- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01253226
A Study for Japanese Participants With Rheumatoid Arthritis (RA)
October 19, 2018 updated by: Eli Lilly and Company
Multiple-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate
This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA.
The study consists of a 20-week treatment period.
All participants will be followed for up to 12 weeks after the last study drug administration.
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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Aichi, Japan
- 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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Chiba, Japan
- 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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Fukui, Japan
- 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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Gunma, Japan
- 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
- 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
- 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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Kanagawa, Japan
- 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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Miyagi, Japan
- 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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Osaka, Japan
- 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
- 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:
- Have given written informed consent
- Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
- Diagnosis of RA
- Active RA
- Current, regular use of Methotrexate, at a stable dose
- Body weight between 40 and 105 kilograms (kg), inclusive
Exclusion Criteria:
- Use of excluded medications (reviewed by study doctor)
- Have medical findings which, in the opinion of the study doctor, put participant at an unacceptable risk for participation in the study
- Have had recent or ongoing infection which, in the opinion of the study doctor put participant at an unacceptable risk for participation
- Evidence of tuberculosis
- Have systemic inflammatory condition other than RA
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 30 milligrams (mg) Tabalumab
30 mg tabalumab every 4 weeks (Q4W) for 20 weeks (6 doses of study drug)
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Administered subcutaneously
Other Names:
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Experimental: 60 mg Tabalumab
60 mg tabalumab Q4W for 20 weeks (6 doses of study drug)
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Administered subcutaneously
Other Names:
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Experimental: 120 mg Tabalumab
120 mg tabalumab Q4W for 20 weeks (6 doses of study drug)
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Administered subcutaneously
Other Names:
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Placebo Comparator: Placebo Q4W
Q4W for 20 weeks
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Administered subcutaneously
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Experimental: 120 mg once every 2 weeks (Q2W) Tabalumab
Initial loading dose of 240 mg tabalumab followed by 120 mg Q2W for 20 weeks (10 doses of study drug)
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Administered subcutaneously
Other Names:
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Placebo Comparator: Placebo Q2W
Q2W for 20 weeks
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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 Adverse Events (AEs) [Clinically Significant Effects]
Time Frame: Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
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Clinically significant effects are defined as serious AEs (SAEs) and other non-serious AEs regardless of causality.
A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
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Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK) of Tabalumab: Area Under the Concentration Time Curve (AUC)
Time Frame: Week 0: Day 1 [predose and 1 hour (h), 3 h, and 6 h postdose], Days 2, 3, and 5, and Weeks 1, 2, 3, and 4 postdose
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The following parameters are reported for the first SC injection of tabalumab: AUC(0-tlast) defined as AUC from time 0 to time t, where t is the time at the end of the dosing interval; AUC(0-2W) defined as AUC from time 0 to Week 2; and AUC(0-tau) defined as AUC during 1 dosing interval at steady state.
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Week 0: Day 1 [predose and 1 hour (h), 3 h, and 6 h postdose], Days 2, 3, and 5, and Weeks 1, 2, 3, and 4 postdose
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PK of Tabalumab: Maximum Observed Drug Concentration (Cmax)
Time Frame: Week 0: Day 1 Predose, 1 h, 3 h, and 6 h postdose
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Cmax for the first SC injection of tabalumab is reported.
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Week 0: Day 1 Predose, 1 h, 3 h, and 6 h postdose
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Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Time Frame: Baseline, Week 0 (Day 2), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and 32
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B-lymphocyte antigen, CD20+, is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells.
Percent change from baseline in B cell counts=[(post-baseline CD20+ B cell count-baseline CD20+ B cell count)/(baseline CD20+ B cell count)]*100.
A negative change indicates a decrease in cell count.
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Baseline, Week 0 (Day 2), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and 32
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Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody [Inova Enzyme-Linked Immunosorbent Assay (ELISA) Method]
Time Frame: Baseline, Week 24
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During the analysis of anti-CCP, the analytical method was changed from the Inova ELISA method to the Roche Cobas 6000 method due to the discontinuation of a reagent used in the Inova ELISA method.
The anti-CCP data are summarized separately for samples collected before and after the method change.
No post-baseline samples from the 120 mg tabalumab Q4W and Q2W cohorts were analyzed using the Inova ELISA method.
For both methods, a decrease in anti-CCP antibodies indicated an improvement in the participant's condition.
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Baseline, Week 24
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Change From Baseline in Anti-CCP Antibody (Roche Cobas 6000 Method)
Time Frame: Baseline, Week 24
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During the analysis of anti-CCP, the analytical method was changed from the Inova ELISA method to the Roche Cobas 6000 method due to the discontinuation of a reagent used in the Inova ELISA method.
The anti-CCP data are summarized separately for samples collected before and after the method change.
No baseline samples from the 30 mg, 60 mg, and 120 mg tabalumab Q4W cohorts were analyzed using the Roche Cobas 6000 method.
For both methods, a decrease in anti-CCP antibodies indicated an improvement in the participant's condition.
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Baseline, Week 24
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Change From Baseline in Rheumatoid Factor (RF)
Time Frame: Baseline, Week 24
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RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis (RA).
Higher RF levels indicate an aggressive RA and a higher risk of joint damage.
A decrease in RF levels indicate an improvement in the participant's condition.
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Baseline, Week 24
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Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
Time Frame: Baseline, Weeks 4, 16, 24, and 32
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Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses.
Their normal blood levels indicate proper immune status.
Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported.
A negative change indicates a decrease in immunoglobulin levels.
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Baseline, Weeks 4, 16, 24, and 32
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Percent Change From Baseline in CRP
Time Frame: Baseline, Weeks 4, 8, 16, and 24
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CRP is an indicator of inflammation.
The percent change from baseline in CRP=[(post-baseline CRP- baseline CRP)/(baseline CRP)]*100.
A negative change indicates an improvement in the participant's condition.
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Baseline, Weeks 4, 8, 16, and 24
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Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time Frame: Baseline, Weeks 4, 8, 16, and 24
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ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Reference ranges are gender-specific and can vary slightly among laboratories.
The normal range is approximately ≤10 millimeters per hour (mm/h) for males and ≤20 mm/h for females.
Higher scores indicate greater inflammation.
The percent change from baseline in ESR=[(post-baseline ESR- baseline ESR)/(baseline ESR)]*100.
A decrease in ESR indicates an improvement in the participant's condition.
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Baseline, Weeks 4, 8, 16, and 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: 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 ), Eli Lilly and Company
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
September 1, 2009
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 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 (Actual)
October 23, 2018
Last Update Submitted That Met QC Criteria
October 19, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13060
- H9B-JE-BCDK (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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