-modifying antirheumatic drugs (cDMARDs) and either:
  • Have had regular use of a 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
  • For participants not receiving a cDMARD at the time of entry, the investigator will document in the participant's history that the participant had failed, was unable to tolerate, or had a contraindication to treatment with a cDMARD

You may not qualify if:

  • 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 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
  • 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)
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (147)

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Glendale, Arizona, 85304, United States

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Peoria, Arizona, 85381, United States

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Phoenix, Arizona, 85023, United States

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Tucson, Arizona, 85724, United States

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Fresno, California, 93720, United States

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La Jolla, California, 92037, United States

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Palm Desert, California, 92260, United States

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Santa Maria, California, 93454, United States

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Upland, California, 91786, United States

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Boulder, Colorado, 80304, United States

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Denver, Colorado, 80230, 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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Naples, Florida, 34102, United States

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New Port Richey, Florida, 34652, United States

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Orlando, Florida, 32806, United States

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Palm Harbor, Florida, 34684, United States

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Tampa, Florida, 33614, United States

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Vernon Hills, Illinois, 60061, United States

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Indianapolis, Indiana, 46260, United States

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Kalamazoo, Michigan, 49009, United States

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Lansing, Michigan, 48910, United States

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Columbia, Missouri, 65212, United States

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St Louis, Missouri, 63117, United States

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Las Vegas, Nevada, 89128, United States

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Freehold, New Jersey, 07728, United States

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Toms River, New Jersey, 08755, 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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Asheville, North Carolina, 28803, United States

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Charlotte, North Carolina, 28207, United States

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Middleburg Heights, Ohio, 44130, United States

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Tulsa, Oklahoma, 74135, United States

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Portland, Oregon, 97239, United States

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Bethlehem, Pennsylvania, 18017, 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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Cypress, Texas, 77429, United States

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Dallas, Texas, 75231, United States

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Lubbock, Texas, 79424, 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, C1128AAF, Argentina

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Córdoba, 5000, Argentina

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Quilmes, B1878DVC, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Camperdown, New South Wales, 2050, Australia

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Maroochydore, Queensland, 4558, Australia

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Merksem, 2170, Belgium

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Mons, 7000, Belgium

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Kelowna, British Columbia, V1Y3G5, Canada

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Victoria, British Columbia, V8V 3P9, Canada

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Winnipeg, Manitoba, R3A 1M3, Canada

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Kitchener, Ontario, N2M 5N6, Canada

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Ottawa, Ontario, K1H 1A2, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Québec, Quebec, G1W 4R4, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Saskatoon, Saskatchewan, S7K 0H6, Canada

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Karlovac, 47000, Croatia

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Osijek, 31000, Croatia

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Varaždin, 42000, Croatia

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Zagreb, 10 000, Croatia

Location

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Brno, 61141, Czechia

Location

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Hustopeče, 693 01, Czechia

Location

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Pardubice, 530 02, Czechia

Location

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Uherské Hradiště, 686 01, Czechia

Location

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Cologne, 50937, Germany

Location

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Gommern, 39245, Germany

Location

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Würzburg, 97080, Germany

Location

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Békéscsaba, 5600, Hungary

Location

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Budapest, 1023, Hungary

Location

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Debrecen, 4043, Hungary

Location

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Székesfehérvár, 8000, Hungary

Location

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Veszprém, 8200, Hungary

Location

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Ahmedabad, 532004, India

Location

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Attavar, Mangalore, 575001, India

Location

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Bangalore, 560 054, India

Location

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Belagavi, 590 010, India

Location

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Gūrgaon, 122001, India

Location

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Hyderabaad, 500072, India

Location

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Jaipur, 302006, India

Location

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Kolkata, 700 020, India

Location

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Lucknow, 226018, India

Location

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Mumbai, 400053, India

Location

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Secunderabad, 500 003, India

Location

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Milan, 20157, Italy

Location

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Prato, 50047, Italy

Location

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Rozzano, 20089, Italy

Location

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Valeggio sul Mincio, 37067, Italy

Location

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Aichi, 470-1192, Japan

Location

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Hiroshima, 730-0017, Japan

Location

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Hokkaido, 060-8648, Japan

Location

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Kagawa, 761-0793, Japan

Location

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Okayama, 700-8607, Japan

Location

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Saitama, 359-1111, Japan

Location

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Tochigi, 329- 0498, Japan

Location

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Tokyo, 104-8560, Japan

Location

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Toyama, 933-0874, Japan

Location

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Mexicali, 21200, Mexico

Location

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Mexico City, 06600, Mexico

Location

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Bydgoszcz, 85-168, Poland

Location

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Elblag, 82-300, Poland

Location

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Gdansk, 80-546, Poland

Location

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Lodz, 90-242, Poland

Location

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Nadarzyn, 05-830, Poland

Location

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Almada, 2805-267, Portugal

Location

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Ponte de Lima, 4990-041, Portugal

