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A Study of LY3337641 in Rheumatoid Arthritis (RAjuvenate)

Primary Purpose

Rheumatoid Arthritis

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LY3337641

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Desert Medical Advances
Stanford University Hospital
Denver Arthritis Center
Innovative Research of West Florida
Jeffrey Alper MD Research
Sun Coast Clinical Research, Inc
Lovelace Scientific Resources
Center for Arthritis & Osteoporosis
Clayton Medical Research
Rowan Regional Medical Center
PMG Research of Wilmington, LLC
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
Accurate Clinical Research
Accurate Clinical Research
Rheumatology and Immunotherapy Center
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Office: Perez-De Jesus, Amarilis
Mindful Medical Research
Latin Clinical Trial Center
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.
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.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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.
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.
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.
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.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part A 5 mg LY3337641

Part A 10 mg LY3337641

Part A 30 mg LY3337641

Part A Placebo

Part B 5 mg LY3337641

Part B 10 mg LY3337641

Part B 30 mg LY3337641

Part B Placebo

Arm Description

Given once a day for 4 weeks.

Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Given once a day for 12 weeks.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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: 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.

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.

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

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.

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.

Full Information

NCT ID

NCT02628028

First Posted

December 9, 2015

Last Updated

September 19, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02628028

Brief Title

A Study of LY3337641 in Rheumatoid Arthritis

Acronym

RAjuvenate

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

August 22, 2016 (Actual)

Primary Completion Date

April 25, 2018 (Actual)

Study Completion Date

August 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

286 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A 5 mg LY3337641

Arm Type

Experimental

Arm Description

Given once a day for 4 weeks.

Arm Title

Part A 10 mg LY3337641

Arm Type

Experimental

Arm Description

Given once a day for 4 weeks.

Arm Title

Part A 30 mg LY3337641

Arm Type

Experimental

Arm Description

Given once a day for 4 weeks.

Arm Title

Part A Placebo

Arm Type

Placebo Comparator

Arm Description

Given once a day for 4 weeks.

Arm Title

Part B 5 mg LY3337641

Arm Type

Experimental

Arm Description

Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Arm Title

Part B 10 mg LY3337641

Arm Type

Experimental

Arm Description

Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Arm Title

Part B 30 mg LY3337641

Arm Type

Experimental

Arm Description

Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Arm Title

Part B Placebo

Arm Type

Placebo Comparator

Arm Description

Given once a day for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

LY3337641

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to 6 Weeks

Title

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

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Week 12

Title

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

Description

Time Frame

Week 12

Title

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

Description

Time Frame

Baseline, Week 12

Title

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

Description

Time Frame

Week 12

Title

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

Description

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.

Time Frame

Week 12

Title

Pharmacokinetics (PK): Clearance Parameter of LY3337641

Description

Time Frame

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Desert Medical Advances

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Stanford University Hospital

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Denver Arthritis Center

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Innovative Research of West Florida

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Jeffrey Alper MD Research

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Sun Coast Clinical Research, Inc

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Lovelace Scientific Resources

City

Venice

State/Province

Florida

ZIP/Postal Code

34292

Country

United States

Facility Name

Center for Arthritis & Osteoporosis

City

Elizabethtown

State/Province

Kentucky

ZIP/Postal Code

42701

Country

United States

Facility Name

Clayton Medical Research

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

Rowan Regional Medical Center

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

PMG Research of Wilmington, LLC

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Accurate Clinical Research

City

League City

State/Province

Texas

ZIP/Postal Code

77573

Country

United States

Facility Name

Accurate Clinical Research

City

Nassau Bay

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Rheumatology and Immunotherapy Center

City

Franklin

State/Province

Wisconsin

ZIP/Postal Code

53132

Country

United States

Facility Name

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.

City

Buenos Aires

ZIP/Postal Code

C1430EGF

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1128AAF

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1204AAD

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1426AAL

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

c1440AAD

Country

Argentina

Facility Name

City

Cordoba

ZIP/Postal Code

X5000EDC

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

S2000CFJ

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

S2000PBJ

Country

Argentina

Facility Name

City

San Fernando

ZIP/Postal Code

B1646DBM

Country

Argentina

Facility Name

City

San Juan

ZIP/Postal Code

J5402DIL

Country

Argentina

Facility Name

City

San Miguel de Tucuman

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

City

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

City

Maroochydore

ZIP/Postal Code

4558

Country

Australia

Facility Name

City

Woodville South

ZIP/Postal Code

5011

Country

Australia

Facility Name

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

City

Torino

ZIP/Postal Code

10154

Country

Italy

Facility Name

City

Asahikawa

ZIP/Postal Code

070-8644

Country

Japan

Facility Name

City

Chiba

ZIP/Postal Code

275-8580

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

810-8539

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

810-8563

Country

Japan

Facility Name

City

Hokkaido

ZIP/Postal Code

060-0001

Country

Japan

Facility Name

City

Kitakyushu

ZIP/Postal Code

807-8556

Country

Japan

Facility Name

City

Nagano

ZIP/Postal Code

380-8582

Country

Japan

Facility Name

City

Omura

ZIP/Postal Code

856-8562

Country

Japan

Facility Name

City

Sapporo

ZIP/Postal Code

060-0004

Country

Japan

Facility Name

City

Sapporo

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

City

Sasebo

ZIP/Postal Code

857-1195

Country

Japan

Facility Name

City

Sendai

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

City

Jung-gu

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

07345

Country

Korea, Republic of

Facility Name

City

Col. Roma

ZIP/Postal Code

6700

Country

Mexico

Facility Name

City

Distrito Federal

ZIP/Postal Code

3100

Country

Mexico

Facility Name

City

Mexicali

ZIP/Postal Code

21100

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

06700

Country

Mexico

Facility Name

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

City

Gdansk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

03-291

Country

Poland

Facility Name

Office: Perez-De Jesus, Amarilis

City

Caguas

ZIP/Postal Code

00725

Country

Puerto Rico

Facility Name

Mindful Medical Research

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

Latin Clinical Trial Center

City

Santurce

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

City

Bratislava

ZIP/Postal Code

85101

Country

Slovakia

Facility Name

City

Zvolen

ZIP/Postal Code

96001

Country

Slovakia

Facility Name

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

City

Pinelands

ZIP/Postal Code

7405

Country

South Africa

Facility Name

City

Stellenbosch

ZIP/Postal Code

7600

Country

South Africa

Facility Name

City

Umhlanga

ZIP/Postal Code

4319

Country

South Africa

Facility Name

City

Alicante

ZIP/Postal Code

03570

Country

Spain

Facility Name

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://www.clinicalstudydatarequest.com/

Citations:

PubMed Identifier

33323529

Citation

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.

Results Reference

derived

Learn more about this trial

A Study of LY3337641 in Rheumatoid Arthritis

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