NCT00689728

Brief Summary

The purpose of this study is to explore whether LY2127399 is effective in relieving signs and symptoms of rheumatoid arthritis (RA) in patients with a history of inadequate response or intolerance to at least 1 Tumor Necrosis Factor-Alpha (TNFα) inhibitor therapy. Examples of these TNFα inhibitor therapies that are currently on the market include Enbrel® (etanercept), Remicade® (infliximab), and Humira® (adalimumab).

Trial Health

98
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2008

Geographic Reach
10 countries

45 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

Study Start

First participant enrolled

June 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

December 6, 2018

Completed
Last Updated

December 6, 2018

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

June 2, 2008

Results QC Date

March 24, 2018

Last Update Submit

November 10, 2018

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16

    ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR50 Responder is defined as a participant with greater than 50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient 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.

    16 weeks

Secondary Outcomes (19)

  • Number of Participants Experiencing An Adverse Event

    Baseline up to 68 weeks

  • Change From Baseline in Medical Outcome Study 36-Item Short Form Health Survey (SF-36) at Week 16

    Baseline, 16 weeks

  • Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16

    16 weeks

  • Percentage of Participants Achieving American College of Rheumatology (ACR)70 Response at Week 16

    16 weeks

  • Change From Baseline in Tender Joint Count at Week 16

    Baseline, 16 weeks

  • +14 more secondary outcomes

Study Arms (3)

30 milligram (mg) LY2127399

EXPERIMENTAL

Double-blind Treatment: 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints, could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on initial randomized treatment up to Week 24. Follow-up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery.

Biological: LY2127399

80 mg LY2127399

EXPERIMENTAL

Double-blind Treatment: 80 mg LY2127399 administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints, could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on initial randomized treatment up to Week 24. Follow-up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery.

Biological: LY2127399

Placebo

PLACEBO COMPARATOR

Double-blind Treatment: Placebo comparator administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on same initial randomized treatment up to Week 24. Follow-Up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery.

Drug: Placebo

Interventions

LY2127399BIOLOGICAL

LY2127399 will be administered as a single IV infusion over 30 minutes.

30 milligram (mg) LY212739980 mg LY2127399
PlaceboDRUG

Placebo will be administered as a single IV infusion over 30 minutes.

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 approval
  • Women must not be at risk to become pregnant during study participation
  • Diagnosis of Rheumatoid Arthritis
  • Active Rheumatoid Arthritis
  • Current, regular use of Methotrexate, at a stable dose
  • Have been on at least 1 biologic tumor necrosis factor-alpha (TNFα) inhibitor therapy and either failed or were intolerant to treatment
  • Other criteria to be reviewed by study doctor

You may not qualify if:

  • Use of excluded medications (reviewed by study doctor)
  • Have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study
  • Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation
  • Evidence of tuberculosis
  • Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis.
  • Other criteria to be reviewed by study doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

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

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Mesa, Arizona, 85208, United States

Location

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Palm Desert, California, 92260, United States

Location

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Riverside, California, 92501, United States

Location

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Santa Maria, California, 93454, United States

Location

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Upland, California, 91786, United States

Location

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Jupiter, Florida, 33458, United States

Location

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Vero Beach, Florida, 32960, United States

Location

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Zephyrhills, Florida, 33542, United States

Location

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Baltimore, Maryland, 21239, United States

Location

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St Louis, Missouri, 63141, United States

Location

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Hickory, North Carolina, 28601, United States

Location

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Middleburg Heights, Ohio, 44130, United States

Location

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Philadelphia, Pennsylvania, 19152, United States

Location

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Orangeburg, South Carolina, 29118, United States

Location

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Memphis, Tennessee, 38119, United States

Location

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Austin, Texas, 78705, United States

Location

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Dallas, Texas, 75235, United States

Location

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Mesquite, Texas, 75150, United States

Location

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Buenos Aires, C1055AAF, Argentina

Location

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Caba, C1180AAX, Argentina

Location

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San Juan, 5400, Argentina

Location

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San Miguel de Tucumán, 4000, Argentina

Location

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Vienna, 1100, Austria

Location

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Liège, 4000, Belgium

Location

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Campinas, 13015-011, Brazil

Location

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Curitiba, 80060-240, Brazil

Location

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Goiânia, 74605-050, Brazil

Location

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Porto Alegre, 90610-970, Brazil

Location

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Setor Oeste/Goiania, 74110-010, Brazil

Location

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Winnipeg, Manitoba, R3A 1M4, Canada

Location

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Hamilton, Ontario, N2M 5N6, Canada

Location

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Kitchener, Ontario, N2M 5N6, Canada

Location

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Göttingen, 37075, Germany

Location

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Hildesheim, 31134, Germany

Location

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Vogelsang, 39245, Germany

Location

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Chihuahua City, 31000, Mexico

Location

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Cuernavaca, 62270, Mexico

Location

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Guadalajara, 44100, Mexico

Location

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Monterrey, 64020, Mexico

Location

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Morelia, 58240, Mexico

Location

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Lublin, 20-954, Poland

Location

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Torun, 87-100, Poland

Location

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Warsaw, 00-235, Poland

Location

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San Juan, 00918, Puerto Rico

Location

Related Publications (1)

  • Genovese MC, Fleischmann RM, Greenwald M, Satterwhite J, Veenhuizen M, Xie L, Berclaz PY, Myers S, Benichou O. Tabalumab, an anti-BAFF monoclonal antibody, in patients with active rheumatoid arthritis with an inadequate response to TNF inhibitors. Ann Rheum Dis. 2013 Sep 1;72(9):1461-8. doi: 10.1136/annrheumdis-2012-202775. Epub 2012 Dec 25.

    PMID: 23268367DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tabalumab

Condition Hierarchy (Ancestors)

ArthritisJoint 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
800-545-5979

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 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2008

First Posted

June 4, 2008

Study Start

June 1, 2008

Primary Completion

February 1, 2010

Study Completion

May 1, 2010

Last Updated

December 6, 2018

Results First Posted

December 6, 2018

Record last verified: 2018-11

Locations

CA(3)BE(1)ME(5)DE(3)AR(4)BR(5)AU(1)PL(3)PR(1)US(19)