Status:
COMPLETED
A Rheumatoid Arthritis Study in Participants
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 with or without background disease-modifying anti-rheumatic drug (DMARD)...
Detailed Description
In consideration of disease severity, all participants were assessed for non-response at Week 16. A total of 66 joints were examined for swelling, and a total of 66 joint were examined for tenderness....
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Use of an investigational drug within the last month
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
1004 Patients enrolled
Trial Details
Trial ID
NCT01202760
Start Date
January 1 2011
End Date
July 1 2013
Last Update
April 25 2018
Active Locations (213)
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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.
Paradise Valley, Arizona, United States, 85253
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.
Peoria, Arizona, United States, 85381
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.
Phoenix, Arizona, United States, 85018