Back to resultsA Study of LY2439821 in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
LY2439821
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Participants who have received 7 injections of LY2439821 subcutaneously in the 30-, 80-, or 180-mg dose cohorts, or 11 injections in the 240-mg loading dose/120-mg once-a-week maintenance dose group, and completed the follow-up period (14 weeks) in Study I1F-JE-RHAL ((NCT01253265).
Ambulatory male or female participants.
- Male participants: Agree to use a reliable method of birth control during the study including barrier contraceptives or a monogamous relationship with a partner who is not child bearing.
- Female participants: Are women who test negative for pregnancy at the time of entry based on a pregnancy test and are not breast feeding. Women of child bearing potential must agree to use a reliable method of birth control during the study.
- Participants who have been treated with methotrexate (MTX) throughout Study I1F-JE-RHAL (NCT01253265). Bucillamine, sulfasalazine and/or hydroxychloroquine are allowed to be administered in addition to MTX. In such a case, the participant needs to have been on a stable dose of the drug(s) throughout Study I1F-JE-RHAL (NCT01253265) and I1F-JE-RHAM.
- Participants who have given written informed consent approved by the Sponsor and the Institutional Review Board (IRB) governing the investigational site.
Exclusion Criteria:
- Participants who have had, during Study I1F-JE-RHAL (NCT01253265), any safety event including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment , that in the opinion of the investigator poses an unacceptable risk to participation in this study.
Participants who have any of the following abnormalities of clinical laboratory test results by Week 26 of Study I1F-JE-RHAL (NCT01253265):
- Absolute neutrophil count <1000 cells/microliters (μL);
- Lymphocyte count <500 cells/μL; or
- White Blood Cells (WBC) count <2000 cells/μL
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
30 milligrams (mg) LY2439821
80 mg LY2439821
160 mg LY2439821
Arm Description
Participants will start receiving LY2439821 30 mg once every week for the first 3 doses and then once every 2 weeks until week 44. Investigators or its designees will increase the LY2439821 dose to 160 mg at any visit once the safety of LY2439821 180 mg is confirmed by the Data Review Meeting in Study I1F-JE-RHAL (NCT01253265).
Participants will start receiving LY2439821 80 mg once every week for the first 3 doses and then once every 2 weeks until week 44. Investigators or its designees will increase the LY2439821 dose to 160 mg at any visit once the safety of LY2439821 180 mg is confirmed by the Data Review Meeting in Study I1F-JE-RHAL (NCT01253265).
Participants will start receiving LY2439821 160 mg once every 2 weeks for the first 3 doses and then once every 4 weeks until Week 44.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events (AEs) [Clinically Significant Events]
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01236118
Brief Title
A Study of LY2439821 in Rheumatoid Arthritis
Official Title
An Open-Label Extension Study to Evaluate Safety and Tolerability of Multiple Subcutaneous Doses of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of LY2439821 subcutaneously administered for 48 weeks in Japanese participants with rheumatoid arthritis who have completed Study I1F-JE-RHAL (NCT01253265).
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 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
30 milligrams (mg) LY2439821
Arm Type
Experimental
Arm Description
Participants will start receiving LY2439821 30 mg once every week for the first 3 doses and then once every 2 weeks until week 44. Investigators or its designees will increase the LY2439821 dose to 160 mg at any visit once the safety of LY2439821 180 mg is confirmed by the Data Review Meeting in Study I1F-JE-RHAL (NCT01253265).
Arm Title
80 mg LY2439821
Arm Type
Experimental
Arm Description
Participants will start receiving LY2439821 80 mg once every week for the first 3 doses and then once every 2 weeks until week 44. Investigators or its designees will increase the LY2439821 dose to 160 mg at any visit once the safety of LY2439821 180 mg is confirmed by the Data Review Meeting in Study I1F-JE-RHAL (NCT01253265).
Arm Title
160 mg LY2439821
Arm Type
Experimental
Arm Description
Participants will start receiving LY2439821 160 mg once every 2 weeks for the first 3 doses and then once every 4 weeks until Week 44.
Intervention Type
Drug
Intervention Name(s)
LY2439821
Intervention Description
Administered subcutaneously
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) [Clinically Significant Events]
Description
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.
Time Frame
Baseline through study completion (up to Week 56)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who have received 7 injections of LY2439821 subcutaneously in the 30-, 80-, or 180-mg dose cohorts, or 11 injections in the 240-mg loading dose/120-mg once-a-week maintenance dose group, and completed the follow-up period (14 weeks) in Study I1F-JE-RHAL ((NCT01253265).
Ambulatory male or female participants.
Male participants: Agree to use a reliable method of birth control during the study including barrier contraceptives or a monogamous relationship with a partner who is not child bearing.
Female participants: Are women who test negative for pregnancy at the time of entry based on a pregnancy test and are not breast feeding. Women of child bearing potential must agree to use a reliable method of birth control during the study.
Participants who have been treated with methotrexate (MTX) throughout Study I1F-JE-RHAL (NCT01253265). Bucillamine, sulfasalazine and/or hydroxychloroquine are allowed to be administered in addition to MTX. In such a case, the participant needs to have been on a stable dose of the drug(s) throughout Study I1F-JE-RHAL (NCT01253265) and I1F-JE-RHAM.
Participants who have given written informed consent approved by the Sponsor and the Institutional Review Board (IRB) governing the investigational site.
Exclusion Criteria:
Participants who have had, during Study I1F-JE-RHAL (NCT01253265), any safety event including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment , that in the opinion of the investigator poses an unacceptable risk to participation in this study.
Participants who have any of the following abnormalities of clinical laboratory test results by Week 26 of Study I1F-JE-RHAL (NCT01253265):
Absolute neutrophil count <1000 cells/microliters (μL);
Lymphocyte count <500 cells/μL; or
White Blood Cells (WBC) count <2000 cells/μL
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
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
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
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
Hyogo
ZIP/Postal Code
673-1462
Country
Japan
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
Nagasaki
ZIP/Postal Code
857
Country
Japan
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
Niigata
ZIP/Postal Code
940-2085
Country
Japan
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
Okayama
ZIP/Postal Code
712-8044
Country
Japan
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
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of LY2439821 in Rheumatoid Arthritis
We'll reach out to this number within 24 hrs