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Trial record 1 of 11 for:    Baricitinib AND Rheumatoid Arthritis
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A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02265705
First Posted: October 16, 2014
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as baricitinib in participants with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate therapy.

Condition Intervention Phase
Rheumatoid Arthritis Drug: Baricitinib Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Proportion of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • Change from Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline to Week 12 in Disease Activity Score Modified to Include the 28 Diarthroidal Joint Count (DAS28)-High Sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Baseline, Week 12 ]
  • Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3 [ Time Frame: Week 12 ]
  • Mean Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12 [ Time Frame: Week 12 ]
  • Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12 [ Time Frame: Week 12 ]
  • Mean Worst Tiredness Numeric Rating Scale (NRS) in the 7 Days Prior to Week 12 [ Time Frame: Week 12 ]
  • Mean Worst Pain NRS in the 7 Days Prior to Week 12 [ Time Frame: Week 12 ]

Estimated Enrollment: 288
Study Start Date: October 2014
Study Completion Date: May 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baricitinib

4 milligrams (mg) baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.

Participants will continue to take background methotrexate (MTX) therapy throughout study. Other background therapies, including non-steroidal anti-inflammatory drugs (NSAIDs) and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.

Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104
  • INCB 028050
Placebo Comparator: Placebo

Placebo administered orally once a day through week 24. At week 24, participants will be given 2 mg (participants with renal impairment) or 4 mg baricitinib orally once a day through Week 52.

Participants will continue to take background MTX therapy throughout study. Other background therapies, including NSAIDs and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.

Drug: Placebo
Administered orally

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of adult-onset RA as defined by the ACR/European League Against Rheumatism (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 CRP (or hsCRP) measurement ≥ 6 mg/liter (L) based on the most recent data (if available).
  • Have had regular use of MTX for at least the 12 weeks prior to study entry at a dose that, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response. The dose of MTX must have been a stable, unchanging oral dose of 7.5 to 25 mg/week (or the equivalent injectable dose) for at least the 8 weeks prior to study entry. The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons.

Exclusion Criteria:

  • Are currently receiving corticosteroids at doses >10 mg of prednisone per day (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization.
  • Have started treatment with NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization.
  • Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine or combination of any 3 conventional disease modifying anti-rheumatic drugs (cDMARDs).
  • Are currently receiving or have received cDMARDs (for example, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 8 weeks prior to study entry.
  • Have received leflunomide in the 12 weeks prior to study entry (or within 4 weeks prior to study entry if the standard 11 days of cholestyramine is used to washout leflunomide).
  • Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry.
  • Have ever received any biologic DMARD (such as tumor necrosis factor (TNF), interleukin-1, interleukin-6 (IL-6), or T-cell- or B-cell-targeted therapies).
  • Have received any parenteral corticosteroid administered by intramuscular or intravenous injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
  • Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
  • Have 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.
  • 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 milliliters/minute/1.73 meters squared (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 upper limit of normal (ULN) or the most recent available total bilirubin 1.5 times the ULN.
  • Have a current or recent (<30 days prior to study entry) clinically serious viral, bacterial, fungal, or parasitic infection.
  • Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  • Have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB.
  • Have evidence of active TB or have previously had evidence of active TB and did not receive appropriate and documented treatment.
  • Are pregnant or nursing at the time of study entry.
  • Are females of childbearing potential who do not agree to use 2 forms of highly effective birth control when engaging in intercourse while enrolled in the study and for at least 28 days following the last dose of orally administered investigational product.
  • Are males who do not agree to use 2 forms of highly effective birth control while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 28 days following the last dose of orally administered investigational product.
  • Have previously been randomized in this study or any other study investigating baricitinib.
  • Have received prior treatment with an oral janus kinase inhibitor.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265705


Locations
Argentina
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.
Ciudad Autonoma de Buenos Aire, Argentina, C1015ABO
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Ciudad Autonoma de Buenos Aire, Argentina, C1431FWO
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Ciudad Autonoma de Buenos Aire, Argentina, C1440AAD
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Rosario, Argentina, S2000CFJ
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San Juan, Argentina, J5402DIL
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San Miguel De Tucuman, Argentina, T4000AXL
Brazil
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Sao Paulo, Brazil, 04266-010
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São Paulo, Brazil, 01244-030
China
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Beijing, China, 100029
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Beijing, China, 100044
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.
Bengbu, China, 233004
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Changsha, China, 410008
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Changsha, China, 410011
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Chengdu, China, 610041
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Guangzhou, China, 510080
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Hefei, China, 230001
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Hefei, China, 230022
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Jinan, China, 250012
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Kunming, China, 650032
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Nanjing, China, 210029
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Ningbo, China, 315010
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Pingxiang, China, 337055
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Shanghai, China, 200001
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.
Shanghai, China, 200032
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.
Shanghai, China, 200052
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.
Shantou, China, 515041
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Tianjin, China, 300052
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Wuhan City, China, 430030
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Yancheng, China, 224005
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ZhuZhou, China, 412007
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02265705     History of Changes
Other Study ID Numbers: 14875
I4V-CR-JAGS ( Other Identifier: Eli Lilly and Company )
First Submitted: October 13, 2014
First Posted: October 16, 2014
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors