NCT00966875

Brief Summary

The primary purpose of the study is to help answer the following research questions, and not to provide treatment for Rheumatoid Arthritis (RA):

  • The safety of LY2439821 and any side effects that might be associated with it.
  • Whether LY2439821 can help participants with active RA.
  • How much LY2439821 should be given to participants.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
448

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach
11 countries

75 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

August 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4 years until next milestone

Results Posted

Study results publicly available

May 26, 2016

Completed
Last Updated

May 26, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

August 25, 2009

Results QC Date

April 20, 2016

Last Update Submit

April 20, 2016

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisRA

Outcome Measures

Primary Outcomes (1)

  • Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population

    ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient's Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) \* 100.

    Week 12

Secondary Outcomes (36)

  • Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population

    Week 12

  • Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population

    Week 12

  • Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population

    Week 12

  • Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population

    Week 12

  • Change From Baseline in Disease Activity Score (DAS28)-Part A

    Baseline, up to Week 12

  • +31 more secondary outcomes

Study Arms (9)

3 mg LY2439821 (bDMARD-naive population)

EXPERIMENTAL

3 milligrams (mg) LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. \[Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)\]

Biological: LY2439821

10 mg LY2439821 (bDMARD-naive population)

EXPERIMENTAL

10 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.

Biological: LY2439821

30 mg LY2439821 (bDMARD-naive population)

EXPERIMENTAL

30 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.

Biological: LY2439821

80 mg LY2439821 (bDMARD-naive population)

EXPERIMENTAL

80 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.

Biological: LY2439821

180 mg LY2439821 (bDMARD-naive population)

EXPERIMENTAL

180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.

Biological: LY2439821

80 mg LY2439821 (TNFa-IR population)

EXPERIMENTAL

80 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. \[Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)\]

Biological: LY2439821

180 mg LY2439821 (TNFa-IR population)

EXPERIMENTAL

180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.

Biological: LY2439821

Placebo (bDMARD-naive population)

PLACEBO COMPARATOR

Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.

Drug: Placebo

Placebo (TNFa-IR population)

PLACEBO COMPARATOR

Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.

Drug: Placebo

Interventions

LY2439821BIOLOGICAL

Subcutaneous

Also known as: ixekizumab
10 mg LY2439821 (bDMARD-naive population)180 mg LY2439821 (TNFa-IR population)180 mg LY2439821 (bDMARD-naive population)3 mg LY2439821 (bDMARD-naive population)30 mg LY2439821 (bDMARD-naive population)80 mg LY2439821 (TNFa-IR population)80 mg LY2439821 (bDMARD-naive population)
PlaceboDRUG

Subcutaneous

Placebo (TNFa-IR population)Placebo (bDMARD-naive population)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • You must be between the ages of 18 and 75
  • You must have active RA
  • Qualifications Specific to the bDMARD-naive Population:
  • You must be regularly using methotrexate (MTX) for at least 12 weeks before your participation in this study
  • Qualifications Specific to the TNFα-IR Population:
  • You must have been treated with at least 1 biologic TNFα inhibitor therapy and either had an insufficient response to at least 3 months of treatment OR have been intolerant of such treatment
  • You must be regularly using at least 1 conventional DMARD in a stable treatment regimen

You may not qualify if:

  • You are concomitantly using non-steroidal anti-inflammatory drugs (NSAIDS), unless you are on a stable dose within the last 2 weeks
  • You are a woman who is lactating or breast feeding
  • You have donated more than 300 milliliters (mL) of blood within the last month
  • You have received glucocorticoid administered by intra-articular, intramuscular, or intravenous injection or oral corticosteroids at an average daily dose of greater than 10 mg per day of prednisone or its equivalent within the last 4 weeks
  • You had surgery on a joint that is to be assessed in the study within 2 months of study enrollment, or will require such during the study
  • You have another serious disorder or illness
  • You suffered a serious bacterial infection (for example, pneumonia, cellulitis, or bone or joint infections) within the last 3 months
  • You have a history of uncontrolled high blood pressure
  • You have clinical laboratory test results at entry that are outside the normal reference range
  • You are an employee of the clinic or you are an immediate family member of an employee of the clinic. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
  • You are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug
  • If you are a woman and you could become pregnant during this study, you must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study.
  • If you are a post-menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months
  • If you are a post-menopausal woman between 40 and 45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test to see if you can participate.
  • If you are male, you must agree to reduce the risk of your female partner becoming pregnant during the study.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (75)

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Peoria, Arizona, 85381, United States

Location

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La Mesa, California, 91942, United States

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Palm Desert, California, 92260, United States

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San Jose, California, 95126, United States

