A Study for Japanese Participants With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis Clinical Trial

Official title:

Multiple-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253226
• Other study ID #: 13060
• Secondary ID: H9B-JE-BCDK
• Status: Completed
• Phase: Phase 1
• Start date: September 2009
• Est. completion date: August 2011

Study information

• Verified date: October 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• LY2127399 (Tabalumab)
Administered subcutaneously
• Placebo
Administered subcutaneously

Locations

Country	Name	City	State
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) [Clinically Significant Effects]	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.	Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
Secondary	Pharmacokinetics (PK) of Tabalumab: Area Under the Concentration Time Curve (AUC)	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.	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
Secondary	PK of Tabalumab: Maximum Observed Drug Concentration (Cmax)	Cmax for the first SC injection of tabalumab is reported.	Week 0: Day 1 Predose, 1 h, 3 h, and 6 h postdose
Secondary	Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts	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.	Baseline, Week 0 (Day 2), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and 32
Secondary	Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody [Inova Enzyme-Linked Immunosorbent Assay (ELISA) Method]	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.	Baseline, Week 24
Secondary	Change From Baseline in Anti-CCP Antibody (Roche Cobas 6000 Method)	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.	Baseline, Week 24
Secondary	Change From Baseline in Rheumatoid Factor (RF)	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.	Baseline, Week 24
Secondary	Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)	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.	Baseline, Weeks 4, 16, 24, and 32
Secondary	Percent Change From Baseline in CRP	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.	Baseline, Weeks 4, 8, 16, and 24
Secondary	Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	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.	Baseline, Weeks 4, 8, 16, and 24