A Study of LY3337641 in Rheumatoid Arthritis | NCT02628028

NCT02628028

ID	Type	Description	Link
I8K-MC-JPDA	Other Identifier	Eli Lilly and Company
2015-003289-97	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A 5 mg LY3337641	Experimental	Given once a day for 4 weeks.	Drug: LY3337641
Part A 10 mg LY3337641	Experimental	Given once a day for 4 weeks.	Drug: LY3337641
Part A 30 mg LY3337641	Experimental	Given once a day for 4 weeks.	Drug: LY3337641
Part A Placebo	Placebo Comparator	Given once a day for 4 weeks.	Drug: Placebo
Part B 5 mg LY3337641	Experimental	Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.	Drug: LY3337641
Part B 10 mg LY3337641	Experimental	Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Name	Type	Description	Arm Group Labels	Other Names
LY3337641	Drug	Administered orally	Part A 10 mg LY3337641 Part A 30 mg LY3337641 Part A 5 mg LY3337641 Part B 10 mg LY3337641

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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.	Up to 6 Weeks
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response in Part B	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.	Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response in Part B	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.

Eligibility Module

Eligibility Criteria

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)

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

Contacts/Locations Module

Name	Affiliation	Role
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	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Desert Medical Advances		Palm Desert	California	92260	United States
Stanford University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33323529	Derived	Genovese MC, Spindler A, Sagawa A, Park W, Dudek A, Kivitz A, Chao J, Chan LSM, Witcher J, Barchuk W, Nirula A. Safety and Efficacy of Poseltinib, Bruton's Tyrosine Kinase Inhibitor, in Patients With Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled, 2-part Phase II Study. J Rheumatol. 2021 Jul;48(7):969-976. doi: 10.3899/jrheum.200893. Epub 2020 Dec 15.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part A: Placebo	Participants received oral dose of placebo once daily (QD) for 4 weeks.
FG001	Part A: 5 mg LY3337641	Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 5, 2017	Sep 18, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Part B 30 mg LY3337641

Part B 5 mg LY3337641

All randomized participants who received at least 1 dose of the study drug.

Arm/Group Information

ID	Title	Description
BG000	Part A: Placebo	Participants received oral dose of placebo once daily (QD) for 4 weeks.
BG001	Part A: 5 mg LY3337641	Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
BG002	Part A: 10 mg LY3337641	Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
BG003	Part A: 30 mg LY3337641	Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
BG004	Part B: Placebo	Participants received oral dose of placebo QD for 12 weeks.
BG005	Part B: 5 mg LY3337641	Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.
BG006	Part B: 10 mg LY3337641	Participants received oral dose of 10 mg LY3337641 QD for 12 weeks.
BG007	Part B: 30 mg LY3337641	Participants received oral dose of 30 mg LY3337641 QD for 12 weeks.
BG008	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00054.3± 11.43 BG00154.0± 11.75 BG00256.9± 6.44 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0008 BG0018 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0011 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Puerto Rico

Title	Measurements
	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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.

All randomized participants who received at least 1 dose of the study drug in Part A.

Posted

Count of Participants

Participants

Up to 6 Weeks

ID	Title	Description
OG000	Part A: Placebo	Participants received oral dose of placebo once daily (QD) for 4 weeks.
OG001	Part A: 5 mg LY3337641	Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
OG002	Part A: 10 mg LY3337641	Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
OG003	Part A: 30 mg LY3337641	Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.

Units	Counts
Participants	OG0009 OG0019 OG00210 OG003

Title

Denominators

Categories

TEAEs

Title	Measurements
	OG0003 OG0011 OG0026 OG003

Primary

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response in Part B

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.

All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).

Posted

Number

95% Confidence Interval

Percentage of Participants

Week 12

ID	Title	Description
OG000	Part B: Placebo	Participants received oral dose of placebo QD for 12 weeks.
OG001	Part B: 5 mg LY3337641	Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.

Secondary

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response in Part B

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.

Posted

Number

95% Confidence Interval

Percentage of Participants

Week 12

ID	Title	Description
OG000	Part B: Placebo	Participants received oral dose of placebo QD for 12 weeks.
OG001	Part B: 5 mg LY3337641	Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.
OG002	Part B: 10 mg LY3337641

Secondary

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response in Part B

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:

Posted

Number

95% Confidence Interval

Percentage of Participants

Week 12

ID	Title	Description
OG000	Part B: Placebo	Participants received oral dose of placebo QD for 12 weeks.
OG001	Part B: 5 mg LY3337641	Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.
OG002	Part B: 10 mg LY3337641

Secondary

Change From Baseline in the Disease Activity Score (DAS) 28-high-sensitivity C-reactive Protein (hsCRP) in Part B

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	Part B: Placebo	Participants received oral dose of placebo QD for 12 weeks.
OG001	Part B: 5 mg LY3337641	Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.
OG002	Part B: 10 mg LY3337641

Secondary

Percentage of Participants Who Achieve Low Disease Activity Using DAS28-hsCRP in Part B

Posted

Number

95% Confidence Interval

Percentage of Participants

Week 12

ID	Title	Description
OG000	Part B: Placebo	Participants received oral dose of placebo QD for 12 weeks.
OG001	Part B: 5 mg LY3337641	Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.
OG002	Part B: 10 mg LY3337641

Secondary

Percentage of Participants Who Achieve Clinical Remission Using DAS28-hsCRP in Part B

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.

Posted

Number

95% Confidence Interval

Percentage of Participants

Week 12

ID	Title	Description
OG000	Part B: Placebo	Participants received oral dose of placebo QD for 12 weeks.
OG001	Part B: 5 mg LY3337641	Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.
OG002	Part B: 10 mg LY3337641

Secondary

Pharmacokinetics (PK): Clearance Parameter of LY3337641

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.

All randomized participants who received at least 1 dose of the study drug and have evaluable PK data in in Part A and Part B.

Posted

Mean

Standard Error

Liter per hour (L/hr)

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)

ID	Title	Description
OG000	LY3337641	Participants received oral doses of 5 mg, 10 mg and 30 mg LY3337641 QD for 4 weeks in Part A and 12 weeks in Part B.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A: Placebo	Participants received oral dose of placebo once daily (QD) for 4 weeks.	0	9	0	9	3	9
EG001	Part A: 5 mg LY3337641	Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.	0	9	0	9	1	9
EG002	Part A: 10 mg LY3337641	Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.	0	10	0	10	6	10
EG003	Part A: 30 mg LY3337641	Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.	0	8	0	8	2	8
EG004	Part B: Placebo	Participants received oral dose of placebo QD for 12 weeks.	0	62	2	62	7	62
EG005	Part B: 5 mg LY3337641	Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.	0	63	0	63	10	63
EG006	Part B: 10 mg LY3337641	Participants received oral dose of 10 mg LY3337641 QD for 12 weeks.	0	62	0	62	12	62
EG007	Part B: 30 mg LY3337641	Participants received oral dose of 30 mg LY3337641 QD for 12 weeks.	1	63	3	63	19	63
EG008	Long-Term Extension: 5 mg LY3337641	Participants who completed Part B of study received oral dose of 5 mg LY3337641 QD for an additional 52 weeks.	0	61	1	61	11	61
EG009	Long-Term Extension: 10 mg LY3337641	Participants who completed Part B of study received oral dose of 10 mg LY3337641 QD for an additional 52 weeks.	0	58	3	58	12	58
EG010	Long-Term Extension: 30 mg LY3337641	Participants who completed Part B of study received oral dose of 30 mg LY3337641 QD for an additional 52 weeks.	0	61	1	61	10	61

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG0030 events0 affected8 at risk EG0041 events1 affected62 at risk EG0050 events0 affected63 at risk EG0060 events0 affected62 at risk EG0070 events0 affected63 at risk EG0080 events0 affected61 at risk EG0090 events0 affected58 at risk EG0100 events0 affected61 at risk
Pneumonia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG0031 events1 affected8 at risk EG0040 events0 affected62 at risk EG0050 events0 affected63 at risk EG0061 events1 affected62 at risk EG0070 events0 affected63 at risk EG0080 events0 affected61 at risk EG0090 events0 affected58 at risk EG0100 events0 affected61 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected9 at risk EG0020 events0 affected10 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0021 events1 affected10 at risk EG003
Fatigue	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0021 events1 affected10 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Laryngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0021 events1 affected10 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Sinusitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0021 events1 affected10 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0021 events1 affected10 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected9 at risk EG0020 events0 affected10 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Carotid artery aneurysm	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected9 at risk EG0020 events0 affected10 at risk EG003
Headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0022 events2 affected10 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected1 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected1 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected9 at risk EG0021 events1 affected10 at risk EG003

The trial was terminated after an interim analysis of efficacy and safety data did not warrant continuation of the trial.

Certain Agreements

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Participants received oral dose of 10 mg LY3337641 QD for 12 weeks.

EG0040 events0 affected62 at risk

EG0050 events0 affected63 at risk

EG0060 events0 affected62 at risk

EG0070 events0 affected63 at risk

EG0080 events0 affected61 at risk

EG0090 events0 affected58 at risk

EG0101 events1 affected61 at risk

EG0040 events0 affected62 at risk

EG0050 events0 affected63 at risk

EG0060 events0 affected62 at risk

EG0070 events0 affected63 at risk

EG0080 events0 affected61 at risk

EG0091 events1 affected58 at risk

EG0100 events0 affected61 at risk

EG0040 events0 affected62 at risk

EG0050 events0 affected63 at risk

EG0060 events0 affected62 at risk

EG0071 events1 affected63 at risk

EG0080 events0 affected61 at risk

EG0090 events0 affected58 at risk

EG0100 events0 affected61 at risk

EG0040 events0 affected62 at risk

EG0050 events0 affected63 at risk

EG0060 events0 affected62 at risk

EG0070 events0 affected63 at risk

EG0080 events0 affected61 at risk

EG0091 events1 affected58 at risk

EG0100 events0 affected61 at risk

EG0041 events1 affected62 at risk

EG0050 events0 affected63 at risk

EG0060 events0 affected62 at risk

EG0070 events0 affected63 at risk

EG0080 events0 affected61 at risk

EG0090 events0 affected58 at risk

EG0100 events0 affected61 at risk

EG0040 events0 affected62 at risk

EG0050 events0 affected63 at risk

EG0060 events0 affected62 at risk

EG0071 events1 affected63 at risk

EG0080 events0 affected61 at risk

EG0090 events0 affected58 at risk

EG0100 events0 affected61 at risk

EG0040 events0 affected62 at risk

EG0050 events0 affected63 at risk

EG0060 events0 affected62 at risk

EG0070 events0 affected63 at risk

EG0080 events0 affected61 at risk

EG0091 events1 affected58 at risk

EG0100 events0 affected61 at risk

EG0040 events0 affected62 at risk

EG0050 events0 affected63 at risk

EG0060 events0 affected62 at risk

EG0070 events0 affected63 at risk

EG0080 events0 affected61 at risk

EG0091 events1 affected58 at risk

EG0100 events0 affected61 at risk

EG0040 events0 affected62 at risk

EG0050 events0 affected63 at risk

EG0060 events0 affected62 at risk

EG0070 events0 affected63 at risk

EG0080 events0 affected61 at risk

EG0091 events1 affected58 at risk

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