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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02833350
• Date of registration: 12/07/2016
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
• Scientific 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)
• Date of first enrolment: September 9, 2016
• Target sample size: 578
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02833350
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Brazil, Bulgaria, Chile, Colombia, Korea, Republic of, Mexico, Poland, Russian Federation, Serbia, Ukraine, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Adalimumab

Drug: Placebo

Drug: MTX

Drug: Folic Acid

Drug: GDC-0853

Primary Outcome(s)

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1) [Time Frame: Day 84]

Percentage of Participants With Adverse Events [Time Frame: Day 1 up to 8 weeks after last dose (up to Week 20)]

Secondary Outcome(s)

Change From Baseline in C-Reactive Protein (CRP) Levels [Time Frame: Days 7, 14, 28, 56, and 84]

Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) [Time Frame: Days 7, 14, 28, 56, and 84]

Minimum Observed Plasma Concentration of GDC-0853 at Steady State (Cmin,ss) [Time Frame: Pre-dose (0 hours) up to 10 hours post-dose on Day 28]

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components [Time Frame: Day 84]

Area Under the Concentration Time Curve From Time 0 to Time 24 of GDC-0853 at Steady State (AUC0-24,ss) [Time Frame: Pre-dose (0 hours) up to 10 hours post-dose on Day 28]

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [Time Frame: Days 7, 14, 28, 56, and 84]

Change From Baseline in Patient Global Assessment Score of Arthritis Pain [Time Frame: Days 7, 14, 28, 56, and 84]

Percentage of Participants Meeting the Boolean-based Remission Criteria [Time Frame: Days 7, 14, 28, 56, and 84]

Change From Baseline in Physician's Global Assessment Score of Arthritis [Time Frame: Days 7, 14, 28, 56, and 84]

Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1) [Time Frame: Day 84]

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response [Time Frame: Days 7, 14, 28, 56, and 84]

Change From Baseline in Swollen Joint Count (66 Joint Count) [Time Frame: Days 7, 14, 28, 56, and 84]

Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) [Time Frame: Days 7, 14, 28, 56, and 84]

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response [Time Frame: Days 7, 14, 28, 56, and 84]

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response [Time Frame: Days 7, 14, 28, 56, and 84]

Percentage of Participants Meeting the CDAI-based Remission Criteria [Time Frame: Days 7, 14, 28, 56, and 84]

Percentage of Participants With DAS Remission [Time Frame: Days 7, 14, 28, 56, and 84]

Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) [Time Frame: Days 7, 14, 28, 56, and 84]

Change From Baseline in Clinical Disease Activity Index (CDAI) [Time Frame: Baseline, Days 7, 14, 28, 56 and 84]

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score [Time Frame: Day 84]

Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 2) [Time Frame: Day 84]

Change From Baseline in Patient Assessment Score of Arthritis Pain [Time Frame: Days 7, 14, 28, 56, and 84]

Percentage of Participants Meeting the SDAI-based Remission Criteria [Time Frame: Days 7, 14, 28, 56, and 84]

Change From Baseline in Simplified Disease Activity Index (SDAI) [Time Frame: Baseline, Days 7, 14, 28, 56 and 84]

Change From Baseline in Tender/Painful Joint Count (68 Joint Count) [Time Frame: Days 7, 14, 28, 56, and 84]

Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) [Time Frame: Days 7, 14, 28, 56, and 84]

Percentage of Participants With DAS Low Disease Activity [Time Frame: Days 7, 14, 28, 56, and 84]

Maximum Observed Plasma Concentration of GDC-0853 at Steady State (Cmax,ss) [Time Frame: Pre-dose (0 hours) up to 10 hours post-dose on Day 28]

Secondary ID(s)

GA29350

2016-000335-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/09/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02833350