An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate



Status:Terminated
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2013
End Date:January 2015

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

A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX

Primary Objective:

To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to
etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an
inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity
Score for 28 joints (DAS28).

Secondary Objectives:

To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab
in combination with methotrexate (MTX).

To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in
combination with methotrexate (MTX).

To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in
patients with rheumatoid arthritis (RA).

The maximum study duration per patient enrolled in the Main study is 54 weeks broken down as
follows:

- screening/run-in up to a maximum of 24 weeks

- treatment up to a maximum of 24 weeks

- follow-up of 6 weeks after treatment discontinuation.

The maximum study duration per patient enrolled in the Sub-study is 58 weeks broken down as
follows:

- treatment up to a maximum of 52 weeks

- follow-up of 6 weeks after treatment discontinuation.

Inclusion criteria:

- Diagnosis of rheumatoid arthritis (RA) >/= 3 months duration.

- Continuous treatment of methotrexate (MTX) 10 - 25 mg/week (or per local labeling
requirements if the dose range differs) for at least 12 weeks before screening visit
and on a stable dose for 8 weeks before screening visit.

- Active disease defined as: at least 6/66 swollen and 8/68 tender joints and high
sensitivity C-reactive protein > 10 mg/L.

Exclusion criteria:

- Age < 18 years.

- Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks
of the screening visit.

- Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per
day, or a change in dosage within 4 weeks of the screening visit.

- Prior treatment with a TNF (tumor necrosis factor)-alpha inhibitor, or other
biological disease modifying anti-rheumatoid drug (DMARD) or Janus Kinase inhibitor.

- New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory
drugs (NSAIDs) or cyclo-oxygenase-2 inhibitors (COX-2 inhibitors within 4 weeks of
the screening visit.

- Treatment with traditional oral disease-modifying antirheumatic drugs (DMARD)
/immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the
screening visit, depending on DMARD.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
We found this trial at
31
sites
?
mi
from
Battle Creek, 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
Buenos Aires,
Click here to add this to my saved trials
Clarksburg, West Virginia 26301
?
mi
from
Clarksburg, WV
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
?
mi
from
Cumberland, MD
Click here to add this to my saved trials
?
mi
from
Danbury, CT
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Glendale, CA
Click here to add this to my saved trials
?
mi
from
Hagerstown, MD
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
Jackson, TN
Click here to add this to my saved trials
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
?
mi
from
Lansing, MI
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Mesquite, TX
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
North Charleston, South Carolina 29406
?
mi
from
North Charleston, SC
Click here to add this to my saved trials
?
mi
from
Ormond Beach, FL
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
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Thousand Oaks, California 91360
?
mi
from
Thousand Oaks, CA
Click here to add this to my saved trials
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
?
mi
from
Upland, CA
Click here to add this to my saved trials
?
mi
from
Victorville, CA
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials