Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:10/27/2018
Start Date:August 8, 2016
End Date:May 2019

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

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy

The primary objective of this study is to evaluate the effects of filgotinib in combination
with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).


Key Inclusion Criteria:

- Have a diagnosis of RA (2010 ACR/EULAR criteria) and are ACR functional class I-III.

- Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥
6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both
screening and Day 1.

- Limited or no prior treatment with MTX

Key Exclusion Criteria:

- Previous treatment with any janus kinase (JAK) inhibitor

- Previous therapy for longer than 3 months with conventional synthetic disease
modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine

- Use of any licensed or investigational biologic disease-modifying antirheumatic drugs
(DMARDs)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
46
sites
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
?
mi
from
Carrollton, TX
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
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
Corpus Christi, TX
Click here to add this to my saved trials
?
mi
from
Covina, CA
Click here to add this to my saved trials
?
mi
from
Cumberland, MD
Click here to add this to my saved trials
?
mi
from
Debary, FL
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
?
mi
from
Eagan, MN
Click here to add this to my saved trials
?
mi
from
Elizabethtown, KY
Click here to add this to my saved trials
?
mi
from
Freehold, NJ
Click here to add this to my saved trials
?
mi
from
Hattiesburg, MS
Click here to add this to my saved trials
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
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
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orangeburg, SC
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Palm Desert, CA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Plano, TX
Click here to add this to my saved trials
?
mi
from
Plantation, FL
Click here to add this to my saved trials
?
mi
from
Saint Clair Shores, MI
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
Springfield, IL
Click here to add this to my saved trials
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
?
mi
from
Victorville, CA
Click here to add this to my saved trials
?
mi
from
Webster, TX
Click here to add this to my saved trials
?
mi
from
Wheaton, MD
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials
?
mi
from
Worcester, MA
Click here to add this to my saved trials
?
mi
from
Wyomissing, PA
Click here to add this to my saved trials