A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate
NCT ID: NCT01198002
Last Updated: 2018-05-08
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
1041 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-12-31
Study Completion Date
2014-01-31
Brief Summary
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The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate.
This study is comprised of 3 periods:
Period 1: 52-week blinded treatment
Period 2: additional 48-week unblinded treatment
Period 3: 48-week post-treatment follow-up
This study is comprised of 3 periods:
Period 1: 52-week blinded treatment
Period 2: additional 48-week unblinded treatment
Period 3: 48-week post-treatment follow-up
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Detailed Description
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Conditions
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Rheumatoid Arthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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120 milligrams (mg) LY2127399
Given every 4 weeks (Q4W) for 100 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 Weeks 16 and 52, 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 100-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 100-week treatment period.
Group Type
EXPERIMENTAL
LY2127399
Intervention Type
DRUG
Administered Subcutaneously (SC)
Placebo Q4W
Intervention Type
DRUG
Administered SC
Methotrexate
Intervention Type
DRUG
Methotrexate is a background therapy.
90 mg LY2127399
Given Q2W for 100 weeks. Participants receive a 180 mg loading dose when initiating treatment.
At Weeks 16 and 52, responders will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q4W for the rest of the 100-week treatment period.
At Week 16, 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 100-week treatment period.
Group Type
EXPERIMENTAL
LY2127399
Intervention Type
DRUG
Administered Subcutaneously (SC)
Methotrexate
Intervention Type
DRUG
Methotrexate is a background therapy.
Placebo
Given Q2W for 52 weeks. At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 52 weeks.
At Week 52, responders are randomized to receive 1 of the 2 doses of LY2127399, with loading dose of 240 mg or 180 mg of LY2127399, followed by 120 mg of LY2127399 Q4W or 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.
At Week 16, NR will receive a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.
Group Type
PLACEBO_COMPARATOR
LY2127399
Intervention Type
DRUG
Administered Subcutaneously (SC)
Placebo Q2W
Intervention Type
DRUG
Administered SC
Methotrexate
Intervention Type
DRUG
Methotrexate is a background therapy.
Interventions
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LY2127399
Administered Subcutaneously (SC)
Intervention Type
DRUG
Placebo Q2W
Administered SC
Intervention Type
DRUG
Placebo Q4W
Administered SC
Intervention Type
DRUG
Methotrexate
Methotrexate is a background therapy.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
* Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks
* At least 8 tender and swollen joints
* At least one erosion of a hand or foot joint observed on an X-ray
* 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
* Woman must not be pregnant, breastfeeding, or become pregnant during the study
* Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks
* At least 8 tender and swollen joints
* At least one erosion of a hand or foot joint observed on an X-ray
* 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
* Woman must not be pregnant, breastfeeding, or become pregnant during the study
Exclusion Criteria
* 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 an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)
* History of a serious reaction to other biological DMARDs
* History of the use of rituximab or other B cell therapy
* Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
* Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide)
* 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
* History of the use of rituximab, any other B cell targeted biotherapy, or denosumab
* 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 an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)
* History of a serious reaction to other biological DMARDs
* History of the use of rituximab or other B cell therapy
* Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
* Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide)
* 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
* History of the use of rituximab, any other B cell targeted biotherapy, or denosumab
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Paradise Valley, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Escondido, California, United States
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Fresno, California, United States
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Hemet, California, United States
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DeBary, Florida, United States
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Marietta, Georgia, United States
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Stockbridge, Georgia, United States
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Peoria, Illinois, United States
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Indianapolis, Indiana, United States
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Shawnee Mission, Kansas, United States
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Owensboro, Kentucky, United States
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Worcester, Massachusetts, United States
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Bingham Farms, Michigan, United States
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Flowood, Mississippi, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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Syracuse, New York, United States
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Charlotte, North Carolina, United States
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Sanford, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Tulsa, Oklahoma, United States
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Erie, Pennsylvania, United States
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Phoenixville, Pennsylvania, United States
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Pottstown, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Myrtle Beach, South Carolina, United States
Site Status
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Watertown, South Dakota, United States
Site Status
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Memphis, Tennessee, United States
Site Status
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Austin, Texas, United States
Site Status
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Houston, Texas, United States
Site Status
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Lubbock, Texas, United States
Site Status
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Mesquite, Texas, United States
Site Status
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Nassau Bay, Texas, United States
Site Status
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North Richland Hills, Texas, United States
Site Status
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San Antonio, Texas, United States
Site Status
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Waco, Texas, United States
Site Status
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Racine, Wisconsin, United States
Site Status
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Buenos Aires, , Argentina
Site Status
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Córdoba, , Argentina
Site Status
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Luján, , Argentina
Site Status
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Mar del Plata, , Argentina
Site Status
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Quilmes, , Argentina
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San Juan, , Argentina
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San Miguel de Tucumán, , Argentina
Site Status
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Campbelltown, New South Wales, Australia
Site Status
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Herston, Queensland, Australia
Site Status
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Malvern East, , Australia
Site Status
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Campinas, , Brazil
Site Status
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Caxias do Sul, , Brazil
Site Status
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Curitiba, , Brazil
Site Status
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Fortaleza, , Brazil
Site Status
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Goiânia, , Brazil
Site Status
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Juiz de Fora, , Brazil
Site Status
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Rio de Janeiro, , Brazil
Site Status
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São Paulo, , Brazil
Site Status
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Burgas, , Bulgaria
Site Status
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Pleven, , Bulgaria
Site Status
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Plovdiv, , Bulgaria
Site Status
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Rousse, , Bulgaria
Site Status
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Sevlievo, , Bulgaria
Site Status
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Sofia, , Bulgaria
Site Status
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Varna, , Bulgaria
Site Status
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Bogotá, , Colombia
Site Status
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Medellín, , Colombia
Site Status
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Opatija, , Croatia
Site Status
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Osijek, , Croatia
Site Status
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Rijeka, , Croatia
Site Status
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Baja, , Hungary
Site Status
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Balassagyarmat, , Hungary
Site Status
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Budapest, , Hungary
Site Status
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Debrecen, , Hungary
Site Status
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Esztergom, , Hungary
Site Status
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Kiskunhalas, , Hungary
Site Status
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Sátoraljaújhely, , Hungary
Site Status
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Szikszó, , Hungary
Site Status
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Veszprém, , Hungary
Site Status
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Ahmedabad, , India
Site Status
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Bangalore, , India
Site Status
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Chennai, , India
Site Status
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Hyderabaad, , India
Site Status
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Jaipur, , India
Site Status
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Lucknow, , India
Site Status
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Mysore, , India
Site Status
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Nellore, , India
Site Status
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New Delhi, , India
Site Status
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Secunderabad, , India
Site Status
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Surat, , India
Site Status
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Aichi, , Japan
Site Status
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Chiba, , Japan
Site Status
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Fukuoka, , Japan
Site Status
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Gunma, , Japan
Site Status
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Hokkaido, , Japan
Site Status
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Hyōgo, , Japan
Site Status
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Ibaraki, , Japan
Site Status
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Ibaraki, , Japan
Site Status
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Japan, , Japan
Site Status
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Kagoshima, , Japan
Site Status
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Kanagawa, , Japan
Site Status
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Kumamoto, , Japan
Site Status
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Mie, , Japan
Site Status
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Miyagi, , Japan
Site Status
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Miyazaki, , Japan
Site Status
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Nagano, , Japan
Site Status
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Nagasaki, , Japan
Site Status
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Nara, , Japan
Site Status
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Ohita, , Japan
Site Status
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Okayama, , Japan
Site Status
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Osaka, , Japan
Site Status
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Saga, , Japan
Site Status
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Saitama, , Japan
Site Status
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Sapporo, , Japan
Site Status
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Tokushima, , Japan
Site Status
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Tokyo, , Japan
Site Status
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Toyama, , Japan
Site Status
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Klaipedos, , Lithuania
Site Status
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Vilnius, , Lithuania
Site Status
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Kota Bharu, , Malaysia
Site Status
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Perak, , Malaysia
Site Status
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Putrajaya, , Malaysia
Site Status
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Sarawak, , Malaysia
Site Status
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Aguascalientes, , Mexico
Site Status
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Barrio San Mateo, , Mexico
Site Status
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Chihuahua City, , Mexico
Site Status
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Guadalajara, , Mexico
Site Status
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Mexicali, , Mexico
Site Status
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Mexico City, , Mexico
Site Status
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Monterrey, , Mexico
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Morelia, , Mexico
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Querétaro, , Mexico
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San Luis Potosí City, , Mexico
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Tijuana, , Mexico
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Hamilton, , New Zealand
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Rotorua, , New Zealand
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Tauranga, , New Zealand
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Timaru, , New Zealand
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Bydgoszcz, , Poland
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Działdowo, , Poland
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Elblag, , Poland
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Gdynia, , Poland
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Lublin, , Poland
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Płock, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Włoszczowa, , Poland
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Brasov, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
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Ploieşti, , Romania
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Barnaul, , Russia
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Kazan', , Russia
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Kemerovo, , Russia
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Khanty-Mansiysk, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Petrozavodsk, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Stavropol, , Russia
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Voronezh, , Russia
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Yaroslavl, , Russia
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Bratislava, , Slovakia
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Dunajská Streda, , Slovakia
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Piešťany, , Slovakia
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Benoni, , South Africa
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Bloemfontein, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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Limpopo, , South Africa
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Pretoria, , South Africa
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Somerset West, , South Africa
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Stellenbosch, , South Africa
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Busan, , South Korea
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Daegu, , South Korea
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Daejeon, , South Korea
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Incheon, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Colombo, , Sri Lanka
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Galle, , Sri Lanka
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Kalubowila, , Sri Lanka
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Nugegoda, , Sri Lanka
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Chiayi City, , Taiwan
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Keelung, , Taiwan
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Kuei Shan Hsiang, , Taiwan
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Niao Sung Hsiang, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Dnipropetrovsk, , Ukraine
Site Status
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Donetsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Odesa, , Ukraine
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Poltava, , Ukraine
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Vinnytsia, , Ukraine
Site Status
Countries
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United States
Argentina
Australia
Brazil
Bulgaria
Colombia
Croatia
Hungary
India
Japan
Lithuania
Malaysia
Mexico
New Zealand
Poland
Romania
Russia
Slovakia
South Africa
South Korea
Sri Lanka
Taiwan
Ukraine
References
Explore related publications, articles, or registry entries linked to this study.
Smolen JS, Weinblatt ME, van der Heijde D, Rigby WF, van Vollenhoven R, Bingham CO 3rd, Veenhuizen M, Gill A, Zhao F, Komocsar WJ, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-B-cell-activating factor monoclonal antibody, in patients with rheumatoid arthritis who had an inadequate response to methotrexate therapy: results from a phase III multicentre, randomised, double-blind study. Ann Rheum Dis. 2015 Aug;74(8):1567-70. doi: 10.1136/annrheumdis-2014-207090. Epub 2015 Apr 14.
Reference Type
DERIVED
Other Identifiers
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H9B-MC-BCDM
Identifier Type: OTHER
Identifier Source: secondary_id
CTRI/2011/07/001870
Identifier Type: REGISTRY
Identifier Source: secondary_id
11352
Identifier Type: -
Identifier Source: org_study_id
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