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 |
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).
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
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Stanford University School of Medicine Vast in both its physical scale and its impact on...
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