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Santa Maria, California, 93454, United States

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Stanford, California, 94305, United States

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Westlake Village, California, 91361, United States

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Denver, Colorado, 80230, United States

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Washington D.C., District of Columbia, 20003, United States

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Lake Mary, Florida, 32746, United States

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Melbourne, Florida, 32901, United States

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Sarasota, Florida, 34239, United States

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St. Petersburg, Florida, 33710, United States

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Tampa, Florida, 33614, United States

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Vero Beach, Florida, 32962, United States

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Decatur, Georgia, 30329, United States

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Rome, Georgia, 30165, United States

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Idaho Falls, Idaho, 83404, United States

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Springfield, Illinois, 62704, United States

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Cumberland, Maryland, 21502, United States

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Frederick, Maryland, 21702, United States

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Wheaton, Maryland, 20902, United States

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Bingham Farms, Michigan, 48025, United States

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St Louis, Missouri, 63117, United States

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Wilmington, North Carolina, 28401, United States

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Tulsa, Oklahoma, 74135, United States

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Bethlehem, Pennsylvania, 18017, United States

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Sellersville, Pennsylvania, 18960, United States

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Charleston, South Carolina, 29407, United States

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Memphis, Tennessee, 38119, United States

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Sugar Land, Texas, 77479, United States

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Temple, Texas, 76508, United States

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Salt Lake City, Utah, 84143, United States

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Arlington, Virginia, 22205, United States

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Olympia, Washington, 98502, United States

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Spokane, Washington, 99202, United States

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Milwaukee, Wisconsin, 53217, United States

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Buenos Aires, C1425AWC, Argentina

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Quilmes, B1878DVC, Argentina

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San Juan, 05400, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Santiago, Chile

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Freiburg im Breisgau, 79106, Germany

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Hamburg, 22415, Germany

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Hohenfelde, 18209, Germany

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Tübingen, D-72076, Germany

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Bangalore, 560079, India

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Hyderabaad, 500082, India

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Jaipur, 302023, India

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Secunderabad, 500 003, India

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Arequipa, Peru

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Lima, Lima 27, Peru

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Pueblo Libre, Lima 21, Peru

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Bytom, 41-902, Poland

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Częstochowa, 42-200, Poland

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Gmina Końskie, 26-200, Poland

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Kościan, 64-000, Poland

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Krakow, 30-510, Poland

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Poznan, 60-773, Poland

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Torun, 87-100, Poland

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Warsaw, 02-507, Poland

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Baia Mare, 430110, Romania

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Bucharest, 10584, Romania

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Cluj-Napoca, 400006, Romania

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Iași, 700656, Romania

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Moscow, 115522, Russia

Location

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.

Saint Petersburg, 115522, Russia

Location

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Daejeon, 302-799, South Korea

Location

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Pusan, 602-739, South Korea

Location

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Seoul, 150-713, South Korea

Location

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Kaohsiung County, 833, Taiwan

Location

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Taichung, 40201, Taiwan

Location

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Taichung, 404, Taiwan

Location

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Taipei, 100, Taiwan

Location

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Taoyuan District, 333, Taiwan

Location

Related Publications (2)

  • Genovese MC, Braun DK, Erickson JS, Berclaz PY, Banerjee S, Heffernan MP, Carlier H. Safety and Efficacy of Open-label Subcutaneous Ixekizumab Treatment for 48 Weeks in a Phase II Study in Biologic-naive and TNF-IR Patients with Rheumatoid Arthritis. J Rheumatol. 2016 Feb;43(2):289-97. doi: 10.3899/jrheum.140831. Epub 2015 Dec 15.

    PMID: 26669919DERIVED

  • Genovese MC, Greenwald M, Cho CS, Berman A, Jin L, Cameron GS, Benichou O, Xie L, Braun D, Berclaz PY, Banerjee S. A phase II randomized study of subcutaneous ixekizumab, an anti-interleukin-17 monoclonal antibody, in rheumatoid arthritis patients who were naive to biologic agents or had an inadequate response to tumor necrosis factor inhibitors. Arthritis Rheumatol. 2014 Jul;66(7):1693-704. doi: 10.1002/art.38617.

    PMID: 24623718DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ixekizumab

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
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

August 25, 2009

First Posted

August 27, 2009

Study Start

August 1, 2009

Primary Completion

March 1, 2011

Study Completion

June 1, 2012

Last Updated

May 26, 2016

Results First Posted

May 26, 2016

Record last verified: 2016-04

Locations

PL(8)CL(1)RO(4)US(37)DE(4)IN(4)RU(2)TW(5)AR(4)PE(3)KR(3)