Status:
TERMINATED
A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate
Lead Sponsor:
Eli Lilly and Company
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 comprise...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
1041 Patients enrolled
Trial Details
Trial ID
NCT01198002
Start Date
December 1 2010
End Date
January 1 2014
Last Update
May 8 2018
Active Locations (234)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Birmingham, Alabama, United States, 35216
2
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.
Huntsville, Alabama, United States, 35801
3
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.
Paradise Valley, Arizona, United States, 85253
4
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.
Peoria, Arizona, United States, 85381