NCT01676701|TerminatedPhase 3Results

Study Stopped

Insufficient efficacy observed in study BCDM(NCT01198002) and BCDV(NCT01202773)

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

Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

14598H9B-MC-BCEF

Study Type

interventional

Target

Locations

6 countries

Sites

Timeline

RegisteredAug 2012

StartedSep 2012

CompletionAug 2013

Brief Summary

The purpose of this study is to evaluate the serum concentration of tabalumab after the administration using either prefilled syringe or auto-injector after the initial loading dose and after 12 weeks of treatment. Treatment period is followed by 40 weeks optional safety extension.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline

Completed

Started Sep 2012

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach

6 countries

37 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

August 29, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed

1 day until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed

4.7 years until next milestone

Results Posted

Study results publicly available

April 26, 2018

Completed

Last Updated

April 26, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

August 29, 2012

Results QC Date

March 24, 2018

Last Update Submit

March 24, 2018

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

Tabalumab Prefilled Syringe

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
Active RA (at least 8/68 tender and at least 8/66 swollen joints)
Screening C-reactive protein (CRP) \>1.2 times the upper limit of normal (ULN) or a screening erythrocyte sedimentation rate (ESR) \>28 millimeters per hour (mm/hr)
Documented history of, or current, positive rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (anti-CCP Ab) test
Regular use of methotrexate (MTX) for at least 12 weeks and stable dose (10 to 25 mg/week) for at least 8 weeks prior to baseline
American College of Rheumatology (ACR) functional class I, II, or III
Able and willing to inject tabalumab by themselves (or have an assistant who will inject tabalumab) and able and willing to complete all study procedures
Able and willing to have blood drawn for pharmacokinetic (PK) sampling

You may not qualify if:

Use of oral corticosteroids at average daily doses of \>10 milligrams per day (mg/day) of prednisone or its equivalent within 6 weeks prior to baseline
Injection of any parenteral (including intraarticular) corticosteroid within 6 weeks of baseline
Have previously discontinued treatment with a biologic disease-modifying antirheumatic drug (DMARD) or a novel drug that interrupts cytokine signaling \[for example, Janus kinase (JAK) inhibitors\] due to insufficient efficacy
Participants who had discontinued biologic DMARDS for reasons other than efficacy will not be excluded but must have done so prior to baseline
Participants who discontinued a JAK inhibitor for lack of efficacy
Participants who discontinued a JAK inhibitor for reasons other than efficacy will not be excluded, but must have done so prior to baseline for 21 days
Previous severe reaction to any biologic therapy that, in the opinion of the Investigator, would pose an unacceptable risk to the participant if participating in the study
Have had an inadequate response to treatment with 3 or more of the following DMARDs prescribed alone or in combination at approved doses for a minimum of 90 days: leflunomide, azathioprine, cyclosporine, and/or sulfasalazine
Use of other DMARDs (for example, gold salts, cyclosporin, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine, chloroquine, or sulfasalazine, or the use of a JAK inhibitor in the 8 weeks prior to baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

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

Location

Lewes, Delaware, 19958, United States

Location

DeBary, Florida, 32713, United States

Location

Tamarac, Florida, 33321, United States

Location

Indianapolis, Indiana, 46260, United States

Location

Prairie Village, Kansas, 66206, United States

Location

Lansing, Michigan, 48910, United States

Location

Springfield, Missouri, 68507, United States

Location

St Louis, Missouri, 63141, United States

Location

Las Vegas, Nevada, 89128, United States

Location

Freehold, New Jersey, 07728, United States

Location

Philadelphia, Pennsylvania, 19152, United States

Location

Wyomissing, Pennsylvania, 19610, United States

Location

Spokane, Washington, 99204, United States

Location

Buenos Aires, C1015ABO, Argentina

Location

Córdoba, 5000, Argentina

Location

Quilmes, B1878DVC, Argentina

Location

San Juan, 5400, Argentina

Location

San Miguel de Tucumán, 4000, Argentina

Location

Hostivice, 253-01, Czechia

Location

Plzen-Bory, 305 99, Czechia

Location

Prague, 140 59, Czechia

Location

Uherské Hradiště, 686 01, Czechia

Location

Zlín, 760 01, Czechia

Location

Bialystok, 15-351, Poland

Location

Bydgoszcz, 85-168, Poland

Location

Elblag, 82300, Poland

Location

Lublin, 20-607, Poland

Location

Poznan, 60-218, Poland

Location

Ponce, 00716, Puerto Rico

Location

San Juan, 00918, Puerto Rico

Location

Santurce, 00909, Puerto Rico

Location

Moscow, 119435, Russia

Location

Saint Petersburg, 194291, Russia

Location

Saratov, 410026, Russia

Location

Ulyanovsk, 432063, Russia

Location

Yaroslavl, 150003, Russia

Location

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

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 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 26, 2018

Results First Posted

April 26, 2018

Record last verified: 2018-03

Locations

RU(5)CZ(5)AR(5)PR(3)US(14)PL(5)

Brief Summary

Trial Health

Trial Health Score

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:

You may not 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

Study Design

Study Record Dates

Locations