Trials Sponsors Conditions Drugs Pricing

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose
Days 4, 7, 9, 11, and 14 after loading dose administered
PK: Area Under the Concentration Time Curve From Time 0 to 14 Days [AUC(0-14)]
Days 4, 7, 9, 11, and 14 after loading dose administered

Secondary Outcomes (8)

Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set
Baseline, Week 12
Percentage of Participants Achieving ACR Response
Week 12
Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index
Baseline, Week 12
Change From Baseline to 12-Week Endpoint in Disease Activity Score Based on a 28-Joint Count and C-Reactive Protein (DAS28-CRP) Level
Baseline, Week 12
Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28)
Week 12
+3 more secondary outcomes

Study Arms (2)

Tabalumab Auto-Injector

EXPERIMENTAL

Tabalumab 180 milligram (mg) loading dose administered using auto-injectors at Week 0 as 2 subcutaneous (SC) injections (90 mg each), followed by a 90 mg SC injection every 2 weeks (Q2W) up to Week 12.

Drug: Tabalumab Auto-Injector

Tabalumab Prefilled Syringe

EXPERIMENTAL

Tabalumab 180 mg loading dose administered using prefilled syringes at Week 0 as 2 SC injections (90 mg each), followed by a 90 mg SC injection Q2W up to Week 12.

Drug: Tabalumab Prefilled Syringe

Interventions

Tabalumab Auto-InjectorDrug

Administered SC by auto-injector

Also known as: LY2127399

Tabalumab Auto-Injector

Tabalumab Prefilled SyringeDrug

Administered SC by prefilled syringe

Also known as: LY2127399

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Ambulatory males or females ≥18 years of age
Diagnosis of adult-onset RA

Sponsors & Collaborators

Eli Lilly and Company
Industrylead

Study Sites (37)

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.

Glendale, Arizona, 85304, United States

Lewes, Delaware, 19958, United States

DeBary, Florida, 32713, United States

Tamarac, Florida, 33321, United States

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tabalumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

Due to early termination of the trial, no participant had outcome measure data analyzed. Participants who received study treatment had disposition, demographic, and adverse event data reported.

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

8 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

August 29, 2012

First Posted

August 31, 2012

Study Start

September 2012

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (2)

Tabalumab Auto-Injector

Tabalumab Prefilled Syringe

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (37)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (2)

Tabalumab Auto-Injector

Tabalumab Prefilled Syringe

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (37)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations