Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Mavrilimumab, CAM-3001
Brief summary
The primary objectives of this study is to assess the safety, tolerability and efficacy of multiple doses of the mavrilimumab (CAM-3001) administered subcutaneously in subjects with moderately active Rheumatoid Arthritis (RA).
Detailed description
This is a Phase 2, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the efficacy and safety of multiple doses of the mavrilimumab (CAM-3001) (10 milligram \[mg\], 30 mg, 50 mg, and 100 mg) administered subcutaneously in adult subjects with moderately active RA.
Interventions
BIOLOGICALMavrilimumab 10 mg
Mavrilimumab (CAM-3001) 10 mg injection subcutaneously every other week for 12 weeks.
BIOLOGICALMavrilimumab 30 mg
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks.
BIOLOGICALMavrilimumab 50 mg
Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks.
BIOLOGICALMavrilimumab 100 mg
Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks.
OTHERPlacebo
Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks.
Sponsors
MedImmune Ltd
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 through 80 years (20 to 75 years in Japan) * Written consent * Diagnosis of adult onset Rheumatoid Arthritis (RA) of at least 3 months duration as defined by the 1987 American College of Rheumatology (ACR) classification criteria (Arnett et al, 1988) * Treatment with methotrexate at a stable and tolerated doses * Positive anti-cyclic citrullinated peptide (CCP) immuno-globulin G antibodies (more than \[\>\] 5 international unit per milliliter \[IU/mL\]) and/or rheumatoid factor (RF \>14 IU/mL) at screening * Received more than or equal to (\>=) 5 milligram (mg) per week folic acid as a single or divided dose during the study.
Exclusion criteria
* A rheumatic autoimmune disease other than RA * A history of, or current, inflammatory joint disease other than RA or other systemic autoimmune disorder * Subjects at a high risk of infection * Subjects (male and female) of reproductive potential who are not willing to use contraception from screening through the end date of the trial * History of methotrexate or any drug-induced lung fibrosis or pneumonitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 | Day 85 | DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per Liter \[mg/L\]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (\<) 3.2 = low disease activity, greater than or equal to (\>=) 3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85. |
| Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region | Day 85 | DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85. DAS28 (CRP) response at Day 85 for the European and Japanese regions were reported. |
| Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 | Day 85 | DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85. |
| Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region | Day 85 | DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85. DAS28 (ESR) response at Day 85 for the European and Japanese regions were reported. |
| Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Day 85 | DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline \>1.2 with baseline DAS28 (CRP) \<3.2; moderate response: change from baseline \>1.2 with baseline DAS28 (CRP) \>=3.2 to less than or equal to (=\<) 5.1 or change from baseline \>=0.6 to =\< 1.2 with baseline DAS28 (CRP) \>=3.2 to =\<5.1; no response: change from baseline \<0.6 or change from baseline \>=0.6 and =\<1.2 with baseline DAS28 (CRP) \>5.1. |
| Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Day 85 | DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline \>1.2 with baseline DAS28 (CRP) \<3.2; moderate response: change from baseline \>1.2 with baseline DAS28 (CRP) \>=3.2 to =\< 5.1 or change from baseline \>=0.6 to =\< 1.2 with baseline DAS28 (CRP) \>=3.2 to =\<5.1; no response: change from baseline \<0.6 or change from baseline \>=0.6 and =\<1.2 with baseline DAS28 (CRP) \>5.1. DAS28 (CRP) response by EULAR category at Day 85 for the European and Japanese regions were reported. |
| Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Day 85 | DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline \>1.2 with baseline DAS28 (ESR) \<3.2; moderate response: change from baseline \>1.2 with baseline DAS28 (ESR) \>=3.2 to =\< 5.1 or change from baseline \>=0.6 to =\< 1.2 with baseline DAS28 (ESR) \>=3.2 to =\<5.1; no response: change from baseline \<0.6 or change from baseline \>=0.6 and =\<1.2 with baseline DAS28 (ESR) \>5.1. |
| Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Day 85 | DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline \>1.2 with baseline DAS28 (ESR) \<3.2; moderate response: change from baseline \>1.2 with baseline DAS28 (ESR) \>=3.2 to =\< 5.1 or change from baseline \>=0.6 to =\< 1.2 with baseline DAS28 (ESR) \>=3.2 to =\<5.1; no response: change from baseline \<0.6 or change from baseline \>=0.6 and =\<1.2 with baseline DAS28 (ESR) \>5.1. DAS28 (ESR) response by EULAR category at Day 85 for the European and Japanese regions were reported. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Baseline up to Day 169 (follow-up) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up Day 169 that were absent before treatment or that worsened relative to pretreatment state. |
| Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Day 169 (follow-up) | Vital sign assessments included blood pressure, pulse rate, temperature, and respiration rate. Vital signs abnormalities reported as TEAEs were reported. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Results | Baseline up to Day 169 (follow-up) | 12-lead ECG was recorded and corrected QT (QTc) interval was measured with the participant in a rested supine position for at least 10 minutes. Any ECG abnormality deemed clinically significant as per investigator's discretion were reported. |
| Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Day 85 | FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. |
| Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | Day 85 | FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 and FVC at Day 85 for the European and Japanese regions were reported. |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Baseline and Day 85 | FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. |
| Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Day 85 | DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide. |
| Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region | Day 85 | DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% for the European and Japanese regions were reported. |
| Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Baseline and Day 85 | DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. |
| Dyspnea Score at Day 85 | Day 85 | Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing. |
| Change From Baseline in Dyspnea Score at Day 85 | Baseline and Day 85 | Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing. |
| Categorized Dyspnea Score at Day 85 | Day 85 | Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing. The modified BORG dyspnea scale was categorized as - no/slight (0 to 2), moderate (3 and 4), severe (5 and 6) and very severe breathlessness (7 and above). |
| Oxygen Saturation Level at Day 85 | Day 85 | Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. |
| Oxygen Saturation Level at Day 85 by Region | Day 85 | Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. Oxygen saturation for the European and Japanese regions were reported. |
| Change From Baseline in Oxygen Saturation Level at Day 85 | Baseline and Day 85 | Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. |
| Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Day 169 (follow-up) | Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, reticulocytes, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, mean corpuscular volume, mean corpuscular haemoglobin concentration); serum chemistry (creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, gamma glutamyl transferase, CRP, ESR, albumin, total cholesterol, triglycerides, rheumatoid factor and anti-cyclic citrullinated peptide antibodies); urinalysis (albumin, glucose, protein, blood, nitrite). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of C-Reactive Protein (CRP) | Day 85 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Serum Concentration of C-Reactive Protein (CRP) by Region | Day 85 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for European and Japanese regions were reported. |
| Serum Concentration of Erythrocyte Sedimentation Rate (ESR) | Day 85 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. |
| Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region | Day 85 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Data for European and Japanese regions were reported. |
| Serum Concentration of Rheumatoid Factor (RF) | Day 85 | — |
| Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA) | Day 85 | — |
| Number of Participants Who Had Additional Medications | Baseline up to Day 169 | Additional medication included concomitant medication (medication used for purposes other than managing rheumatoid arthritis \[RA\]) and RA medication (for managing RA). Number of participants who used concomitant medication and RA medication was reported by anatomical therapeutic chemical (ATC) classification system. |
| Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | Baseline, Day 1 to 85, Day 86 to 169 | Participants received MTX at stable and tolerated dose during baseline were categorized as low dose (\<12.5 mg per week \[mg/wk\]), medium dose (\>=12.5 - \<20 mg/wk), and high dose (\>=20 mg/wk). Participants received oral CST at stable dose during baseline were categorized as low dose (\<5 mg/day), and high dose (\>=5 mg/day). Change in MTX and CST dose from baseline between Day 1-85 and Day 86-169 were categorized as follows: 'Increased', 'no change' and 'decreased'. Participants were counted once with dose increases counted first, followed by no change and then dose decreases. |
| Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region | Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169 | Data for European and Japanese regions were reported. |
| Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region | Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169 | Data for European and Japanese regions were reported. |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region | Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169 | Data for European and Japanese regions were reported. |
| Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region | Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169 | Data for European and Japanese regions were reported. |
| Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region | Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169 | Data for European and Japanese regions were reported. |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region | Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169 | Data for European and Japanese regions were reported. |
| Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region | Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Data for European and Japanese regions were reported. |
| Accumulation Ratio for Mavrilimumab After Last Dose by Region | Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169 | Accumulation ratio was calculated as ratio of AUCtau after last dose and AUCtau after first dose. Data for European and Japanese regions were reported. |
| Patient Pain Assessment Score | Day 85 | Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. |
| Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit | Day 1 up to Day 169 | ADA detection measured by using electrochemiluminescence assays. |
| Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | Baseline and Day 85 | DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. |
| Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Baseline and Day 85 | DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported. |
| Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 | Day 85 | DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score. |
| Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | Day 85 | DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported. |
| Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | Baseline up to Day 169 (follow-up) | DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. |
| Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | Baseline up to Day 169 (follow-up) | DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Time to response for DAS28 (CRP) and DAS28 (ESR) by region were reported. Time to remission for DAS28 (CRP) and DAS28 (ESR) by region were not analyzed because time to remission for the overall study population could not be achieved. |
| Patient Pain Assessment Score by Region | Day 85 | Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. Data for European and Japanese regions were reported. |
| Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission | Baseline up to Day 169 | DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Expected duration of response (DOR) was calculated as response rate (in percentage) multiplied by mean DOR (in days) by using Weibull Model. Duration of DAS28 (CRP) and DAS28 (ESR) remission were not analyzed because very few participants achieved remission in the overall study population. |
| Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | Day 85 | ACR20, ACR50, and ACR70, were defined as greater than or equal to (\>=) 20 percent (%),\>=50%, or \>=70% improvement, respectively, in: swollen joint count and tender joint count and \>=20%, \>=50%, or \>=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). |
| Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Day 85 | ACR20, ACR50, and ACR70, were defined as \>=20%, \>=50%, or \>=70% improvement, respectively, in: SJC and TJC and \>=20%, \>=50%, or \>=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Data for the European and Japanese regions were reported. |
| Number of Participants Who Achieved ACR Categorical Responses | Day 85 | ACR20, ACR50, and ACR70, were defined as \>=20%, \>=50%, or \>=70% improvement, respectively, in: SJC and TJC and \>=20%, \>=50%, or \>=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. ACR responses were categorized as No response, ACR20 but not ACR50, ACR50 but not ACR70, and ACR70. |
| Continuous ACR (ACRn) Score | Day 85 | ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. |
| Continuous ACR (ACRn) Score by Region | Day 85 | ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Data for European and Japanese regions were reported. |
| Swollen and Tender Joint Count | Day 85 | Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. |
| Swollen and Tender Joint Count by Region | Day 85 | Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Data for the European and Japanese regions were reported. |
| Physician Global Assessment of Disease Activity Score | Day 85 | Physician Global Assessment of Arthritis was measured on a 0 to 10 centimeter (cm) Visual Analogue Scale (VAS), where 0 cm = very good and 10 cm = very bad. |
| Physician Global Assessment of Disease Activity Score by Region | Day 85 | Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad. Data for European and Japanese regions were reported. |
| Patient Global Assessment of Disease Activity Score | Day 85 | Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly. |
| Patient Global Assessment of Disease Activity Score by Region | Day 85 | Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly. Data for European and Japanese regions were reported. |
| Health Assessments Questionnaire-Disability Index (HAQ-DI) Score | Day 85 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
| Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region | Day 85 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Data for European and Japanese regions were reported. |
| Health Assessments Questionnaire (HAQ) Pain Score | Day 85 | Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain. |
| Health Assessments Questionnaire (HAQ) Pain Score by Region | Day 85 | Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain. Data for European and Japanese regions were reported. |
Countries
Bulgaria, Czechia, Estonia, Hungary, Japan, Latvia, Lithuania, Poland, Romania, Russia, Ukraine
Participant flow
Pre-assignment details
A total of 516 participants were screened out of which 290 participants were randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Mavrilimumab 10 mg Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. | 48 |
| Mavrilimumab 30 mg Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. | 49 |
| Mavrilimumab 50 mg Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. | 48 |
| Mavrilimumab 100 mg Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. | 47 |
| Placebo Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally. | 92 |
| Total | 284 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 0 | 2 |
| Overall Study | Data integrity issues | 0 | 0 | 1 | 1 | 4 |
| Overall Study | Other | 3 | 2 | 1 | 1 | 5 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 3 |
Baseline characteristics
| Characteristic | Mavrilimumab 10 mg | Mavrilimumab 30 mg | Mavrilimumab 50 mg | Mavrilimumab 100 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 11.9 | 51.1 years STANDARD_DEVIATION 12.1 | 52.7 years STANDARD_DEVIATION 10.3 | 50.1 years STANDARD_DEVIATION 12.1 | 52.1 years STANDARD_DEVIATION 12.8 | 51.7 years STANDARD_DEVIATION 11.9 |
| Sex: Female, Male Female | 39 Participants | 43 Participants | 44 Participants | 40 Participants | 82 Participants | 248 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 4 Participants | 7 Participants | 10 Participants | 36 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 32 / 48 | 29 / 49 | 26 / 49 | 28 / 48 | 46 / 96 |
| serious Total, serious adverse events | 2 / 48 | 2 / 49 | 1 / 49 | 0 / 48 | 1 / 96 |
Outcome results
Primary
Categorized Dyspnea Score at Day 85
Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing. The modified BORG dyspnea scale was categorized as - no/slight (0 to 2), moderate (3 and 4), severe (5 and 6) and very severe breathlessness (7 and above).
