A Moderate to Severe Rheumatoid Arthritis Study (RA-BEACON)

This study is currently recruiting participants.
Verified April 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01721044
First received: November 1, 2012
Last updated: April 21, 2014
Last verified: April 2014

November 1, 2012
April 21, 2014
January 2013
April 2014   (final data collection date for primary outcome measure)
Proportion of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01721044 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in the Disease Activity Score based on a 28-Joint Count (DAS-28) [ Time Frame: Baseline, up to Week 12 ] [ Designated as safety issue: No ]
  • Proportion of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response [ Time Frame: Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in Patient Reported Outcomes [ Time Frame: Baseline, up to Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in Measures of Clinical Disease Activity and Severity [ Time Frame: Baseline, up to Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in the Disease Activity Score based on a 28-Joint Count (DAS-28) [ Time Frame: Baseline, up to Week 24 ] [ Designated as safety issue: No ]
  • Proportion of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response [ Time Frame: Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in Patient Reported Outcomes [ Time Frame: Baseline, up to Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in Measures of Clinical Disease Activity and Severity [ Time Frame: Baseline, up to Week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Moderate to Severe Rheumatoid Arthritis Study
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Placebo
    Administered orally
  • Drug: Baricitinib
    Administered orally
    Other Names:
    • LY 3009104
    • INCB 028050
  • Placebo Comparator: Placebo

    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.

    Intervention: Drug: Placebo
  • Experimental: Baricitinib 2 mg

    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.

    Intervention: Drug: Baricitinib
  • Experimental: Baricitinib 4 mg

    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.

    Intervention: Drug: Baricitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
525
September 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 patient
  • Have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or have New York Heart Association stage IV heart failure
  • Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data
  • Are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair
  • Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of < (less than) 40 milliliter per minute per 1.73 m^2 (mL/min/1.73 m^2)
  • Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN
  • Have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years
  • Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination)
  • Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection
  • Have had symptomatic herpes zoster infection within 12 weeks prior to study entry
  • Have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, postherpetic neuralgia)
  • Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
  • Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  • Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the participant's participation in the study
  • Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the participant's participation in the study (e.g. Fridericia's corrected QT interval >500 millisecond [msec])
  • Have symptomatic herpes simplex at the time of study enrollment
  • Have evidence of active or latent tuberculosis (TB)
Both
18 Years and older
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
United States,   Argentina,   Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Greece,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Spain,   Switzerland,   Turkey,   United Kingdom
 
NCT01721044
14058, I4V-MC-JADW
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP