Status:

COMPLETED

A Study of Japanese Rheumatoid Arthritis Participants

Lead Sponsor:

Eli Lilly and Company

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

20-75 years

Phase:

PHASE1

Brief 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. A...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2014

    Estimated Enrollment :

    26 Patients enrolled

    Trial Details

    Trial ID

    NCT01253291

    Start Date

    May 1 2010

    End Date

    March 1 2014

    Last Update

    March 1 2019

    Active Locations (9)

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    Page 1 of 3 (9 locations)

    1

    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.

    Aichi, Japan, 460-0001

    2

    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.

    Chiba, Japan, 2892511

    3

    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.

    Fukui, Japan, 910-0067

    4

    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.

    Gunma, Japan, 370-0053