Time frame: Day 85
Population: The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Categorized Dyspnea Score at Day 85 | No/Slight breathlessness | 89 participants | 0.58 |
| Placebo | Categorized Dyspnea Score at Day 85 | Moderate breathlessness | 0 participants | 0.53 |
| Placebo | Categorized Dyspnea Score at Day 85 | Severe breathlessness | 0 participants | — |
| Placebo | Categorized Dyspnea Score at Day 85 | Very severe breathlessness | 0 participants | — |
| Mavrilimumab 10 mg | Categorized Dyspnea Score at Day 85 | No/Slight breathlessness | 45 participants | 0.88 |
| Mavrilimumab 10 mg | Categorized Dyspnea Score at Day 85 | Very severe breathlessness | 0 participants | — |
| Mavrilimumab 10 mg | Categorized Dyspnea Score at Day 85 | Moderate breathlessness | 0 participants | 0.62 |
| Mavrilimumab 10 mg | Categorized Dyspnea Score at Day 85 | Severe breathlessness | 0 participants | — |
| Mavrilimumab 30 mg | Categorized Dyspnea Score at Day 85 | Very severe breathlessness | 0 participants | — |
| Mavrilimumab 30 mg | Categorized Dyspnea Score at Day 85 | Moderate breathlessness | 2 participants | 0.44 |
| Mavrilimumab 30 mg | Categorized Dyspnea Score at Day 85 | Severe breathlessness | 0 participants | — |
| Mavrilimumab 30 mg | Categorized Dyspnea Score at Day 85 | No/Slight breathlessness | 45 participants | 0.59 |
| Mavrilimumab 50 mg | Categorized Dyspnea Score at Day 85 | No/Slight breathlessness | 49 participants | 0.49 |
| Mavrilimumab 50 mg | Categorized Dyspnea Score at Day 85 | Moderate breathlessness | 0 participants | 0.35 |
| Mavrilimumab 50 mg | Categorized Dyspnea Score at Day 85 | Very severe breathlessness | 0 participants | — |
| Mavrilimumab 50 mg | Categorized Dyspnea Score at Day 85 | Severe breathlessness | 0 participants | — |
| Mavrilimumab 100 mg | Categorized Dyspnea Score at Day 85 | Very severe breathlessness | 0 participants | — |
| Mavrilimumab 100 mg | Categorized Dyspnea Score at Day 85 | Severe breathlessness | 0 participants | — |
| Mavrilimumab 100 mg | Categorized Dyspnea Score at Day 85 | Moderate breathlessness | 1 participants | 0.56 |
| Mavrilimumab 100 mg | Categorized Dyspnea Score at Day 85 | No/Slight breathlessness | 46 participants | 0.59 |
Primary
Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85
DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide.
Time frame: Baseline and Day 85
Population: The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Baseline (n=86,40,45,49,48) | 91.5 percent diffusion capacity | Standard Deviation 12.5 |
| Placebo | Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Change at Day 85 (n=87,46,47,49,47) | 0.1 percent diffusion capacity | Standard Deviation 14.3 |
| Mavrilimumab 10 mg | Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Baseline (n=86,40,45,49,48) | 96.3 percent diffusion capacity | Standard Deviation 17.7 |
| Mavrilimumab 10 mg | Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Change at Day 85 (n=87,46,47,49,47) | -3.1 percent diffusion capacity | Standard Deviation 17.3 |
| Mavrilimumab 30 mg | Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Baseline (n=86,40,45,49,48) | 93.7 percent diffusion capacity | Standard Deviation 15.5 |
| Mavrilimumab 30 mg | Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Change at Day 85 (n=87,46,47,49,47) | 0.4 percent diffusion capacity | Standard Deviation 11.1 |
| Mavrilimumab 50 mg | Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Change at Day 85 (n=87,46,47,49,47) | -2.5 percent diffusion capacity | Standard Deviation 10.8 |
| Mavrilimumab 50 mg | Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Baseline (n=86,40,45,49,48) | 97.5 percent diffusion capacity | Standard Deviation 14.8 |
| Mavrilimumab 100 mg | Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Baseline (n=86,40,45,49,48) | 92.5 percent diffusion capacity | Standard Deviation 13.7 |
| Mavrilimumab 100 mg | Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Change at Day 85 (n=87,46,47,49,47) | -3.7 percent diffusion capacity | Standard Deviation 11.3 |
Primary
Change From Baseline in Dyspnea Score at Day 85
Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.
Time frame: Baseline and Day 85
Population: The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Dyspnea Score at Day 85 | Baseline (n=96,48,49,49,48) | 0.29 units on a scale | Standard Deviation 0.58 |
| Placebo | Change From Baseline in Dyspnea Score at Day 85 | Change at Day 85 (n=89,45,47,49,47) | -0.06 units on a scale | Standard Deviation 0.53 |
| Mavrilimumab 10 mg | Change From Baseline in Dyspnea Score at Day 85 | Baseline (n=96,48,49,49,48) | 0.26 units on a scale | Standard Deviation 0.88 |
| Mavrilimumab 10 mg | Change From Baseline in Dyspnea Score at Day 85 | Change at Day 85 (n=89,45,47,49,47) | -0.14 units on a scale | Standard Deviation 0.62 |
| Mavrilimumab 30 mg | Change From Baseline in Dyspnea Score at Day 85 | Baseline (n=96,48,49,49,48) | 0.26 units on a scale | Standard Deviation 0.59 |
| Mavrilimumab 30 mg | Change From Baseline in Dyspnea Score at Day 85 | Change at Day 85 (n=89,45,47,49,47) | 0.10 units on a scale | Standard Deviation 0.44 |
| Mavrilimumab 50 mg | Change From Baseline in Dyspnea Score at Day 85 | Change at Day 85 (n=89,45,47,49,47) | -0.04 units on a scale | Standard Deviation 0.35 |
| Mavrilimumab 50 mg | Change From Baseline in Dyspnea Score at Day 85 | Baseline (n=96,48,49,49,48) | 0.19 units on a scale | Standard Deviation 0.49 |
| Mavrilimumab 100 mg | Change From Baseline in Dyspnea Score at Day 85 | Baseline (n=96,48,49,49,48) | 0.32 units on a scale | Standard Deviation 0.59 |
| Mavrilimumab 100 mg | Change From Baseline in Dyspnea Score at Day 85 | Change at Day 85 (n=89,45,47,49,47) | 0.02 units on a scale | Standard Deviation 0.56 |
Primary
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85
FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time frame: Baseline and Day 85
Population: The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Baseline: FEV1 (n=87,43,45,49,48) | 2.790 liters | Standard Deviation 0.77 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Change at Day 85: FEV1 (n=87,46,47,49,47) | -0.039 liters | Standard Deviation 0.234 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Baseline: FVC (n=87,43,45,49,48) | 3.456 liters | Standard Deviation 0.948 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Change at Day 85: FVC (n=87,46,47,49,47) | -0.012 liters | Standard Deviation 0.301 |
| Mavrilimumab 10 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Baseline: FEV1 (n=87,43,45,49,48) | 2.788 liters | Standard Deviation 0.773 |
| Mavrilimumab 10 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Change at Day 85: FVC (n=87,46,47,49,47) | 0.048 liters | Standard Deviation 0.243 |
| Mavrilimumab 10 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Change at Day 85: FEV1 (n=87,46,47,49,47) | 0.044 liters | Standard Deviation 0.231 |
| Mavrilimumab 10 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Baseline: FVC (n=87,43,45,49,48) | 3.486 liters | Standard Deviation 0.963 |
| Mavrilimumab 30 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Change at Day 85: FVC (n=87,46,47,49,47) | -0.013 liters | Standard Deviation 0.239 |
| Mavrilimumab 30 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Change at Day 85: FEV1 (n=87,46,47,49,47) | 0.016 liters | Standard Deviation 0.196 |
| Mavrilimumab 30 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Baseline: FVC (n=87,43,45,49,48) | 3.759 liters | Standard Deviation 0.868 |
| Mavrilimumab 30 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Baseline: FEV1 (n=87,43,45,49,48) | 2.990 liters | Standard Deviation 0.765 |
| Mavrilimumab 50 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Baseline: FEV1 (n=87,43,45,49,48) | 2.760 liters | Standard Deviation 0.43 |
| Mavrilimumab 50 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Change at Day 85: FEV1 (n=87,46,47,49,47) | -0.059 liters | Standard Deviation 0.249 |
| Mavrilimumab 50 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Change at Day 85: FVC (n=87,46,47,49,47) | -0.039 liters | Standard Deviation 0.268 |
| Mavrilimumab 50 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Baseline: FVC (n=87,43,45,49,48) | 3.409 liters | Standard Deviation 0.496 |
| Mavrilimumab 100 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Change at Day 85: FVC (n=87,46,47,49,47) | -0.017 liters | Standard Deviation 0.218 |
| Mavrilimumab 100 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Baseline: FVC (n=87,43,45,49,48) | 3.506 liters | Standard Deviation 0.804 |
| Mavrilimumab 100 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Change at Day 85: FEV1 (n=87,46,47,49,47) | -0.049 liters | Standard Deviation 0.221 |
| Mavrilimumab 100 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Baseline: FEV1 (n=87,43,45,49,48) | 2.831 liters | Standard Deviation 0.681 |
Primary
Change From Baseline in Oxygen Saturation Level at Day 85
Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
Time frame: Baseline and Day 85
Population: The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Oxygen Saturation Level at Day 85 | Change at Day 85 (n=88,45,47,49,47) | 0.0 percent saturation | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Oxygen Saturation Level at Day 85 | Baseline (n=96,48,49,49,48) | 97.5 percent saturation | Standard Deviation 1.3 |
| Mavrilimumab 10 mg | Change From Baseline in Oxygen Saturation Level at Day 85 | Change at Day 85 (n=88,45,47,49,47) | -0.2 percent saturation | Standard Deviation 1.5 |
| Mavrilimumab 10 mg | Change From Baseline in Oxygen Saturation Level at Day 85 | Baseline (n=96,48,49,49,48) | 97.8 percent saturation | Standard Deviation 1.6 |
| Mavrilimumab 30 mg | Change From Baseline in Oxygen Saturation Level at Day 85 | Change at Day 85 (n=88,45,47,49,47) | 0.1 percent saturation | Standard Deviation 1.4 |
| Mavrilimumab 30 mg | Change From Baseline in Oxygen Saturation Level at Day 85 | Baseline (n=96,48,49,49,48) | 97.6 percent saturation | Standard Deviation 1.2 |
| Mavrilimumab 50 mg | Change From Baseline in Oxygen Saturation Level at Day 85 | Baseline (n=96,48,49,49,48) | 97.6 percent saturation | Standard Deviation 1.4 |
| Mavrilimumab 50 mg | Change From Baseline in Oxygen Saturation Level at Day 85 | Change at Day 85 (n=88,45,47,49,47) | -0.3 percent saturation | Standard Deviation 1.9 |
| Mavrilimumab 100 mg | Change From Baseline in Oxygen Saturation Level at Day 85 | Change at Day 85 (n=88,45,47,49,47) | 0.1 percent saturation | Standard Deviation 2.1 |
| Mavrilimumab 100 mg | Change From Baseline in Oxygen Saturation Level at Day 85 | Baseline (n=96,48,49,49,48) | 97.2 percent saturation | Standard Deviation 1.7 |
Primary
Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85
DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide.
Time frame: Day 85
Population: The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | 91.7 percent diffusion capacity | Standard Deviation 16.7 |
| Mavrilimumab 10 mg | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | 95.0 percent diffusion capacity | Standard Deviation 16.2 |
| Mavrilimumab 30 mg | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | 95.0 percent diffusion capacity | Standard Deviation 15.1 |
| Mavrilimumab 50 mg | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | 95.0 percent diffusion capacity | Standard Deviation 15.7 |
| Mavrilimumab 100 mg | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | 89.3 percent diffusion capacity | Standard Deviation 12 |
Primary
Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region
DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% for the European and Japanese regions were reported.
Time frame: Day 85
Population: The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region | European region: (n=71,37,39,40,39) | 90.4 percent diffusion capacity | Standard Deviation 16.5 |
| Placebo | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region | Japanese region (n=16,9,8,9,8) | 97.6 percent diffusion capacity | Standard Deviation 16.9 |
| Mavrilimumab 10 mg | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region | European region: (n=71,37,39,40,39) | 96.0 percent diffusion capacity | Standard Deviation 16.9 |
| Mavrilimumab 10 mg | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region | Japanese region (n=16,9,8,9,8) | 91.0 percent diffusion capacity | Standard Deviation 13.3 |
| Mavrilimumab 30 mg | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region | European region: (n=71,37,39,40,39) | 94.0 percent diffusion capacity | Standard Deviation 15.2 |
| Mavrilimumab 30 mg | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region | Japanese region (n=16,9,8,9,8) | 100.1 percent diffusion capacity | Standard Deviation 14.6 |
| Mavrilimumab 50 mg | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region | Japanese region (n=16,9,8,9,8) | 96.0 percent diffusion capacity | Standard Deviation 12.6 |
| Mavrilimumab 50 mg | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region | European region: (n=71,37,39,40,39) | 94.8 percent diffusion capacity | Standard Deviation 16.5 |
| Mavrilimumab 100 mg | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region | European region: (n=71,37,39,40,39) | 88.6 percent diffusion capacity | Standard Deviation 10.7 |
| Mavrilimumab 100 mg | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region | Japanese region (n=16,9,8,9,8) | 93.0 percent diffusion capacity | Standard Deviation 17.2 |
Primary
Dyspnea Score at Day 85
Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.
Time frame: Day 85
Population: The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Dyspnea Score at Day 85 | 0.25 units on a scale | Standard Deviation 0.48 |
| Mavrilimumab 10 mg | Dyspnea Score at Day 85 | 0.13 units on a scale | Standard Deviation 0.38 |
| Mavrilimumab 30 mg | Dyspnea Score at Day 85 | 0.35 units on a scale | Standard Deviation 0.7 |
| Mavrilimumab 50 mg | Dyspnea Score at Day 85 | 0.15 units on a scale | Standard Deviation 0.44 |
| Mavrilimumab 100 mg | Dyspnea Score at Day 85 | 0.35 units on a scale | Standard Deviation 0.59 |
Primary
Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85
FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time frame: Day 85
Population: The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | FVC | 3.439 liters | Standard Deviation 0.949 |
| Placebo | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | FEV1 | 2.730 liters | Standard Deviation 0.764 |
| Mavrilimumab 10 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | FEV1 | 2.877 liters | Standard Deviation 0.821 |
| Mavrilimumab 10 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | FVC | 3.582 liters | Standard Deviation 0.967 |
| Mavrilimumab 30 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | FVC | 3.667 liters | Standard Deviation 0.882 |
| Mavrilimumab 30 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | FEV1 | 2.949 liters | Standard Deviation 0.722 |
| Mavrilimumab 50 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | FEV1 | 2.701 liters | Standard Deviation 0.489 |
| Mavrilimumab 50 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | FVC | 3.370 liters | Standard Deviation 0.527 |
| Mavrilimumab 100 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | FEV1 | 2.793 liters | Standard Deviation 0.69 |
| Mavrilimumab 100 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | FVC | 3.499 liters | Standard Deviation 0.766 |
Primary
Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region
FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 and FVC at Day 85 for the European and Japanese regions were reported.
Time frame: Day 85
Population: The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | European: FEV1 (n=71,37,39,40,39) | 2.811 liters | Standard Deviation 0.79 |
| Placebo | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | European: FVC (n=71,37,39,40,39) | 3.537 liters | Standard Deviation 0.996 |
| Placebo | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | Japanese: FEV1 (n=16,9,8,9,8) | 2.367 liters | Standard Deviation 0.51 |
| Placebo | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | Japanese: FVC (n=16,9,8,9,8) | 3.005 liters | Standard Deviation 0.534 |
| Mavrilimumab 10 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | European: FEV1 (n=71,37,39,40,39) | 2.902 liters | Standard Deviation 0.81 |
| Mavrilimumab 10 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | Japanese: FVC (n=16,9,8,9,8) | 3.378 liters | Standard Deviation 1.076 |
| Mavrilimumab 10 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | European: FVC (n=71,37,39,40,39) | 3.632 liters | Standard Deviation 0.948 |
| Mavrilimumab 10 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | Japanese: FEV1 (n=16,9,8,9,8) | 2.774 liters | Standard Deviation 0.908 |
| Mavrilimumab 30 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | Japanese: FVC (n=16,9,8,9,8) | 3.119 liters | Standard Deviation 0.37 |
| Mavrilimumab 30 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | European: FVC (n=71,37,39,40,39) | 3.779 liters | Standard Deviation 0.917 |
| Mavrilimumab 30 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | Japanese: FEV1 (n=16,9,8,9,8) | 2.493 liters | Standard Deviation 0.354 |
| Mavrilimumab 30 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | European: FEV1 (n=71,37,39,40,39) | 3.042 liters | Standard Deviation 0.745 |
| Mavrilimumab 50 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | European: FEV1 (n=71,37,39,40,39) | 2.698 liters | Standard Deviation 0.501 |
| Mavrilimumab 50 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | European: FVC (n=71,37,39,40,39) | 3.355 liters | Standard Deviation 0.537 |
| Mavrilimumab 50 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | Japanese: FVC (n=16,9,8,9,8) | 3.434 liters | Standard Deviation 0.505 |
| Mavrilimumab 50 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | Japanese: FEV1 (n=16,9,8,9,8) | 2.712 liters | Standard Deviation 0.457 |
| Mavrilimumab 100 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | Japanese: FVC (n=16,9,8,9,8) | 3.235 liters | Standard Deviation 0.725 |
| Mavrilimumab 100 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | Japanese: FEV1 (n=16,9,8,9,8) | 2.520 liters | Standard Deviation 0.616 |
| Mavrilimumab 100 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | European: FVC (n=71,37,39,40,39) | 3.553 liters | Standard Deviation 0.772 |
| Mavrilimumab 100 mg | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | European: FEV1 (n=71,37,39,40,39) | 2.848 liters | Standard Deviation 0.699 |
Primary
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, reticulocytes, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, mean corpuscular volume, mean corpuscular haemoglobin concentration); serum chemistry (creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, gamma glutamyl transferase, CRP, ESR, albumin, total cholesterol, triglycerides, rheumatoid factor and anti-cyclic citrullinated peptide antibodies); urinalysis (albumin, glucose, protein, blood, nitrite).
Time frame: Baseline up to Day 169 (follow-up)
Population: The safety population included all participants who received any dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypercholesterolemia | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood and lymphatic system disorders | 10 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Urinalysis abnormalities | 3 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hepatic abnormality | 3 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood cholesterol increased | 0 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood triglycerides increased | 1 participants |
| Placebo | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperglycemia | 1 participants |
| Mavrilimumab 10 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood and lymphatic system disorders | 3 participants |
| Mavrilimumab 10 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypercholesterolemia | 1 participants |
| Mavrilimumab 10 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperglycemia | 0 participants |
| Mavrilimumab 10 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Urinalysis abnormalities | 0 participants |
| Mavrilimumab 10 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood cholesterol increased | 0 participants |
| Mavrilimumab 10 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hepatic abnormality | 5 participants |
| Mavrilimumab 10 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood triglycerides increased | 0 participants |
| Mavrilimumab 30 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood triglycerides increased | 0 participants |
| Mavrilimumab 30 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood cholesterol increased | 0 participants |
| Mavrilimumab 30 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hepatic abnormality | 3 participants |
| Mavrilimumab 30 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood and lymphatic system disorders | 3 participants |
| Mavrilimumab 30 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Urinalysis abnormalities | 3 participants |
| Mavrilimumab 30 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypercholesterolemia | 1 participants |
| Mavrilimumab 30 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperglycemia | 0 participants |
| Mavrilimumab 50 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Urinalysis abnormalities | 1 participants |
| Mavrilimumab 50 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hepatic abnormality | 2 participants |
| Mavrilimumab 50 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypercholesterolemia | 1 participants |
| Mavrilimumab 50 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood cholesterol increased | 1 participants |
| Mavrilimumab 50 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood and lymphatic system disorders | 3 participants |
| Mavrilimumab 50 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood triglycerides increased | 0 participants |
| Mavrilimumab 50 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperglycemia | 1 participants |
| Mavrilimumab 100 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hepatic abnormality | 3 participants |
| Mavrilimumab 100 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood triglycerides increased | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypercholesterolemia | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperglycemia | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood cholesterol increased | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Urinalysis abnormalities | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood and lymphatic system disorders | 4 participants |
Primary
Number of Participants With Abnormal Electrocardiogram (ECG) Results
12-lead ECG was recorded and corrected QT (QTc) interval was measured with the participant in a rested supine position for at least 10 minutes. Any ECG abnormality deemed clinically significant as per investigator's discretion were reported.
