A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Registration Number
- NCT02041091
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to evaluate the amount of tabalumab in the blood after it is given by two different injection methods - A traditional syringe or a spring loaded syringe for 12 weeks. Participants may continue to receive study drug for up to 52 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 226
- Diagnosis of Lupus.
- Able and willing to have blood drawn for PK sampling.
- Have severe active lupus nephritis.
- Have severe active central nervous system (CNS) or peripheral neurologic disease or other severe neurologic involvement requiring treatment within approximately 3 months prior to screening.
- Have received high dose corticosteroid within approximately 1 month prior to baseline.
- Have initiated or adjusted treatment with immunosuppressant drugs within approximately 1 month prior to baseline.
- Have received plasmapheresis within approximately 3 months prior to baseline.
- Have previously received approved or experimental B cell targeted therapies within the last year.
- Have received any biologic or non-biologic therapy within approximately 3 months or 5 half-lives (whichever is longer).
- Have a history of severe reaction to any biologic therapy.
- Have an active or recent infection within approximately 1 month prior to Week 0.
- Have had a serious infection within approximately 3 month or serious bone/joint infection within approximately 6 months prior to baseline.
- Have evidence of or test positive for active hepatitis B or are positive for hepatitis C or human immunodeficiency virus (HIV).
- Have evidence of active or latent tuberculosis.
- Have significant hematological abnormalities.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tabalumab Auto-Injector Tabalumab Auto-Injector Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks. Tabalumab Prefilled Syringe Tabalumab Prefilled Syringe Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by body weight (low \<60 kilograms (kg), medium 60kg- 100kg, high \>100kg). PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
Number of Participants Reporting Incomplete Tabalumab Dose Administration Week 0 through Week 12 Participants reporting incomplete dose administration from the study drug administration log.
Number of Participants Developing Anti-Tabalumab Antibodies Week 0 through Week 12 Participants with treatment-emergent anti-tabalumab antibodies were participants who had any samples from baseline up to and through Week 12 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of tabalumab. Percentage of participants with anti-tabalumab antibodies = (number of participants with treatment-emergent anti-tabalumab antibodies / number of participants assessed)\*100.
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score Week 0, Week 4 and Week 8 The SQAAQ is a 12-item questionnaire using a 7-point Likert scale (from "Strongly Disagree" as 1 to "Strongly Agree" as 7) that provides assessment of ease of use and confidence with using a prefilled syringe or auto-injector to administer a subcutaneous injection of drug. The 12 items are: A-Easy for me to learn how to use, B-Easy for me to unlock, C- Easy to hold in my hand when I inject my dose, D- Easy to inject my dose, E- Easy to know that my dose is complete, F- Easy to store the device in my refrigerator, G- Easy to remove needle shield/cover, H- Easy to pick up, I- Overall, easy to use, J- The device is stable against my skin during the injection, K- I am confident in my ability to use the device, L- I am confident my dose is complete.
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab Area under the concentration time curve in medium body weight group after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval , stratified by body weight (low \<60 kilograms (kg), medium 60kg- 100kg, high \>100kg).PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.
Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab Maximum serum concentration of tabalumab in medium body weight group, after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
Trial Locations
- Locations (42)
The Feinstein Institute for Medical Research
🇺🇸Manhasset, New York, United States
Medvin Clinical Research
🇺🇸Covina, California, United States
Desert Medical Advances
🇺🇸Palm Desert, California, United States
Wallace Rheumatic Study Center
🇺🇸Los Angeles, California, United States
TriWest Research Associates
🇺🇸El Cajon, California, United States
Inlande Rheumatology Clinical Trials
🇺🇸Upland, California, United States
Denver Arthritis Center
🇺🇸Denver, Colorado, United States
New England Research Associates
🇺🇸Trumbull, Connecticut, United States
Advanced Pharma Clinical Research
🇺🇸Miami, Florida, United States
Arthritis Research of Florida
🇺🇸Palm Harbor, Florida, United States
Indiana University Health
🇺🇸Indianapolis, Indiana, United States
The Arthritis & Diabetes Clinic Inc.
🇺🇸Monroe, Louisiana, United States
West Michigan Rheumatology
🇺🇸Grand Rapids, Michigan, United States
Clayton Medical Research
🇺🇸Saint Louis, Missouri, United States
Westroads Clinical Research-Omaha
🇺🇸Omaha, Nebraska, United States
Innovative Health Research
🇺🇸Las Vegas, Nevada, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Box Arthritis & Rheumatology of the Carolinas, PLLC
🇺🇸Charlotte, North Carolina, United States
Oklahoma Arthritis Center
🇺🇸Edmond, Oklahoma, United States
Paramount Medical Research
🇺🇸Middleburg Heights, Ohio, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
Shanahan Rheumatology & Immunotherapy
🇺🇸Raleigh, North Carolina, United States
Low Country Research Center
🇺🇸North Charleston, South Carolina, United States
Tekton Research, Inc.
🇺🇸Austin, Texas, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Clinical Research Center of Reading, LLP
🇺🇸Wyomissing, Pennsylvania, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Arthritis Northwest Rheumatology
🇺🇸Spokane, Washington, United States
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.
🇰🇷Seoul, Korea, Republic of
Virginia Clinical Research
🇺🇸Norfolk, Virginia, United States
Office: Perez de Jesus, Amarylis
🇵🇷Caguas, Puerto Rico
Ramon L. Ortega Colon
🇵🇷Carolina, Puerto Rico
GCM Medical Group PSC
🇵🇷San Juan, Puerto Rico
Mindful Medical Research
🇵🇷San Juan, Puerto Rico
Latin Clinical Trial Center
🇵🇷Santurce, Puerto Rico
New Horizon Research Center
🇺🇸Miami, Florida, United States
ProHealth Partners Medical Group
🇺🇸Long Beach, California, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Physician Research Collaboration, LLC
🇺🇸Lincoln, Nebraska, United States
(AOA) Arthritis & Osteoporosis Associates
🇺🇸Freehold, New Jersey, United States
Mountain State Clinical Research
🇺🇸Clarksburg, West Virginia, United States
PMG Research of Salisbury
🇺🇸Salisbury, North Carolina, United States