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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-α Inhibitors (FLEX V)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Rheumatoid Arthritis

Thank you

Trial Information

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-α Inhibitors (FLEX V)


Inclusion Criteria:



- Diagnosis of Rheumatoid Arthritis (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 one 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

Exclusion Criteria:

- 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 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 (e.g., 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Percentage of patients with American College of Rheumatology 20% response (ACR20)

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

13732

NCT ID:

NCT01202773

Start Date:

January 2011

Completion Date:

March 2014

Related Keywords:

  • Rheumatoid Arthritis
  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

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.Denver, Colorado  
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.Manhassaet, New York  
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