Location

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Caguas, 00725, Puerto Rico

Location

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San Germán, 00683, Puerto Rico

Location

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San Juan, 00918, Puerto Rico

Location

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Santurce, 00909, Puerto Rico

Location

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Bucharest, 011172, Romania

Location

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Cluj-Napoca, 400006, Romania

Location

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Constanța, 900591, Romania

Location

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Moscow, 115522, Russia

Location

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Saint Petersburg, 194291, Russia

Location

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Ulyanovsk, 432063, Russia

Location

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Yaroslavl, 150003, Russia

Location

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Bratislava, 83103, Slovakia

Location

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Partizánske, 95801, Slovakia

Location

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Topoľčany, 95501, Slovakia

Location

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Gwangju, 510-757, South Korea

Location

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Incheon, 400-711, South Korea

Location

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Seoul, 150-713, South Korea

Location

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Bilbao, 48013, Spain

Location

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Getafe, 28905, Spain

Location

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Santander, 39008, Spain

Location

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Valencia, 46026, Spain

Location

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Villajoyosa, 03570, Spain

Location

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Kaohsiung City, 83301, Taiwan

Location

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Neihu Taipei, 114, Taiwan

Location

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Taichung, 40201, Taiwan

Location

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Taichung, 404, Taiwan

Location

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Taipei, 10630, Taiwan

Location

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Yong Kung City, 71004, Taiwan

Location

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London, England, SE1 9RT, United Kingdom

Location

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Basingstoke, Hampshire, RG24 9NA, United Kingdom

Location

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North Shields, Tyneside, NE29 8NH, United Kingdom

Location

Related Publications (13)

  • 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

  • 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.

    PMID: 34526397DERIVED

  • 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

  • Thudium CS, Bay-Jensen AC, Cahya S, Dow ER, Karsdal MA, Koch AE, Zhang W, Benschop RJ. The Janus kinase 1/2 inhibitor baricitinib reduces biomarkers of joint destruction in moderate to severe rheumatoid arthritis. Arthritis Res Ther. 2020 Oct 12;22(1):235. doi: 10.1186/s13075-020-02340-7.

    PMID: 33046136DERIVED

  • 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

  • Bingham CO 3rd, Gaich CL, DeLozier AM, Engstrom KD, Naegeli AN, de Bono S, Banerjee P, Taylor PC. Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: rationale and implementation. Trials. 2019 Mar 22;20(1):182. doi: 10.1186/s13063-019-3272-0.

    PMID: 30902094DERIVED

  • Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6. No abstract available.

    PMID: 30842122DERIVED

  • 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

  • Wells AF, Greenwald M, Bradley JD, Alam J, Arora V, Kartman CE. Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs in United States and Rest of World: A Subset Analysis. Rheumatol Ther. 2018 Jun;5(1):43-55. doi: 10.1007/s40744-018-0110-x. Epub 2018 Apr 21.

    PMID: 29680881DERIVED

  • 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

  • Emery P, Blanco R, Maldonado Cocco J, Chen YC, Gaich CL, DeLozier AM, de Bono S, Liu J, Rooney T, Chang CH, Dougados M. Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis. RMD Open. 2017 Mar 21;3(1):e000410. doi: 10.1136/rmdopen-2016-000410. eCollection 2017.

    PMID: 28405473DERIVED

  • Dougados M, van der Heijde D, Chen YC, Greenwald M, Drescher E, Liu J, Beattie S, Witt S, de la Torre I, Gaich C, Rooney T, Schlichting D, de Bono S, Emery P. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017 Jan;76(1):88-95. doi: 10.1136/annrheumdis-2016-210094. Epub 2016 Sep 29.

    PMID: 27689735DERIVED

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

December 1, 2012

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

September 18, 2019

Results First Posted

June 12, 2017

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

PL(5)AU(2)CR(4)AR(4)DE(3)JP(9)ME(2)CA(9)PT(2)US(48)RO(3)RU(4)KR(3)ES(5)SL(3)GB(3)IN(11)IT(4)CZ(4)HU(5)PR(4)BE(4)TW(6)