Brief Summary

To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in participants with Rheumatoid Arthritis

Trial Health

On Track

Trial Health Score

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

Enrollment

182

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline

Completed

Started Feb 2009

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach

13 countries

61 active sites

Status

completed

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

2.9 years study duration

Study Start

First participant enrolled

February 1, 2009

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed

6.3 years until next milestone

Results Posted

Study results publicly available

April 25, 2018

Completed

Last Updated

April 25, 2018

Status Verified

March 1, 2018

Enrollment Period

1.9 years

First QC Date

February 3, 2009

Results QC Date

March 24, 2018

Last Update Submit

March 24, 2018

Conditions

Rheumatoid Arthritis

Keywords

Arthritis

Outcome Measures

Primary Outcomes (2)

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early \[early discontinuation (ED)\], the post-study treatment follow-up started immediately afterwards. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\].
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
For each planned laboratory evaluation, the range of values to be reported as AEs, regardless of causality, was pre-specified. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\].
Baseline through Week 112

Secondary Outcomes (22)

Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set]
Baseline, up to and through Week 52
Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)
Baseline, up to and through Week 52
Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)
Baseline, up to and through Week 52
Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)
Baseline, up to and through Week 52
Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set]
Baseline, up to and through Week 52
+17 more secondary outcomes

Other Outcomes (1)

Number of Participants Who Died, Any Cause
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 72 and start of Week 73 up to and through Week 112)

Study Arms (1)

LY2127399

EXPERIMENTAL

Biological: LY2127399

Interventions

LY2127399BIOLOGICAL

60 milligrams \[(mg) with potential for dose escalation to 120 mg\] subcutaneously every 4 weeks for 48 weeks

LY2127399

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Have given written informed consent
Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
Have participated in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)

You may not qualify if:

Have had, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any safety event, \[including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment\] that in the opinion of the investigator poses an unacceptable risk to participation in the study.
Have received, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any drug not allowed by the study protocol including unapproved drugs, biologic disease-modifying anti-rheumatic drugs (DMARDs), or live vaccines.
Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (62)

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.

Birmingham, Alabama, 35205, United States

Location

Huntsville, Alabama, 35801, United States

Location

Mesa, Arizona, 85208, United States

Location

Palm Desert, California, 92260, United States

Location

Riverside, California, 92501, United States

Location

Santa Maria, California, 93454, United States

Location

Upland, California, 91786, United States

Location

Jupiter, Florida, 33458, United States

Location

Vero Beach, Florida, 32960, United States

Location

Zephyrhills, Florida, 33542, United States

Location

Baltimore, Maryland, 21239, United States

Location

St Louis, Missouri, 63141, United States

Location

Hickory, North Carolina, 28601, United States

Location

Middleburg Heights, Ohio, 44130, United States

Location

Philadelphia, Pennsylvania, 19152, United States

Location

Orangeburg, South Carolina, 29118, United States

Location

Memphis, Tennessee, 38119, United States

Location

Dallas, Texas, 75231, United States

Location

Mesquite, Texas, 75150, United States

Location

Elizabeth Vale, South Australia, 5112, Australia

Location

Vienna, 1100, Austria

Location

Liège, 4000, Belgium

Location

Campinas, 13015-011, Brazil

Location

Curitiba, 80060-240, Brazil

Location

Goiânia, 74605-050, Brazil

Location

Porto Alegre, 90610-970, Brazil

Location

Setor Oeste/Goiania, 74100-125, Brazil

Location

Winnipeg, Manitoba, R3A 1M4, Canada

Location

Hamilton, Ontario, N2M 5N6, Canada

Location

Kitchener, Ontario, N2M 5N6, Canada

Location

Santiago, Chile

Location

Valdivia, Chile

Location

Viña del Mar, Chile

Location

Hildesheim, 31134, Germany

Location

Leipzig, 04103, Germany

Location

Budapest, 1023, Hungary

Location

Esztergom, 2500, Hungary

Location

Kistarcsa, 2143, Hungary

Location

Szolnok, 5000, Hungary

Location

Lucknow, 226018, India

Location

Pune, 411001, India

Location

Secunderabad, 500003, India

Location

Chihuahua City, 31000, Mexico

Location

Cuernavaca, 62270, Mexico

Location

Guadalajara, 44100, Mexico

Location

Mexico City, 06700, Mexico

Location

Monterrey, 64000, Mexico

Location

San Luis Potosí City, 78210, Mexico

Location

Tampico, 89000, Mexico

Location

Bialystok, 15-337, Poland

Location

Chełm Śląski, 41-403, Poland

Location

Elblag, 82-300, Poland

Location

Krakow, 30-510, Poland

Location

Lubin, 20-022, Poland

Location

Lublin, 20-954, Poland

Location

Poznan, 60-356, Poland

Location

Torun, 87-100, Poland

Location

Warsaw, 00-235, Poland

Location

Wroclaw, 50-088, Poland

Location

San Juan, 00918, Puerto Rico

Location

Brasov, 500365, Romania

Location

Târgu Mureş, 540136, Romania

Location

Related Publications (1)

Greenwald M, Szczepanski L, Kennedy A, Veenhuizen M, Komocsar WJ, Polasek E, Guerrettaz K, Berclaz PY, Lee C. A 52-week, open-label study evaluating the safety and efficacy of tabalumab, an anti-B-cell-activating factor monoclonal antibody, for rheumatoid arthritis. Arthritis Res Ther. 2014 Aug 29;16(4):415. doi: 10.1186/s13075-014-0415-2.
PMID: 25168268DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

tabalumab

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Data integrity issues were identified at 1 study site involving 1 participant. Therefore, this site/participant is excluded from all efficacy analyses/results.

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 9AM - 5PM Eastern time (UCT/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 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 5, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

April 25, 2018

Results First Posted

April 25, 2018

Record last verified: 2018-03

Locations

HU(4)PL(10)IN(3)PR(1)US(19)BE(1)AU(1)DE(2)ME(7)RO(2)CL(3)BR(5)CA(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (22)

Other Outcomes (1)

Study Arms (1)

LY2127399

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (62)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations