Rheumatoid Arthritis
Conditions
Brief 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).
Interventions
DRUGGDC-0853
Participants will receive GDC-0853 at low, mid, or high doses, orally once or twice daily for 12 weeks in Cohort 1 or 2.
DRUGAdalimumab
Participants will receive adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks.
DRUGFolic Acid
Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
DRUGMTX
Participants will receive stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines).
DRUGPlacebo
Participants will receive placebo matched to adalimumab, subcutaneously Q2W and/or placebo matched to GDC-0853, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1) | Day 84 | 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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\]. |
| Percentage of Participants With Adverse Events | Day 1 up to 8 weeks after last dose (up to Week 20) | An Adverse event 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. A SAE was any experience that suggested a significant hazard, contraindication, side effect or precaution that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Days 7, 14, 28, 56, and 84 | 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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\] |
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Days 7, 14, 28, 56, and 84 | 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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\]. |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Days 7, 14, 28, 56, and 84 | 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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\]. |
| Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Days 7, 14, 28, 56, and 84 | 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. |
| Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Days 7, 14, 28, 56, and 84 | 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. |
| Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Days 7, 14, 28, 56, and 84 | 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. |
| Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Days 7, 14, 28, 56, and 84 | 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. |
| Percentage of Participants With DAS Low Disease Activity | Days 7, 14, 28, 56, and 84 | 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. LDAS is defined as DAS28 ≤ 3.2 |
| Percentage of Participants With DAS Remission | Days 7, 14, 28, 56, and 84 | 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 |
| Percentage of Participants Meeting the Boolean-based Remission Criteria | Days 7, 14, 28, 56, and 84 | Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). |
| Change From Baseline in Clinical Disease Activity Index (CDAI) | Baseline, Days 7, 14, 28, 56 and 84 | 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. |
| Percentage of Participants Meeting the CDAI-based Remission Criteria | Days 7, 14, 28, 56, and 84 | Clinical Disease Activity Index is defined as CDAI= : SJC(28) + TJC(28) + PGA + MDG where TJC and SJC are the tender and swollen joint counts from 28 joints, PGA is the patient's global assessment of disease activity (on a 0-10 scale) and MDG is physician global assessment of disease activity (on a 0-10 scale). The cutoff value for CDAI remission is \<=2.8. |
| Change From Baseline in Simplified Disease Activity Index (SDAI) | Baseline, Days 7, 14, 28, 56 and 84 | 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 |
| Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1) | Day 84 | 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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\]. |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Day 84 | 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. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Day 84 | 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). |
| Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Days 7, 14, 28, 56, and 84 | 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. |
| Change From Baseline in Swollen Joint Count (66 Joint Count) | Days 7, 14, 28, 56, and 84 | 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. |
| Change From Baseline in Patient Assessment Score of Arthritis Pain | Days 7, 14, 28, 56, and 84 | 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 |
| Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Days 7, 14, 28, 56, and 84 | 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. |
| Change From Baseline in Physician's Global Assessment Score of Arthritis | Days 7, 14, 28, 56, and 84 | 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. |
| Change From Baseline in C-Reactive Protein (CRP) Levels | Days 7, 14, 28, 56, and 84 | C-reactive protein is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL) |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Days 7, 14, 28, 56, and 84 | 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. |
| Area Under the Concentration Time Curve From Time 0 to Time 24 of GDC-0853 at Steady State (AUC0-24,ss) | Pre-dose (0 hours) up to 10 hours post-dose on Day 28 | The Pharmacokinetics (PK) evaluation may include, but will not be limited to, plasma GDC-0853 concentrations and population PK model estimated PK exposures (area under the plasma concentration-time curve \[AUC\]. AUC was measured in Nanograms(ng) per millilitre(mL)\*hour (hr) |
| Maximum Observed Plasma Concentration of GDC-0853 at Steady State (Cmax,ss) | Pre-dose (0 hours) up to 10 hours post-dose on Day 28 | Cmax is the maximum (peak) plasma concentration over the dosing interval at steady state (ss) |
| Minimum Observed Plasma Concentration of GDC-0853 at Steady State (Cmin,ss) | Pre-dose (0 hours) up to 10 hours post-dose on Day 28 | Cmin is the minimum concentration over the dosing interval at steady state (ss) |
| Percentage of Participants Meeting the SDAI-based Remission Criteria | Days 7, 14, 28, 56, and 84 | The SDAI was the numerical sum of five outcome parameter: SJC and TJC (based on a 28-joint assessment), PGA and MDG (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. The SDAI =\< 3.3 indicates disease remission |
| Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 2) | Day 84 | 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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\]. |
Countries
Argentina, Brazil, Bulgaria, Colombia, Mexico, Poland, Russia, Serbia, South Korea, Ukraine, United States
Participant flow
Recruitment details
578 participants were enrolled in the study and 578 were dosed. One (1) subject in Cohort 2 in the Placebo arm was incorrectly dosed with the High Dose. The ITT data set included participants according to their randomization while SAF data set included participants according to the treatment administered.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo Participants of Cohort 1 received GDC-0853 low dose, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion. | 40 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo Participants of Cohort 1 received GDC-0853 mid dose, orally twice daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion. | 109 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo Participants of Cohort 1 received GDC-0853 high dose, orally once daily along with placebo matched to adalimumab, subcutaneously every 2 weeks (Q2W) starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 milligrams per week (mg/week) (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion. | 110 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo Participants of Cohort 1 received placebo matched to GDC-0853, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion. | 110 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Participants of Cohort 1 received placebo matched to GDC-0853, orally once daily along with adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion. | 111 |
| Cohort 2: GDC-0853 High Dose Participants of Cohort 2 received GDC-0853 high dose, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion. | 49 |
| Cohort 2: GDC-0853 Placebo Participants of Cohort 2 received placebo matched to GDC-0853, orally twice daily for 12 weeks. Participants remained on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week were allowed only if there was clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigators discretion. | 49 |
| Total | 578 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 | 4 | 4 | 1 | 0 | 1 |
| Overall Study | Death | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 0 | 2 | 1 | 4 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 3 | 2 | 0 | 2 | 0 | 2 |
Baseline characteristics
| Characteristic | Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Cohort 1: GDC-0853 Placebo + Adalimumab | Cohort 2: GDC-0853 High Dose | Cohort 2: GDC-0853 Placebo | Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 11 Participants | 12 Participants | 13 Participants | 8 Participants | 9 Participants | 5 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants | 99 Participants | 98 Participants | 98 Participants | 41 Participants | 40 Participants | 35 Participants | 506 Participants |
| Age, Continuous | 50.4 Years STANDARD_DEVIATION 11 | 49.9 Years STANDARD_DEVIATION 12.4 | 50.2 Years STANDARD_DEVIATION 11.6 | 49.9 Years STANDARD_DEVIATION 12.4 | 51.3 Years STANDARD_DEVIATION 13.2 | 54.6 Years STANDARD_DEVIATION 11.5 | 52.3 Years STANDARD_DEVIATION 12 | 50.7 Years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized American Indian or Alaska native | 8 Participants | 12 Participants | 11 Participants | 9 Participants | 6 Participants | 5 Participants | 0 Participants | 51 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black of African American | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 38 Participants | 40 Participants | 38 Participants | 39 Participants | 17 Participants | 15 Participants | 8 Participants | 195 Participants |
| Race/Ethnicity, Customized Multiple | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 68 Participants | 69 Participants | 72 Participants | 70 Participants | 32 Participants | 33 Participants | 31 Participants | 375 Participants |
| Race/Ethnicity, Customized Not Stated | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 96 Participants | 96 Participants | 95 Participants | 99 Participants | 42 Participants | 42 Participants | 36 Participants | 506 Participants |
| Sex: Female, Male Female | 92 Participants | 85 Participants | 90 Participants | 87 Participants | 37 Participants | 37 Participants | 35 Participants | 463 Participants |
| Sex: Female, Male Male | 17 Participants | 25 Participants | 20 Participants | 24 Participants | 12 Participants | 12 Participants | 5 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 109 | 1 / 110 | 0 / 110 | 0 / 111 | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 9 / 40 | 18 / 109 | 11 / 110 | 15 / 110 | 16 / 111 | 3 / 49 | 7 / 49 |
| serious Total, serious adverse events | 0 / 40 | 1 / 109 | 3 / 110 | 1 / 110 | 2 / 111 | 0 / 49 | 0 / 49 |
Outcome results
Primary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1)
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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
Time frame: Day 84
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 collected is indicated for each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1) | 17.5 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1) | 27.5 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1) | 34.5 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1) | 14.5 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1) | 36.0 Percentage |
p-value: 0.250395% CI: [-5.64, 21.64]Cochran-Mantel-Haenszel
p-value: 0.016495% CI: [2.37, 23.48]Cochran-Mantel-Haenszel
p-value: 0.000395% CI: [9.21, 30.79]Cochran-Mantel-Haenszel
Primary
Percentage of Participants With Adverse Events
An Adverse event 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. A SAE was any experience that suggested a significant hazard, contraindication, side effect or precaution that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
Time frame: Day 1 up to 8 weeks after last dose (up to Week 20)
Population: Safety population included all participants according to treatment administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants With Adverse Events | 37.5 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants With Adverse Events | 42.2 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants With Adverse Events | 50.9 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants With Adverse Events | 45.5 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants With Adverse Events | 45.0 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants With Adverse Events | 22.4 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants With Adverse Events | 44.9 Percentage |
Secondary
Area Under the Concentration Time Curve From Time 0 to Time 24 of GDC-0853 at Steady State (AUC0-24,ss)
The Pharmacokinetics (PK) evaluation may include, but will not be limited to, plasma GDC-0853 concentrations and population PK model estimated PK exposures (area under the plasma concentration-time curve \[AUC\]. AUC was measured in Nanograms(ng) per millilitre(mL)\*hour (hr)
Time frame: Pre-dose (0 hours) up to 10 hours post-dose on Day 28
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 collected is indicated for each time point. Data were presented only for arms in which GDC-0853 was administered.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Area Under the Concentration Time Curve From Time 0 to Time 24 of GDC-0853 at Steady State (AUC0-24,ss) | 1170 Ng/mL*(hr) | Standard Deviation 1600 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Area Under the Concentration Time Curve From Time 0 to Time 24 of GDC-0853 at Steady State (AUC0-24,ss) | 2910 Ng/mL*(hr) | Standard Deviation 3180 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Area Under the Concentration Time Curve From Time 0 to Time 24 of GDC-0853 at Steady State (AUC0-24,ss) | 9380 Ng/mL*(hr) | Standard Deviation 4860 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Area Under the Concentration Time Curve From Time 0 to Time 24 of GDC-0853 at Steady State (AUC0-24,ss) | 9890 Ng/mL*(hr) | Standard Deviation 5480 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components
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.
