A Study of LY3337641 in Rheumatoid Arthritis



Status:Terminated
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 65
Updated:8/29/2018
Start Date:August 22, 2016
End Date:August 15, 2018

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A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects With Rheumatoid Arthritis: The RAjuvenate Study

The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in
adults with rheumatoid arthritis (RA).


Inclusion Criteria:

- Female subjects of childbearing potential test negative for pregnancy at screening and
agree not to breastfeed

- Female subjects: agree to use a reliable method of birth control from the start of
screening until 28 days after the last dose of study drug or be of nonchildbearing
potential

- Male subjects: agree to use a reliable method of birth control from the start of
screening until 2 weeks after the last dose of study drug or have undergone vasectomy

- Have a diagnosis of RA based on the 2010 ACR/European League against Rheumatism
criteria

- Have at least 1 of the following:

- rheumatoid factor or anti-citrullinated peptide antibodies (ACPA) at screening OR

- radiographs documenting bony erosions

- Have active RA, defined as:

- Part A: ≥3 swollen joints (based on 66-joint counts)

- Part B:

- ≥6 swollen joints (based on 66-joint counts)

- ≥6 tender joints (based on 68-joint counts)

- hsCRP levels greater than the upper limit of normal (ULN) OR positive for ACPA

- Part B only: Have had inadequate response, loss of response, or intolerance to at
least 1 synthetic OR biologic disease-modifying antirheumatic drug (DMARD)

Exclusion Criteria:

- Have received any of the following:

- Part B only: any prior treatment with a product directly targeting Bruton's
tyrosine kinase (BTK) (marketed or investigational)

- belimumab, natalizumab, or vedolizumab within 6 months prior to baseline

- B-cell-depleting agents (such as rituximab) or other cell-depleting biologics
(eg, anti-CD3 antibody) within 12 months prior to screening for Part A or at any
time prior to screening for Part B

- Have known hypogammaglobulinemia

- Have hepatitis C virus, hepatitis B virus or human immunodeficiency virus

- Have active tuberculosis (TB)

- Are at high risk of infection or have recent evidence of clinically significant
infection

- Have had lymphoma, leukemia, or any malignancy within the previous 5 years except for
treated basal cell or squamous epithelial carcinomas of the skin

- Have received a live (attenuated) vaccine within 28 days prior to baseline or plan to
receive one during the study
We found this trial at
16
sites
Clearwater, Florida 33756
Principal Investigator: Miguel Trevino
Phone: 727-584-6368
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Buenos Aires,
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Denver, Colorado 80230
Principal Investigator: Christopher Antolini
Phone: 303-394-2828
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Denver, CO
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Elizabethtown, Kentucky 42701
Principal Investigator: Daksha Mehta
Phone: 270-769-2535
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Elizabethtown, KY
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Franklin, Wisconsin 53132
Principal Investigator: Alvin Wells
Phone: 414-435-0025
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Franklin, WI
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3725 East League City Parkway
League City, Texas 77573
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League City, TX
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Naples, Florida 34102
Principal Investigator: Jeffrey Alper
Phone: 239-262-1745
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Naples, FL
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Nassau Bay, Texas 77058
Principal Investigator: Prashanth Sunkureddi
Phone: 713-677-0086
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Nassau Bay, TX
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New Port Richey, Florida 34652
Principal Investigator: Farrukh Zaidi
Phone: 727-849-4131
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New Port Richey, FL
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North Charleston, South Carolina 29406
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North Charleston, SC
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Palm Desert, California 92260
Principal Investigator: Maria Greenwald
Phone: 760-341-6800
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Palm Desert, CA
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Palo Alto, California 94305
Principal Investigator: Mark Genovese
Phone: 650-498-4528
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Palo Alto, CA
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Saint Louis, Missouri 63117
Principal Investigator: John Budd
Phone: 314-646-0688
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Saint Louis, MO
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Salisbury, North Carolina 28144
Principal Investigator: Rakesh Patel
Phone: 704-647-9913
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Salisbury, NC
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Venice, Florida
Principal Investigator: Jeffrey Kaine
Phone: 941-485-8314
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Venice, FL
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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Wilmington, NC
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