Clinical trial NCT02041091: A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
Official title: Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lupus Erythematosus, Systemic
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Lupus.
* Able and willing to have blood drawn for PK sampling.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose
timeFrame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose
timeFrame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Secondary outcomes:
measure: Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight
timeFrame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
measure: Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight
timeFrame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
measure: Number of Participants Reporting Incomplete Tabalumab Dose Administration
timeFrame: Week 0 through Week 12
measure: Number of Participants Developing Anti-Tabalumab Antibodies
timeFrame: Week 0 through Week 12
measure: Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
timeFrame: Week 0, Week 4 and Week 8
measure: Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications
timeFrame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
measure: Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications
timeFrame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Other outcomes:
Locations:
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates
state: California
city: Long Beach
country: United States
facility: ProHealth Partners Medical Group
state: California
city: Los Angeles
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Upland
country: United States
facility: Inlande Rheumatology Clinical Trials
state: California
city: Denver
country: United States
facility: Denver Arthritis Center
state: Colorado
city: Trumbull
country: United States
facility: New England Research Associates
state: Connecticut
city: Miami
country: United States
facility: Advanced Pharma Clinical Research
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Research of Florida
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Monroe
country: United States
facility: The Arthritis & Diabetes Clinic Inc.
state: Louisiana
city: Grand Rapids
country: United States
facility: West Michigan Rheumatology
state: Michigan
city: Saint Louis
country: United States
facility: Clayton Medical Research
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Omaha
country: United States
facility: Westroads Clinical Research-Omaha
state: Nebraska
city: Las Vegas
country: United States
facility: Innovative Health Research
state: Nevada
city: Freehold
country: United States
facility: (AOA) Arthritis & Osteoporosis Associates
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: Charlotte
country: United States
facility: Box Arthritis & Rheumatology of the Carolinas, PLLC
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Raleigh
country: United States
facility: Shanahan Rheumatology & Immunotherapy
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research
state: Ohio
city: Edmond
country: United States
facility: Oklahoma Arthritis Center
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLP
state: Pennsylvania
city: North Charleston
country: United States
facility: Low Country Research Center
state: South Carolina
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Spokane
country: United States
facility: Arthritis Northwest Rheumatology
state: Washington
city: Clarksburg
country: United States
facility: Mountain State Clinical Research
state: West Virginia
city: Daejeon
country: Korea, Republic of
facility: 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.
city: Incheon
country: Korea, Republic of
facility: 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.
city: Seoul
country: Korea, Republic of
facility: 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.
city: Caguas
country: Puerto Rico
facility: Office: Perez de Jesus, Amarylis
city: Carolina
country: Puerto Rico
facility: Ramon L. Ortega Colon
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research
city: Santurce
country: Puerto Rico
facility: Latin Clinical Trial Center
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: