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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01236118 |
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Date of registration:
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04/11/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of LY2439821 in Rheumatoid Arthritis
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Scientific title:
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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 |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01236118 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1
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Countries of recruitment
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Japan
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Contacts
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Name:
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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) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: LY2439821
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Primary Outcome(s)
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Number of Participants With Adverse Events (AEs) [Clinically Significant Events]
[Time Frame: Baseline through study completion (up to Week 56)]
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Secondary ID(s)
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13625
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I1F-JE-RHAM
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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