Brief Summary

To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks

Trial Health

On Track

Trial Health Score

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

Enrollment

158

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline

Completed

Started Oct 2008

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach

12 countries

48 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

2.2 years study duration

Study Start

First participant enrolled

October 1, 2008

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed

7.6 years until next milestone

Results Posted

Study results publicly available

July 10, 2018

Completed

Last Updated

July 10, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

November 3, 2008

Results QC Date

March 24, 2018

Last Update Submit

June 11, 2018

Conditions

Rheumatoid Arthritis

Keywords

Arthritis

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR50 Responder is defined as a participant with \>50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.
Up to week 24

Secondary Outcomes (17)

Percentage of Participants Achieving The American College of Rheumatology (ACR)20 Response up to 24 Weeks
Up to 24 weeks
Change From Baseline in the Tender Joint Count up to 24 Weeks
Baseline, up to 24 weeks
Change From Baseline in Swollen Joint Count up to 24 Weeks
Baseline, up to 24 weeks
Change From Baseline in the Disease Activity Score (DAS) up to 24 Weeks
Baseline, up to 24 weeks
Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks
Up to 24 weeks
+12 more secondary outcomes

Study Arms (7)

Placebo

EXPERIMENTAL

Drug: Placebo

1 mg LY2127399

EXPERIMENTAL

Biological: LY2127399

3 mg LY2127399

EXPERIMENTAL

Biological: LY2127399

10 mg LY2127399

EXPERIMENTAL

Biological: LY2127399

30 mg LY2127399

EXPERIMENTAL

Biological: LY2127399

60 mg LY2127399

EXPERIMENTAL

Biological: LY2127399

120 mg LY2127399

EXPERIMENTAL

Biological: LY2127399

Interventions

LY2127399BIOLOGICAL

Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).

1 mg LY212739910 mg LY2127399120 mg LY21273993 mg LY212739930 mg LY212739960 mg LY2127399

PlaceboDRUG

Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Have given written informed consent
Women must not be at risk to become pregnant during study participation
Diagnosis of Rheumatoid Arthritis (RA)
Current, regular use of Methotrexate, at a stable dose
Other criteria to be reviewed by study doctor

You may not qualify if:

Use of excluded medications(reviewed by study doctor)
Have not failed biologic tumor necrosis factor-alpha (TNF-α) inhibitor therapy
Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study
Evidence of tuberculosis
Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy
Other criteria to be reviewed by study doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (48)

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.

Huntsville, Alabama, 35801, United States

Location

Calabasas, California, 91302, United States

Location

Upland, California, 91786, United States

Location

Vero Beach, Florida, 32960, United States

Location

Philadelphia, Pennsylvania, 19152, United States

Location

Dallas, Texas, 75235, United States

Location

Buenos Aires, C1417EYG, Argentina

Location

Quilmes, 1878, Argentina

Location

Brisbane, Queensland, 4066, Australia

Location

Maroochydore, Queensland, 4558, Australia

Location

Elizabeth Vale, South Australia, 5112, Australia

Location

Santiago, Chile

Location

Valdivia, Chile

Location

Viña del Mar, Chile

Location

Leipzig, 04103, Germany

Location

Budapest, 1023, Hungary

Location

Esztergom, 2500, Hungary

Location

Kistarcsa, 2143, Hungary

Location

Szolnok, 5000, Hungary

Location

Hyderabaad, 400082, India

Location

Lucknow, 226018, India

Location

Pune, 411001, India

Location

Secunderabad, 800003, India

Location

Chihuahua City, 31000, Mexico

Location

Cuernavaca, 62270, Mexico

Location

Guadalajara, 44100, Mexico

Location

Mexico City, 06700, Mexico

Location

Monterrey, 64020, 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, 02-777, Poland

Location

Wroclaw, 50-088, Poland

Location

Brasov, 500365, Romania

Location

Târgu Mureş, 540136, Romania

Location

Bratislava, 83103, Slovakia

Location

Rimavska, 97101, Slovakia

Location

Ivano-Frankivsk, 76018, Ukraine

Location

Kiev, 1601, Ukraine

Location

Odesa, 65027, Ukraine

Location

Simferopol, 95017, Ukraine

Location

Related Publications (1)

Genovese MC, Lee E, Satterwhite J, Veenhuizen M, Disch D, Berclaz PY, Myers S, Sides G, Benichou O. A phase 2 dose-ranging study of subcutaneous tabalumab for the treatment of patients with active rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2013 Sep 1;72(9):1453-60. doi: 10.1136/annrheumdis-2012-202864. Epub 2013 Apr 18.
PMID: 23599435DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

tabalumab

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective 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 - 5PM 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 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 3, 2008

First Posted

November 5, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2010

Study Completion

December 1, 2010

Last Updated

July 10, 2018

Results First Posted

July 10, 2018

Record last verified: 2018-06

Locations

AR(2)DE(1)PL(10)CL(3)AU(3)HU(4)US(6)RO(2)IN(4)SL(2)ME(7)UA(4)

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 (1)

Secondary Outcomes (17)

Study Arms (7)

Placebo

1 mg LY2127399

3 mg LY2127399

10 mg LY2127399

30 mg LY2127399

60 mg LY2127399

120 mg LY2127399

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (48)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations