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Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
- Autoimmune Disorder
- Rheumatoid Arthritis
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Countries
- Argentina
- Brazil
- Bulgaria
- Colombia
- Mexico
- Poland
- Russia
- Serbia
- South Korea
- Ukraine
- United States
Trial Identifier:
NCT02833350 2016-000335-40 GA29350
Trial Summary
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).
Genentech, Inc.
Sponsor
Phase 2
Phase
NCT02833350, GA29350, 2016-000335-40
Trial Identifier
GDC-0853, Adalimumab, Folic Acid, MTX, Placebo
Treatments
Rheumatoid Arthritis
Condition
Official Title
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)
Eligibility Criteria
All
Gender
≥ 18 Years & ≤ 75 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com