Trial Outcomes & Findings for A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350 (NCT NCT02983227)

Last Updated: 2020-08-03

Results Overview

An Adverse Event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

496 participants

Primary outcome timeframe

Day 1 up until 8 weeks after the last dose of study drug (up to 1 year, 2 months)

Results posted on

2020-08-03

Participant Flow

The study was conducted at 138 centers in 19 countries.

496 participants were enrolled into this OLE study and were included in the ITT and Safety populations.

Participant milestones

Participant milestones
Measure	GDC-0853 (200mg BID) Cohort 1 Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Overall Study STARTED	410	86
Overall Study COMPLETED	351	72
Overall Study NOT COMPLETED	59	14

Reasons for withdrawal

Reasons for withdrawal
Measure	GDC-0853 (200mg BID) Cohort 1 Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Overall Study Adverse Event	21	3
Overall Study Death	3	0
Overall Study Lack of Efficacy	8	1
Overall Study Lost to Follow-up	3	0
Overall Study Multiple Reasons	2	1
Overall Study Physician Decision	3	1
Overall Study Withdrawal by Subject	19	8

Baseline Characteristics

A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GDC-0853 (200mg BID) Cohort 1 n=410 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.	Total n=496 Participants Total of all reporting groups
Age, Continuous	49.9 Years STANDARD_DEVIATION 11.7 • n=5 Participants	53.5 Years STANDARD_DEVIATION 12.5 • n=7 Participants	50.5 Years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	334 Participants n=5 Participants	64 Participants n=7 Participants	398 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	22 Participants n=7 Participants	98 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	136 Participants n=5 Participants	30 Participants n=7 Participants	166 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	267 Participants n=5 Participants	56 Participants n=7 Participants	323 Participants n=5 Participants
Race/Ethnicity, Customized Not Stated	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska native	27 Participants n=5 Participants	11 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized White	365 Participants n=5 Participants	71 Participants n=7 Participants	436 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 up until 8 weeks after the last dose of study drug (up to 1 year, 2 months)

Population: The Safety-Evaluable Population was defined as all participants who received any study drug and had at least one assessment of safety.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=410 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Percentage of Participants With Adverse Events (AEs)	60.2 Percentage	57.0 Percentage

PRIMARY outcome

Timeframe: Week 52

Population: The Intent-To-Treat (ITT) Population was defined as all eligible participants enrolled in this OLE study.

ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\].

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=410 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 52	57.1 Percentage Interval 52.28 to 61.86	50.0 Percentage Interval 39.43 to 60.57

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: The Intent-To-Treat (ITT) Population was defined as all eligible participants enrolled in this OLE study.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=410 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Percentage of Participants Achieving ACR50 Response up to Week 12 Week 4	37.1 Percentage Interval 32.4 to 41.75	29.1 Percentage Interval 19.47 to 38.67
Percentage of Participants Achieving ACR50 Response up to Week 12 Week 8	42.4 Percentage Interval 37.65 to 47.22	34.9 Percentage Interval 24.81 to 44.96
Percentage of Participants Achieving ACR50 Response up to Week 12 Week 12	45.6 Percentage Interval 40.79 to 50.43	39.5 Percentage Interval 29.2 to 49.87

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

Population: The Intent-To-Treat (ITT) Population was defined as all eligible participants enrolled in this OLE study.

ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\]

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=410 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 8	72.9 Percentage Interval 68.63 to 77.23	68.6 Percentage Interval 58.8 to 78.41
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 4	69.0 Percentage Interval 64.55 to 73.5	58.1 Percentage Interval 47.71 to 68.57
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 12	74.4 Percentage Interval 70.17 to 78.62	73.3 Percentage Interval 63.9 to 82.61
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 24	75.4 Percentage Interval 71.2 to 79.54	72.1 Percentage Interval 62.61 to 81.57
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 36	75.1 Percentage Interval 70.94 to 79.31	72.1 Percentage Interval 62.61 to 81.57
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 52	75.4 Percentage Interval 71.2 to 79.54	68.6 Percentage Interval 58.8 to 78.41

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

Population: The Intent-To-Treat (ITT) Population was defined as all eligible participants enrolled in this OLE study.

ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\].

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=410 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 4	19.8 Percentage Interval 15.9 to 23.61	12.8 Percentage Interval 5.73 to 19.85
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 12	23.9 Percentage Interval 19.77 to 28.03	19.8 Percentage Interval 11.35 to 28.18
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 52	36.3 Percentage Interval 31.69 to 41.0	27.9 Percentage Interval 18.43 to 37.39
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 8	21.7 Percentage Interval 17.72 to 25.7	17.4 Percentage Interval 9.42 to 25.46
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 24	30.2 Percentage Interval 25.8 to 34.69	20.9 Percentage Interval 12.33 to 29.53
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 36	32.2 Percentage Interval 27.67 to 36.72	25.6 Percentage Interval 16.36 to 34.8

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 52

Population: The Intent-To-Treat (ITT) Population was defined as all eligible participants enrolled in this OLE study. Number of participants for whom data were actually collected is indicated for each time point.

The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \< 2.6.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=406 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 CRP) Baseline	5.49 Score on a scale Standard Deviation 0.85	5.59 Score on a scale Standard Deviation 0.90
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 CRP) Week 4	3.64 Score on a scale Standard Deviation 1.11	4.09 Score on a scale Standard Deviation 1.19
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 CRP) Week 8	3.48 Score on a scale Standard Deviation 1.06	3.81 Score on a scale Standard Deviation 1.15
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 CRP) Week 12	3.37 Score on a scale Standard Deviation 1.09	3.73 Score on a scale Standard Deviation 1.11
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 CRP) Week 24	3.16 Score on a scale Standard Deviation 1.05	3.55 Score on a scale Standard Deviation 1.18
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 CRP) Week 36	3.05 Score on a scale Standard Deviation 1.05	3.36 Score on a scale Standard Deviation 1.06
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 CRP) Week 52	2.90 Score on a scale Standard Deviation 1.03	3.17 Score on a scale Standard Deviation 1.28

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 52

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=391 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 CRP) Week 8	3.53 Score on a scale Standard Deviation 1.13	3.92 Score on a scale Standard Deviation 1.25
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 CRP) Week 24	3.18 Score on a scale Standard Deviation 1.13	3.64 Score on a scale Standard Deviation 1.27
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 CRP) Week 52	2.87 Score on a scale Standard Deviation 1.09	3.22 Score on a scale Standard Deviation 1.40
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 CRP) Baseline	5.83 Score on a scale Standard Deviation 0.88	5.95 Score on a scale Standard Deviation 0.94
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 CRP) Week 4	3.70 Score on a scale Standard Deviation 1.19	4.22 Score on a scale Standard Deviation 1.34
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 CRP) Week 12	3.39 Score on a scale Standard Deviation 1.14	3.81 Score on a scale Standard Deviation 1.21
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 CRP) Week 36	3.06 Score on a scale Standard Deviation 1.14	3.44 Score on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 52

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=404 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR) Week 4	4.25 Score on a Scale Standard Deviation 1.16	4.80 Score on a Scale Standard Deviation 1.26
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR) Week 8	4.04 Score on a Scale Standard Deviation 1.14	4.51 Score on a Scale Standard Deviation 1.17
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR) Week 12	3.89 Score on a Scale Standard Deviation 1.16	4.40 Score on a Scale Standard Deviation 1.11
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR) Week 24	3.65 Score on a Scale Standard Deviation 1.08	4.15 Score on a Scale Standard Deviation 1.27
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR) Week 36	3.46 Score on a Scale Standard Deviation 1.15	3.96 Score on a Scale Standard Deviation 1.15
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR) Week 52	3.35 Score on a Scale Standard Deviation 1.14	3.74 Score on a Scale Standard Deviation 1.31
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR) Baseline	6.17 Score on a Scale Standard Deviation 0.79	6.38 Score on a Scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 52

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=390 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR) Week 24	3.62 Score on a Scale Standard Deviation 1.16	4.20 Score on a Scale Standard Deviation 1.37
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR) Baseline	6.48 Score on a Scale Standard Deviation 0.85	6.71 Score on a Scale Standard Deviation 0.96
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR) Week 4	4.27 Score on a Scale Standard Deviation 1.25	4.89 Score on a Scale Standard Deviation 1.41
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR) Week 8	4.04 Score on a Scale Standard Deviation 1.23	4.58 Score on a Scale Standard Deviation 1.29
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR) Week 12	3.87 Score on a Scale Standard Deviation 1.23	4.44 Score on a Scale Standard Deviation 1.25
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR) Week 36	3.43 Score on a Scale Standard Deviation 1.24	3.99 Score on a Scale Standard Deviation 1.30
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR) Week 52	3.27 Score on a Scale Standard Deviation 1.20	3.74 Score on a Scale Standard Deviation 1.42

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

Population: The Intent-To-Treat (ITT) Population was defined as all eligible participants enrolled in this OLE study.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=410 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) Week 4	8.8 Percentage of Participants	7.0 Percentage of Participants
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) Week 8	10.7 Percentage of Participants	8.1 Percentage of Participants
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) Week 12	13.9 Percentage of Participants	8.1 Percentage of Participants
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) Week 24	17.8 Percentage of Participants	14.0 Percentage of Participants
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) Week 36	22.4 Percentage of Participants	11.6 Percentage of Participants
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) Week 52	25.6 Percentage of Participants	23.3 Percentage of Participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

Population: The Intent-To-Treat (ITT) Population was defined as all eligible participants enrolled in this OLE study.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=410 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Percentage of Participants With Low Disease Activity (LDA) Based on DAS28 Week 4	20.0 Percentage of Participants	12.8 Percentage of Participants
Percentage of Participants With Low Disease Activity (LDA) Based on DAS28 Week 8	21.2 Percentage of Participants	17.4 Percentage of Participants
Percentage of Participants With Low Disease Activity (LDA) Based on DAS28 Week 12	26.6 Percentage of Participants	12.8 Percentage of Participants
Percentage of Participants With Low Disease Activity (LDA) Based on DAS28 Week 24	33.7 Percentage of Participants	27.9 Percentage of Participants
Percentage of Participants With Low Disease Activity (LDA) Based on DAS28 Week 36	38.3 Percentage of Participants	29.1 Percentage of Participants
Percentage of Participants With Low Disease Activity (LDA) Based on DAS28 Week 52	42.2 Percentage of Participants	29.1 Percentage of Participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

Assessed according to the Boolean based definition (tender joint count =\<1, swollen joint count =\<1, C-reactive Protein (CRP) =\<1, and patient global assessment =\<1)

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=401 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Percentage of Participants With ACR/EULAR Remission Week 4	5.0 Percentage of Participants	5.8 Percentage of Participants
Percentage of Participants With ACR/EULAR Remission Week 8	7.8 Percentage of Participants	5.9 Percentage of Participants
Percentage of Participants With ACR/EULAR Remission Week 12	7.4 Percentage of Participants	7.2 Percentage of Participants
Percentage of Participants With ACR/EULAR Remission Week 24	13.0 Percentage of Participants	6.0 Percentage of Participants
Percentage of Participants With ACR/EULAR Remission Week 36	15.6 Percentage of Participants	11.4 Percentage of Participants
Percentage of Participants With ACR/EULAR Remission Week 52	17.8 Percentage of Participants	10.7 Percentage of Participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =\< 3.3 indicates disease remission, \> 3.4 to 11 indicates low disease activity, \> 11 to 26 indicates moderate disease activity, and \> 26 indicates high disease activity

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=373 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=84 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Change From Baseline in Simplified Disease Activity Index (SDAI) Week 4	-24.36 Score on a Scale Standard Deviation 13.58	-21.00 Score on a Scale Standard Deviation 13.49
Change From Baseline in Simplified Disease Activity Index (SDAI) Week 8	-26.17 Score on a Scale Standard Deviation 13.58	-24.06 Score on a Scale Standard Deviation 13.57
Change From Baseline in Simplified Disease Activity Index (SDAI) Week 12	-27.91 Score on a Scale Standard Deviation 12.89	-25.21 Score on a Scale Standard Deviation 13.37
Change From Baseline in Simplified Disease Activity Index (SDAI) Week 24	-29.61 Score on a Scale Standard Deviation 13.14	-26.45 Score on a Scale Standard Deviation 14.17
Change From Baseline in Simplified Disease Activity Index (SDAI) Week 36	-30.47 Score on a Scale Standard Deviation 13.72	-28.22 Score on a Scale Standard Deviation 14.16
Change From Baseline in Simplified Disease Activity Index (SDAI) Week 52	-31.69 Score on a Scale Standard Deviation 13.12	-29.68 Score on a Scale Standard Deviation 13.77

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

CDAI was derived as the sum of the following: tender joint count (TJC), swollen joint count (SJC), participant global assessment (PGA) of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest. Negative values indicate improvement/reduction in RA disease activity.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=374 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Change From Baseline in Clinical Disease Activity Index (CDAI) Week 24	-28.52 Score on a Scale Standard Deviation 12.52	-25.09 Score on a Scale Standard Deviation 13.18
Change From Baseline in Clinical Disease Activity Index (CDAI) Week 36	-29.40 Score on a Scale Standard Deviation 12.99	-26.66 Score on a Scale Standard Deviation 12.98
Change From Baseline in Clinical Disease Activity Index (CDAI) Week 4	-23.41 Score on a Scale Standard Deviation 13.11	-19.81 Score on a Scale Standard Deviation 13.15
Change From Baseline in Clinical Disease Activity Index (CDAI) Week 8	-25.14 Score on a Scale Standard Deviation 13.06	-22.48 Score on a Scale Standard Deviation 12.59
Change From Baseline in Clinical Disease Activity Index (CDAI) Week 12	-26.82 Score on a Scale Standard Deviation 12.31	-23.82 Score on a Scale Standard Deviation 12.37
Change From Baseline in Clinical Disease Activity Index (CDAI) Week 52	-30.61 Score on a Scale Standard Deviation 12.43	-27.43 Score on a Scale Standard Deviation 13.43

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

Population: Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were actually collected is indicated for each time point.

Tender Joint Count: a total of 68 joints will be assessed for tenderness. Each joint is assessed for the presence/absence of tenderness. 68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=406 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Change From Baseline in Tender/Painful Joint Count Based on 68 Joints Week 4	-15.02 Score on a Scale Standard Deviation 12.38	-13.23 Score on a Scale Standard Deviation 12.27
Change From Baseline in Tender/Painful Joint Count Based on 68 Joints Week 8	-16.11 Score on a Scale Standard Deviation 12.45	-15.19 Score on a Scale Standard Deviation 12.59
Change From Baseline in Tender/Painful Joint Count Based on 68 Joints Week 12	-16.55 Score on a Scale Standard Deviation 12.39	-15.99 Score on a Scale Standard Deviation 12.03
Change From Baseline in Tender/Painful Joint Count Based on 68 Joints Week 24	-17.96 Score on a Scale Standard Deviation 12.24	-16.65 Score on a Scale Standard Deviation 11.35
Change From Baseline in Tender/Painful Joint Count Based on 68 Joints Week 36	-18.48 Score on a Scale Standard Deviation 12.77	-17.51 Score on a Scale Standard Deviation 11.60
Change From Baseline in Tender/Painful Joint Count Based on 68 Joints Week 52	-18.70 Score on a Scale Standard Deviation 12.99	-17.73 Score on a Scale Standard Deviation 11.88

