At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
LY2127399drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate
In Brief
A Phase 1 clinical trial evaluating LY2127399 for Rheumatoid Arthritis. Completed, enrolled 26 participants across 9 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
First PostedDec 2010
Primary CompletionSep 2013
Study CompletionMar 2014
TodayJul 2026
First PostedDec 3, 2010
Enrollment StartMay 1, 2010
Primary CompletionSep 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.6 years ago
Interventions
LY2127399drug
Administered subcutaneously every 4 weeks for 48 weeks