- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01253265
A Study in Rheumatoid Arthritis
April 20, 2016 updated by: Eli Lilly and Company
Multiple-Dose, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate Treatment
The purpose of this study is to evaluate the safety and tolerability of multiple doses of LY2439821 in Japanese patients with rheumatoid arthritis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan, 820-8505
- 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.
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Hyogo, Japan, 673-1462
- 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.
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Ibaragi, Japan, 316-0035
- 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.
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Nagasaki, Japan, 857-1165
- 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.
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Niigata, Japan, 940-2085
- 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.
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Okayama, Japan, 712-8044
- 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.
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Shimane, Japan, 699-0293
- 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.
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Tokyo, Japan, 164-8541
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ambulatory male or female patients between the ages of 20 and 75 years
- Male patients: 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 patients: 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.
- Patients who are between the body weight of 40 and 105 kilogram (kg)
- Patients who have an established diagnosis of Rheumatoid Arthritis (RA)
- Patients who have C reactive protein (CRP) measurement greater than the upper limit of normal or erythrocyte sedimentation rate of at least 28 millimeters per hour (mm/hr)
- Patients who have been treated with regular use of Methotrexate (MTX) for at least 12 weeks, and stable treatment (at least 7.5 milligrams per week (mg/week)) for at least 8 weeks
- Patients who have given written informed consent approved by the Sponsor and the Institutional Review Board (IRB) governing the investigational site
- Patients who have reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Exclusion Criteria:
- Patients who use oral corticosteroids at average daily doses of >10 mg/day of prednisone or its equivalent or use of variable doses of oral corticosteroids within the last 4 weeks
- Patients who have had a live vaccination within the last 12 weeks, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical study within the last 12 weeks
- Patients who have a diagnosis of any systemic inflammatory condition other than RA
- Patients who have evidence of active vasculitis or uveitis
- Patients who have a diagnosis of Felty's syndrome
- Patients who have had surgical treatment of a joint within the last 8 weeks, or will require it during the study
- Patients who have had lymphoma, leukemia, or any malignancy within the last 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease
- Patients who have suffered a serious bacterial infection within the last 12 weeks, or a recent or ongoing infection
- Patients who have an evidence or suspicion of active tuberculosis (TB) by medical history, physical examination, and/or chest radiograph or documentation of TB by a positive purified protein derivative (PPD) test
- Patients who have uncontrolled arterial hypertension characterized by a systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg
- Patients who have an evidence of positive hepatitis B (HBV) surface antigen, positive hepatitis B surface antibody, positive hepatitis B core antibody, or hepatitis B DNA (HBV DNA); an evidence of human immunodeficiency virus (HIV), evidence of hepatitis B; or an evidence of hepatitis C
- Patients who have clinical laboratory test results at entry that are outside the normal reference range, or results with unacceptable deviations that are considered clinically significant by the investigator
- Patients who have a serum creatinine >2.0 milligrams per deciliter (mg/dL)
- Patients who have known hypogammaglobulinemia or a serum immunoglobulin (Ig) G (IgG), IgM, or IgA concentration less than the lower limit of normal
- Patients who have an abnormality in the 12 lead electrocardiogram (ECG).
- Patients who have donated of blood more than 200 mL within the past 30 days, or more than 400 milliliters (mL) within the past 90 days
- Patients who are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. For unapproved Disease-Modifying Anti-Rheumatic Drug (DMARDs), have received 30 days or 5 fold of the half life prior to inclusion whichever is longer
- Patients who previously completed or withdrawn from this study or any other study investigating LY2439821
- Patients who have been treated with any biologic DMARD currently or previously for 5 half lives
- Patients who have had serious reaction to other biologic Disease-Modifying Anti-Rheumatic Drug (DMARDs)
- Patients who have received non biologics DMARDs (other than MTX, sulfasalazine, bucillamine or hydroxychloroquine)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 30 mg LY2439821
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
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Administered subcutaneously
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Experimental: 80 mg LY2439821
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
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Administered subcutaneously
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Experimental: 180 mg LY2439821
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
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Administered subcutaneously
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Placebo Comparator: Placebo
Placebo is administered subcutaneously in the same manner as active drug in each dose group
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Administered subcutaneously
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Experimental: 120 mg LY2439821
Administered subcutaneously at 240 mg as a single loading dose followed by 120 mg every week
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Administered subcutaneously
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Clinically Significant Effects
Time Frame: Baseline up to 26 weeks
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Clinically significant events were defined as serious and other non-serious adverse events.
A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.
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Baseline up to 26 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein
Time Frame: Baseline, 16 weeks
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C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter.
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Baseline, 16 weeks
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Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR)
Time Frame: Baseline, 16 weeks
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Erythrocyte Sedimentation Rate (ESR) is a disease related biomarker and measured in millimeters per hour (mm/h).
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Baseline, 16 weeks
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Change From Baseline to 26 Week Endpoint in Neutrophil Counts
Time Frame: Baseline, 26 weeks
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Baseline, 26 weeks
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Change From Baseline to 26 Week Endpoint in Lymphocyte Counts
Time Frame: Baseline, 26 weeks
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Baseline, 26 weeks
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Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss)
Time Frame: Week 10 pre-dose up to 2 weeks post-dose (Week 12)
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AUCτ,ss= area under the concentration versus time curve (τ) at steady state (ss)
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Week 10 pre-dose up to 2 weeks post-dose (Week 12)
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Pharmacokinetics - Maximum Plasma Drug Concentration (Cmax) at Steady State (ss)
Time Frame: Week 10 pre-dose up to 2 weeks post-dose (Week 12)
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Cmax,ss = maximum observed drug concentration (Cmax) at steady state (ss)
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Week 10 pre-dose up to 2 weeks post-dose (Week 12)
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Pharmacokinetics - Time of Maximum Observed Drug Concentration (Tmax) at Steady State (ss)
Time Frame: Week 10 pre-dose up to 2 weeks post-dose (Week 12)
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tmax,ss = time of maximum observed drug concentration (tmax) at steady state (ss)
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Week 10 pre-dose up to 2 weeks post-dose (Week 12)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
December 1, 2010
First Submitted That Met QC Criteria
December 1, 2010
First Posted (Estimate)
December 3, 2010
Study Record Updates
Last Update Posted (Estimate)
May 26, 2016
Last Update Submitted That Met QC Criteria
April 20, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13061
- I1F-JE-RHAL (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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