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

Swollen Joint Count: a total of 66 joints will be assessed for swelling. Each joint is assessed for the presence/absence of swelling. 66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=406 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Change From Baseline in Swollen Joint Count Based on 66 Joints Week 8	-10.95 Score on a Scale Standard Deviation 8.48	-9.12 Score on a Scale Standard Deviation 6.65
Change From Baseline in Swollen Joint Count Based on 66 Joints Week 12	-11.40 Score on a Scale Standard Deviation 8.22	-9.08 Score on a Scale Standard Deviation 6.84
Change From Baseline in Swollen Joint Count Based on 66 Joints Week 4	-10.20 Score on a Scale Standard Deviation 8.43	-7.85 Score on a Scale Standard Deviation 6.71
Change From Baseline in Swollen Joint Count Based on 66 Joints Week 24	-11.93 Score on a Scale Standard Deviation 8.33	-9.86 Score on a Scale Standard Deviation 6.61
Change From Baseline in Swollen Joint Count Based on 66 Joints Week 36	-12.15 Score on a Scale Standard Deviation 8.57	-9.98 Score on a Scale Standard Deviation 6.96
Change From Baseline in Swollen Joint Count Based on 66 Joints Week 52	-12.17 Score on a Scale Standard Deviation 8.55	-9.59 Score on a Scale Standard Deviation 8.78

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=371 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Change From Baseline in Patient's Assessment of Arthritis Pain, Using Visual Analog Scale (VAS) Score Week 52	-42.40 Score on a Scale Standard Deviation 26.22	-38.21 Score on a Scale Standard Deviation 26.37
Change From Baseline in Patient's Assessment of Arthritis Pain, Using Visual Analog Scale (VAS) Score Week 4	-30.62 Score on a Scale Standard Deviation 26.60	-26.34 Score on a Scale Standard Deviation 25.98
Change From Baseline in Patient's Assessment of Arthritis Pain, Using Visual Analog Scale (VAS) Score Week 8	-32.57 Score on a Scale Standard Deviation 26.77	-27.21 Score on a Scale Standard Deviation 23.36
Change From Baseline in Patient's Assessment of Arthritis Pain, Using Visual Analog Scale (VAS) Score Week 12	-35.68 Score on a Scale Standard Deviation 26.44	-29.49 Score on a Scale Standard Deviation 26.70
Change From Baseline in Patient's Assessment of Arthritis Pain, Using Visual Analog Scale (VAS) Score Week 24	-37.19 Score on a Scale Standard Deviation 26.85	-30.30 Score on a Scale Standard Deviation 26.42
Change From Baseline in Patient's Assessment of Arthritis Pain, Using Visual Analog Scale (VAS) Score Week 36	-39.50 Score on a Scale Standard Deviation 27.20	-33.14 Score on a Scale Standard Deviation 27.22

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

Participant-assessed arthritis pain was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of arthritis pain (0 mm=none; 100 mm=very severe). Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest, where negative change indicated a decrease in participant-assessed arthritis pain.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=375 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Change From Baseline in Patient's Global Assessment of Arthritis, Using VAS Score Week 4	-30.21 Score on a Scale Standard Deviation 27.47	-26.03 Score on a Scale Standard Deviation 24.50
Change From Baseline in Patient's Global Assessment of Arthritis, Using VAS Score Week 52	-42.91 Score on a Scale Standard Deviation 25.90	-36.58 Score on a Scale Standard Deviation 24.74
Change From Baseline in Patient's Global Assessment of Arthritis, Using VAS Score Week 8	-32.67 Score on a Scale Standard Deviation 26.85	-28.79 Score on a Scale Standard Deviation 23.07
Change From Baseline in Patient's Global Assessment of Arthritis, Using VAS Score Week 12	-35.63 Score on a Scale Standard Deviation 26.19	-31.16 Score on a Scale Standard Deviation 25.32
Change From Baseline in Patient's Global Assessment of Arthritis, Using VAS Score Week 24	-36.94 Score on a Scale Standard Deviation 27.23	-31.76 Score on a Scale Standard Deviation 25.09
Change From Baseline in Patient's Global Assessment of Arthritis, Using VAS Score Week 36	-39.40 Score on a Scale Standard Deviation 26.77	-33.73 Score on a Scale Standard Deviation 25.82

