NCT01202760

Brief Summary

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic drug (DMARD) therapy. This study is comprised of 2 periods: Period 1 - 24-week blinded treatment Period 2 - 48-week post-treatment follow-up

Trial Health

98
On Track

Trial Health Score

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

Strong global presence with extensive site network
Enrollment
1,004

participants targeted

Target at P75+ for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Jan 2011

Geographic Reach
22 countries

213 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

First Submitted

Initial submission to the registry

September 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
4.8 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

September 14, 2010

Results QC Date

March 24, 2018

Last Update Submit

March 24, 2018

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With American College of Rheumatology 20% (ACR20) Response

    ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had \>=20% improvement from baseline in both 68 tender and 66 swollen joint counts and \>=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)\*100. All non-responders at Week 16 as well as all participants who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.

    Up to 24 weeks

Secondary Outcomes (18)

  • Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses

    Up to 24 weeks

  • Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)

    Up to 24 weeks

  • Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)

    Baseline, up to 24 weeks

  • Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)

    Baseline, up to 24 weeks

  • Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)

    Baseline, up to 24 weeks

  • +13 more secondary outcomes

Study Arms (3)

120 mg LY2127399

EXPERIMENTAL

LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment. During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks. After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.

Drug: LY2127399Drug: Placebo

90 mg LY2127399

EXPERIMENTAL

LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment. After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.

Drug: LY2127399

Placebo

PLACEBO COMPARATOR

Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment. After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.

Drug: LY2127399Drug: Placebo

Interventions

LY2127399DRUG
Also known as: Tabalumab
120 mg LY212739990 mg LY2127399Placebo
PlaceboDRUG
120 mg LY2127399Placebo

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
  • Global Assessment of Disease Activity visual analog scale (VAS) greater than or equal to 20/100 millimeters (mm)
  • If on one or more conventional disease-modifying anti-rheumatic Drugs (DMARDs) at randomization, must have been on a stable dose for at least 8 weeks prior to study start.
  • Women must not be pregnant, breastfeeding, or become pregnant during the study

You may not qualify if:

  • Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks
  • Steroid injection or intravenous (IV) infusion in the last 6 weeks
  • Use of more than 10 milligrams per day (mg/day) of oral steroids in the last 6 weeks
  • Use of biologic DMARD concurrently or recently
  • History of a serious reaction to other biological DMARDs
  • Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the last 8 weeks
  • Surgery on a joint or other major surgery less than 2 months prior to study start, or plans to have joint surgery or major surgery during the study
  • Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
  • Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
  • Received a live vaccine within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
  • Hepatitis or human immunodeficiency virus (HIV)
  • A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
  • Symptoms of herpes zoster or herpes simplex within the last month
  • Active or latent tuberculosis (TB)
  • Current symptoms of a serious disorder or illness
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (213)

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Birmingham, Alabama, 35216, United States

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Paradise Valley, Arizona, 85253, United States

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Peoria, Arizona, 85381, United States

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Phoenix, Arizona, 85018, United States

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Scottsdale, Arizona, 85251, United States

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Tucson, Arizona, 85704, United States

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Hot Springs, Arkansas, 71913, United States

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Little Rock, Arkansas, 72205, United States

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San Diego, California, 92103, United States

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Torrance, California, 90505, United States

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Tustin, California, 92780, United States

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Whittier, California, 90606, United States

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Wildomar, California, 92595, United States

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Colorado Springs, Colorado, 80910, United States

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Lewes, Delaware, 19958, United States

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Aventura, Florida, 33180, United States

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DeBary, Florida, 32713, United States

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Palm Harbor, Florida, 34684, United States

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Pinellas Park, Florida, 33781, United States

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St. Petersburg, Florida, 33716, United States

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Tamarac, Florida, 33321, United States

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Venice, Florida, 34292, United States

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Zephyrhills, Florida, 33542, United States

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Decatur, Georgia, 30033, United States

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Gainesville, Georgia, 30501, United States

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Lawrenceville, Georgia, 30045, United States

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Marietta, Georgia, 30060, United States

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Savannah, Georgia, 31405, United States

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Eagle, Idaho, 83616, United States

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Morton Grove, Illinois, 60053, United States

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Rockford, Illinois, 61103, United States

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Indianapolis, Indiana, 46227, United States

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Wichita, Kansas, 67208, United States

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Cumberland, Maryland, 21502, United States

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Hyannis, Massachusetts, 02601, United States

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Worcester, Massachusetts, 01605, United States

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Bingham Farms, Michigan, 48025, United States

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Saint Clair Shores, Michigan, 48081, United States

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Flowood, Mississippi, 39232, United States

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Jackson, Mississippi, 39202, United States

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St Louis, Missouri, 63131, United States

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Lincoln, Nebraska, 68516, United States

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Omaha, Nebraska, 68134, United States

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Las Vegas, Nevada, 89123, United States

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Albuquerque, New Mexico, 87108, United States

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Brooklyn, New York, 11201, United States

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Roslyn, New York, 11576, United States

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Syracuse, New York, 13210, United States

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Charlotte, North Carolina, 28210, United States

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Hickory, North Carolina, 28601, United States

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Raleigh, North Carolina, 27609, United States

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Cincinnati, Ohio, 45242, United States

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Oklahoma City, Oklahoma, 73103, United States

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Tulsa, Oklahoma, 74135, United States

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Bend, Oregon, 97701, United States

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Bethlehem, Pennsylvania, 18017, United States

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Limerick, Pennsylvania, 19468, United States

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Philadelphia, Pennsylvania, 19152, United States

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Pottstown, Pennsylvania, 19464, United States

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Columbia, South Carolina, 29204, United States

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Greenville, South Carolina, 29601, United States

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Greer, South Carolina, 29650, United States

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Myrtle Beach, South Carolina, 29572, United States

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North Charleston, South Carolina, 29406, United States

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Knoxville, Tennessee, 37909, United States

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Memphis, Tennessee, 38119, United States

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Nashville, Tennessee, 37205, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75231, United States

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Lake Jackson, Texas, 77566, United States

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Lubbock, Texas, 79424, United States

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Mesquite, Texas, 75150, United States

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Nassau Bay, Texas, 77058, United States

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North Richland Hills, Texas, 76180, United States

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San Antonio, Texas, 78217, United States

Location

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Sugar Land, Texas, 77478, United States

Location

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Spokane, Washington, 99204, United States

Location

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Buenos Aires, C1280AEB, Argentina

Location

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Córdoba, X5016KEH, Argentina

Location

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Mar del Plata, B7600FZN, Argentina

Location

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Rosario, 2000, 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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Kogarah, New South Wales, 04266-010, Australia

Location

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Herston, Queensland, 4029, Australia

Location

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Malvern East, 3145, Australia

Location

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Burgas, 8000, Bulgaria

Location

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Pleven, 5800, Bulgaria

Location

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Plovdiv, 4003, Bulgaria

Location

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Rousse, 7002, Bulgaria

Location

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Sevlievo, 5400, Bulgaria

Location

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Sofia, 1784, Bulgaria

Location

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Varna, 9000, Bulgaria

Location

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Bogotá, Colombia

Location

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Medellín, Colombia

Location

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Opatija, 51410, Croatia

Location

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Rijeka, HR-51000, Croatia

Location

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Split, 21000, Croatia

Location

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Budapest, 1036, Hungary

Location

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Debrecen, 4032, Hungary

Location

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Kiskunhalas, 6400, Hungary

Location

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Nyíregyháza, 4400, Hungary

Location

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Sátoraljaújhely, 3980, Hungary

Location

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Szikszó, 3800, Hungary

Location

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Veszprém, 8200, Hungary

Location

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Ahmedabad, 3800015, India

Location

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Bangalore, 5600092, India

Location

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Chennai, 600100, India

Location

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Hyderabaad, 500033, India

Location

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Jaipur, 302023, India

Location

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Mysore, 570023, India

Location

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Nellore, 524003, India

Location

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New Delhi, 110 076, India

Location

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Secunderabad, 500 003, India

Location

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Surat, 560092, India

Location

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Aichi, 460-0001, Japan

Location

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Fukuoka, 820-8505, Japan

Location

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Gunma, 370-0053, Japan

Location

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Hokkaido, 063-0811, Japan

Location

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Hyōgo, 650-0017, Japan

Location

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Ibaraki, 316-0035, Japan

Location

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Kanagawa, 252-0392, Japan

Location

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Kumamoto, 861-8520, Japan

Location

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Mie, 514-1101, Japan

Location

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Miyagi, 982-0032, Japan

Location

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Nagano, 390-8601, Japan

Location

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Nagasaki, 857-1195, Japan

Location

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Nara, 634-0007, Japan

Location

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Ohita, 874-0011, Japan

Location

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Okayama, 712-8044, Japan

Location

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Osaka, 586-8521, Japan

Location

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Saga, 843-0393, Japan

Location

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Saitama, 337-0012, Japan

Location

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Sapporo, 060-8648, Japan

Location

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Shizuoka, 420-8623, Japan

Location

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Tokyo, 185-0012, Japan

Location

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Tomakomai, 053-8567, Japan

Location

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Alytus, 62114, Lithuania

Location

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Kaunas, 49475, Lithuania

Location

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Klaipedos, 92288, Lithuania

Location

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Šiauliai, 73231, Lithuania

Location

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Vilnius, LT-08661, Lithuania

Location

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Batu Caves, 68100, Malaysia

Location

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Kuantan Pahang, 25100, Malaysia

Location

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Perak, 30990, Malaysia

Location

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Sarawak, 93586, Malaysia

Location

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Aguascalientes, 20203, Mexico

Location

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Chihuahua City, 31000, Mexico

Location

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Guadalajara, 44690, Mexico

Location

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Mexicali, 21100, Mexico

Location

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Mexico City, 06100, Mexico

Location

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Monterrey, 64000, Mexico

Location

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Morelia, 58070, Mexico

Location

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Querétaro, 76000, Mexico

Location

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San Luis Potosí City, 78200, Mexico

Location

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Tijuana, 22010, Mexico

Location

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Tlalpan, 14080, Mexico

Location

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Hamilton, 3204, New Zealand

Location

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Rotorua, 3010, New Zealand

Location

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Tauranga, 3140, New Zealand

Location

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Timaru, New Zealand

Location

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Bydgoszcz, 85-168, Poland

Location

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Elblag, 82-300, Poland

Location

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Gdynia, 81-384, Poland

Location

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Krakow, 30-510, Poland

Location

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Lublin, 20-607, Poland

Location

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Torun, 87-100, Poland

Location

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Warsaw, 01-192, Poland

Location

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Brasov, 500365, Romania

Location

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Cluj-Napoca, 400130, Romania

Location

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Iași, 700656, Romania

Location

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Ploieşti, 100337, Romania

Location

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Barnaul, 656038, Russia

Location

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Kemerovo, 650066, Russia

Location

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Kursk, 305007, Russia

Location

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Moscow, 111539, Russia

Location

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Nizhny Novgorod, 603005, Russia

Location

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Novosibirsk, 630047, Russia

Location

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Ryazan, 390026, Russia

Location

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Saint Petersburg, 197022, Russia

Location

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Stavropol, 355017, Russia

Location

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Bratislava, 84231, Slovakia

Location

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Piešťany, 921 12, Slovakia

Location

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Benoni, 1500, South Africa

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Bloemfontein, 9301, South Africa

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Breyten, 2330, South Africa

Location

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Cape Town, 7925, South Africa

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Durban, 4092, South Africa

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Limpopo, 0380, South Africa

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Pretoria, 0184, South Africa

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Somerset West, 7130, South Africa

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Stellenbosch, 7600, South Africa

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Westville, 3630, South Africa

Location

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Busan, 602-715, South Korea

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Daegu, 700-721, South Korea

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Seoul, 134-727, South Korea

Location

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Colombo, Sri Lanka

Location

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Galle, Sri Lanka

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Kalubowila, Sri Lanka

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Nugegoda, Sri Lanka

Location

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Keelong, 333, Taiwan

Location

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Kuei Shan Hsiang, 33305, Taiwan

Location

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Taichung, 407, Taiwan

Location

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Taipei, 112, Taiwan

Location

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Dnipropetrovsk, 49008, Ukraine

Location

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Donetsk, 83045, Ukraine

Location

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Kharkiv, 61178, Ukraine

Location

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Kiev, 04114, Ukraine

Location

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Kyiv, 03151, Ukraine

Location

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Odesa, 65026, Ukraine

Location

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Poltava, 36038, Ukraine

Location

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Simferopol, 95017, Ukraine

Location

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Vinnytsia, 21018, Ukraine

Location

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 3
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

September 14, 2010

First Posted

September 16, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

April 25, 2018

Results First Posted

April 25, 2018

Record last verified: 2018-03

Locations

IN(10)ME(11)RO(4)ZA(10)CO(2)CR(3)AU(3)RU(9)TW(4)SR(4)JP(22)US(77)MY(4)PL(7)HU(7)AR(6)LI(5)BU(7)KR(3)NZ(4)SL(2)UA(9)