Time frame: Day 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Physical component score change: baseline-week 12 | 5.57 Number on a scale | Standard Deviation 5.98 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Mental component score change: baseline-week 12 | 7.04 Number on a scale | Standard Deviation 9.32 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Physical component score change: baseline-week 12 | 5.71 Number on a scale | Standard Deviation 6.85 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Mental component score change: baseline-week 12 | 4.89 Number on a scale | Standard Deviation 10.57 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Physical component score change: baseline-week 12 | 6.59 Number on a scale | Standard Deviation 7.54 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Mental component score change: baseline-week 12 | 6.92 Number on a scale | Standard Deviation 12.06 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Physical component score change: baseline-week 12 | 3.54 Number on a scale | Standard Deviation 6.81 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Mental component score change: baseline-week 12 | 4.29 Number on a scale | Standard Deviation 10.51 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Physical component score change: baseline-week 12 | 6.41 Number on a scale | Standard Deviation 6.43 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Mental component score change: baseline-week 12 | 6.50 Number on a scale | Standard Deviation 10.79 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Physical component score change: baseline-week 12 | 5.35 Number on a scale | Standard Deviation 7.48 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Mental component score change: baseline-week 12 | 5.76 Number on a scale | Standard Deviation 10.22 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Physical component score change: baseline-week 12 | 1.75 Number on a scale | Standard Deviation 6.39 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components | Mental component score change: baseline-week 12 | 5.11 Number on a scale | Standard Deviation 10.1 |
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI)
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.
Time frame: Baseline, Days 7, 14, 28, 56 and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 4 Day 28 | -10.36 Score on a scale | Standard Deviation 10.88 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 1 Day 7 | -5.45 Score on a scale | Standard Deviation 7.69 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 12 Day 84 | -16.99 Score on a scale | Standard Deviation 11.21 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 2 Day 14 | -6.85 Score on a scale | Standard Deviation 11.1 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 8 Day 56 | -14.76 Score on a scale | Standard Deviation 10.04 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 4 Day 28 | -13.84 Score on a scale | Standard Deviation 12.11 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 2 Day 14 | -10.33 Score on a scale | Standard Deviation 10.45 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 8 Day 56 | -18.61 Score on a scale | Standard Deviation 13.48 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 1 Day 7 | -6.70 Score on a scale | Standard Deviation 8.26 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 12 Day 84 | -22.05 Score on a scale | Standard Deviation 12.19 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 12 Day 84 | -22.10 Score on a scale | Standard Deviation 11.83 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 2 Day 14 | -11.33 Score on a scale | Standard Deviation 10.47 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 1 Day 7 | -7.40 Score on a scale | Standard Deviation 9.97 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 4 Day 28 | -13.78 Score on a scale | Standard Deviation 11.46 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 8 Day 56 | -18.10 Score on a scale | Standard Deviation 12.99 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 4 Day 28 | -9.43 Score on a scale | Standard Deviation 14.77 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 1 Day 7 | -4.71 Score on a scale | Standard Deviation 12.91 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 2 Day 14 | -7.44 Score on a scale | Standard Deviation 13.39 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 8 Day 56 | -15.49 Score on a scale | Standard Deviation 15.74 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 12 Day 84 | -17.02 Score on a scale | Standard Deviation 16.24 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 1 Day 7 | -9.64 Score on a scale | Standard Deviation 8.93 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 12 Day 84 | -22.22 Score on a scale | Standard Deviation 11.76 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 4 Day 28 | -17.74 Score on a scale | Standard Deviation 10.84 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 8 Day 56 | -21.36 Score on a scale | Standard Deviation 11.69 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 2 Day 14 | -13.44 Score on a scale | Standard Deviation 10.52 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 1 Day 7 | -8.61 Score on a scale | Standard Deviation 10.67 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 12 Day 84 | -20.42 Score on a scale | Standard Deviation 13.2 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 8 Day 56 | -17.38 Score on a scale | Standard Deviation 12.39 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 2 Day 14 | -9.64 Score on a scale | Standard Deviation 12.17 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 4 Day 28 | -11.83 Score on a scale | Standard Deviation 11.08 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 8 Day 56 | -7.57 Score on a scale | Standard Deviation 10.51 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 2 Day 14 | -7.70 Score on a scale | Standard Deviation 10.64 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 4 Day 28 | -7.49 Score on a scale | Standard Deviation 11.46 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 1 Day 7 | -5.26 Score on a scale | Standard Deviation 9.79 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) | Week 12 Day 84 | -12.23 Score on a scale | Standard Deviation 12.06 |
Comparison: Week 1, Day 7p-value: 0.49695% CI: [-6.73, 2.02]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.273695% CI: [-5.34, 0.98]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.060895% CI: [-6.26, 0.1]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.923795% CI: [-6.02, 3.52]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.089395% CI: [-6.6, 0.33]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.013895% CI: [-7.51, -0.63]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.335895% CI: [-8.24, 1.8]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.007895% CI: [-8.2, -0.94]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.005995% CI: [-8.3, -1.06]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.650395% CI: [-7.39, 2.8]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.128295% CI: [-6.84, 0.59]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.167595% CI: [-6.65, 0.78]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.42295% CI: [-7.96, 2.09]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.002795% CI: [-8.77, -1.42]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.001195% CI: [-9.15, -1.78]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.045595% CI: [0.05, 6.37]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.230995% CI: [-0.87, 5.48]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.069895% CI: [-0.18, 6.72]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.285195% CI: [-1.09, 5.76]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.013195% CI: [0.69, 7.9]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.016195% CI: [0.59, 7.78]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.03695% CI: [0.18, 7.51]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.025295% CI: [0.37, 7.7]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.903295% CI: [-2.59, 4.66]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.979195% CI: [-2.97, 4.3]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.092795% CI: [-6.98, 0.54]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.320295% CI: [-6.33, 2.09]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.047695% CI: [-8.36, -0.04]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 54p-value: <0.000195% CI: [-14.31, -5.55]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.000395% CI: [-12.56, -3.9]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in C-Reactive Protein (CRP) Levels
C-reactive protein is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL)
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 4 Day 28 | 0.15 (ng/mL) nanograms per milliliter | Standard Deviation 2.45 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 1 Day 7 | 0.14 (ng/mL) nanograms per milliliter | Standard Deviation 2.09 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 2 Day 14 | 0.27 (ng/mL) nanograms per milliliter | Standard Deviation 1.78 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 8 Day 56 | -0.49 (ng/mL) nanograms per milliliter | Standard Deviation 1.66 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 12 Day 84 | -0.59 (ng/mL) nanograms per milliliter | Standard Deviation 1.43 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 1 Day 7 | 0.30 (ng/mL) nanograms per milliliter | Standard Deviation 2.58 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 12 Day 84 | -0.77 (ng/mL) nanograms per milliliter | Standard Deviation 1.89 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 8 Day 56 | -0.52 (ng/mL) nanograms per milliliter | Standard Deviation 1.83 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 4 Day 28 | -0.25 (ng/mL) nanograms per milliliter | Standard Deviation 2.55 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 2 Day 14 | -0.10 (ng/mL) nanograms per milliliter | Standard Deviation 1.92 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 1 Day 7 | 0.22 (ng/mL) nanograms per milliliter | Standard Deviation 2.49 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 2 Day 14 | -0.21 (ng/mL) nanograms per milliliter | Standard Deviation 2.29 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 4 Day 28 | -0.44 (ng/mL) nanograms per milliliter | Standard Deviation 2.3 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 8 Day 56 | -0.89 (ng/mL) nanograms per milliliter | Standard Deviation 3.16 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 12 Day 84 | -1.30 (ng/mL) nanograms per milliliter | Standard Deviation 2.88 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 8 Day 56 | -0.39 (ng/mL) nanograms per milliliter | Standard Deviation 1.64 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 12 Day 84 | -0.45 (ng/mL) nanograms per milliliter | Standard Deviation 1.71 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 1 Day 7 | 0.01 (ng/mL) nanograms per milliliter | Standard Deviation 1.29 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 2 Day 14 | -0.12 (ng/mL) nanograms per milliliter | Standard Deviation 1.53 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 4 Day 28 | 0.14 (ng/mL) nanograms per milliliter | Standard Deviation 2 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 2 Day 14 | -0.93 (ng/mL) nanograms per milliliter | Standard Deviation 2.7 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 4 Day 28 | -1.11 (ng/mL) nanograms per milliliter | Standard Deviation 2.17 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 12 Day 84 | -1.03 (ng/mL) nanograms per milliliter | Standard Deviation 2.01 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 8 Day 56 | -1.14 (ng/mL) nanograms per milliliter | Standard Deviation 2.39 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 1 Day 7 | -1.21 (ng/mL) nanograms per milliliter | Standard Deviation 2.37 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 4 Day 28 | -0.30 (ng/mL) nanograms per milliliter | Standard Deviation 2.58 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 1 Day 7 | -0.12 (ng/mL) nanograms per milliliter | Standard Deviation 2.6 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 8 Day 56 | -1.19 (ng/mL) nanograms per milliliter | Standard Deviation 2.18 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 12 Day 84 | -1.55 (ng/mL) nanograms per milliliter | Standard Deviation 2.35 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 2 Day 14 | -0.20 (ng/mL) nanograms per milliliter | Standard Deviation 2.38 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 1 Day 7 | -0.10 (ng/mL) nanograms per milliliter | Standard Deviation 1.76 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 2 Day 14 | -0.25 (ng/mL) nanograms per milliliter | Standard Deviation 2.6 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 12 Day 84 | -0.56 (ng/mL) nanograms per milliliter | Standard Deviation 2.75 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 8 Day 56 | -0.26 (ng/mL) nanograms per milliliter | Standard Deviation 2.55 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in C-Reactive Protein (CRP) Levels | Week 4 Day 28 | -0.24 (ng/mL) nanograms per milliliter | Standard Deviation 2.8 |
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
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).
Time frame: Day 84
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 collected is indicated for each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | 9.00 Score on a scale | Standard Deviation 10.57 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | 8.21 Score on a scale | Standard Deviation 10.22 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | 8.95 Score on a scale | Standard Deviation 10.04 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | 7.08 Score on a scale | Standard Deviation 10.88 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | 9.59 Score on a scale | Standard Deviation 9.02 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | 8.85 Score on a scale | Standard Deviation 9.57 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | 5.71 Score on a scale | Standard Deviation 9.24 |
Secondary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
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.
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 Day 28 | -0.34 Score on a scale | Standard Deviation 0.47 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 1 Day 7 | -0.20 Score on a scale | Standard Deviation 0.37 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 Day 84 | -0.51 Score on a scale | Standard Deviation 0.57 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 Day 14 | -0.24 Score on a scale | Standard Deviation 0.39 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 Day 56 | -0.49 Score on a scale | Standard Deviation 0.47 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 Day 28 | -0.32 Score on a scale | Standard Deviation 0.48 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 Day 14 | -0.23 Score on a scale | Standard Deviation 0.46 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 Day 56 | -0.44 Score on a scale | Standard Deviation 0.56 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 1 Day 7 | -0.15 Score on a scale | Standard Deviation 0.35 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 Day 84 | -0.57 Score on a scale | Standard Deviation 0.57 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 Day 84 | -0.65 Score on a scale | Standard Deviation 0.6 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 Day 14 | -0.28 Score on a scale | Standard Deviation 0.5 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 1 Day 7 | -0.22 Score on a scale | Standard Deviation 0.48 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 Day 28 | -0.40 Score on a scale | Standard Deviation 0.5 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 Day 56 | -0.56 Score on a scale | Standard Deviation 0.55 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 Day 28 | -0.19 Score on a scale | Standard Deviation 0.56 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 1 Day 7 | -0.10 Score on a scale | Standard Deviation 0.38 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 Day 14 | -0.17 Score on a scale | Standard Deviation 0.45 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 Day 56 | -0.40 Score on a scale | Standard Deviation 0.64 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 Day 84 | -0.35 Score on a scale | Standard Deviation 0.68 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 1 Day 7 | -0.26 Score on a scale | Standard Deviation 0.42 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 Day 84 | -0.65 Score on a scale | Standard Deviation 0.61 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 Day 28 | -0.50 Score on a scale | Standard Deviation 0.5 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 Day 56 | -0.60 Score on a scale | Standard Deviation 0.55 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 Day 14 | -0.35 Score on a scale | Standard Deviation 0.47 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 1 Day 7 | -0.19 Score on a scale | Standard Deviation 0.36 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 Day 84 | -0.53 Score on a scale | Standard Deviation 0.61 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 Day 56 | -0.45 Score on a scale | Standard Deviation 0.5 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 Day 14 | -0.23 Score on a scale | Standard Deviation 0.45 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 Day 28 | -0.23 Score on a scale | Standard Deviation 0.42 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 Day 56 | -0.23 Score on a scale | Standard Deviation 0.55 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 Day 14 | -0.13 Score on a scale | Standard Deviation 0.49 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 Day 28 | -0.17 Score on a scale | Standard Deviation 0.44 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 1 Day 7 | -0.14 Score on a scale | Standard Deviation 0.46 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 Day 84 | -0.30 Score on a scale | Standard Deviation 0.62 |
Secondary
Change From Baseline in Patient Assessment Score of Arthritis Pain
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
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 4 Day 28 | -13.41 Score on a scale | Standard Deviation 16.79 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 1 Day 7 | -9.00 Score on a scale | Standard Deviation 18.66 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 12 Day 84 | -23.14 Score on a scale | Standard Deviation 21.14 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 2 Day 14 | -6.08 Score on a scale | Standard Deviation 21.64 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 8 Day 56 | -18.38 Score on a scale | Standard Deviation 19.35 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 4 Day 28 | -15.75 Score on a scale | Standard Deviation 21.97 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 2 Day 14 | -12.16 Score on a scale | Standard Deviation 20.09 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 8 Day 56 | -23.21 Score on a scale | Standard Deviation 22.1 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 1 Day 7 | -9.20 Score on a scale | Standard Deviation 20.56 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 12 Day 84 | -26.48 Score on a scale | Standard Deviation 23.3 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 12 Day 84 | -30.63 Score on a scale | Standard Deviation 28.49 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 2 Day 14 | -17.08 Score on a scale | Standard Deviation 23.46 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 1 Day 7 | -11.18 Score on a scale | Standard Deviation 21.64 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 4 Day 28 | -18.63 Score on a scale | Standard Deviation 24.87 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 8 Day 56 | -25.95 Score on a scale | Standard Deviation 27.5 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 4 Day 28 | -10.08 Score on a scale | Standard Deviation 27.16 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 1 Day 7 | -4.12 Score on a scale | Standard Deviation 22.43 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 2 Day 14 | -8.22 Score on a scale | Standard Deviation 25.72 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 8 Day 56 | -16.37 Score on a scale | Standard Deviation 27.65 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 12 Day 84 | -17.88 Score on a scale | Standard Deviation 29.42 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 1 Day 7 | -15.75 Score on a scale | Standard Deviation 18.71 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 12 Day 84 | -26.30 Score on a scale | Standard Deviation 23.87 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 4 Day 28 | -20.21 Score on a scale | Standard Deviation 21.97 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 8 Day 56 | -24.70 Score on a scale | Standard Deviation 22.23 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 2 Day 14 | -18.13 Score on a scale | Standard Deviation 17.71 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 1 Day 7 | -11.94 Score on a scale | Standard Deviation 21.25 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 12 Day 84 | -26.49 Score on a scale | Standard Deviation 27.65 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 8 Day 56 | -21.21 Score on a scale | Standard Deviation 27.13 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 2 Day 14 | -15.08 Score on a scale | Standard Deviation 21.87 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 4 Day 28 | -16.64 Score on a scale | Standard Deviation 27.86 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 8 Day 56 | -7.13 Score on a scale | Standard Deviation 25.73 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 2 Day 14 | -4.72 Score on a scale | Standard Deviation 17.64 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 4 Day 28 | -7.54 Score on a scale | Standard Deviation 23.8 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 1 Day 7 | -2.76 Score on a scale | Standard Deviation 18.24 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Patient Assessment Score of Arthritis Pain | Week 12 Day 84 | -13.98 Score on a scale | Standard Deviation 25.32 |
Secondary
Change From Baseline in Patient Global Assessment Score of Arthritis Pain
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.
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 4 Day 28 | -12.11 Score on a scale | Standard Deviation 16.68 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 1 Day 7 | -9.00 Score on a scale | Standard Deviation 15.88 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 12 Day 84 | -23.33 Score on a scale | Standard Deviation 22.03 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 2 Day 14 | -5.50 Score on a scale | Standard Deviation 20.98 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 8 Day 56 | -19.19 Score on a scale | Standard Deviation 16.88 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 4 Day 28 | 16.10 Score on a scale | Standard Deviation 23.48 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 2 Day 14 | -13.70 Score on a scale | Standard Deviation 19.63 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 8 Day 56 | -24.06 Score on a scale | Standard Deviation 24.99 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 1 Day 7 | -10.30 Score on a scale | Standard Deviation 20.82 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 12 Day 84 | -26.67 Score on a scale | Standard Deviation 26.89 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 12 Day 84 | -27.33 Score on a scale | Standard Deviation 27.33 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 2 Day 14 | -14.84 Score on a scale | Standard Deviation 24.08 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 1 Day 7 | -11.82 Score on a scale | Standard Deviation 22.52 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 4 Day 28 | -17.75 Score on a scale | Standard Deviation 22.73 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 8 Day 56 | -22.59 Score on a scale | Standard Deviation 26.81 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 4 Day 28 | -6.36 Score on a scale | Standard Deviation 25.99 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 1 Day 7 | -3.07 Score on a scale | Standard Deviation 20.83 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 2 Day 14 | -5.39 Score on a scale | Standard Deviation 26.13 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 8 Day 56 | -14.19 Score on a scale | Standard Deviation 29.8 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 12 Day 84 | -16.87 Score on a scale | Standard Deviation 28.68 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 1 Day 7 | -18.33 Score on a scale | Standard Deviation 20.81 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 12 Day 84 | -26.24 Score on a scale | Standard Deviation 27.02 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 4 Day 28 | -21.78 Score on a scale | Standard Deviation 25.53 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 8 Day 56 | -26.77 Score on a scale | Standard Deviation 25.69 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 2 Day 14 | -18.94 Score on a scale | Standard Deviation 22.33 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 1 Day 7 | -13.15 Score on a scale | Standard Deviation 22.17 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 12 Day 84 | -25.55 Score on a scale | Standard Deviation 27.52 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 8 Day 56 | -21.17 Score on a scale | Standard Deviation 25.98 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 2 Day 14 | -15.46 Score on a scale | Standard Deviation 21.67 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 4 Day 28 | -18.26 Score on a scale | Standard Deviation 27.53 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 8 Day 56 | -11.82 Score on a scale | Standard Deviation 21.66 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 2 Day 14 | -8.64 Score on a scale | Standard Deviation 19.43 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 4 Day 28 | -10.96 Score on a scale | Standard Deviation 21.54 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 1 Day 7 | -4.96 Score on a scale | Standard Deviation 19.18 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Patient Global Assessment Score of Arthritis Pain | Week 12 Day 84 | -13.80 Score on a scale | Standard Deviation 22.17 |
Secondary
Change From Baseline in Physician's Global Assessment Score of Arthritis
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.
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 4 Day 28 | -16.89 Score on a scale | Standard Deviation 19.06 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 1 Day 7 | -7.89 Score on a scale | Standard Deviation 13.16 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 12 Day 84 | -26.81 Score on a scale | Standard Deviation 16.2 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 2 Day 14 | -11.10 Score on a scale | Standard Deviation 15.65 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 8 Day 56 | -24.59 Score on a scale | Standard Deviation 15.06 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 4 Day 28 | -22.02 Score on a scale | Standard Deviation 18.61 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 2 Day 14 | -15.86 Score on a scale | Standard Deviation 16.77 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 8 Day 56 | -28.52 Score on a scale | Standard Deviation 21.11 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 1 Day 7 | -10.68 Score on a scale | Standard Deviation 15.41 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 12 Day 84 | -32.43 Score on a scale | Standard Deviation 19.24 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 12 Day 84 | -34.48 Score on a scale | Standard Deviation 19.49 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 2 Day 14 | -18.30 Score on a scale | Standard Deviation 19.04 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 1 Day 7 | -12.82 Score on a scale | Standard Deviation 17.03 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 4 Day 28 | -20.92 Score on a scale | Standard Deviation 17.71 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 8 Day 56 | -29.67 Score on a scale | Standard Deviation 20.01 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 4 Day 28 | -14.01 Score on a scale | Standard Deviation 21.03 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 1 Day 7 | -5.85 Score on a scale | Standard Deviation 15.44 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 2 Day 14 | -9.01 Score on a scale | Standard Deviation 18.07 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 8 Day 56 | -20.87 Score on a scale | Standard Deviation 23.85 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 12 Day 84 | -23.19 Score on a scale | Standard Deviation 23.39 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 1 Day 7 | -14.23 Score on a scale | Standard Deviation 16.13 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 12 Day 84 | -37.18 Score on a scale | Standard Deviation 21.02 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 4 Day 28 | -28.81 Score on a scale | Standard Deviation 19.34 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 8 Day 56 | -36.16 Score on a scale | Standard Deviation 21.82 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 2 Day 14 | -21.33 Score on a scale | Standard Deviation 19.61 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 1 Day 7 | -9.57 Score on a scale | Standard Deviation 17.1 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 12 Day 84 | -30.82 Score on a scale | Standard Deviation 21.95 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 8 Day 56 | -22.40 Score on a scale | Standard Deviation 20.43 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 2 Day 14 | -14.23 Score on a scale | Standard Deviation 18.5 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 4 Day 28 | -17.70 Score on a scale | Standard Deviation 20.49 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 8 Day 56 | -9.91 Score on a scale | Standard Deviation 19.67 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 2 Day 14 | -9.85 Score on a scale | Standard Deviation 17.55 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 4 Day 28 | -12.73 Score on a scale | Standard Deviation 20.42 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 1 Day 7 | -7.66 Score on a scale | Standard Deviation 18.33 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Physician's Global Assessment Score of Arthritis | Week 12 Day 84 | -18.44 Score on a scale | Standard Deviation 21.86 |
Secondary
Change From Baseline in Simplified Disease Activity Index (SDAI)
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
Time frame: Baseline, Days 7, 14, 28, 56 and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 4 Day 28 | -10.53 Score on a scale | Standard Deviation 11.03 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 1 Day 7 | -5.36 Score on a scale | Standard Deviation 7.86 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 12 Day 84 | -17.54 Score on a scale | Standard Deviation 11.36 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 2 Day 14 | -6.50 Score on a scale | Standard Deviation 10.54 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 8 Day 56 | -15.25 Score on a scale | Standard Deviation 10.41 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 4 Day 28 | -14.47 Score on a scale | Standard Deviation 12.41 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 2 Day 14 | -10.46 Score on a scale | Standard Deviation 10.97 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 8 Day 56 | -18.95 Score on a scale | Standard Deviation 13.8 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 1 Day 7 | -6.48 Score on a scale | Standard Deviation 8.87 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 12 Day 84 | -22.89 Score on a scale | Standard Deviation 12.52 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 12 Day 84 | -23.24 Score on a scale | Standard Deviation 12.5 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 2 Day 14 | -11.44 Score on a scale | Standard Deviation 10.85 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 1 Day 7 | -6.99 Score on a scale | Standard Deviation 10.49 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 4 Day 28 | -14.21 Score on a scale | Standard Deviation 12.2 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 8 Day 56 | -18.97 Score on a scale | Standard Deviation 13.91 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 4 Day 28 | -8.92 Score on a scale | Standard Deviation 15.17 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 1 Day 7 | -4.75 Score on a scale | Standard Deviation 13.25 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 2 Day 14 | -7.54 Score on a scale | Standard Deviation 13.74 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 8 Day 56 | -15.74 Score on a scale | Standard Deviation 16.18 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 12 Day 84 | -17.47 Score on a scale | Standard Deviation 16.7 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 1 Day 7 | -10.86 Score on a scale | Standard Deviation 9.33 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 12 Day 84 | -23.33 Score on a scale | Standard Deviation 11.97 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 4 Day 28 | -18.87 Score on a scale | Standard Deviation 11.2 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 8 Day 56 | -22.62 Score on a scale | Standard Deviation 11.97 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 2 Day 14 | -14.39 Score on a scale | Standard Deviation 10.99 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 1 Day 7 | -8.73 Score on a scale | Standard Deviation 11.21 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 12 Day 84 | -21.97 Score on a scale | Standard Deviation 13.78 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 8 Day 56 | -18.57 Score on a scale | Standard Deviation 12.8 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 2 Day 14 | -9.84 Score on a scale | Standard Deviation 12.29 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 4 Day 28 | -12.13 Score on a scale | Standard Deviation 11.13 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 8 Day 56 | -7.82 Score on a scale | Standard Deviation 11.2 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 2 Day 14 | -8.13 Score on a scale | Standard Deviation 11.01 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 4 Day 28 | -7.74 Score on a scale | Standard Deviation 12.02 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 1 Day 7 | -5.37 Score on a scale | Standard Deviation 9.49 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) | Week 12 Day 84 | -12.92 Score on a scale | Standard Deviation 12.61 |
Comparison: Week 1, Day 7p-value: 0.545595% CI: [-7, 2.27]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.411495% CI: [-5.3, 1.36]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.173995% CI: [-5.97, 0.72]Cochran-Mantel-Haenszel
Comparison: Week 2, Week 14p-value: 0.976195% CI: [-5.93, 4.06]Cochran-Mantel-Haenszel
Comparison: Week 2, Week 14p-value: 0.099895% CI: [-6.78, 0.41]Cochran-Mantel-Haenszel
Comparison: Week 2, Week 14p-value: 0.023995% CI: [-7.54, -0.39]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.201895% CI: [-9.25, 1.3]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.001195% CI: [-9.48, -1.87]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.002695% CI: [-9.06, -1.48]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.633695% CI: [-7.84, 2.9]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.09595% CI: [-7.38, 0.41]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.145195% CI: [-7.06, 0.71]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.343495% CI: [-8.43, 1.87]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.001695% CI: [-9.23, -1.68]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.000695% CI: [-9.65, -2.1]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.002595% CI: [1.31, 7.96]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.012995% CI: [0.64, 7.32]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.020695% CI: [0.46, 7.62]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.084195% CI: [-0.3, 6.82]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.008895% CI: [0.91, 8.42]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.003495% CI: [1.34, 8.81]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.013895% CI: [0.71, 8.39]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.007395% CI: [1.02, 8.69]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.828495% CI: [-2.46, 5.03]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.952595% CI: [-2.88, 4.6]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.085695% CI: [-6.91, 0.46]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.337495% CI: [-6.36, 2.2]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.053495% CI: [-8.53, 0.06]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: <0.000195% CI: [-15.33, -6.32]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: <0.000195% CI: [-13.63, -4.81]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Swollen Joint Count (66 Joint Count)
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.
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 4 Day 28 | -4.38 Score on a scale | Standard Deviation 4.55 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 1 Day 7 | -1.84 Score on a scale | Standard Deviation 5.19 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 12 Day 84 | -7.36 Score on a scale | Standard Deviation 5.88 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 2 Day 14 | -3.95 Score on a scale | Standard Deviation 6.44 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 8 Day 56 | -6.54 Score on a scale | Standard Deviation 5.78 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 4 Day 28 | -6.33 Score on a scale | Standard Deviation 7.98 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 2 Day 14 | -4.78 Score on a scale | Standard Deviation 5.99 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 8 Day 56 | -8.06 Score on a scale | Standard Deviation 8.13 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 1 Day 7 | -2.89 Score on a scale | Standard Deviation 5.01 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 12 Day 84 | -8.89 Score on a scale | Standard Deviation 8.23 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 12 Day 84 | -8.48 Score on a scale | Standard Deviation 7.01 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 2 Day 14 | -5.06 Score on a scale | Standard Deviation 5.14 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 1 Day 7 | -3.45 Score on a scale | Standard Deviation 6.02 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 4 Day 28 | -5.95 Score on a scale | Standard Deviation 6.09 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 8 Day 56 | -7.72 Score on a scale | Standard Deviation 7.44 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 4 Day 28 | -5.47 Score on a scale | Standard Deviation 9.26 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 1 Day 7 | -3.35 Score on a scale | Standard Deviation 9.38 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 2 Day 14 | -4.23 Score on a scale | Standard Deviation 9.88 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 8 Day 56 | -7.41 Score on a scale | Standard Deviation 10.82 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 12 Day 84 | -8.26 Score on a scale | Standard Deviation 11.48 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 1 Day 7 | -3.94 Score on a scale | Standard Deviation 5.33 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 12 Day 84 | -9.94 Score on a scale | Standard Deviation 6.91 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 4 Day 28 | -8.50 Score on a scale | Standard Deviation 6.39 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 8 Day 56 | -9.60 Score on a scale | Standard Deviation 6.94 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 2 Day 14 | -6.26 Score on a scale | Standard Deviation 5.98 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 1 Day 7 | -3.45 Score on a scale | Standard Deviation 4.9 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 12 Day 84 | -7.65 Score on a scale | Standard Deviation 6.75 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 8 Day 56 | -6.81 Score on a scale | Standard Deviation 6.16 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 2 Day 14 | -3.29 Score on a scale | Standard Deviation 5.69 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 4 Day 28 | -4.21 Score on a scale | Standard Deviation 6.39 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 8 Day 56 | -3.02 Score on a scale | Standard Deviation 7.76 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 2 Day 14 | -2.96 Score on a scale | Standard Deviation 6.27 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 4 Day 28 | -3.46 Score on a scale | Standard Deviation 5.62 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 1 Day 7 | -1.49 Score on a scale | Standard Deviation 4.49 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Swollen Joint Count (66 Joint Count) | Week 12 Day 84 | -4.86 Score on a scale | Standard Deviation 5.84 |
Secondary
Change From Baseline in Tender/Painful Joint Count (68 Joint Count)
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.
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 4 Day 28 | -6.00 Score on a scale | Standard Deviation 8.89 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 1 Day 7 | -2.79 Score on a scale | Standard Deviation 7.25 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 12 Day 84 | -10.33 Score on a scale | Standard Deviation 9.4 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 2 Day 19 | -4.33 Score on a scale | Standard Deviation 12.31 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 8 Day 56 | -9.72 Score on a scale | Standard Deviation 8.2 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 4 Day 28 | -7.90 Score on a scale | Standard Deviation 11.28 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 2 Day 19 | -6.36 Score on a scale | Standard Deviation 10.88 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 8 Day 56 | -11.57 Score on a scale | Standard Deviation 12.18 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 1 Day 7 | -4.12 Score on a scale | Standard Deviation 8.14 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 12 Day 84 | -12.72 Score on a scale | Standard Deviation 12.05 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 12 Day 84 | -11.49 Score on a scale | Standard Deviation 11.15 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 2 Day 19 | -5.91 Score on a scale | Standard Deviation 9.38 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 1 Day 7 | -3.33 Score on a scale | Standard Deviation 9.27 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 4 Day 28 | -6.84 Score on a scale | Standard Deviation 9.53 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 8 Day 56 | -9.75 Score on a scale | Standard Deviation 10.93 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 4 Day 28 | -7.55 Score on a scale | Standard Deviation 12.97 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 1 Day 7 | -3.81 Score on a scale | Standard Deviation 10.85 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 2 Day 19 | -5.78 Score on a scale | Standard Deviation 11.5 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 8 Day 56 | -10.75 Score on a scale | Standard Deviation 14.37 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 12 Day 84 | -10.55 Score on a scale | Standard Deviation 14.37 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 1 Day 7 | -5.58 Score on a scale | Standard Deviation 9.41 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 12 Day 84 | -15.49 Score on a scale | Standard Deviation 12.31 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 4 Day 28 | -11.61 Score on a scale | Standard Deviation 11.43 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 8 Day 56 | -14.12 Score on a scale | Standard Deviation 11.33 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 2 Day 19 | -8.62 Score on a scale | Standard Deviation 10.46 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 1 Day 7 | -6.57 Score on a scale | Standard Deviation 8.66 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 12 Day 84 | -13.73 Score on a scale | Standard Deviation 12.81 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 8 Day 56 | -11.65 Score on a scale | Standard Deviation 10.34 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 2 Day 19 | -6.08 Score on a scale | Standard Deviation 8.53 |
| Cohort 2: GDC-0853 High Dose | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 4 Day 28 | -7.79 Score on a scale | Standard Deviation 7.93 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 8 Day 56 | -4.60 Score on a scale | Standard Deviation 12.41 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 2 Day 19 | -3.92 Score on a scale | Standard Deviation 10.77 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 4 Day 28 | -4.40 Score on a scale | Standard Deviation 12.37 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 1 Day 7 | -3.06 Score on a scale | Standard Deviation 11.01 |
| Cohort 2: GDC-0853 Placebo | Change From Baseline in Tender/Painful Joint Count (68 Joint Count) | Week 12 Day 84 | -7.14 Score on a scale | Standard Deviation 13.32 |
Secondary
Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
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.
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 4 Day 28 | -0.75 Score on a scale | Standard Deviation 0.86 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 1 Day 7 | -0.34 Score on a scale | Standard Deviation 0.6 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 12 Day 84 | -1.30 Score on a scale | Standard Deviation 0.95 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 2 Day 14 | -0.47 Score on a scale | Standard Deviation 0.72 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 8 Day 56 | -1.14 Score on a scale | Standard Deviation 0.9 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 4 Day 28 | -0.90 Score on a scale | Standard Deviation 0.96 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 2 Day 14 | -0.63 Score on a scale | Standard Deviation 0.84 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 8 Day 56 | -1.35 Score on a scale | Standard Deviation 1.12 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 1 Day 7 | -0.35 Score on a scale | Standard Deviation 0.66 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 12 Day 84 | -1.72 Score on a scale | Standard Deviation 1.11 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 12 Day 84 | -1.70 Score on a scale | Standard Deviation 1.02 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 2 Day 14 | -0.70 Score on a scale | Standard Deviation 0.8 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 1 Day 7 | -0.37 Score on a scale | Standard Deviation 0.8 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 4 Day 28 | -0.91 Score on a scale | Standard Deviation 0.97 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 8 Day 56 | -1.37 Score on a scale | Standard Deviation 1.11 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 4 Day 28 | -0.62 Score on a scale | Standard Deviation 1.04 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 1 Day 7 | -0.33 Score on a scale | Standard Deviation 0.84 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 2 Day 14 | -.54 Score on a scale | Standard Deviation 0.9 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 8 Day 56 | -1.08 Score on a scale | Standard Deviation 1.19 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 12 Day 84 | -1.17 Score on a scale | Standard Deviation 1.24 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 1 Day 7 | -0.92 Score on a scale | Standard Deviation 0.71 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 12 Day 84 | -1.87 Score on a scale | Standard Deviation 1.02 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 4 Day 28 | -1.45 Score on a scale | Standard Deviation 0.87 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 8 Day 56 | -1.75 Score on a scale | Standard Deviation 0.98 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 2 Day 14 | -1.09 Score on a scale | Standard Deviation 0.81 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 1 Day 7 | -0.49 Score on a scale | Standard Deviation 0.84 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 12 Day 84 | -1.62 Score on a scale | Standard Deviation 1.15 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 8 Day 56 | -1.33 Score on a scale | Standard Deviation 0.98 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 2 Day 14 | -0.65 Score on a scale | Standard Deviation 0.87 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 4 Day 28 | -0.77 Score on a scale | Standard Deviation 0.9 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 8 Day 56 | -0.56 Score on a scale | Standard Deviation 0.87 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 2 Day 14 | -0.45 Score on a scale | Standard Deviation 0.69 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 4 Day 28 | -0.44 Score on a scale | Standard Deviation 0.84 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 1 Day 7 | -0.36 Score on a scale | Standard Deviation 0.63 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Week 12 Day 84 | -0.86 Score on a scale | Standard Deviation 1.03 |
Comparison: Week 2, Day 14p-value: 0.263495% CI: [-0.45, 0.08]ANCOVA
Comparison: Week 4, Day 28p-value: 0.288595% CI: [-0.72, 0.14]ANCOVA
Comparison: Week 4, Day 28p-value: 0.059895% CI: [-0.61, 0.01]ANCOVA
Comparison: Week 1, Day 7p-value: 0.850495% CI: [-0.45, 0.23]ANCOVA
Comparison: At week 1, Day 7p-value: 0.988495% CI: [-0.28, 0.21]ANCOVA
Comparison: Week 1 Day 7p-value: 0.92395% CI: [-0.31, 0.18]ANCOVA
Comparison: Week 2, Day 14p-value: 0.985395% CI: [-0.43, 0.31]ANCOVA
Comparison: Week 2, Day 14p-value: 0.682695% CI: [-0.38, 0.15]ANCOVA
Comparison: Week 4, Day 28p-value: 0.04495% CI: [-0.62, -0.01]ANCOVA
Comparison: Week 8, Day 56p-value: 0.427195% CI: [-0.76, 0.2]ANCOVA
Comparison: Week 8, Day 56p-value: 0.096995% CI: [-0.66, 0.04]ANCOVA
Comparison: Week 8, Day 56p-value: 0.061295% CI: [-0.68, 0.01]ANCOVA
Comparison: Week 12, Day 84p-value: 0.207995% CI: [-0.84, 0.12]ANCOVA
Comparison: Week 12, Day 84p-value: 0.000395% CI: [-0.92, -0.22]ANCOVA
Comparison: Week 12, Day 84p-value: 0.000395% CI: [-0.92, -0.22]ANCOVA
Comparison: Week 1, Day 7p-value: <0.000195% CI: [0.34, 0.82]ANCOVA
Comparison: Week 1, Day 7p-value: <0.000195% CI: [0.31, 0.8]ANCOVA
Comparison: Week 2, Day 14p-value: <0.000195% CI: [0.2, 0.74]ANCOVA
Comparison: Week 2, Day 14p-value: 0.000995% CI: [0.13, 0.66]ANCOVA
Comparison: Week 4, Day 28p-value: <0.000195% CI: [0.25, 0.87]ANCOVA
Comparison: Week 4, Day 28p-value: <0.000195% CI: [0.24, 0.85]ANCOVA
Comparison: Week 8, Day 56p-value: 0.009595% CI: [0.08, 0.76]ANCOVA
Comparison: Week 8, Day 56p-value: 0.015395% CI: [0.06, 0.74]ANCOVA
Comparison: Week 12, Day 84p-value: 0.483995% CI: [-0.16, 0.54]ANCOVA
Comparison: Week 12, Day 84p-value: 0.503595% CI: [-0.16, 0.53]ANCOVA
Comparison: Week 1, Day 7p-value: 0.428695% CI: [-0.38, 0.16]ANCOVA
Comparison: Week 2, Day 14p-value: 0.183195% CI: [-0.5, 0.1]ANCOVA
Comparison: Week 4, Day 28p-value: 0.066795% CI: [-0.65, 0.02]ANCOVA
Comparison: Week 8, Day 56p-value: <0.000195% CI: [-1.11, -0.42]ANCOVA
Comparison: Week 12, Day 84p-value: 0.000295% CI: [-1.15, -0.38]ANCOVA
Secondary
Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
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.
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 4 Day 28 | -0.88 Score on a scale | Standard Deviation 0.9 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 1 Day 7 | -0.43 Score on a scale | Standard Deviation 0.67 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 12 Day 84 | -1.53 Score on a scale | Standard Deviation 0.95 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 2 Day 14 | -0.51 Score on a scale | Standard Deviation 0.85 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 8 Day 56 | -1.31 Score on a scale | Standard Deviation 0.91 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 4 Day 28 | -1.06 Score on a scale | Standard Deviation 1.02 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 2 Day 14 | -0.77 Score on a scale | Standard Deviation 0.86 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 8 Day 56 | -1.56 Score on a scale | Standard Deviation 1.21 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 1 Day 7 | -0.48 Score on a scale | Standard Deviation 0.73 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 12 Day 84 | -1.97 Score on a scale | Standard Deviation 1.2 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 12 Day 84 | -1.93 Score on a scale | Standard Deviation 1.11 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 2 Day 14 | -0.84 Score on a scale | Standard Deviation 0.86 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 1 Day 7 | -0.49 Score on a scale | Standard Deviation 0.86 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 4 Day 28 | -1.08 Score on a scale | Standard Deviation 1.03 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 8 Day 56 | -1.57 Score on a scale | Standard Deviation 1.16 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 4 Day 28 | -0.65 Score on a scale | Standard Deviation 1.16 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 1 Day 7 | -0.37 Score on a scale | Standard Deviation 0.91 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 2 Day 14 | -0.57 Score on a scale | Standard Deviation 1 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 8 Day 56 | 1.20 Score on a scale | Standard Deviation 1.3 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 12 Day 84 | -1.33 Score on a scale | Standard Deviation 1.33 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 1 Day 7 | -1.10 Score on a scale | Standard Deviation 0.75 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 12 Day 84 | -2.06 Score on a scale | Standard Deviation 1.08 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 4 Day 28 | -1.61 Score on a scale | Standard Deviation 0.94 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 8 Day 56 | -1.97 Score on a scale | Standard Deviation 1.03 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 2 Day 14 | -1.26 Score on a scale | Standard Deviation 0.89 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 1 Day 7 | -0.63 Score on a scale | Standard Deviation 0.91 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 12 Day 84 | -1.83 Score on a scale | Standard Deviation 1.22 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 8 Day 56 | -1.51 Score on a scale | Standard Deviation 1.05 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 2 Day 14 | -0.81 Score on a scale | Standard Deviation 0.98 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 4 Day 28 | -0.95 Score on a scale | Standard Deviation 1.04 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 8 Day 56 | -0.67 Score on a scale | Standard Deviation 1.01 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 2 Day 14 | -0.54 Score on a scale | Standard Deviation 0.8 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 4 Day 28 | -0.55 Score on a scale | Standard Deviation 0.94 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 1 Day 7 | -.40 Score on a scale | Standard Deviation 0.69 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Week 12 Day 84 | -1.00 Score on a scale | Standard Deviation 1.11 |
Comparison: Week 1, Day 7p-value: 0.580795% CI: [-0.55, 0.19]ANCOVA
Comparison: Week 1, Day 7p-value: 0.62795% CI: [-0.39, 0.14]ANCOVA
Comparison: Week 1, Day 7p-value: 0.447595% CI: [-0.42, 0.12]ANCOVA
Comparison: Week 2, Day 14p-value: 0.989195% CI: [-0.47, 0.35]ANCOVA
Comparison: Week 2, Day 14p-value: 0.224495% CI: [-0.51, 0.08]ANCOVA
Comparison: Week 2, Day 14p-value: 0.058695% CI: [-0.58, 0.01]ANCOVA
Comparison: Week 4, Day 28p-value: 0.133895% CI: [-0.85, 0.08]ANCOVA
Comparison: Week 4, Day 28p-value: 0.011995% CI: [-0.74, -0.07]ANCOVA
Comparison: Week 4, Day 28p-value: 0.004695% CI: [-0.77, -0.11]ANCOVA
Comparison: Week 8, Day 56p-value: 0.394395% CI: [-0.82, 0.2]ANCOVA
Comparison: Week 8, Day 56p-value: 0.052695% CI: [-0.74, 0]ANCOVA
Comparison: Week 8, Day 56p-value: 0.036595% CI: [-0.76, -0.02]ANCOVA
Comparison: Week 12, Day 84p-value: 0.169695% CI: [-0.93, 0.11]ANCOVA
Comparison: Week 12, Day 84p-value: 0.000295% CI: [-1.01, -0.25]ANCOVA
Comparison: Week 12, Day 84p-value: 0.000395% CI: [-1, -0.24]ANCOVA
Comparison: Week 1, Day 7p-value: <0.000195% CI: [0.37, 0.9]ANCOVA
Comparison: Week 1, Day 7p-value: <0.000195% CI: [0.34, 0.88]ANCOVA
Comparison: Week 2, Day 14p-value: 0.000195% CI: [0.21, 0.79]ANCOVA
Comparison: Week 2, Day 14p-value: 0.001295% CI: [0.14, 0.72]ANCOVA
Comparison: Week 4, Day 28p-value: <0.000195% CI: [0.25, 0.91]ANCOVA
Comparison: Week 4, Day 28p-value: 0.000295% CI: [0.21, 0.87]ANCOVA
Comparison: Week 8, Day 56p-value: 0.008495% CI: [0.09, 0.82]ANCOVA
Comparison: Week 8, Day 56p-value: 0.012495% CI: [0.07, 0.8]ANCOVA
Comparison: Week 12, Day 84p-value: 0.756595% CI: [-0.23, 0.52]ANCOVA
Comparison: Week 12, Day 84p-value: 0.715895% CI: [-0.22, 0.53]ANCOVA
Comparison: Week 1, Day 7p-value: 0.136895% CI: [-0.52, 0.07]ANCOVA
Comparison: Week 2, Day 14p-value: 0.097495% CI: [-0.62, 0.05]ANCOVA
Comparison: Week 4, Day 28p-value: 0.047995% CI: [-0.76, 0]ANCOVA
Comparison: Week 8, Day 56p-value: <0.000195% CI: [-1.22, -0.46]ANCOVA
Comparison: Week 12, Day 84p-value: 0.000195% CI: [-1.24, -0.42]ANCOVA
Secondary
Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
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.
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 4 Day 28 | -0.88 Score on a scale | Standard Deviation 0.89 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 1 Day 7 | -0.35 Score on a scale | Standard Deviation 0.57 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 12 Day 84 | -1.51 Score on a scale | Standard Deviation 1.01 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 2 Day 14 | -0.60 Score on a scale | Standard Deviation 0.89 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 8 Day 56 | -1.25 Score on a scale | Standard Deviation 0.85 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 4 Day 28 | -0.99 Score on a scale | Standard Deviation 0.98 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 2 Day 14 | -0.69 Score on a scale | Standard Deviation 0.84 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 8 Day 56 | -1.44 Score on a scale | Standard Deviation 1.14 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 1 Day 7 | -0.42 Score on a scale | Standard Deviation 0.65 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 12 Day 84 | -1.80 Score on a scale | Standard Deviation 1.25 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 12 Day 84 | -1.80 Score on a scale | Standard Deviation 0.99 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 2 Day 14 | -0.68 Score on a scale | Standard Deviation 0.74 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 1 Day 7 | -0.39 Score on a scale | Standard Deviation 0.68 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 4 Day 28 | -0.97 Score on a scale | Standard Deviation 0.9 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 8 Day 56 | -1.40 Score on a scale | Standard Deviation 1.06 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 4 Day 28 | -0.75 Score on a scale | Standard Deviation 1.02 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 1 Day 7 | -0.34 Score on a scale | Standard Deviation 0.86 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 2 Day 14 | -0.55 Score on a scale | Standard Deviation 0.92 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 8 Day 56 | -1.15 Score on a scale | Standard Deviation 1.19 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 12 Day 84 | -1.30 Score on a scale | Standard Deviation 1.22 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 1 Day 7 | -0.72 Score on a scale | Standard Deviation 0.72 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 12 Day 84 | -1.85 Score on a scale | Standard Deviation 1.06 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 4 Day 28 | -1.47 Score on a scale | Standard Deviation 1.02 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 8 Day 56 | -1.74 Score on a scale | Standard Deviation 0.98 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 2 Day 14 | -1.02 Score on a scale | Standard Deviation 0.84 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 1 Day 7 | -0.50 Score on a scale | Standard Deviation 0.73 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 12 Day 84 | -1.65 Score on a scale | Standard Deviation 1.06 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 8 Day 56 | -1.35 Score on a scale | Standard Deviation 0.96 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 2 Day 14 | -0.64 Score on a scale | Standard Deviation 0.81 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 4 Day 28 | -0.85 Score on a scale | Standard Deviation 0.81 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 8 Day 56 | -0.70 Score on a scale | Standard Deviation 0.98 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 2 Day 14 | -0.51 Score on a scale | Standard Deviation 0.73 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 4 Day 28 | -0.50 Score on a scale | Standard Deviation 0.83 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 1 Day 7 | -0.31 Score on a scale | Standard Deviation 0.6 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Week 12 Day 84 | -0.94 Score on a scale | Standard Deviation 10.6 |
Comparison: Week 1, Day 7p-value: 0.919395% CI: [-0.41, 0.24]ANCOVA
Comparison: Week 1, Day 7p-value: 0.706295% CI: [-0.33, 0.14]ANCOVA
Comparison: Week 1, Day 7p-value: 0.854295% CI: [-0.31, 0.16]ANCOVA
Comparison: Week 2, Day 14p-value: 0.809595% CI: [-0.51, 0.24]ANCOVA
Comparison: Week 2, Day 14p-value: 0.386295% CI: [-0.44, 0.11]ANCOVA
Comparison: Week 2, Day 14p-value: 0.432895% CI: [-0.43, 0.12]ANCOVA
Comparison: Week 4, Day 28p-value: 0.491595% CI: [-0.68, 0.2]ANCOVA
Comparison: Week 4, Day 28p-value: 0.144195% CI: [-0.58, 0.06]ANCOVA
Comparison: Week 4, Day 28p-value: 0.18995% CI: [-0.56, 0.07]ANCOVA
Comparison: Week 8, Day 56p-value: 0.556695% CI: [-0.74, -0.24]ANCOVA
Comparison: Week 8, Day 56p-value: 0.09295% CI: [-0.68, 0.04]ANCOVA
Comparison: Week 8, Day 56p-value: 0.139195% CI: [-0.65, 0.06]ANCOVA
Comparison: Week 12, Day 84p-value: 0.287395% CI: [-0.86, 0.17]ANCOVA
Comparison: Week 12, Day 84p-value: 0.00295% CI: [-0.91, -0.16]ANCOVA
Comparison: Week 12, Day 84p-value: 0.001695% CI: [-0.92, -0.17]ANCOVA
Comparison: Week 1, Day 7p-value: 0.00595% CI: [0.07, 0.55]ANCOVA
Comparison: Week 1, Day 7p-value: 0.00295% CI: [0.1, 0.57]ANCOVA
Comparison: Week 2, Day 14p-value: 0.008295% CI: [0.07, 0.62]ANCOVA
Comparison: Week 2, Day 14p-value: 0.005695% CI: [0.08, 0.63]ANCOVA
Comparison: Week 4, Day 28p-value: 0.000495% CI: [0.19, 0.82]ANCOVA
Comparison: Week 4, Day 28p-value: 0.000295% CI: [0.21, 0.84]ANCOVA
Comparison: Week 8, Day 56p-value: 0.06595% CI: [-0.01, 0.69]ANCOVA
Comparison: Week 8, Day 56p-value: 0.036595% CI: [0.02, 0.72]ANCOVA
Comparison: Week 12, Day 84p-value: 0.933895% CI: [-0.28, 0.47]ANCOVA
Comparison: Week 12, Day 84p-value: 0.95295% CI: [-0.29, 0.46]ANCOVA
Comparison: Week 1, Day 7p-value: 0.149695% CI: [-0.45, 0.07]ANCOVA
Comparison: Week 2, Day 14p-value: 0.393695% CI: [-0.43, 0.17]ANCOVA
Comparison: Week 4, Day 28p-value: 0.034695% CI: [-0.68, -0.03]ANCOVA
Comparison: Week 8, Day 56p-value: 0.000495% CI: [-1.04, -0.31]ANCOVA
Comparison: Week 12, Day 84p-value: 0.000395% CI: [-1.11, -0.34]ANCOVA
Secondary
Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
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.
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 4 Day 28 | -1.00 Score on a scale | Standard Deviation 0.95 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 1 Day 7 | -0.45 Score on a scale | Standard Deviation 0.63 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 12 Day 84 | -1.76 Score on a scale | Standard Deviation 1.04 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 2 Day 14 | -0.63 Score on a scale | Standard Deviation 0.98 |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 8 Day 56 | -1.43 Score on a scale | Standard Deviation 0.88 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 4 Day 28 | -1.16 Score on a scale | Standard Deviation 1.06 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 2 Day 14 | -0.85 Score on a scale | Standard Deviation 0.85 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 8 Day 56 | -1.67 Score on a scale | Standard Deviation 1.25 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 1 Day 7 | -0.54 Score on a scale | Standard Deviation 0.72 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 12 Day 84 | -2.06 Score on a scale | Standard Deviation 1.36 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 12 Day 84 | -2.05 Score on a scale | Standard Deviation 1.08 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 2 Day 14 | -0.84 Score on a scale | Standard Deviation 0.82 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 1 Day 7 | -0.52 Score on a scale | Standard Deviation 0.77 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 4 Day 28 | -1.15 Score on a scale | Standard Deviation 0.98 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 8 Day 56 | -1.63 Score on a scale | Standard Deviation 1.14 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 4 Day 28 | -0.79 Score on a scale | Standard Deviation 1.16 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 1 Day 7 | -0.37 Score on a scale | Standard Deviation 0.95 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 2 Day 14 | -0.58 Score on a scale | Standard Deviation 1.03 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 8 Day 56 | -1.29 Score on a scale | Standard Deviation 1.31 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 12 Day 84 | -1.46 Score on a scale | Standard Deviation 1.32 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 1 Day 7 | -0.93 Score on a scale | Standard Deviation 0.76 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 12 Day 84 | -2.08 Score on a scale | Standard Deviation 1.14 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 4 Day 28 | -1.65 Score on a scale | Standard Deviation 1.11 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 8 Day 56 | -2.00 Score on a scale | Standard Deviation 1.06 |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 2 Day 14 | -1.22 Score on a scale | Standard Deviation 0.94 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 1 Day 7 | -0.65 Score on a scale | Standard Deviation 0.8 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 12 Day 84 | -1.89 Score on a scale | Standard Deviation 1.15 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 8 Day 56 | -1.54 Score on a scale | Standard Deviation 1.04 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 2 Day 14 | -0.81 Score on a scale | Standard Deviation 0.92 |
| Cohort 2: GDC-0853 High Dose | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 4 Day 28 | -1.04 Score on a scale | Standard Deviation 0.95 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 8 Day 56 | -0.81 Score on a scale | Standard Deviation 1.12 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 2 Day 14 | -0.60 Score on a scale | Standard Deviation 0.84 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 4 Day 28 | -0.61 Score on a scale | Standard Deviation 0.96 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 1 Day 7 | -0.36 Score on a scale | Standard Deviation 0.66 |
| Cohort 2: GDC-0853 Placebo | Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Week 12 Day 84 | -1.08 Score on a scale | Standard Deviation 1.17 |
Comparison: Week 1, Day 7p-value: 0.608395% CI: [-0.53, 0.19]ANCOVA
Comparison: Week 1, Day 7p-value: 0.267295% CI: [-0.44, 0.08]ANCOVA
Comparison: Week 1, Day 7p-value: 0.315895% CI: [-0.43, 0.09]ANCOVA
Comparison: Week 2, Day 14p-value: 0.849595% CI: [-0.55, 0.28]ANCOVA
Comparison: Week 2, Day 14p-value: 0.085695% CI: [-0.58, 0.03]ANCOVA
Comparison: Week 2, Day 14p-value: 0.102195% CI: [-0.57, 0.04]ANCOVA
Comparison: Week 4, Day 28p-value: 0.276295% CI: [-0.82, 0.15]ANCOVA
Comparison: Week 4, Day 28p-value: 0.028695% CI: [-0.73, -0.03]ANCOVA
Comparison: Week 4, Day 28p-value: 0.027495% CI: [-0.73, -0.03]ANCOVA
Comparison: Week 8, Day 56p-value: 0.498195% CI: [-0.81, 0.24]ANCOVA
Comparison: Week 8, Day 56p-value: 0.047295% CI: [-0.78, 0]ANCOVA
Comparison: Week 8, Day 56p-value: 0.075395% CI: [-0.75, 0.03]ANCOVA
Comparison: Week 12, Day 84p-value: 0.185395% CI: [-0.99, 0.13]ANCOVA
Comparison: Week 12, Day 84p-value: 0.000995% CI: [-1.03, -0.21]ANCOVA
Comparison: Week 12, Day 84p-value: 0.000895% CI: [-1.03, -0.21]ANCOVA
Comparison: Week 1, Day 7p-value: 0.000595% CI: [0.15, 0.67]ANCOVA
Comparison: Week 1, Day 7p-value: 0.000395% CI: [0.16, 0.68]ANCOVA
Comparison: Week 2, Day 14p-value: 0.00695% CI: [0.09, 0.69]ANCOVA
Comparison: Week 2, Day 14p-value: 0.003995% CI: [0.1, 0.7]ANCOVA
Comparison: Week 4, Day 28p-value: 0.000795% CI: [0.18, 0.88]ANCOVA
Comparison: Week 4, Day 28p-value: 0.000795% CI: [0.19, 0.88]ANCOVA
Comparison: Week 8, Day 56p-value: 0.04595% CI: [0.01, 0.77]ANCOVA
Comparison: Week 8, Day 56p-value: 0.025995% CI: [0.04, 0.8]ANCOVA
Comparison: Week 12, Day 84p-value: 0.988195% CI: [-0.34, 0.46]ANCOVA
Comparison: Week 12, Day 84p-value: 0.989195% CI: [-0.34, 0.46]ANCOVA
Comparison: Week 1, Day 7p-value: 0.046395% CI: [-0.57, 0]ANCOVA
Comparison: Week 2, Day 14p-value: 0.186795% CI: [-0.56, 0.11]ANCOVA
Comparison: Week 4, Day 28p-value: 0.021395% CI: [-0.81, -0.07]ANCOVA
Comparison: Week 8. Day 56p-value: 0.000395% CI: [-1.19, -0.37]ANCOVA
Comparison: Week 12, Day 84p-value: 0.000295% CI: [-1.24, -0.4]ANCOVA
Secondary
Maximum Observed Plasma Concentration of GDC-0853 at Steady State (Cmax,ss)
Cmax is the maximum (peak) plasma concentration over the dosing interval at steady state (ss)
Time frame: Pre-dose (0 hours) up to 10 hours post-dose on Day 28
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 collected is indicated for each time point. Data were presented only for arms in which GDC-0853 was administered.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Maximum Observed Plasma Concentration of GDC-0853 at Steady State (Cmax,ss) | 110 Nanogram per Milliliter (ng/mL) | Standard Deviation 116 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Maximum Observed Plasma Concentration of GDC-0853 at Steady State (Cmax,ss) | 280 Nanogram per Milliliter (ng/mL) | Standard Deviation 223 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Maximum Observed Plasma Concentration of GDC-0853 at Steady State (Cmax,ss) | 591 Nanogram per Milliliter (ng/mL) | Standard Deviation 282 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Maximum Observed Plasma Concentration of GDC-0853 at Steady State (Cmax,ss) | 621 Nanogram per Milliliter (ng/mL) | Standard Deviation 302 |
Secondary
Minimum Observed Plasma Concentration of GDC-0853 at Steady State (Cmin,ss)
Cmin is the minimum concentration over the dosing interval at steady state (ss)
Time frame: Pre-dose (0 hours) up to 10 hours post-dose on Day 28
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 collected is indicated for each time point. Data were presented only for arms in which GDC-0853 was administered.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Minimum Observed Plasma Concentration of GDC-0853 at Steady State (Cmin,ss) | 22.4 Nanogram per Milliliter (ng/mL) | Standard Deviation 41 |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Minimum Observed Plasma Concentration of GDC-0853 at Steady State (Cmin,ss) | 54.7 Nanogram per Milliliter (ng/mL) | Standard Deviation 83.4 |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Minimum Observed Plasma Concentration of GDC-0853 at Steady State (Cmin,ss) | 250 Nanogram per Milliliter (ng/mL) | Standard Deviation 146 |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Minimum Observed Plasma Concentration of GDC-0853 at Steady State (Cmin,ss) | 263 Nanogram per Milliliter (ng/mL) | Standard Deviation 170 |
Secondary
Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1)
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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
Time frame: Day 84
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 collected is indicated for each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1) | 17.5 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1) | 27.5 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1) | 34.5 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1) | 14.5 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1) | 36.0 Percentage |
p-value: 0.169495% CI: [-20.82, 3.66]Cochran-Mantel-Haenszel
p-value: 0.813295% CI: [-13.96, 10.95]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 2)
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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
Time frame: Day 84
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 collected is indicated for each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 2) | 25.0 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 2) | 12.0 Percentage |
p-value: 0.071795% CI: [-1.21, 28.61]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\]
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 4 Day 28 | 30.0 Percentage |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 1 Day 7 | 10.0 Percentage |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 12 Day 84 | 60.0 Percentage |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 2 Day 14 | 12.5 Percentage |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 8 Day 56 | 50.0 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 4 Day 28 | 34.9 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 2 Day 14 | 19.3 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 8 Day 56 | 52.3 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 1 Day 7 | 14.7 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 12 Day 84 | 56.0 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 12 Day 84 | 59.1 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 2 Day 14 | 27.3 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 1 Day 7 | 13.6 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 4 Day 28 | 41.8 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 8 Day 56 | 58.2 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 4 Day 28 | 25.5 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 1 Day 7 | 10.0 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 2 Day 14 | 16.4 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 8 Day 56 | 37.3 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 12 Day 84 | 36.4 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 1 Day 7 | 25.2 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 12 Day 84 | 72.1 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 4 Day 28 | 59.5 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 8 Day 56 | 71.2 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 2 Day 14 | 48.6 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 1 Day 7 | 22.9 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 12 Day 84 | 58.3 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 8 Day 56 | 47.9 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 2 Day 14 | 25.0 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 4 Day 28 | 35.4 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 8 Day 56 | 18.0 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 2 Day 14 | 10.0 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 4 Day 28 | 24.0 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 1 Day 7 | 2.0 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | Week 12 Day 84 | 24.0 Percentage |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 4 day 28 | 5.0 Percentage |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 1 Day 7 | 2.5 Percentage |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 12 Day 84 | 17.5 Percentage |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 2 Day 14 | 0.0 Percentage |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 8 Day 56 | 15.0 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 4 day 28 | 9.2 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 2 Day 14 | 1.8 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 8 Day 56 | 18.3 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 1 Day 7 | 2.8 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 12 Day 84 | 27.5 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 12 Day 84 | 34.5 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 2 Day 14 | 7.3 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 1 Day 7 | 3.6 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 4 day 28 | 10.0 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 8 Day 56 | 22.7 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 4 day 28 | 6.4 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 1 Day 7 | 2.7 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 2 Day 14 | 2.7 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 8 Day 56 | 17.3 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 12 Day 84 | 14.5 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 1 Day 7 | 4.5 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 12 Day 84 | 36.0 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 4 day 28 | 25.2 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 8 Day 56 | 32.4 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 2 Day 14 | 9.0 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 1 Day 7 | 6.3 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 12 Day 84 | 25.0 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 8 Day 56 | 22.9 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 2 Day 14 | 10.4 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 4 day 28 | 10.4 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 8 Day 56 | 10.0 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 2 Day 14 | 0.00 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 4 day 28 | 6.0 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 1 Day 7 | 2.0 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 12 Day 84 | 12.0 Percentage |
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 4 Day 28 | 0 Percentage |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 1 Day 7 | 0.0 Percentage |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 12 Day 84 | 5.0 Percentage |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 2 Day 14 | 0.0 Percentage |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 8 Day 56 | 0.0 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 4 Day 28 | 2.8 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 2 Day 14 | 0.9 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 8 Day 56 | 7.3 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 1 Day 7 | 0.9 Percentage |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 12 Day 84 | 9.2 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 12 Day 84 | 12.7 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 2 Day 14 | 0.0 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 1 Day 7 | 0.9 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 4 Day 28 | 4.5 Percentage |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 8 Day 56 | 9.1 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 4 Day 28 | 0.9 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 1 Day 7 | 0.0 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 2 Day 14 | 0.00 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 8 Day 56 | 3.6 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 12 Day 84 | 7.3 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 1 Day 7 | 0.0 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 12 Day 84 | 18.0 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 4 Day 28 | 6.3 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 8 Day 56 | 14.4 Percentage |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 2 Day 14 | 3.6 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 1 Day 7 | 0.0 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 12 Day 84 | 14.6 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 8 Day 56 | 6.3 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 2 Day 14 | 4.2 Percentage |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 4 Day 28 | 2.1 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 8 Day 56 | 4.0 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 2 Day 14 | 0.0 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 4 Day 28 | 2.0 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 1 Day 7 | 0.0 Percentage |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 12 Day 84 | 4.0 Percentage |
Secondary
Percentage of Participants Meeting the Boolean-based Remission Criteria
Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale).
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 4 Day 28 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 8 Day 56 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 12 Day 84 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 8 Day 56 | 2.0 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 4 Day 28 | 1.0 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 1 Day 7 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 12 Day 84 | 2.0 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 8 Day 56 | 1.90 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 4 Day 28 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 12 Day 84 | 4.1 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 4 Day 28 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 8 Day 56 | 1.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 12 Day 84 | 1.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 4 Day 28 | 2.8 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 8 Day 56 | 3.7 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 12 Day 84 | 6.5 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 8 Day 56 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 12 Day 84 | 8.5 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 4 Day 28 | 2.1 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 12 Day 84 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 8 Day 56 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the Boolean-based Remission Criteria | Week 4 Day 28 | 0.0 Percentage of participants |
Comparison: Week 1, Day 7p-value: 195% CI: [-6.28, 6.28]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.594195% CI: [-2.5, 4.37]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 195% CI: [-2.93, 2.93]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-6.17, 6.17]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-2.95, 2.95]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-2.92, 2.92]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.892995% CI: [-6.62, 5.77]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.942495% CI: [-3.78, 3.51]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.592795% CI: [-4.4, 2.51]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.878895% CI: [-6.31, 5.4]Cochran-Mantel-Haenszel
Comparison: Week 8 Day 56p-value: 0.687695% CI: [-3.36, 5.09]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.665695% CI: [-3.42, 5.35]Cochran-Mantel-Haenszel
Comparison: Week 12 Day 84p-value: 0.878795% CI: [-6.34, 5.42]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.710195% CI: [-3.17, 4.66]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.242595% CI: [-2.16, 8.55]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 195% CI: [-8.68, 8.68]Cochran-Mantel-Haenszel
Comparison: Week 2 Day 14p-value: 195% CI: [-8.39, 8.39]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.665895% CI: [-7.17, 11.22]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 195% CI: [-8.77, 8.77]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.245795% CI: [-4.52, 17.66]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Meeting the CDAI-based Remission Criteria
Clinical Disease Activity Index is defined as CDAI= : SJC(28) + TJC(28) + PGA + MDG where TJC and SJC are the tender and swollen joint counts from 28 joints, PGA is the patient's global assessment of disease activity (on a 0-10 scale) and MDG is physician global assessment of disease activity (on a 0-10 scale). The cutoff value for CDAI remission is \<=2.8.
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 4 Day 28 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 8 Day 56 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 12 Day 84 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 8 Day 56 | 2.8 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 1 Day 7 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 4 Day 28 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 12 Day 84 | 5.5 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 8 Day 56 | 5.5 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 1 Day 7 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 4 Day 28 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 12 Day 84 | 6.4 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 8 Day 56 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 4 Day 28 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 12 Day 84 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 12 Day 84 | 9.9 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 2 Day 14 | 1.8 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 4 Day 28 | 4.5 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 8 Day 56 | 7.2 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 4 Day 28 | 2.1 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 8 Day 56 | 4.2 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 12 Day 84 | 6.3 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 8 Day 56 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 4 Day 28 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the CDAI-based Remission Criteria | Week 12 Day 84 | 6.0 Percentage of participants |
Comparison: Week 1, Day 7p-value: 195% CI: [-6.06, 6.06]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.597695% CI: [-2.48, 4.3]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.597695% CI: [-2.47, 4.28]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-6.06, 6.06]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-2.92, 2.92]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-2.91, 2.91]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 195% CI: [-6.06, 6.06]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.572695% CI: [-2.26, 4.09]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.597695% CI: [-2.47, 4.28]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 195% CI: [-6.06, 6.06]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.144695% CI: [-0.94, 6.42]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.028695% CI: [0.57, 10.34]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.897995% CI: [-6.51, 5.71]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.070895% CI: [-0.39, 9.52]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.047895% CI: [0.05, 10.86]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 195% CI: [-8.31, 8.31]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-8.31, 8.31]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.656495% CI: [-7, 11.11]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.383895% CI: [-5.14, 13.36]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.900995% CI: [-10.1, 11.47]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Meeting the SDAI-based Remission Criteria
The SDAI was the numerical sum of five outcome parameter: SJC and TJC (based on a 28-joint assessment), PGA and MDG (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. The SDAI =\< 3.3 indicates disease remission
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 4 Day 28 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 1 Day 7 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 12 Day 84 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 2 Day 14 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 8 Day 56 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 4 Day 28 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 2 Day 14 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 8 Day 56 | 2.8 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 1 Day 7 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 12 Day 84 | 4.6 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 12 Day 84 | 6.4 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 2 Day 14 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 1 Day 7 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 4 Day 28 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 8 Day 56 | 3.6 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 4 Day 28 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 1 Day 7 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 2 Day 14 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 8 Day 56 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 12 Day 84 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 1 Day 7 | 0.00 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 12 Day 84 | 9.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 4 Day 28 | 4.5 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 8 Day 56 | 6.3 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 2 Day 14 | 1.8 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 1 Day 7 | 0.00 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 12 Day 84 | 6.3 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 8 Day 56 | 0.00 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 2 Day 14 | 0.00 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 4 Day 28 | 2.1 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 8 Day 56 | 0.00 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 2 Day 14 | 0.00 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 4 Day 28 | 0.00 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 1 Day 7 | 0.00 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants Meeting the SDAI-based Remission Criteria | Week 12 Day 84 | 6.0 Percentage of participants |
Comparison: Week 1, Day 7p-value: 195% CI: [-6.06, 6.06]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.597695% CI: [-2.48, 4.3]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 195% CI: [-2.91, 2.91]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-6.06, 6.06]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-2.92, 2.92]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-2.91, 2.91]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 195% CI: [-6.06, 6.06]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.572695% CI: [-2.26, 4.09]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.597695% CI: [-2.47, 4.28]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 195% CI: [-6.06, 6.06]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.144695% CI: [-0.94, 6.42]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.10595% CI: [-0.76, 8.03]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.897995% CI: [-6.51, 5.71]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.12795% CI: [-1.04, 8.35]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.050195% CI: [0, 10.91]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 195% CI: [-8.31, 8.31]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-8.31, 8.31]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.656495% CI: [-7, 11.11]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 195% CI: [-8.31, 8.31]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.905195% CI: [-10.58, 11.95]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With DAS Low Disease Activity
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. LDAS is defined as DAS28 ≤ 3.2
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 2 day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 12 Day 84 | 7.5 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 8 Day 56 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 4 Day 28 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 12 Day 84 | 19.3 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 2 day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 8 Day 56 | 8.3 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 4 Day 28 | 1.8 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 1 Day 7 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 4 Day 28 | 6.4 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 1 Day 7 | 1.8 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 2 day 14 | 1.8 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 8 Day 56 | 11.8 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 12 Day 84 | 14.5 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 2 day 14 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 12 Day 84 | 3.6 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 4 Day 28 | 1.8 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants With DAS Low Disease Activity | Week 8 Day 56 | 3.6 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants With DAS Low Disease Activity | Week 2 day 14 | 4.5 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants With DAS Low Disease Activity | Week 1 Day 7 | 1.8 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants With DAS Low Disease Activity | Week 8 Day 56 | 18.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants With DAS Low Disease Activity | Week 4 Day 28 | 11.7 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants With DAS Low Disease Activity | Week 12 Day 84 | 17.1 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants With DAS Low Disease Activity | Week 2 day 14 | 2.1 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants With DAS Low Disease Activity | Week 8 Day 56 | 2.1 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants With DAS Low Disease Activity | Week 1 Day 7 | 2.1 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants With DAS Low Disease Activity | Week 12 Day 84 | 14.6 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants With DAS Low Disease Activity | Week 4 Day 28 | 2.1 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants With DAS Low Disease Activity | Week 12 Day 84 | 4.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants With DAS Low Disease Activity | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants With DAS Low Disease Activity | Week 8 Day 56 | 2.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants With DAS Low Disease Activity | Week 2 day 14 | 2.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants With DAS Low Disease Activity | Week 4 Day 28 | 0.0 Percentage of participants |
Comparison: Week 1, Day 7p-value: 195% CI: [-6.06, 6.06]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.597695% CI: [-2.48, 4.3]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.348295% CI: [-1.98, 5.62]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.897995% CI: [-6.51, 5.71]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.597695% CI: [-4.3, 2.48]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.654695% CI: [-3.07, 4.89]Cochran-Mantel-Haenszel
Comparison: Week 4 Day 28p-value: 0.798895% CI: [-6.95, 5.35]Cochran-Mantel-Haenszel
Comparison: Week 4 Day 28p-value: 0.997595% CI: [-4.35, 4.36]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.118595% CI: [-1.16, 10.25]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.476595% CI: [-9.01, 4.21]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.165595% CI: [-1.9, 11.12]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.023495% CI: [1.11, 15.26]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.54995% CI: [-7.27, 13.67]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.000395% CI: [7.22, 24.03]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.004495% CI: [3.39, 18.43]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.658895% CI: [-7.07, 11.18]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.885395% CI: [-8.62, 9.99]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.656495% CI: [-7, 11.11]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.885395% CI: [-8.62, 9.99]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.058495% CI: [-0.41, 23.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With DAS Remission
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
Time frame: Days 7, 14, 28, 56, and 84
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 collected is indicated for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 4 Day 28 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 12 Day 84 | 2.5 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 8 Day 56 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 4 Day 28 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 8 Day 56 | 3.7 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 12 Day 84 | 7.3 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 12 Day 84 | 8.2 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 2 Day 14 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 4 Day 28 | 1.8 Percentage of participants |
| Cohort 1: GDC-0853 High Dose + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 8 Day 56 | 4.5 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 4 Day 28 | 0.9 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 8 Day 56 | 1.8 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab Placebo | Percentage of Participants With DAS Remission | Week 12 Day 84 | 3.6 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants With DAS Remission | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants With DAS Remission | Week 12 Day 84 | 9.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants With DAS Remission | Week 4 Day 28 | 4.5 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants With DAS Remission | Week 8 Day 56 | 9.0 Percentage of participants |
| Cohort 1: GDC-0853 Placebo + Adalimumab | Percentage of Participants With DAS Remission | Week 2 Day 14 | 0.9 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants With DAS Remission | Week 1 Day 7 | 2.1 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants With DAS Remission | Week 12 Day 84 | 4.2 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants With DAS Remission | Week 8 Day 56 | 0.00 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants With DAS Remission | Week 2 Day 14 | 0.00 Percentage of participants |
| Cohort 2: GDC-0853 High Dose | Percentage of Participants With DAS Remission | Week 4 Day 28 | 0.00 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants With DAS Remission | Week 8 Day 56 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants With DAS Remission | Week 2 Day 14 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants With DAS Remission | Week 4 Day 28 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants With DAS Remission | Week 1 Day 7 | 0.0 Percentage of participants |
| Cohort 2: GDC-0853 Placebo | Percentage of Participants With DAS Remission | Week 12 Day 84 | 4.0 Percentage of participants |
Comparison: Week 1, Day 7p-value: 195% CI: [-6.06, 6.06]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 195% CI: [-2.92, 2.92]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 195% CI: [-2.91, 2.91]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-6.06, 6.06]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 195% CI: [-2.92, 2.92]Cochran-Mantel-Haenszel
Comparison: Week 2, Day 14p-value: 0.597695% CI: [-2.47, 4.28]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.897995% CI: [-6.51, 5.71]Cochran-Mantel-Haenszel
Comparison: Week 4 Day 28p-value: 0.597695% CI: [-4.3, 2.48]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 0.666995% CI: [-3.23, 5.05]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.630995% CI: [-8.13, 4.93]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.447395% CI: [-2.9, 6.56]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 0.302195% CI: [-2.45, 7.91]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.713495% CI: [-10.14, 6.94]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.263595% CI: [-2.79, 10.19]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.174995% CI: [-2.02, 11.11]Cochran-Mantel-Haenszel
Comparison: Week 1, Day 7p-value: 0.658895% CI: [-7.07, 11.18]Cochran-Mantel-Haenszel
Comparison: Week 2 Day 14p-value: 195% CI: [-8.31, 8.31]Cochran-Mantel-Haenszel
Comparison: Week 4, Day 28p-value: 195% CI: [-8.31, 8.31]Cochran-Mantel-Haenszel
Comparison: Week 8, Day 56p-value: 195% CI: [-8.31, 8.31]Cochran-Mantel-Haenszel
Comparison: Week 12, Day 84p-value: 0.784895% CI: [-8.46, 11.2]Cochran-Mantel-Haenszel