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

Physician's assessment of participant's disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's assessment of the participant's disease activity (0 mm=very good; 100 mm=very poor). Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest, where negative change from baseline indicated an improvement in physician-assessed disease activity.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=399 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Change From Baseline in Physician's Global Assessment of Arthritis, Using VAS Score Week 4	-37.07 Score on a Scale Standard Deviation 20.75	-30.65 Score on a Scale Standard Deviation 24.09
Change From Baseline in Physician's Global Assessment of Arthritis, Using VAS Score Week 12	-42.23 Score on a Scale Standard Deviation 20.20	-37.37 Score on a Scale Standard Deviation 22.14
Change From Baseline in Physician's Global Assessment of Arthritis, Using VAS Score Week 8	-39.29 Score on a Scale Standard Deviation 20.30	-35.32 Score on a Scale Standard Deviation 22.36
Change From Baseline in Physician's Global Assessment of Arthritis, Using VAS Score Week 24	-44.40 Score on a Scale Standard Deviation 20.94	-41.11 Score on a Scale Standard Deviation 23.86
Change From Baseline in Physician's Global Assessment of Arthritis, Using VAS Score Week 36	-45.52 Score on a Scale Standard Deviation 20.76	-43.13 Score on a Scale Standard Deviation 24.14
Change From Baseline in Physician's Global Assessment of Arthritis, Using VAS Score Week 52	-48.57 Score on a Scale Standard Deviation 19.99	-44.81 Score on a Scale Standard Deviation 23.85

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

C-reactive protein is a biological marker of inflammation and is measured in milligrams per decilitre (mg/dL)

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=398 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=84 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Change From Baseline in C-Reactive Protein (CRP) Levels Week 4	-0.95 (mg/dL) Standard Deviation 2.18	-1.09 (mg/dL) Standard Deviation 3.10
Change From Baseline in C-Reactive Protein (CRP) Levels Week 8	-1.02 (mg/dL) Standard Deviation 2.41	-1.58 (mg/dL) Standard Deviation 2.60
Change From Baseline in C-Reactive Protein (CRP) Levels Week 12	-1.03 (mg/dL) Standard Deviation 2.21	-1.40 (mg/dL) Standard Deviation 3.38
Change From Baseline in C-Reactive Protein (CRP) Levels Week 24	-1.03 (mg/dL) Standard Deviation 2.48	-1.46 (mg/dL) Standard Deviation 2.99
Change From Baseline in C-Reactive Protein (CRP) Levels Week 36	-1.11 (mg/dL) Standard Deviation 2.44	-1.56 (mg/dL) Standard Deviation 3.04
Change From Baseline in C-Reactive Protein (CRP) Levels Week 52	-1.12 (mg/dL) Standard Deviation 2.55	-1.81 (mg/dL) Standard Deviation 2.75

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36 and 52

The Stanford Health Assessment Questionnaire disability index is a patient-reported outcome used to assess difficulty in performing activities of daily living. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. To respond to each question, a four-level response with higher scores showing larger functional limitations, was chosen. Scoring is as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. The composite HAQ-DI score is the mean of the eight domain scores and the score ranges from 0 (no functional impairment) to 3 (maximum functional impairment). A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=360 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=81 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Week 4	-0.70 Score on a Scale Standard Deviation 0.64	-0.55 Score on a Scale Standard Deviation 0.56
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Week 8	-0.77 Score on a Scale Standard Deviation 0.65	-0.59 Score on a Scale Standard Deviation 0.62
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Week 12	-0.80 Score on a Scale Standard Deviation 0.67	-0.60 Score on a Scale Standard Deviation 0.59
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Week 24	-0.83 Score on a Scale Standard Deviation 0.66	-0.63 Score on a Scale Standard Deviation 0.58
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Week 36	-0.89 Score on a Scale Standard Deviation 0.63	-0.62 Score on a Scale Standard Deviation 0.66
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Week 52	-0.98 Score on a Scale Standard Deviation 0.64	-0.69 Score on a Scale Standard Deviation 0.62

SECONDARY outcome

Timeframe: Weeks 12, 24 and 52

The 36-Item Short Form Health Survey (SF-36v2) is a questionnaire used to assess functional health and well-being and consists of eight domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The SF-36v2 is summarized into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. The PCS and MCS scores range from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=356 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=83 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components Week 12 (Physical Component Score change)	11.35 Number on a Scale Standard Deviation 9.13	8.22 Number on a Scale Standard Deviation 8.73
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components Week 12 (Mental Component Score change)	6.52 Number on a Scale Standard Deviation 12.98	4.74 Number on a Scale Standard Deviation 11.53
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components Week 24 (Physical Component Score change)	12.31 Number on a Scale Standard Deviation 9.12	8.28 Number on a Scale Standard Deviation 8.53
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components Week 24 (Mental Component Score change)	6.63 Number on a Scale Standard Deviation 13.23	6.08 Number on a Scale Standard Deviation 11.76
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components Week 52 (Physical Component Score change)	13.89 Number on a Scale Standard Deviation 9.32	10.42 Number on a Scale Standard Deviation 8.94
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components Week 52 (Mental Component Score change)	7.00 Number on a Scale Standard Deviation 13.81	6.77 Number on a Scale Standard Deviation 11.60

SECONDARY outcome

Timeframe: Weeks 12, 24 and 52

The FACIT-Fatigue Scale consists of 13 items designed to measure the degree of fatigue experienced by the patient in the previous 7 days. For each question, there are five possible responses: 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). A total fatigue score is calculated by summing all items, and possible total scores range from 0 (maximum fatigue) to 52 (no fatigue). A positive change from baseline indicates an improvement in the patient's fatigue (less fatigue).

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=350 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=83 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Week 12	11.44 Score on a Scale Standard Deviation 10.36	9.28 Score on a Scale Standard Deviation 8.51
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Week 24	11.74 Score on a Scale Standard Deviation 10.75	10.41 Score on a Scale Standard Deviation 8.51
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Week 52	12.87 Score on a Scale Standard Deviation 10.58	10.87 Score on a Scale Standard Deviation 9.25

SECONDARY outcome

Timeframe: Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination

Population: The PK-Evaluable population was defined as all participants that received any fenebrutinib/GDC-0853 and had sufficient data to enable estimation of key PK parameters. Participants who received incorrect therapy different from the intended therapy were summarized in the group according to the therapy actually received.

Population PK model estimated AUC of GDC-0853 at steady-state. AUC was measured in Nanograms (ng) per millilitre(mL)\*hour (hr).

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=388 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=81 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Area Under the Concentration Time Curve (AUC) of GDC-0853 at Steady State (AUC,ss)	13400 Ng/mL*(hr) Standard Deviation 6930	15600 Ng/mL*(hr) Standard Deviation 7850

SECONDARY outcome

Timeframe: Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination

Population PK model estimated minimal plasma concentration (Ctrough) of GDC-0853 at steady-state (ss).

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=388 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=81 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)	387 ng/mL Standard Deviation 244	467 ng/mL Standard Deviation 285

SECONDARY outcome

Timeframe: Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination

Population PK model estimated plasma decay half life of GDC-0853 at steady-state.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=388 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=81 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)	7.94 hr Standard Deviation 3.16	9.01 hr Standard Deviation 4.9

SECONDARY outcome

Timeframe: Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination

Population PK model estimated apparent oral clearance of GDC-0853 at steady-state.

Outcome measures

Outcome measures
Measure	GDC-0853 (200mg BID) Cohort 1 n=388 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=81 Participants Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)	39.5 L/hr Standard Deviation 12.6	35.3 L/hr Standard Deviation 10.3

Adverse Events

GDC-0853 (200mg BID) Cohort 1

Serious events: 26 serious events

Other events: 22 other events

Deaths: 3 deaths

GDC-0853 (200mg BID) Cohort 2

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GDC-0853 (200mg BID) Cohort 1 n=410 participants at risk Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.	GDC-0853 (200mg BID) Cohort 2 n=86 participants at risk Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Infections and infestations URINARY TRACT INFECTION	5.4% 22/410 • Number of events 28 • Day 1 up until 8 weeks after the last dose of study drug (up to 1 year, 2 months). The Safety-evaluable population was defined as all participants who received any study drug and had at least one assessment of safety. AEs that were entered into the database at the time of the database lock were included in the AE analysis.	4.7% 4/86 • Number of events 7 • Day 1 up until 8 weeks after the last dose of study drug (up to 1 year, 2 months). The Safety-evaluable population was defined as all participants who received any study drug and had at least one assessment of safety. AEs that were entered into the database at the time of the database lock were included in the AE analysis.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER