Rheumatoid Arthritis
Conditions
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).
Interventions
DRUGLY2439821
Administered subcutaneously
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) [Clinically Significant Events] | Baseline through study completion (up to Week 56) | 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. |
Countries
Japan
Participant flow
Pre-assignment details
Eligible participants must have completed Study I1F-JE-RHAL (NCT01253265) to meet the enrollment criteria of this study.
Participants by arm
| Arm | Count |
|---|---|
| 30 mg LY2439821 Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. | 6 |
| 80 mg LY2439821 Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and then Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. | 5 |
| 160 mg LY2439821 Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 Q2W subcutaneous injection for the first 3 doses then Q4W until Week 44. | 17 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 2 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 30 mg LY2439821 | 80 mg LY2439821 | 160 mg LY2439821 | Total |
|---|---|---|---|---|
| Age, Continuous | 53.2 years STANDARD_DEVIATION 15 | 61.2 years STANDARD_DEVIATION 8.1 | 57.6 years STANDARD_DEVIATION 11.4 | 57.3 years STANDARD_DEVIATION 11.6 |
| Body Mass Index (BMI) | 20.68 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 2.37 | 23.38 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.5 | 23.95 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 5.28 | 23.15 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 5 Participants | 17 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 161.62 centimeters (cm) STANDARD_DEVIATION 9.62 | 152.34 centimeters (cm) STANDARD_DEVIATION 6.2 | 159.52 centimeters (cm) STANDARD_DEVIATION 8.87 | 158.69 centimeters (cm) STANDARD_DEVIATION 8.9 |
| Number of Participants Given Doses in Study I1F-JE-RHAL (NCT01253265) LY2439821 | 4 participants | 4 participants | 14 participants | 22 participants |
| Number of Participants Given Doses in Study I1F-JE-RHAL (NCT01253265) Placebo | 2 participants | 1 participants | 3 participants | 6 participants |
| Race/Ethnicity, Customized Asian | 6 participants | 5 participants | 17 participants | 28 participants |
| Region of Enrollment Japan | 6 participants | 5 participants | 17 participants | 28 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 7 Participants | 10 Participants |
| Weekly Dose of Methotrexate (MTX) | 9.08 milligrams per week (mg/week) STANDARD_DEVIATION 1.86 | 8.40 milligrams per week (mg/week) STANDARD_DEVIATION 0.89 | 8.35 milligrams per week (mg/week) STANDARD_DEVIATION 0.79 | 8.52 milligrams per week (mg/week) STANDARD_DEVIATION 1.1 |
| Weight | 54.23 kilograms (kg) STANDARD_DEVIATION 9.69 | 54.12 kilograms (kg) STANDARD_DEVIATION 7.66 | 61.25 kilograms (kg) STANDARD_DEVIATION 15.55 | 58.47 kilograms (kg) STANDARD_DEVIATION 13.48 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 6 | 5 / 5 | 16 / 17 |
| serious Total, serious adverse events | 1 / 6 | 0 / 5 | 2 / 17 |
Outcome results
Primary
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.
Time frame: Baseline through study completion (up to Week 56)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 30 mg LY2439821 | Number of Participants With Adverse Events (AEs) [Clinically Significant Events] | AEs (Drug-Related) | 3 participants |
| 30 mg LY2439821 | Number of Participants With Adverse Events (AEs) [Clinically Significant Events] | AEs (All Causalities) | 6 participants |
| 30 mg LY2439821 | Number of Participants With Adverse Events (AEs) [Clinically Significant Events] | SAEs | 1 participants |
| 80 mg LY2439821 | Number of Participants With Adverse Events (AEs) [Clinically Significant Events] | AEs (Drug-Related) | 4 participants |
| 80 mg LY2439821 | Number of Participants With Adverse Events (AEs) [Clinically Significant Events] | AEs (All Causalities) | 5 participants |
| 80 mg LY2439821 | Number of Participants With Adverse Events (AEs) [Clinically Significant Events] | SAEs | 0 participants |
| 160 mg LY2439821 | Number of Participants With Adverse Events (AEs) [Clinically Significant Events] | AEs (All Causalities) | 16 participants |
| 160 mg LY2439821 | Number of Participants With Adverse Events (AEs) [Clinically Significant Events] | SAEs | 2 participants |
| 160 mg LY2439821 | Number of Participants With Adverse Events (AEs) [Clinically Significant Events] | AEs (Drug-Related) | 7 participants |