Trials Sponsors Conditions Drugs Pricing

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (2)

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose
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.
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose
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.
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 (7)

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
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
Number of Participants Reporting Incomplete Tabalumab Dose Administration
Week 0 through Week 12
Number of Participants Developing Anti-Tabalumab Antibodies
Week 0 through Week 12
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0, Week 4 and Week 8
+2 more secondary outcomes

Study Arms (2)

Tabalumab Auto-Injector

EXPERIMENTAL

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.

Drug: Tabalumab Auto-Injector

Tabalumab Prefilled Syringe

EXPERIMENTAL

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.

Drug: Tabalumab Prefilled Syringe

Interventions

Tabalumab Auto-InjectorDrug

Administered SC

Also known as: LY2127399

Tabalumab Auto-Injector

Tabalumab Prefilled SyringeDrug

Administered SC

Also known as: LY2127399

Tabalumab Prefilled Syringe

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Eli Lilly and Company
Industrylead

Study Sites (44)

Medvin Clinical Research

Covina, California, 91723, United States

TriWest Research Associates

El Cajon, California, 92020, United States

ProHealth Partners Medical Group

Long Beach, California, 90808, United States

Wallace Rheumatic Study Center

Los Angeles, California, 90048, United States

Desert Medical Advances

Palm Desert, California, 92260, United States

Inlande Rheumatology Clinical Trials

Upland, California, 91786, United States

Denver Arthritis Center

Denver, Colorado, 80230, United States

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

tabalumab

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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 DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Enrollment

226 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 20, 2014

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (2)

Tabalumab Auto-Injector

Tabalumab Prefilled Syringe

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (44)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (2)

Tabalumab Auto-Injector

Tabalumab Prefilled Syringe

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (44)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations