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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02628028
Registration number
NCT02628028
Ethics application status
Date submitted
9/12/2015
Date registered
11/12/2015
Date last updated
9/10/2019
Titles & IDs
Public title
A Study of LY3337641 in Rheumatoid Arthritis
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Scientific title
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
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Secondary ID [1]
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I8K-MC-JPDA
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Secondary ID [2]
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16173
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Universal Trial Number (UTN)
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Trial acronym
RAjuvenate
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LY3337641
Treatment: Drugs - Placebo
Experimental: Part A 5 mg LY3337641 - Given once a day for 4 weeks.
Experimental: Part A 10 mg LY3337641 - Given once a day for 4 weeks.
Experimental: Part A 30 mg LY3337641 - Given once a day for 4 weeks.
Placebo Comparator: Part A Placebo - Given once a day for 4 weeks.
Experimental: Part B 5 mg LY3337641 - Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.
Experimental: Part B 10 mg LY3337641 - Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.
Experimental: Part B 30 mg LY3337641 - Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.
Placebo Comparator: Part B Placebo - Given once a day for 12 weeks.
Treatment: Drugs: LY3337641
Administered orally
Treatment: Drugs: Placebo
Administered orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs) or Adverse Events of Special Interest (AESIs) or Any Serious AEs (SAEs) in Part A
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Assessment method [1]
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TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. Skin Rash was the only event that was considered an AESI. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
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Timepoint [1]
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Up to 6 Weeks
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Primary outcome [2]
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response in Part B
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Assessment method [2]
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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, Patient's Global Assessment of Arthritis Pain using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI) and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and /or participants who discontinue study or drug before analysis timepoint are deemed non-responders.
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Timepoint [2]
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Week 12
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Secondary outcome [1]
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response in Part B
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Assessment method [1]
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ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR50 Responder" is a participant who has at least 50% 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, Patient's Global Assessment of Arthritis Pain using VAS, HAQ-DI and hsCRP. Participants with missing responses and/or participants who discontinue study or drug before analysis timepoint are deemed non-responders.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response in Part B
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Assessment method [2]
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ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR70 Responder" is a participant who has at least 70% 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, Patient's Global Assessment of Arthritis Pain using VAS, HAQ-DI and hsCRP. Participants with missing responses and/or participants who discontinue study or drug before analysis timepoint are deemed non-responders.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Change From Baseline in the Disease Activity Score (DAS) 28-high-sensitivity C-reactive Protein (hsCRP) in Part B
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Assessment method [3]
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Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using VAS. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
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Timepoint [3]
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Baseline, Week 12
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Secondary outcome [4]
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Percentage of Participants Who Achieve Low Disease Activity Using DAS28-hsCRP in Part B
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Assessment method [4]
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Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using VAS. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Percentage of Participants Who Achieve Clinical Remission Using DAS28-hsCRP in Part B
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Assessment method [5]
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Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Clinical remission is defined as DAS28-hsCRP <2.6.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Pharmacokinetics (PK): Clearance Parameter of LY3337641
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Assessment method [6]
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Apparent total body clearance of drug after oral administration based on population PK analysis was evaluated. As prespecified per protocol, an overall population estimate of clearance is generated and data from Part A and B were combined for the analysis. The sparse data was then analyzed using population PK methods in Non linear Mixed Effects Model (NONMEM) to generate an overall population estimate of clearance.
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Timepoint [6]
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Part A: Weeks 1, 2, and 4, Day 1 (0.5 to 2 hours postdose); Part B: Weeks 2, 4, 8, and 12, Day 1 (0.5 to 2 hours postdose)
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Eligibility
Key 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 American College of Rheumatology
(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)
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Minimum age
18
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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-cluster of differentiation 3 (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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/08/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/08/2018
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Sample size
Target
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Accrual to date
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Final
286
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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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. - Maroochydore
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Recruitment hospital [2]
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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. - Woodville South
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Recruitment postcode(s) [1]
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4558 - Maroochydore
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Recruitment postcode(s) [2]
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5011 - Woodville South
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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Florida
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Missouri
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North Carolina
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South Carolina
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Cordoba
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Argentina
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Rosario
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Argentina
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San Fernando
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San Miguel de Tucuman
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Tucuman
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Austria
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Innsbruck
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Firenze
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Italy
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Milano
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Italy
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Asahikawa
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Fukuoka
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Hokkaido
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Sendai
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Jung-gu
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Seoul
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Col. Roma
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Mexico
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Distrito Federal
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Mexico
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Mexicali
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Mexico
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Elblag
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Warsaw
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Caguas
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Santurce
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South Africa
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Stellenbosch
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South Africa
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Umhlanga
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Spain
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Alicante
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Spain
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Bilbao
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Spain
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in
adults with rheumatoid arthritis (RA).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02628028
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02628028
Download to PDF