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 |
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).
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
Saint Louis, Missouri 63117
Principal Investigator: John Budd
Phone: 314-646-0688
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Clearwater, Florida 33756
Principal Investigator: Miguel Trevino
Phone: 727-584-6368
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Denver, Colorado 80230
Principal Investigator: Christopher Antolini
Phone: 303-394-2828
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Elizabethtown, Kentucky 42701
Principal Investigator: Daksha Mehta
Phone: 270-769-2535
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Franklin, Wisconsin 53132
Principal Investigator: Alvin Wells
Phone: 414-435-0025
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Naples, Florida 34102
Principal Investigator: Jeffrey Alper
Phone: 239-262-1745
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Nassau Bay, Texas 77058
Principal Investigator: Prashanth Sunkureddi
Phone: 713-677-0086
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New Port Richey, Florida 34652
Principal Investigator: Farrukh Zaidi
Phone: 727-849-4131
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Palm Desert, California 92260
Principal Investigator: Maria Greenwald
Phone: 760-341-6800
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Palo Alto, California 94305
Principal Investigator: Mark Genovese
Phone: 650-498-4528
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Salisbury, North Carolina 28144
Principal Investigator: Rakesh Patel
Phone: 704-647-9913
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Venice, Florida
Principal Investigator: Jeffrey Kaine
Phone: 941-485-8314
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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