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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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12 December 2020 |
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Main ID: |
NCT00380744 |
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Date of registration:
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22/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis
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Scientific title:
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A Phase 1b/2 Multiple-Dose Safety Study and Pharmacokinetic/ Pharmacodynamic Study of LY2189102 in Patients With Rheumatoid Arthritis |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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121 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00380744 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Argentina
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Hungary
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Poland
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Spain
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United States
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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 9AM - 5PM 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:
- diagnosis of rheumatoid arthritis
- regular use of methotrexate
- active rheumatoid arthritis
Exclusion Criteria:
- Juvenile Rheumatoid Arthritis
- evidence of tuberculosis
- women who are pregnant or become pregnant during study, or are breast-feeding
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Arthritis, Rheumatoid
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Intervention(s)
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Drug: LY2189102
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Drug: placebo
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Primary Outcome(s)
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Number of Participants With Adverse Events (AEs)
[Time Frame: Baseline up to Day 98]
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Secondary Outcome(s)
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Change From Baseline in Simple Disease Activity Index Score (SDAI)
[Time Frame: Baseline, Days 7, 21, 35, 63, and 98]
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Change From Baseline in C-Reactive Protein (CRP)
[Time Frame: Baseline, Days 7, 14, 21, 28, 35, 63, and 98]
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Change From Baseline in Health Assessment Questionnaire (HAQ) Score
[Time Frame: Baseline, Days 35, 63, and 98]
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Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval Time 0 to 168 Hours (AUC0-168 hr,ss) of LY2189102
[Time Frame: Part A: Day 1 predose and IAI, 2days post infusion, Day 14 and Day 28 predose and IAI, Day 35, 63 (convenient time)]
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Change From Baseline in Disease Activity Score 28-Joint Count (DAS28)
[Time Frame: Baseline, Days 7, 21, 35, 63, and 98]
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Secondary ID(s)
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H9C-MC-BBDE
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8705
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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