Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:10/21/2018
Start Date:September 9, 2016
End Date:July 2, 2018

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

A Two-Cohort Randomized Phase II, Double-Blind, Parallel Group Study in Patients With Active Rheumatoid Arthritis Evaluating the Efficacy and Safety of GDC-0853 Compared With Placebo and Adalimumab in Patients With an Inadequate Response to Previous Methotrexate Therapy (Cohort 1) and Compared With Placebo in Patients With an Inadequate Response or Intolerance to Previous TNF Therapy (Cohort 2)

This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, active
comparator (Cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and
safety of GDC-0853 in participants with moderate to severe active RA and an inadequate
response to previous methotrexate (MTX) therapy (Cohort 1) or MTX and tumor necrosis factor
(TNF) therapy who may have also had exposure to no more than one non-TNF inhibitor biologic
(Cohort 2).


Inclusion Criteria:

- Have a diagnosis of adult-onset RA as defined by the 2010 American College of
Rheumatology/European League Against Rheumatism Classification Criteria for RA

- RA disease activity by joint counts and laboratory markers of inflammation: greater
than or equal to (>=) 6 tender/painful joints on motion (68 joint count) and >= 6
swollen joints (66 joint count) at both screening and Day 1 (randomization)

- For MTX-inadequate response (IR) participants: must have had an inadequate response to
MTX

- For TNF-IR participants: must have had an inadequate response or intolerance to
previous treatment with at least 1 and no more than 2 biologic TNF-alpha inhibitors
and may have also been exposed to no more than one biologic non-TNF-alpha inhibitor

- High sensitivity C-reactive protein of >= 0.400 milligrams per deciliter (mg/dL) for
Cohort 1 and >= 0.650 mg/dL for Cohort 2 at screening

Exclusion Criteria:

- History of or current inflammatory joint disease other than RA or other systemic
autoimmune disorder

- For MTX-IR participants: History of treatment with any TNF inhibitor, including
biosimilar equivalents and history of treatment with biologic non-TNF-alpha inhibitor
for RA

- For all participants: Previous treatment with cell-depleting therapy including B
cell-depleting therapy (e.g., anti-cluster of differentiation 20-directed therapy such
as rituximab), tofacitinib, or other Janus kinase inhibitor(s), or alkylating agents

- Current treatment with medications that are well known to prolong the QT interval at
doses that have a clinically meaningful effect on QT

- History of non-gallstone-related pancreatitis or chronic pancreatitis

- Evidence of serious uncontrolled concomitant cardiac, neurologic, pulmonary, renal,
hepatic, endocrine, metabolic, or gastrointestinal disease

- Evidence of chronic and/or active hepatitis B or C

- Women who are pregnant, nursing (breast feeding), or intending to become pregnant
during the study or within 60 days after completion of the study
We found this trial at
24
sites
3310 Live Oak Street
Dallas, Texas 75246
347
mi
from
Dallas, TX
Click here to add this to my saved trials
2147 Northeast Coachman Road
Clearwater, Florida 33765
1102
mi
from
Clearwater, FL
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
1383
mi
from
Portland, OR
Click here to add this to my saved trials
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
1329
mi
from
Stanford, CA
Click here to add this to my saved trials
321 East 10th Street
Anniston, Alabama 36207
729
mi
from
Anniston, AL
Click here to add this to my saved trials
Boca Raton, Florida
1299
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Boynton Beach, Florida 33437
1288
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
5827
mi
from
Buenos Aires,
Click here to add this to my saved trials
Covina, California 91723
1148
mi
from
Covina, CA
Click here to add this to my saved trials
Dallas, Texas 75231
348
mi
from
Dallas, TX
Click here to add this to my saved trials
125 Executive Drive
Danville, Virginia 24541
1013
mi
from
Danville, VA
Click here to add this to my saved trials
El Cajon, California 92020
1130
mi
from
El Cajon, CA
Click here to add this to my saved trials
2141 North Harbor Boulevard
Fullerton, California 92835
1155
mi
from
Fullerton, CA
Click here to add this to my saved trials
856
mi
from
Glendale, AZ
Click here to add this to my saved trials
Greensboro, North Carolina 27408
1001
mi
from
Greensboro, NC
Click here to add this to my saved trials
Houston, Texas 77004
569
mi
from
Houston, TX
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
839
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Meridian, Idaho 83642
1050
mi
from
Meridian, ID
Click here to add this to my saved trials
1951 Northwest 7th Avenue
Miami, Florida 33136
1319
mi
from
Miami, FL
Click here to add this to my saved trials
Orlando, Florida 32804
1139
mi
from
Orlando, FL
Click here to add this to my saved trials
Tampa, Florida 33613
1110
mi
from
Tampa, FL
Click here to add this to my saved trials
619
mi
from
Victoria, TX
Click here to add this to my saved trials
Wyomissing, Pennsylvania 19610
1183
mi
from
Wyomissing, PA
Click here to add this to my saved trials