NCT01202773

Brief Summary

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors. This study is comprised of 2 periods: Period 1: 24-week blinded treatment Period 2: 48-week post-treatment follow-up

Trial Health

68
Monitor

Trial Health Score

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

Strong global presence with extensive site network
Enrollment
456

participants targeted

Target at P50-P75 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Jan 2011

Typical duration for phase_3 rheumatoid-arthritis

Geographic Reach
19 countries

201 active sites

Status
terminated

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
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

May 14, 2018

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

September 14, 2010

Results QC Date

March 24, 2018

Last Update Submit

May 11, 2018

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

    ACR Responder Index: composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: a ≥20% improvement from baseline in both 68 tender joint counts (TJC) and 66 swollen joint counts (SJC) and a ≥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 NR at Week 16, as well as all participants who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.

    Baseline through Week 24

Secondary Outcomes (20)

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

    Baseline through Week 24

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

    Baseline through Week 24

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

    Baseline, Week 24

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

    Baseline, Week 24

  • Change From Baseline to Week 24 in Participant's Assessment of Pain [Visual Analog Scale (VAS)]

    Baseline, Week 24

  • +15 more secondary outcomes

Study Arms (3)

120 milligrams (mg) LY2127399

EXPERIMENTAL

Given every 4 weeks (Q4W) for 24 weeks. Participants receive a 240-mg loading dose when initiating treatment. During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks (Q2W). At Week 16, responders will receive 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. At Week 16, non-responders (NR) will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.

Drug: LY2127399Drug: Placebo Q4W

90 mg LY2127399

EXPERIMENTAL

Given Q2W for 24 weeks. Participants receive a 180-mg loading dose when initiating treatment. At Week 16, both responders and NR will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.

Drug: LY2127399

Placebo

PLACEBO COMPARATOR

Given Q2W for 24 weeks. Participants receive 2 injections of placebo when initiating treatment. At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period. At Week 16, NR will receive a 180-mg loading dose of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.

Drug: LY2127399Drug: Placebo Q2W

Interventions

LY2127399DRUG

Administered Subcutaneously (SC)

120 milligrams (mg) LY212739990 mg LY2127399Placebo
Placebo Q4WDRUG

Administered SC

120 milligrams (mg) LY2127399
Placebo Q2WDRUG

Administered SC

Placebo

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of RA of more than 6 months and less than 15 years
  • At least 8 tender and swollen joints
  • An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
  • Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody
  • Previously treated with biologic TNF-α inhibitor therapy (infliximab, certolizumab, golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy or intolerance
  • Regular use of at least 1 conventional disease-modifying anti-rheumatic drug (DMARD), with a stable dose for at least 8 weeks prior to study start
  • Woman must not be pregnant, breastfeeding, or become pregnant during the study

You may not qualify if:

  • Use of unstable doses of non-steroidal anti-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/day (mg/day) of oral steroids in the last 6 weeks
  • 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 ago, 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 received 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
  • Use of an investigational drug within the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (201)

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Birmingham, Alabama, 35216, United States

Location

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Huntsville, Alabama, 35810, United States

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Paradise Valley, Arizona, 85253, United States

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Phoenix, Arizona, 85018, United States

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Scottsdale, Arizona, 85251, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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Escondido, California, 92027, United States

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Fresno, California, 93720, United States

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Hemet, California, 92543, United States

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Huntington Beach, California, 92646, United States

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La Mesa, California, 91942, United States

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Loma Linda, California, 92354, United States

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Long Beach, California, 90808, United States

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Los Angeles, California, 90022, United States

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San Diego, California, 92108, United States

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Santa Monica, California, 90404, United States

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Torrance, California, 90505, United States

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Tustin, California, 92780, United States

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Upland, California, 91786, 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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Denver, Colorado, 80209, United States

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Lewes, Delaware, 19958, United States

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Aventura, Florida, 33180, United States

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Boca Raton, Florida, 33486, United States

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Boynton Beach, Florida, 33472, United States

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DeBary, Florida, 32713, United States

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Miami, Florida, 33173, United States

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New Port Richey, Florida, 34652, 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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Tamarac, Florida, 33321, United States

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Tampa, Florida, 33609, United States

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Venice, Florida, 34292, United States

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Vero Beach, Florida, 32960, United States

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30033, United States

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Dunwoody, Georgia, 30338, United States

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Gainesville, Georgia, 30501, United States

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Marietta, Georgia, 30060, United States

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Stockbridge, Georgia, 30281, United States

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Eagle, Idaho, 83616, United States

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Idaho Falls, Idaho, 83404, United States

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Peoria, Illinois, 61636, United States

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Rock Island, Illinois, 61201, United States

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Brownsburg, Indiana, 46112, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46227, United States

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Kansas City, Kansas, 66160, United States

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Bowling Green, Kentucky, 42101, United States

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Lexington, Kentucky, 40504, United States

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Owensboro, Kentucky, 42303, United States

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Monroe, Louisiana, 71203, United States

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Wheaton, Maryland, 20902, United States

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Haverhill, Massachusetts, 01830, United States

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Worcester, Massachusetts, 01605, United States

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Saint Clair Shores, Michigan, 48081, United States

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Edina, Minnesota, 55435, United States

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Flowood, Mississippi, 39232, United States

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Jackson, Mississippi, 39202, United States

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Cape Girardeau, Missouri, 63703, United States

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Florissant, Missouri, 63031, United States

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St Louis, Missouri, 63131, United States

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Kalispell, Montana, 59901, United States

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Las Vegas, Nevada, 89128, United States

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Nashua, New Hampshire, 03060, United States

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Berkeley Heights, New Jersey, 07922, United States

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Clifton, New Jersey, 07012, United States

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Albuquerque, New Mexico, 87108, United States

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Brooklyn, New York, 11201, United States

Location

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Charlotte, North Carolina, 28210, United States

Location

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Greensboro, North Carolina, 27408, United States

Location

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Hickory, North Carolina, 28601, United States

Location

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Sanford, North Carolina, 27330, United States

Location

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Bismarck, North Dakota, 58502, United States

Location

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Cincinnati, Ohio, 45242, United States

Location

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Cleveland, Ohio, 44109, United States

Location

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Oklahoma City, Oklahoma, 73104, United States

Location

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Tulsa, Oklahoma, 74104, United States

Location

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Bethlehem, Pennsylvania, 18017, United States

Location

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Erie, Pennsylvania, 16508, United States

Location

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Limerick, Pennsylvania, 19468, United States

Location

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Wexford, Pennsylvania, 15090, United States

Location

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Columbia, South Carolina, 29204, United States

Location

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Greenville, South Carolina, 29601, United States

Location

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Greer, South Carolina, 29651, United States

Location

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Myrtle Beach, South Carolina, 29572, United States

Location

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Taylors, South Carolina, 29687, United States

Location

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Knoxville, Tennessee, 37909, United States

Location

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Memphis, Tennessee, 38119, United States

Location

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Nashville, Tennessee, 37205, United States

Location

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Austin, Texas, 78731, United States

Location

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Houston, Texas, 77008, United States

Location

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Lubbock, Texas, 79424, United States

Location

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Mesquite, Texas, 75150, United States

Location

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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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Burlington, Vermont, 05401, United States

Location

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Chesapeake, Virginia, 23320, United States

Location

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Danville, Virginia, 24541, United States

Location

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Richmond, Virginia, 23225, United States

Location

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Spokane, Washington, 99204, United States

Location

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Tacoma, Washington, 98405, United States

Location

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Wenatchee, Washington, 98801, United States

Location

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Clarksburg, West Virginia, 26301, United States

Location

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Milwaukee, Wisconsin, 53226, United States

Location

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Racine, Wisconsin, 53406, United States

Location

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Buenos Aires, C1280AEB, Argentina

Location

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Córdoba, X5016KEH, Argentina

Location

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Luján, 6700, Argentina

Location

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Mar del Plata, B7600FZN, Argentina

Location

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Quilmes, B1878DVC, Argentina

Location

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San Isidro, B1642AKG, 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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Campinas, 13059-000, Brazil

Location

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Goiânia, 74110-120, Brazil

Location

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Juiz de Fora, 36010-570, Brazil

Location

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São Paulo, 04266-010, Brazil

Location

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Bogotá, Colombia

Location

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Medellín, Colombia

Location

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Montpellier, 34295, France

Location

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Nice, 06202, France

Location

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Orléans, 45000, France

Location

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Paris, 75018, France

Location

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Saint-Etienne, 42055, France

Location

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Strasbourg, 67 098, France

Location

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Toulouse, 31059, France

Location

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Bad Doberan, 18209, Germany

Location

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Bad Nauheim, 61231, Germany

Location

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Baden-Baden, 76530, Germany

Location

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Berlin, 14059, Germany

Location

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Cologne, 50924, Germany

Location

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Dresden, 01307, Germany

Location

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Erlangen, 91054, Germany

Location

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Frankfurt, 60590, Germany

Location

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Göttingen, 37075, Germany

Location

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Munich, 80639, Germany

Location

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Haidari/Athens, 12462, Greece

Location

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Heraklion, 71110, Greece

Location

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Larissa, 411 10, Greece

Location

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Thessaloniki, 54642, Greece

Location

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Arenzano, 16011, Italy

Location

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Fukuoka, 807-8555, Japan

Location

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Gunma, 370-0053, Japan

Location

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Hyōgo, 673-1462, Japan

Location

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Kanagawa, 216-8511, Japan

Location

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Miyazaki, 880-0122, Japan

Location

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Nagasaki, 852-8501, Japan

Location

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Okayama, 700-8558, Japan

Location

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Tokyo, 162, Japan

Location

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Perak, 30990, Malaysia

Location

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Putrajaya, 62250, Malaysia

Location

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Sarawak, 93586, Malaysia

Location

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Chihuahua City, 31000, Mexico

Location

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Col Centro, 80000, Mexico

Location

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Guadalajara, 44620, Mexico

Location

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Mexico City, 03720, Mexico

Location

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Monterrey, 64000, 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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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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Lublin, 20-607, Poland

Location

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Płock, 09-400, Poland

Location

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Torun, 87-100, Poland

Location

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Warsaw, 02-118, Poland

Location

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Kazan', 420029, Russia

Location

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Khanty-Mansiysk, 628012, Russia

Location

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Kursk, 305007, Russia

Location

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Moscow, 115093, Russia

Location

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Nizhny Novgorod, 603005, Russia

Location

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Petrozavodsk, 185019, Russia

Location

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Saint Petersburg, 191104, Russia

Location

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Stavropol, 355017, Russia

Location

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Voronezh, 394066, Russia

Location

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Benoni, 1500, South Africa

Location

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Bloemfontein, 9301, South Africa

Location

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Limpopo, 0380, South Africa

Location

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Incheon, 400-711, South Korea

Location

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Seoul, 150-713, South Korea

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Suwon, 442-721, South Korea

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A Coruña, 15006, Spain

Location

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Barcelona, 08034, Spain

Location

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Bilboa, 48013, Spain

Location

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Madrid, 28046, Spain

Location

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Manises, 46940, Spain

Location

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Santiago de Compostela, 15706, Spain

Location

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Keelung, 204, Taiwan

Location

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Taichung, 40705, Taiwan

Location

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Taipei, 112, Taiwan

Location

Related Publications (1)

  • Schiff M, Combe B, Dorner T, Kremer JM, Huizinga TW, Veenhuizen M, Gill A, Komocsar W, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-BAFF monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis and inadequate response to TNF inhibitors: results of a randomised, double-blind, placebo-controlled, phase 3 study. RMD Open. 2015 Aug 12;1(1):e000037. doi: 10.1136/rmdopen-2014-000037. eCollection 2015.

    PMID: 26535134DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tabalumab

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This study has been terminated not based on safety concerns, but due to insufficient efficacy. Early termination led to lower than expected enrollment and was responsible for the large number of discontinuation reason as Sponsor Decision.

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

March 1, 2013

Study Completion

January 1, 2014

Last Updated

May 14, 2018

Results First Posted

May 14, 2018

Record last verified: 2018-05

Locations

GR(4)TW(3)FR(7)AU(3)NZ(4)ZA(3)MY(3)AR(7)IT(1)ES(6)PL(6)CO(2)US(110)ME(8)RU(9)DE(10)BR(4)KR(3)JP(8)