A Study of Japanese Rheumatoid Arthritis Participants

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior LY2127399 clinical study. At the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to assess B-cell recovery.

Official Title
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An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: LY2127399


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Have given written informed consent Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation Must have completed treatment and 12 week follow up period in prior LY2127399 study NCT01253226 [Study H9B-JE-BCDK (BCDK)] Exclusion criteria Have had any safety event during the previous LY2127399 (BCDK) study that participants participated in Have received, during previous study (BCDK), any drugs prohibited in the study protocol which includes unapproved drugs, live vaccines, or any biologic or non-biologic disease-modifying anti-rheumatic drug (DMARD) except for, methotrexate (MTX), hydroxychloroquine, sulfasalazine or bucillamine

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30mg/120 mg LY2127399<br>Participants in the 30 milligrams (mg) every 4 weeks arm of the lead-in study will receive 30 mg every 4 weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead-in study. | Drug: LY2127399<br>* Administered subcutaneously every 4 weeks for 48 weeks<br>* Other names: tabalumab;|
| Experimental: 120 mg LY2127399<br>Participants in the 60 mg every 4 weeks, 120 mg every 4 weeks and 120 mg every 2 weeks arms of the lead-in study will receive 120 mg every 4 weeks as these participants will enroll in this study after the safety of the 120 mg every 4 weeks dose in the lead-in study is confirmed. | Drug: LY2127399<br>* Administered subcutaneously every 4 weeks for 48 weeks<br>* Other names: tabalumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module. | Baseline up to 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody | Anti-CCP is a disease related peripheral blood biomarker used to assess disease progression of rheumatoid arthritis (RA). A reduction in anti-CCP values indicates an improvement. | Baseline and Weeks 12, 24, 36, 52, and 72 | 
| Percent Change From Baseline in Rheumatoid Factor (RF) | RF is a disease-related, peripheral blood biomarker used to assess disease progression of RA. A reduction in RF values indicate an improvement in RA symptoms. | Baseline and Weeks 12, 24, 36, 52, and 72 | 
| Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA] | IgG, IgM and IgA are disease related peripheral blood biomarkers used to assess disease progression of RA. A reduction in Ig values indicate an improvement in RA symptoms. | Baseline and Weeks 12, 24, 36, 52, and 72 | 
| Percent Change From Baseline in CD20+ B-cell Count | CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CD20+ B-cell values indicate an improvement in RA symptoms. | Baseline and Weeks 12, 24, 36, 52, and 72 | 
| Percent Change From Baseline in Peripheral B-cell Subsets | Peripheral B cell subsets (Mature Naive B-cells and Switched Memory B cells) are disease-related peripheral blood biomarkers used to assess disease progression of RA. A reduction in cell values indicate an improvement in RA symptoms. | Baseline and Weeks 12, 24, 36, 52, and 72 | 
| Percent Change From Baseline in C-Reactive Protein (CRP) | CRP is a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CRP values indicate an improvement in RA symptoms. | Baseline and Weeks 12, 24, 36, 52, and 72 | 
| Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | ESR is a disease related peripheral blood biomarker used to assess, in part, the effect of LY2127399 on the participants' RA disease progression. A reduction in ESR values indicate an improvement in RA symptoms. | Baseline and Weeks 12, 24, 36, 52, and 72 |