A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate



Status:Terminated
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:5/10/2018
Start Date:December 2010
End Date:January 2014

Use our guide to learn which trials are right for you!

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 Methotrexate Therapy (FLEX M)

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


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

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
We found this trial at
76
sites
?
mi
from
Lewes, DE
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Aventura, FL
Click here to add this to my saved trials
?
mi
from
Bingham Farms, MI
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Danbury, CT
Click here to add this to my saved trials
?
mi
from
Debary, FL
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Duluth, GA
Click here to add this to my saved trials
?
mi
from
Eagle, ID
Click here to add this to my saved trials
?
mi
from
Erie, PA
Click here to add this to my saved trials
?
mi
from
Escondido, CA
Click here to add this to my saved trials
?
mi
from
Evansville, IN
Click here to add this to my saved trials
?
mi
from
Flowood, MS
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Hemet, CA
Click here to add this to my saved trials
?
mi
from
Hot Springs, AR
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Jackson, MS
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Mesquite, TX
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
?
mi
from
Myrtle Beach, SC
Click here to add this to my saved trials
?
mi
from
Nassau Bay, TX
Click here to add this to my saved trials
North Richland Hills, Texas 76180
?
mi
from
North Richland Hills, TX
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
?
mi
from
Paradise Valley, AZ
Click here to add this to my saved trials
?
mi
from
Peoria, AZ
Click here to add this to my saved trials
?
mi
from
Peoria, IL
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenixville, Pennsylvania 19460
?
mi
from
Phoenixville, PA
Click here to add this to my saved trials
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
?
mi
from
Pottstown, PA
Click here to add this to my saved trials
?
mi
from
Racine, WI
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Sanford, NC
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Shawnee Mission, KS
Click here to add this to my saved trials
?
mi
from
Stockbridge, GA
Click here to add this to my saved trials
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Torrance, CA
Click here to add this to my saved trials
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
?
mi
from
Tustin, CA
Click here to add this to my saved trials
?
mi
from
Upland, CA
Click here to add this to my saved trials
?
mi
from
Venice, FL
Click here to add this to my saved trials
?
mi
from
Vero Beach, FL
Click here to add this to my saved trials
?
mi
from
Waco, TX
Click here to add this to my saved trials
?
mi
from
Watertown, SD
Click here to add this to my saved trials
?
mi
from
Wildomar, CA
Click here to add this to my saved trials
?
mi
from
Worcester, MA
Click here to add this to my saved trials