Time frame: Baseline up to Day 169 (follow-up)
Population: The safety population included all participants who received any dose of investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Results | 0 participants |
| Mavrilimumab 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Results | 1 participants |
| Mavrilimumab 30 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Results | 0 participants |
| Mavrilimumab 50 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Results | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Results | 2 participants |
Primary
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
Vital sign assessments included blood pressure, pulse rate, temperature, and respiration rate. Vital signs abnormalities reported as TEAEs were reported.
Time frame: Baseline up to Day 169 (follow-up)
Population: The safety population included all participants who received any dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Pyrexia | 1 participants |
| Placebo | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertension | 2 participants |
| Mavrilimumab 10 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Pyrexia | 0 participants |
| Mavrilimumab 10 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertension | 0 participants |
| Mavrilimumab 30 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Pyrexia | 0 participants |
| Mavrilimumab 30 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertension | 1 participants |
| Mavrilimumab 50 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertension | 0 participants |
| Mavrilimumab 50 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Pyrexia | 2 participants |
| Mavrilimumab 100 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Pyrexia | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertension | 0 participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up Day 169 that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to Day 169 (follow-up)
Population: The safety population included all participants who received any dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 1 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 46 participants |
| Mavrilimumab 10 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 33 participants |
| Mavrilimumab 10 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 2 participants |
| Mavrilimumab 30 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 2 participants |
| Mavrilimumab 30 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 31 participants |
| Mavrilimumab 50 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 26 participants |
| Mavrilimumab 50 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 1 participants |
| Mavrilimumab 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 28 participants |
Primary
Oxygen Saturation Level at Day 85
Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
Time frame: Day 85
Population: The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Oxygen Saturation Level at Day 85 | 97.5 percent saturation | Standard Deviation 1.2 |
| Mavrilimumab 10 mg | Oxygen Saturation Level at Day 85 | 97.6 percent saturation | Standard Deviation 1.3 |
| Mavrilimumab 30 mg | Oxygen Saturation Level at Day 85 | 97.7 percent saturation | Standard Deviation 1.3 |
| Mavrilimumab 50 mg | Oxygen Saturation Level at Day 85 | 97.2 percent saturation | Standard Deviation 1.8 |
| Mavrilimumab 100 mg | Oxygen Saturation Level at Day 85 | 97.3 percent saturation | Standard Deviation 1.5 |
Primary
Oxygen Saturation Level at Day 85 by Region
Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. Oxygen saturation for the European and Japanese regions were reported.
Time frame: Day 85
Population: The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Oxygen Saturation Level at Day 85 by Region | Japanese region: (n=16,9,8,9,8) | 97.6 percent saturation | Standard Deviation 0.9 |
| Placebo | Oxygen Saturation Level at Day 85 by Region | European region: (n=72,36,39,40,39) | 97.5 percent saturation | Standard Deviation 1.3 |
| Mavrilimumab 10 mg | Oxygen Saturation Level at Day 85 by Region | Japanese region: (n=16,9,8,9,8) | 97.4 percent saturation | Standard Deviation 1 |
| Mavrilimumab 10 mg | Oxygen Saturation Level at Day 85 by Region | European region: (n=72,36,39,40,39) | 97.6 percent saturation | Standard Deviation 1.3 |
| Mavrilimumab 30 mg | Oxygen Saturation Level at Day 85 by Region | European region: (n=72,36,39,40,39) | 97.6 percent saturation | Standard Deviation 1.3 |
| Mavrilimumab 30 mg | Oxygen Saturation Level at Day 85 by Region | Japanese region: (n=16,9,8,9,8) | 98.4 percent saturation | Standard Deviation 1.1 |
| Mavrilimumab 50 mg | Oxygen Saturation Level at Day 85 by Region | European region: (n=72,36,39,40,39) | 97.2 percent saturation | Standard Deviation 2 |
| Mavrilimumab 50 mg | Oxygen Saturation Level at Day 85 by Region | Japanese region: (n=16,9,8,9,8) | 97.4 percent saturation | Standard Deviation 0.7 |
| Mavrilimumab 100 mg | Oxygen Saturation Level at Day 85 by Region | European region: (n=72,36,39,40,39) | 97.3 percent saturation | Standard Deviation 1.6 |
| Mavrilimumab 100 mg | Oxygen Saturation Level at Day 85 by Region | Japanese region: (n=16,9,8,9,8) | 97.3 percent saturation | Standard Deviation 1.3 |
Primary
Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85
DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline \>1.2 with baseline DAS28 (CRP) \<3.2; moderate response: change from baseline \>1.2 with baseline DAS28 (CRP) \>=3.2 to less than or equal to (=\<) 5.1 or change from baseline \>=0.6 to =\< 1.2 with baseline DAS28 (CRP) \>=3.2 to =\<5.1; no response: change from baseline \<0.6 or change from baseline \>=0.6 and =\<1.2 with baseline DAS28 (CRP) \>5.1.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | No response | 51.1 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Good response | 14.1 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Moderate response | 34.8 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Moderate response | 31.3 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | No response | 47.9 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Good response | 20.8 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Moderate response | 38.8 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | No response | 28.6 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Good response | 32.7 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | No response | 35.4 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Good response | 22.9 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Moderate response | 41.7 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Moderate response | 42.6 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | No response | 23.4 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Good response | 34.0 percentage of participants |
Primary
Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region
DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline \>1.2 with baseline DAS28 (CRP) \<3.2; moderate response: change from baseline \>1.2 with baseline DAS28 (CRP) \>=3.2 to =\< 5.1 or change from baseline \>=0.6 to =\< 1.2 with baseline DAS28 (CRP) \>=3.2 to =\<5.1; no response: change from baseline \<0.6 or change from baseline \>=0.6 and =\<1.2 with baseline DAS28 (CRP) \>5.1. DAS28 (CRP) response by EULAR category at Day 85 for the European and Japanese regions were reported.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: No response (n=75,39,41,39,39) | 49.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Moderate response (n=75,39,41,39,39) | 36.0 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Good response (n=75,39,41,39,39) | 14.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: No response (n=17,9,8,9,8) | 58.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Moderate response (n=17,9,8,9,8) | 29.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Good response (n=17,9,8,9,8) | 11.8 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Moderate response (n=17,9,8,9,8) | 22.2 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Good response (n=17,9,8,9,8) | 22.2 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: No response (n=75,39,41,39,39) | 46.2 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Good response (n=75,39,41,39,39) | 20.5 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: No response (n=17,9,8,9,8) | 55.6 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Moderate response (n=75,39,41,39,39) | 33.3 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: No response (n=17,9,8,9,8) | 25.0 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Moderate response (n=17,9,8,9,8) | 25.0 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: No response (n=75,39,41,39,39) | 29.3 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Good response (n=75,39,41,39,39) | 29.3 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Moderate response (n=75,39,41,39,39) | 41.5 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Good response (n=17,9,8,9,8) | 50.0 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: No response (n=17,9,8,9,8) | 44.4 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Moderate response (n=75,39,41,39,39) | 41.0 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Good response (n=75,39,41,39,39) | 25.6 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Good response (n=17,9,8,9,8) | 11.1 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Moderate response (n=17,9,8,9,8) | 44.4 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: No response (n=75,39,41,39,39) | 33.3 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Moderate response (n=17,9,8,9,8) | 25.0 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Good response (n=75,39,41,39,39) | 30.8 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Moderate response (n=75,39,41,39,39) | 46.2 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Good response (n=17,9,8,9,8) | 50.0 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: No response (n=17,9,8,9,8) | 25.0 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: No response (n=75,39,41,39,39) | 23.1 percentage of participants |
Primary
Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85
DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline \>1.2 with baseline DAS28 (ESR) \<3.2; moderate response: change from baseline \>1.2 with baseline DAS28 (ESR) \>=3.2 to =\< 5.1 or change from baseline \>=0.6 to =\< 1.2 with baseline DAS28 (ESR) \>=3.2 to =\<5.1; no response: change from baseline \<0.6 or change from baseline \>=0.6 and =\<1.2 with baseline DAS28 (ESR) \>5.1.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | No response | 55.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Good response | 8.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Moderate response | 35.9 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Moderate response | 45.8 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | No response | 39.6 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Good response | 14.6 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Moderate response | 44.9 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | No response | 36.7 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Good response | 18.4 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | No response | 33.3 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Good response | 12.5 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Moderate response | 54.2 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Moderate response | 53.2 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | No response | 25.5 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Good response | 21.3 percentage of participants |
Primary
Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region
DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline \>1.2 with baseline DAS28 (ESR) \<3.2; moderate response: change from baseline \>1.2 with baseline DAS28 (ESR) \>=3.2 to =\< 5.1 or change from baseline \>=0.6 to =\< 1.2 with baseline DAS28 (ESR) \>=3.2 to =\<5.1; no response: change from baseline \<0.6 or change from baseline \>=0.6 and =\<1.2 with baseline DAS28 (ESR) \>5.1. DAS28 (ESR) response by EULAR category at Day 85 for the European and Japanese regions were reported.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Moderate response (n=75,39,41,39,39) | 38.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: No response (n=75,39,41,39,39) | 53.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Moderate response (n=17,9,8,9,8) | 23.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Good response (n=17,9,8,9,8) | 11.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: No response (n=17,9,8,9,8) | 64.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Good response (n=75,39,41,39,39) | 8.0 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Moderate response (n=75,39,41,39,39) | 46.2 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Good response (n=17,9,8,9,8) | 11.1 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: No response (n=17,9,8,9,8) | 44.4 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: No response (n=75,39,41,39,39) | 38.5 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Good response (n=75,39,41,39,39) | 15.4 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Moderate response (n=17,9,8,9,8) | 44.4 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: No response (n=75,39,41,39,39) | 39.0 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Moderate response (n=75,39,41,39,39) | 43.9 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Good response (n=17,9,8,9,8) | 25.0 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Moderate response (n=17,9,8,9,8) | 50.0 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Good response (n=75,39,41,39,39) | 17.1 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: No response (n=17,9,8,9,8) | 25.0 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Moderate response (n=75,39,41,39,39) | 53.8 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Moderate response (n=17,9,8,9,8) | 55.6 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Good response (n=75,39,41,39,39) | 12.8 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: No response (n=75,39,41,39,39) | 33.3 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Good response (n=17,9,8,9,8) | 11.1 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: No response (n=17,9,8,9,8) | 33.3 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Moderate response (n=17,9,8,9,8) | 62.5 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: No response (n=17,9,8,9,8) | 12.5 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Japanese: Good response (n=17,9,8,9,8) | 25.0 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: No response (n=75,39,41,39,39) | 28.2 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Moderate response (n=75,39,41,39,39) | 51.3 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | European: Good response (n=75,39,41,39,39) | 20.5 percentage of participants |
Primary
Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85
DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per Liter \[mg/L\]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (\<) 3.2 = low disease activity, greater than or equal to (\>=) 3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.
Time frame: Day 85
Population: The intent-to-treat (ITT) population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 | 32.6 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 | 37.5 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 | 63.3 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 | 47.9 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 | 68.1 percentage of participants |
Comparison: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.57895% CI: [-11.5, 22]Fisher Exact
Comparison: p-value was calculated using a two-tailed Fisher's exact test.p-value: <0.00195% CI: [13.4, 46.3]Fisher Exact
Comparison: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.09995% CI: [-1.6, 32.2]Fisher Exact
Comparison: p-value was calculated using a two-tailed Fisher's exact test.p-value: <0.00195% CI: [17.8, 50.6]Fisher Exact
Primary
Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region
DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85. DAS28 (CRP) response at Day 85 for the European and Japanese regions were reported.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region | Japanese Region (n=17, 9, 8, 9, 8) | 23.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region | European Region (n=75, 39, 41, 39, 39) | 34.7 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region | Japanese Region (n=17, 9, 8, 9, 8) | 22.2 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region | European Region (n=75, 39, 41, 39, 39) | 41.0 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region | European Region (n=75, 39, 41, 39, 39) | 61.0 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region | Japanese Region (n=17, 9, 8, 9, 8) | 75.0 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region | European Region (n=75, 39, 41, 39, 39) | 51.3 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region | Japanese Region (n=17, 9, 8, 9, 8) | 33.3 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region | Japanese Region (n=17, 9, 8, 9, 8) | 75.0 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region | European Region (n=75, 39, 41, 39, 39) | 66.7 percentage of participants |
Comparison: European region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.54395% CI: [-11.9, 25.4]Fisher Exact
Comparison: European region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.01195% CI: [7.2, 43.6]Fisher Exact
Comparison: European region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.10895% CI: [-2.5, 35.5]Fisher Exact
Comparison: European region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.00195% CI: [12.5, 49]Fisher Exact
Comparison: Japanese region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-33.7, 35.7]Fisher Exact
Comparison: Japanese region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.02895% CI: [8.2, 77]Fisher Exact
Comparison: Japanese region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.66195% CI: [-24.3, 46.9]Fisher Exact
Primary
Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85
DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 | 37.0 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 | 50.0 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 | 61.2 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 | 58.3 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 | 66.0 percentage of participants |
Comparison: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.15295% CI: [-4.2, 30.3]Fisher Exact
Comparison: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.00895% CI: [7, 40.3]Fisher Exact
Comparison: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.0295% CI: [3.9, 37.8]Fisher Exact
Comparison: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.00295% CI: [11.3, 45]Fisher Exact
Primary
Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region
DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85. DAS28 (ESR) response at Day 85 for the European and Japanese regions were reported.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region | European Region (n=75, 39, 41, 39, 39) | 41.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region | Japanese Region (n=17, 9, 8, 9, 8) | 17.6 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region | European Region (n=75, 39, 41, 39, 39) | 51.3 percentage of participants |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region | Japanese Region (n=17, 9, 8, 9, 8) | 44.4 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region | European Region (n=75, 39, 41, 39, 39) | 58.5 percentage of participants |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region | Japanese Region (n=17, 9, 8, 9, 8) | 75.0 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region | Japanese Region (n=17, 9, 8, 9, 8) | 44.4 percentage of participants |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region | European Region (n=75, 39, 41, 39, 39) | 61.5 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region | European Region (n=75, 39, 41, 39, 39) | 64.1 percentage of participants |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region | Japanese Region (n=17, 9, 8, 9, 8) | 75.0 percentage of participants |
Comparison: European region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.32895% CI: [-9.3, 29.4]Fisher Exact
Comparison: European region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.08495% CI: [-2, 35.6]Fisher Exact
Comparison: European region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.04995% CI: [0.7, 38.2]Fisher Exact
Comparison: European region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.0395% CI: [3.2, 40.7]Fisher Exact
Comparison: Japanese region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.18895% CI: [-9.3, 60.7]Fisher Exact
Comparison: Japanese region: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.0195% CI: [15.2, 81.8]Fisher Exact
Secondary
Accumulation Ratio for Mavrilimumab After Last Dose by Region
Accumulation ratio was calculated as ratio of AUCtau after last dose and AUCtau after first dose. Data for European and Japanese regions were reported.
Time frame: Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169
Population: The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here N signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Accumulation Ratio for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 1.22 ratio | Standard Deviation 2.97 |
| Placebo | Accumulation Ratio for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 1.82 ratio | Standard Deviation 1.85 |
| Mavrilimumab 10 mg | Accumulation Ratio for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 1.66 ratio | Standard Deviation 0.716 |
| Mavrilimumab 10 mg | Accumulation Ratio for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 1.36 ratio | Standard Deviation 2.23 |
| Mavrilimumab 30 mg | Accumulation Ratio for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 2.57 ratio | Standard Deviation 54.1 |
| Mavrilimumab 30 mg | Accumulation Ratio for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 3.21 ratio | Standard Deviation 3.21 |
| Mavrilimumab 50 mg | Accumulation Ratio for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 1.29 ratio | Standard Deviation 0.932 |
| Mavrilimumab 50 mg | Accumulation Ratio for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 2.28 ratio | Standard Deviation 0.616 |
Secondary
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region
Data for European and Japanese regions were reported.
Time frame: Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169
Population: The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here N signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region | European region (n=37,41,40,37) | 860 nanogram*day per milliliter (ng*day/mL) | Standard Deviation 8300 |
| Placebo | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region | Japanese region (n=9,8,9,8) | 504 nanogram*day per milliliter (ng*day/mL) | Standard Deviation 236 |
| Mavrilimumab 10 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region | Japanese region (n=9,8,9,8) | 5820 nanogram*day per milliliter (ng*day/mL) | Standard Deviation 4300 |
| Mavrilimumab 10 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region | European region (n=37,41,40,37) | 6330 nanogram*day per milliliter (ng*day/mL) | Standard Deviation 5320 |
| Mavrilimumab 30 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region | European region (n=37,41,40,37) | 10200 nanogram*day per milliliter (ng*day/mL) | Standard Deviation 10800 |
| Mavrilimumab 30 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region | Japanese region (n=9,8,9,8) | 11300 nanogram*day per milliliter (ng*day/mL) | Standard Deviation 6620 |
| Mavrilimumab 50 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region | European region (n=37,41,40,37) | 62500 nanogram*day per milliliter (ng*day/mL) | Standard Deviation 36600 |
| Mavrilimumab 50 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region | Japanese region (n=9,8,9,8) | 45500 nanogram*day per milliliter (ng*day/mL) | Standard Deviation 12300 |
Secondary
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region
Data for European and Japanese regions were reported.
Time frame: Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169
Population: The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here N signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 1060 ng*day/mL | Standard Deviation 2770 |
| Placebo | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 915 ng*day/mL | Standard Deviation 1020 |
| Mavrilimumab 10 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 12100 ng*day/mL | Standard Deviation 9150 |
| Mavrilimumab 10 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 9260 ng*day/mL | Standard Deviation 26300 |
| Mavrilimumab 30 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 27900 ng*day/mL | Standard Deviation 26700 |
| Mavrilimumab 30 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 34900 ng*day/mL | Standard Deviation 18000 |
| Mavrilimumab 50 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 80500 ng*day/mL | Standard Deviation 64300 |
| Mavrilimumab 50 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 104000 ng*day/mL | Standard Deviation 30300 |
Secondary
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85
DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission.
Time frame: Baseline and Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(CRP): Baseline (n=92,48,49,48,47) | 5.43 units on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(CRP): Change at Day 85 (n=84,45,46,48,46) | -0.97 units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(ESR): Baseline: (n=92,48,49,48,47) | 6.18 units on a scale | Standard Error 0.118 |
| Placebo | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(ESR): Change at Day 85 (n=85,45,47,48,46) | -1.04 units on a scale | Standard Error 0.125 |
| Mavrilimumab 10 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(CRP): Baseline (n=92,48,49,48,47) | 5.24 units on a scale | Standard Error 0.16 |
| Mavrilimumab 10 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(ESR): Change at Day 85 (n=85,45,47,48,46) | -1.39 units on a scale | Standard Error 0.172 |
| Mavrilimumab 10 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(CRP): Change at Day 85 (n=84,45,46,48,46) | -1.27 units on a scale | Standard Error 0.166 |
| Mavrilimumab 10 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(ESR): Baseline: (n=92,48,49,48,47) | 6.06 units on a scale | Standard Error 0.165 |
| Mavrilimumab 30 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(ESR): Change at Day 85 (n=85,45,47,48,46) | -1.80 units on a scale | Standard Error 0.17 |
| Mavrilimumab 30 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(CRP): Change at Day 85 (n=84,45,46,48,46) | -1.63 units on a scale | Standard Error 0.163 |
| Mavrilimumab 30 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(ESR): Baseline: (n=92,48,49,48,47) | 6.31 units on a scale | Standard Error 0.145 |
| Mavrilimumab 30 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(CRP): Baseline (n=92,48,49,48,47) | 5.42 units on a scale | Standard Error 0.139 |
| Mavrilimumab 50 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(CRP): Baseline (n=92,48,49,48,47) | 5.14 units on a scale | Standard Error 0.146 |
| Mavrilimumab 50 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(CRP): Change at Day 85 (n=84,45,46,48,46) | -1.32 units on a scale | Standard Error 0.162 |
| Mavrilimumab 50 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(ESR): Change at Day 85 (n=85,45,47,48,46) | -1.46 units on a scale | Standard Error 0.168 |
| Mavrilimumab 50 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(ESR): Baseline: (n=92,48,49,48,47) | 5.98 units on a scale | Standard Error 0.163 |
| Mavrilimumab 100 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(ESR): Change at Day 85 (n=85,45,47,48,46) | -1.84 units on a scale | Standard Error 0.172 |
| Mavrilimumab 100 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(ESR): Baseline: (n=92,48,49,48,47) | 6.06 units on a scale | Standard Error 0.119 |
| Mavrilimumab 100 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(CRP): Change at Day 85 (n=84,45,46,48,46) | -1.70 units on a scale | Standard Error 0.165 |
| Mavrilimumab 100 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 | DAS28(CRP): Baseline (n=92,48,49,48,47) | 5.34 units on a scale | Standard Error 0.115 |
Comparison: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.p-value: 0.13795% CI: [-0.71, 0.1]Repeated measures model
Comparison: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.p-value: 0.00195% CI: [-1.07, -0.27]Repeated measures model
Comparison: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.p-value: 0.0895% CI: [-0.75, 0.04]Repeated measures model
Comparison: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.p-value: <0.00195% CI: [-1.14, -0.33]Repeated measures model
Comparison: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.p-value: 0.10795% CI: [-0.76, 0.08]Repeated measures model
Comparison: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.p-value: <0.00195% CI: [-1.17, -0.35]Repeated measures model
Comparison: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.p-value: 0.04695% CI: [-0.83, -0.01]Repeated measures model
Comparison: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.p-value: <0.00195% CI: [-1.22, -0.38]Repeated measures model
Secondary
Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region
DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported.
Time frame: Baseline and Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(CRP): Baseline (n=75,39,41,39,39) | 5.58 units on a scale | Standard Error 0.117 |
| Placebo | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(CRP): Day 85 (n=68,36,38,39,38) | -1.00 units on a scale | Standard Error 0.133 |
| Placebo | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(CRP): Baseline (n=17,9,8,9,8) | 4.75 units on a scale | Standard Error 0.242 |
| Placebo | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(CRP): Day 85 (n=16,9,8,9,8) | -0.85 units on a scale | Standard Error 0.281 |
| Placebo | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(ESR): Baseline (n=75,39,41,39,39) | 6.36 units on a scale | Standard Error 0.124 |
| Placebo | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(ESR): Day 85 (n=69,36,39,39,38) | -1.12 units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(ESR): Baseline (n=17,9,8,9,8) | 5.38 units on a scale | Standard Error 0.248 |
| Placebo | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(ESR): Day 85 (n=16,9,8,9,8) | -0.74 units on a scale | Standard Error 0.276 |
| Mavrilimumab 10 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(CRP): Baseline (n=17,9,8,9,8) | 5.00 units on a scale | Standard Error 0.427 |
| Mavrilimumab 10 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(ESR): Day 85 (n=69,36,39,39,38) | -1.51 units on a scale | Standard Error 0.196 |
| Mavrilimumab 10 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(CRP): Baseline (n=75,39,41,39,39) | 5.30 units on a scale | Standard Error 0.172 |
| Mavrilimumab 10 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(CRP): Day 85 (n=16,9,8,9,8) | -0.73 units on a scale | Standard Error 0.358 |
| Mavrilimumab 10 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(CRP): Day 85 (n=68,36,38,39,38) | -1.40 units on a scale | Standard Error 0.187 |
| Mavrilimumab 10 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(ESR): Day 85 (n=16,9,8,9,8) | -0.83 units on a scale | Standard Error 0.359 |
| Mavrilimumab 10 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(ESR): Baseline (n=75,39,41,39,39) | 6.10 units on a scale | Standard Error 0.18 |
| Mavrilimumab 10 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(ESR): Baseline (n=17,9,8,9,8) | 5.87 units on a scale | Standard Error 0.426 |
| Mavrilimumab 30 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(ESR): Baseline (n=17,9,8,9,8) | 6.05 units on a scale | Standard Error 0.309 |
| Mavrilimumab 30 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(ESR): Day 85 (n=16,9,8,9,8) | -1.99 units on a scale | Standard Error 0.382 |
| Mavrilimumab 30 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(CRP): Day 85 (n=16,9,8,9,8) | -2.04 units on a scale | Standard Error 0.381 |
| Mavrilimumab 30 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(ESR): Day 85 (n=69,36,39,39,38) | -1.76 units on a scale | Standard Error 0.19 |
| Mavrilimumab 30 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(CRP): Baseline (n=17,9,8,9,8) | 5.12 units on a scale | Standard Error 0.306 |
| Mavrilimumab 30 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(CRP): Day 85 (n=68,36,38,39,38) | -1.55 units on a scale | Standard Error 0.181 |
| Mavrilimumab 30 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(CRP): Baseline (n=75,39,41,39,39) | 5.48 units on a scale | Standard Error 0.154 |
| Mavrilimumab 30 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(ESR): Baseline (n=75,39,41,39,39) | 6.36 units on a scale | Standard Error 0.163 |
| Mavrilimumab 50 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(CRP): Day 85 (n=68,36,38,39,38) | -1.43 units on a scale | Standard Error 0.181 |
| Mavrilimumab 50 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(CRP): Baseline (n=17,9,8,9,8) | 4.32 units on a scale | Standard Error 0.268 |
| Mavrilimumab 50 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(CRP): Day 85 (n=16,9,8,9,8) | -0.89 units on a scale | Standard Error 0.361 |
| Mavrilimumab 50 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(ESR): Baseline (n=75,39,41,39,39) | 6.23 units on a scale | Standard Error 0.159 |
| Mavrilimumab 50 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(ESR): Day 85 (n=69,36,39,39,38) | -1.53 units on a scale | Standard Error 0.19 |
| Mavrilimumab 50 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(ESR): Day 85 (n=16,9,8,9,8) | -1.24 units on a scale | Standard Error 0.362 |
| Mavrilimumab 50 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(CRP): Baseline (n=75,39,41,39,39) | 5.33 units on a scale | Standard Error 0.155 |
| Mavrilimumab 50 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(ESR): Baseline (n=17,9,8,9,8) | 4.93 units on a scale | Standard Error 0.379 |
| Mavrilimumab 100 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(CRP): Day 85 (n=16,9,8,9,8) | -1.71 units on a scale | Standard Error 0.38 |
| Mavrilimumab 100 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(ESR): Day 85 (n=16,9,8,9,8) | -1.78 units on a scale | Standard Error 0.38 |
| Mavrilimumab 100 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(CRP): Baseline (n=17,9,8,9,8) | 5.04 units on a scale | Standard Error 0.413 |
| Mavrilimumab 100 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | Japanese: DAS28(ESR): Baseline (n=17,9,8,9,8) | 5.78 units on a scale | Standard Error 0.404 |
| Mavrilimumab 100 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(CRP): Baseline (n=75,39,41,39,39) | 5.41 units on a scale | Standard Error 0.111 |
| Mavrilimumab 100 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(ESR): Day 85 (n=69,36,39,39,38) | -1.85 units on a scale | Standard Error 0.193 |
| Mavrilimumab 100 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(CRP): Day 85 (n=68,36,38,39,38) | -1.70 units on a scale | Standard Error 0.183 |
| Mavrilimumab 100 mg | Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region | European: DAS28(ESR): Baseline (n=75,39,41,39,39) | 6.12 units on a scale | Standard Error 0.118 |
Comparison: European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.p-value: 0.08695% CI: [-0.85, 0.06]Repeated measures model
Comparison: European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.p-value: 0.01695% CI: [-0.99, -0.1]Repeated measures model
Comparison: European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.p-value: 0.05995% CI: [-0.87, 0.02]Repeated measures model
Comparison: European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.p-value: 0.00295% CI: [-1.14, -0.25]Repeated measures model
Comparison: European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.p-value: 0.10795% CI: [-0.87, 0.09]Repeated measures model
Comparison: European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.p-value: 0.00795% CI: [-1.11, -0.18]Repeated measures model
Comparison: European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.p-value: 0.08495% CI: [-0.88, 0.06]Repeated measures model
Comparison: European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.p-value: 0.00295% CI: [-1.2, -0.26]Repeated measures model
Comparison: Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.p-value: 0.78595% CI: [-0.78, 1.02]Repeated measures model
Comparison: Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.p-value: 0.01495% CI: [-2.13, -0.26]Repeated measures model
Comparison: Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.p-value: 0.93195% CI: [-0.94, 0.86]Repeated measures model
Comparison: Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.p-value: 0.0795% CI: [-1.8, 0.07]Repeated measures model
Comparison: Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.p-value: 0.85495% CI: [-0.99, 0.82]Repeated measures model
Comparison: Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.p-value: 0.01195% CI: [-2.19, -0.31]Repeated measures model
Comparison: Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.p-value: 0.27195% CI: [-1.4, 0.4]Repeated measures model
Comparison: Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.p-value: 0.03195% CI: [-1.97, -0.1]Repeated measures model
Secondary
Continuous ACR (ACRn) Score
ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Continuous ACR (ACRn) Score | 5.09 units on a scale | Standard Error 4.23 |
| Mavrilimumab 10 mg | Continuous ACR (ACRn) Score | 19.13 units on a scale | Standard Error 5.818 |
| Mavrilimumab 30 mg | Continuous ACR (ACRn) Score | 26.31 units on a scale | Standard Error 5.652 |
| Mavrilimumab 50 mg | Continuous ACR (ACRn) Score | 12.17 units on a scale | Standard Error 5.786 |
| Mavrilimumab 100 mg | Continuous ACR (ACRn) Score | 37.11 units on a scale | Standard Error 5.723 |
p-value: 0.05195% CI: [-0.05, 28.15]Repeated measures model
p-value: 0.00395% CI: [7.39, 35.07]Repeated measures model
p-value: 0.32295% CI: [-6.96, 21.14]Repeated measures model
p-value: <0.00195% CI: [18.08, 45.98]Repeated measures model
Secondary
Continuous ACR (ACRn) Score by Region
ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Data for European and Japanese regions were reported.
Time frame: Day 85
Population: ITT population. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Continuous ACR (ACRn) Score by Region | European region (n=69,36,39,38,38) | 4.71 units on a scale | Standard Error 4.689 |
| Placebo | Continuous ACR (ACRn) Score by Region | Japanese region (n=15,8,8,7,8) | 5.99 units on a scale | Standard Error 10.06 |
| Mavrilimumab 10 mg | Continuous ACR (ACRn) Score by Region | European region (n=69,36,39,38,38) | 19.18 units on a scale | Standard Error 6.489 |
| Mavrilimumab 10 mg | Continuous ACR (ACRn) Score by Region | Japanese region (n=15,8,8,7,8) | 18.09 units on a scale | Standard Error 13.843 |
| Mavrilimumab 30 mg | Continuous ACR (ACRn) Score by Region | European region (n=69,36,39,38,38) | 24.12 units on a scale | Standard Error 6.263 |
| Mavrilimumab 30 mg | Continuous ACR (ACRn) Score by Region | Japanese region (n=15,8,8,7,8) | 37.22 units on a scale | Standard Error 13.843 |
| Mavrilimumab 50 mg | Continuous ACR (ACRn) Score by Region | Japanese region (n=15,8,8,7,8) | 10.20 units on a scale | Standard Error 14.799 |
| Mavrilimumab 50 mg | Continuous ACR (ACRn) Score by Region | European region (n=69,36,39,38,38) | 12.53 units on a scale | Standard Error 6.356 |
| Mavrilimumab 100 mg | Continuous ACR (ACRn) Score by Region | European region (n=69,36,39,38,38) | 36.06 units on a scale | Standard Error 6.356 |
| Mavrilimumab 100 mg | Continuous ACR (ACRn) Score by Region | Japanese region (n=15,8,8,7,8) | 42.09 units on a scale | Standard Error 13.843 |
Comparison: Analysis reported for European region.p-value: 0.07195% CI: [-1.24, 30.22]Repeated measures model
Comparison: Analysis reported for European region.p-value: 0.01395% CI: [4.06, 34.8]Repeated measures model
Comparison: Analysis reported for European region.p-value: 0.3295% CI: [-7.68, 23.36]Repeated measures model
Comparison: Analysis reported for European region.p-value: <0.00195% CI: [15.85, 46.89]Repeated measures model
Comparison: Analysis reported for Japanese region.p-value: 0.48395% CI: [-22.41, 46.64]Repeated measures model
Comparison: Analysis reported for Japanese region.p-value: 0.07595% CI: [-3.28, 65.77]Repeated measures model
Comparison: Analysis reported for Japanese region.p-value: 0.81595% CI: [-31.89, 40.32]Repeated measures model
Comparison: Analysis reported for Japanese region.p-value: 0.04195% CI: [1.58, 70.63]Repeated measures model
Secondary
Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission
DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Expected duration of response (DOR) was calculated as response rate (in percentage) multiplied by mean DOR (in days) by using Weibull Model. Duration of DAS28 (CRP) and DAS28 (ESR) remission were not analyzed because very few participants achieved remission in the overall study population.
Time frame: Baseline up to Day 169
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified parameter for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission | DAS28 (CRP) Response | 43.40 Percentage of days | 0.11 |
| Placebo | Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission | DAS28 (ESR) Response | 46.11 Percentage of days | 0.12 |
| Mavrilimumab 10 mg | Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission | DAS28 (CRP) Response | 42.19 Percentage of days | 0.16 |
| Mavrilimumab 10 mg | Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission | DAS28 (ESR) Response | 52.96 Percentage of days | 0.166 |
| Mavrilimumab 30 mg | Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission | DAS28 (CRP) Response | 81.89 Percentage of days | 0.139 |
| Mavrilimumab 30 mg | Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission | DAS28 (ESR) Response | 71.14 Percentage of days | 0.163 |
| Mavrilimumab 50 mg | Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission | DAS28 (ESR) Response | 75.97 Percentage of days | 0.162 |
| Mavrilimumab 50 mg | Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission | DAS28 (CRP) Response | 54.80 Percentage of days | 0.146 |
| Mavrilimumab 100 mg | Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission | DAS28 (CRP) Response | 83.07 Percentage of days | 0.115 |
| Mavrilimumab 100 mg | Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission | DAS28 (ESR) Response | 96.52 Percentage of days | 0.165 |
Comparison: Analysis reported for DAS28 (ESR) response.p-value: 0.48695% CI: [0.78, 1.69]Exponential,Weibull and Log normal model
Comparison: Analysis reported for DAS28 (ESR) response.p-value: 0.01595% CI: [1.09, 2.18]Exponential,Weibull and Log normal model
Comparison: Analysis reported for DAS28 (ESR) response.p-value: 0.00695% CI: [1.15, 2.36]Exponential,Weibull and Log normal model
Comparison: Analysis reported for DAS28 (ESR) response.p-value: <0.00195% CI: [1.49, 2.93]Exponential,Weibull and Log normal model
Comparison: Analysis reported for DAS28 (CRP) response.p-value: 0.90695% CI: [0.61, 1.55]Exponential,Weibull and Log normal model
Comparison: Analysis reported for DAS28 (CRP) response.p-value: <0.00195% CI: [1.31, 2.71]Exponential,Weibull and Log normal model
Comparison: Analysis reported for DAS28 (CRP) response.p-value: 0.27295% CI: [0.83, 1.91]Exponential,Weibull and Log normal model
Comparison: Analysis reported for DAS28 (CRP) response.p-value: <0.00195% CI: [1.34, 2.72]Exponential,Weibull and Log normal model
Secondary
Health Assessments Questionnaire-Disability Index (HAQ-DI) Score
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Day 85
Population: ITT population. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score | 1.19 units on a scale | Standard Deviation 0.68 |
| Mavrilimumab 10 mg | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score | 1.02 units on a scale | Standard Deviation 0.51 |
| Mavrilimumab 30 mg | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score | 1.02 units on a scale | Standard Deviation 0.64 |
| Mavrilimumab 50 mg | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score | 1.10 units on a scale | Standard Deviation 0.61 |
| Mavrilimumab 100 mg | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score | 0.95 units on a scale | Standard Deviation 0.59 |
Secondary
Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Data for European and Japanese regions were reported.
Time frame: Day 85
Population: ITT population. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region | European region (n=69,36,39,39,38) | 1.22 units on a scale | Standard Deviation 0.65 |
| Placebo | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region | Japanese region (n=16,9,8,9,8) | 1.09 units on a scale | Standard Deviation 0.82 |
| Mavrilimumab 10 mg | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region | European region (n=69,36,39,39,38) | 1.10 units on a scale | Standard Deviation 0.47 |
| Mavrilimumab 10 mg | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region | Japanese region (n=16,9,8,9,8) | 0.72 units on a scale | Standard Deviation 0.61 |
| Mavrilimumab 30 mg | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region | European region (n=69,36,39,39,38) | 1.05 units on a scale | Standard Deviation 0.67 |
| Mavrilimumab 30 mg | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region | Japanese region (n=16,9,8,9,8) | 0.91 units on a scale | Standard Deviation 0.53 |
| Mavrilimumab 50 mg | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region | Japanese region (n=16,9,8,9,8) | 0.82 units on a scale | Standard Deviation 0.44 |
| Mavrilimumab 50 mg | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region | European region (n=69,36,39,39,38) | 1.16 units on a scale | Standard Deviation 0.63 |
| Mavrilimumab 100 mg | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region | European region (n=69,36,39,39,38) | 1.03 units on a scale | Standard Deviation 0.56 |
| Mavrilimumab 100 mg | Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region | Japanese region (n=16,9,8,9,8) | 0.56 units on a scale | Standard Deviation 0.6 |
Secondary
Health Assessments Questionnaire (HAQ) Pain Score
Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Health Assessments Questionnaire (HAQ) Pain Score | 46.3 units on a scale | Standard Deviation 24.3 |
| Mavrilimumab 10 mg | Health Assessments Questionnaire (HAQ) Pain Score | 40.9 units on a scale | Standard Deviation 23.5 |
| Mavrilimumab 30 mg | Health Assessments Questionnaire (HAQ) Pain Score | 39.0 units on a scale | Standard Deviation 25 |
| Mavrilimumab 50 mg | Health Assessments Questionnaire (HAQ) Pain Score | 42.6 units on a scale | Standard Deviation 23.5 |
| Mavrilimumab 100 mg | Health Assessments Questionnaire (HAQ) Pain Score | 35.0 units on a scale | Standard Deviation 20.8 |
Secondary
Health Assessments Questionnaire (HAQ) Pain Score by Region
Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain. Data for European and Japanese regions were reported.
Time frame: Day 85
Population: ITT population. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Health Assessments Questionnaire (HAQ) Pain Score by Region | European region (n=69,36,39,39,38) | 47.0 units on a scale | Standard Deviation 23.9 |
| Placebo | Health Assessments Questionnaire (HAQ) Pain Score by Region | Japanese region (n=16,9,8,9,8) | 43.1 units on a scale | Standard Deviation 26.3 |
| Mavrilimumab 10 mg | Health Assessments Questionnaire (HAQ) Pain Score by Region | European region (n=69,36,39,39,38) | 40.3 units on a scale | Standard Deviation 23.6 |
| Mavrilimumab 10 mg | Health Assessments Questionnaire (HAQ) Pain Score by Region | Japanese region (n=16,9,8,9,8) | 43.1 units on a scale | Standard Deviation 24.5 |
| Mavrilimumab 30 mg | Health Assessments Questionnaire (HAQ) Pain Score by Region | European region (n=69,36,39,39,38) | 40.6 units on a scale | Standard Deviation 24.8 |
| Mavrilimumab 30 mg | Health Assessments Questionnaire (HAQ) Pain Score by Region | Japanese region (n=16,9,8,9,8) | 31.0 units on a scale | Standard Deviation 26.1 |
| Mavrilimumab 50 mg | Health Assessments Questionnaire (HAQ) Pain Score by Region | Japanese region (n=16,9,8,9,8) | 37.3 units on a scale | Standard Deviation 22.9 |
| Mavrilimumab 50 mg | Health Assessments Questionnaire (HAQ) Pain Score by Region | European region (n=69,36,39,39,38) | 43.8 units on a scale | Standard Deviation 23.8 |
| Mavrilimumab 100 mg | Health Assessments Questionnaire (HAQ) Pain Score by Region | European region (n=69,36,39,39,38) | 36.5 units on a scale | Standard Deviation 21.1 |
| Mavrilimumab 100 mg | Health Assessments Questionnaire (HAQ) Pain Score by Region | Japanese region (n=16,9,8,9,8) | 28.3 units on a scale | Standard Deviation 19.1 |
Secondary
Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region
Data for European and Japanese regions were reported.
Time frame: Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169
Population: The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here N signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region | European region (n=37,41,40,37) | 128 nanogram per milliliter (ng/mL) | Standard Deviation 1130 |
| Placebo | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region | Japanese region (n=9,8,9,8) | 61.3 nanogram per milliliter (ng/mL) | Standard Deviation 30.3 |
| Mavrilimumab 10 mg | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region | Japanese region (n=9,8,9,8) | 633 nanogram per milliliter (ng/mL) | Standard Deviation 388 |
| Mavrilimumab 10 mg | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region | European region (n=37,41,40,37) | 917 nanogram per milliliter (ng/mL) | Standard Deviation 796 |
| Mavrilimumab 30 mg | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region | European region (n=37,41,40,37) | 1240 nanogram per milliliter (ng/mL) | Standard Deviation 1200 |
| Mavrilimumab 30 mg | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region | Japanese region (n=9,8,9,8) | 1230 nanogram per milliliter (ng/mL) | Standard Deviation 652 |
| Mavrilimumab 50 mg | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region | European region (n=37,41,40,37) | 6500 nanogram per milliliter (ng/mL) | Standard Deviation 3630 |
| Mavrilimumab 50 mg | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region | Japanese region (n=9,8,9,8) | 4540 nanogram per milliliter (ng/mL) | Standard Deviation 927 |
Secondary
Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region
Data for European and Japanese regions were reported.
Time frame: Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169
Population: The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here N signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 137 ng/mL | Standard Deviation 363 |
| Placebo | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 136 ng/mL | Standard Deviation 156 |
| Mavrilimumab 10 mg | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 1200 ng/mL | Standard Deviation 727 |
| Mavrilimumab 10 mg | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 1030 ng/mL | Standard Deviation 3150 |
| Mavrilimumab 30 mg | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 2950 ng/mL | Standard Deviation 2380 |
| Mavrilimumab 30 mg | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 3340 ng/mL | Standard Deviation 1290 |
| Mavrilimumab 50 mg | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 7880 ng/mL | Standard Deviation 5610 |
| Mavrilimumab 50 mg | Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 10300 ng/mL | Standard Deviation 2470 |
Secondary
Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit
ADA detection measured by using electrochemiluminescence assays.
Time frame: Day 1 up to Day 169
Population: The immunogenicity population included all participants who received at least 1 dose of CAM-3001 and for whom at least one serum sample for immunogenicity testing was available.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Placebo | Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit | 3 participants | 0.11 |
| Mavrilimumab 10 mg | Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit | 10 participants | 0.16 |
| Mavrilimumab 30 mg | Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit | 6 participants | 0.139 |
| Mavrilimumab 50 mg | Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit | 2 participants | 0.146 |
| Mavrilimumab 100 mg | Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit | 2 participants | 0.115 |
Secondary
Number of Participants Who Achieved ACR Categorical Responses
ACR20, ACR50, and ACR70, were defined as \>=20%, \>=50%, or \>=70% improvement, respectively, in: SJC and TJC and \>=20%, \>=50%, or \>=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. ACR responses were categorized as No response, ACR20 but not ACR50, ACR50 but not ACR70, and ACR70.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Participants Who Achieved ACR Categorical Responses | No response | 58 participants | 0.11 |
| Placebo | Number of Participants Who Achieved ACR Categorical Responses | ACR20 but not ACR50 | 23 participants | 0.12 |
| Placebo | Number of Participants Who Achieved ACR Categorical Responses | ACR50 but not ACR70 | 6 participants | — |
| Placebo | Number of Participants Who Achieved ACR Categorical Responses | ACR70 | 5 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Achieved ACR Categorical Responses | No response | 28 participants | 0.16 |
| Mavrilimumab 10 mg | Number of Participants Who Achieved ACR Categorical Responses | ACR70 | 2 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Achieved ACR Categorical Responses | ACR20 but not ACR50 | 10 participants | 0.166 |
| Mavrilimumab 10 mg | Number of Participants Who Achieved ACR Categorical Responses | ACR50 but not ACR70 | 8 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Achieved ACR Categorical Responses | ACR70 | 5 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Achieved ACR Categorical Responses | ACR20 but not ACR50 | 13 participants | 0.163 |
| Mavrilimumab 30 mg | Number of Participants Who Achieved ACR Categorical Responses | ACR50 but not ACR70 | 10 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Achieved ACR Categorical Responses | No response | 21 participants | 0.139 |
| Mavrilimumab 50 mg | Number of Participants Who Achieved ACR Categorical Responses | No response | 30 participants | 0.146 |
| Mavrilimumab 50 mg | Number of Participants Who Achieved ACR Categorical Responses | ACR20 but not ACR50 | 10 participants | 0.162 |
| Mavrilimumab 50 mg | Number of Participants Who Achieved ACR Categorical Responses | ACR70 | 3 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Achieved ACR Categorical Responses | ACR50 but not ACR70 | 5 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Achieved ACR Categorical Responses | ACR70 | 7 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Achieved ACR Categorical Responses | ACR50 but not ACR70 | 9 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Achieved ACR Categorical Responses | ACR20 but not ACR50 | 17 participants | 0.165 |
| Mavrilimumab 100 mg | Number of Participants Who Achieved ACR Categorical Responses | No response | 14 participants | 0.115 |
Secondary
Number of Participants Who Had Additional Medications
Additional medication included concomitant medication (medication used for purposes other than managing rheumatoid arthritis \[RA\]) and RA medication (for managing RA). Number of participants who used concomitant medication and RA medication was reported by anatomical therapeutic chemical (ATC) classification system.
Time frame: Baseline up to Day 169
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Participants Who Had Additional Medications | Concomitant: Blood and blood forming agents | 88 participants | 0.11 |
| Placebo | Number of Participants Who Had Additional Medications | Concomitant: Alimentary tract and metabolism | 45 participants | 0.12 |
| Placebo | Number of Participants Who Had Additional Medications | Concomitant: Cardiovascular system | 30 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | RA: Nervous system | 4 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | Concomitant: Respiratory system | 11 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | Concomitant: Various | 6 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | Concomitant: Sensory organs | 0 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | RA: Dermatologicals | 1 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | RA: Systemic hormonal preps | 47 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | Concomitant: Anti-infective for systemic use | 10 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | Concomitant: Nervous system | 14 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | Concomitant: Dermatologicals | 2 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | RA: Sensory organs | 0 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | RA: Musculo-skeletal system | 65 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | Concomitant:Genito-urinary system and sex hormones | 4 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | Concomitant: Anti-parasitic products | 1 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | RA: Alimentary tract and metabolism | 0 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | Concomitant: Musculo-skeletal system | 11 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | RA: Antineoplastic and immunomodulating agents | 92 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | Concomitant: Systemic hormonal preps | 8 participants | — |
| Placebo | Number of Participants Who Had Additional Medications | RA: Respiratory system | 0 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant: Systemic hormonal preps | 5 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant: Anti-parasitic products | 0 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant: Various | 5 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant: Sensory organs | 2 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant: Dermatologicals | 1 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant: Cardiovascular system | 20 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | RA: Sensory organs | 0 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | RA: Dermatologicals | 0 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant: Nervous system | 9 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | RA: Alimentary tract and metabolism | 2 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant: Musculo-skeletal system | 9 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | RA: Nervous system | 0 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant: Respiratory system | 6 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant: Alimentary tract and metabolism | 25 participants | 0.166 |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | RA: Systemic hormonal preps | 23 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant: Anti-infective for systemic use | 6 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant: Blood and blood forming agents | 47 participants | 0.16 |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | RA: Musculo-skeletal system | 35 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | Concomitant:Genito-urinary system and sex hormones | 6 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | RA: Respiratory system | 0 participants | — |
| Mavrilimumab 10 mg | Number of Participants Who Had Additional Medications | RA: Antineoplastic and immunomodulating agents | 48 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant: Dermatologicals | 5 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant: Blood and blood forming agents | 49 participants | 0.139 |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant: Alimentary tract and metabolism | 25 participants | 0.163 |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant: Cardiovascular system | 19 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant: Nervous system | 9 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant: Musculo-skeletal system | 5 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant: Respiratory system | 7 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant: Anti-infective for systemic use | 6 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant:Genito-urinary system and sex hormones | 6 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant: Systemic hormonal preps | 4 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant: Various | 2 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant: Sensory organs | 3 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | Concomitant: Anti-parasitic products | 0 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | RA: Antineoplastic and immunomodulating agents | 49 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | RA: Musculo-skeletal system | 38 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | RA: Systemic hormonal preps | 21 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | RA: Nervous system | 2 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | RA: Alimentary tract and metabolism | 0 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | RA: Dermatologicals | 0 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | RA: Respiratory system | 0 participants | — |
| Mavrilimumab 30 mg | Number of Participants Who Had Additional Medications | RA: Sensory organs | 0 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | RA: Antineoplastic and immunomodulating agents | 48 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant:Genito-urinary system and sex hormones | 4 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant: Nervous system | 6 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant: Blood and blood forming agents | 47 participants | 0.146 |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | RA: Alimentary tract and metabolism | 1 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant: Respiratory system | 5 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | RA: Sensory organs | 0 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant: Cardiovascular system | 12 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | RA: Systemic hormonal preps | 21 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | RA: Dermatologicals | 0 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant: Anti-infective for systemic use | 8 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant: Dermatologicals | 2 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | RA: Respiratory system | 0 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant: Musculo-skeletal system | 8 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant: Various | 2 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant: Anti-parasitic products | 0 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant: Sensory organs | 2 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | RA: Musculo-skeletal system | 32 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | RA: Nervous system | 2 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant: Systemic hormonal preps | 2 participants | — |
| Mavrilimumab 50 mg | Number of Participants Who Had Additional Medications | Concomitant: Alimentary tract and metabolism | 28 participants | 0.162 |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant: Alimentary tract and metabolism | 23 participants | 0.165 |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant: Anti-parasitic products | 0 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant:Genito-urinary system and sex hormones | 4 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | RA: Antineoplastic and immunomodulating agents | 47 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant: Anti-infective for systemic use | 2 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | RA: Musculo-skeletal system | 31 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant: Respiratory system | 5 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | RA: Respiratory system | 1 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | RA: Systemic hormonal preps | 23 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant: Musculo-skeletal system | 5 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant: Blood and blood forming agents | 45 participants | 0.115 |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | RA: Nervous system | 1 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant: Nervous system | 3 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | RA: Alimentary tract and metabolism | 0 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant: Cardiovascular system | 22 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | RA: Sensory organs | 1 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | RA: Dermatologicals | 1 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant: Dermatologicals | 2 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant: Various | 4 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant: Sensory organs | 2 participants | — |
| Mavrilimumab 100 mg | Number of Participants Who Had Additional Medications | Concomitant: Systemic hormonal preps | 0 participants | — |
Secondary
Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose
Participants received MTX at stable and tolerated dose during baseline were categorized as low dose (\<12.5 mg per week \[mg/wk\]), medium dose (\>=12.5 - \<20 mg/wk), and high dose (\>=20 mg/wk). Participants received oral CST at stable dose during baseline were categorized as low dose (\<5 mg/day), and high dose (\>=5 mg/day). Change in MTX and CST dose from baseline between Day 1-85 and Day 86-169 were categorized as follows: 'Increased', 'no change' and 'decreased'. Participants were counted once with dose increases counted first, followed by no change and then dose decreases.
Time frame: Baseline, Day 1 to 85, Day 86 to 169
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified parameter for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Low dose (Baseline) (n=92,48,49,48,47) | 39 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: No change (Day 86-169) (n=85,45,46,48,45) | 82 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: High dose (Baseline) (n=46,22,21,21,23) | 40 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Decreased (Day 86-169) (n=85,45,46,48,45) | 1 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: No change (Day 86-169) (n=46,21,21,22,23) | 44 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Low dose (Baseline) (n=46,22,21,21,23) | 6 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: High dose (Baseline) (n=92,48,49,48,47) | 9 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Increased (Day 86-169) (n=46,21,21,22,23) | 2 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Increased (Day 1-85) (n=92,48,49,48,47) | 0 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Decreased (Day 86-169) (n=46,21,21,22,23) | 0 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Decreased (Day 1-85) (n=46,22,21,21,23) | 0 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: No change (Day 1-85) (n=92,48,49,48,47) | 90 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Medium dose (Baseline) (n=92,48,49,48,47) | 44 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: No change (Day 1-85) (n=46,22,21,21,23) | 44 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Decreased (Day 1-85) (n=92,48,49,48,47) | 2 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Increased (Day 1-85) (n=46,22,21,21,23) | 2 participants |
| Placebo | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Increased (Day 86-169) (n=85,45,46,48,45) | 2 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Decreased (Day 1-85) (n=92,48,49,48,47) | 2 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Decreased (Day 1-85) (n=46,22,21,21,23) | 0 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: No change (Day 86-169) (n=85,45,46,48,45) | 42 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: No change (Day 86-169) (n=46,21,21,22,23) | 20 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Medium dose (Baseline) (n=92,48,49,48,47) | 25 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Low dose (Baseline) (n=46,22,21,21,23) | 4 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Increased (Day 1-85) (n=46,22,21,21,23) | 0 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Decreased (Day 86-169) (n=85,45,46,48,45) | 0 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: No change (Day 1-85) (n=92,48,49,48,47) | 46 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Low dose (Baseline) (n=92,48,49,48,47) | 18 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: No change (Day 1-85) (n=46,22,21,21,23) | 22 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: High dose (Baseline) (n=92,48,49,48,47) | 5 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Decreased (Day 86-169) (n=46,21,21,22,23) | 0 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Increased (Day 86-169) (n=46,21,21,22,23) | 1 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: High dose (Baseline) (n=46,22,21,21,23) | 18 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Increased (Day 86-169) (n=85,45,46,48,45) | 3 participants |
| Mavrilimumab 10 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Increased (Day 1-85) (n=92,48,49,48,47) | 0 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: High dose (Baseline) (n=46,22,21,21,23) | 19 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Low dose (Baseline) (n=92,48,49,48,47) | 24 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Medium dose (Baseline) (n=92,48,49,48,47) | 21 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: High dose (Baseline) (n=92,48,49,48,47) | 4 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Increased (Day 1-85) (n=92,48,49,48,47) | 0 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: No change (Day 1-85) (n=92,48,49,48,47) | 47 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Decreased (Day 1-85) (n=92,48,49,48,47) | 2 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Increased (Day 86-169) (n=85,45,46,48,45) | 3 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: No change (Day 86-169) (n=85,45,46,48,45) | 42 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Decreased (Day 86-169) (n=85,45,46,48,45) | 1 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Low dose (Baseline) (n=46,22,21,21,23) | 2 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Increased (Day 1-85) (n=46,22,21,21,23) | 0 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: No change (Day 1-85) (n=46,22,21,21,23) | 21 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Decreased (Day 1-85) (n=46,22,21,21,23) | 0 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Increased (Day 86-169) (n=46,21,21,22,23) | 2 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: No change (Day 86-169) (n=46,21,21,22,23) | 19 participants |
| Mavrilimumab 30 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Decreased (Day 86-169) (n=46,21,21,22,23) | 0 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: No change (Day 86-169) (n=85,45,46,48,45) | 46 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Increased (Day 86-169) (n=85,45,46,48,45) | 2 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: High dose (Baseline) (n=46,22,21,21,23) | 20 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Decreased (Day 1-85) (n=92,48,49,48,47) | 1 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Increased (Day 1-85) (n=46,22,21,21,23) | 0 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: No change (Day 1-85) (n=92,48,49,48,47) | 47 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: No change (Day 1-85) (n=46,22,21,21,23) | 21 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Increased (Day 1-85) (n=92,48,49,48,47) | 0 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Low dose (Baseline) (n=92,48,49,48,47) | 29 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Decreased (Day 1-85) (n=46,22,21,21,23) | 0 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: High dose (Baseline) (n=92,48,49,48,47) | 4 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Increased (Day 86-169) (n=46,21,21,22,23) | 2 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Medium dose (Baseline) (n=92,48,49,48,47) | 15 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Decreased (Day 86-169) (n=46,21,21,22,23) | 0 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Decreased (Day 86-169) (n=85,45,46,48,45) | 0 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: No change (Day 86-169) (n=46,21,21,22,23) | 20 participants |
| Mavrilimumab 50 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Low dose (Baseline) (n=46,22,21,21,23) | 1 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Low dose (Baseline) (n=46,22,21,21,23) | 1 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Decreased (Day 1-85) (n=46,22,21,21,23) | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: High dose (Baseline) (n=92,48,49,48,47) | 1 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: High dose (Baseline) (n=46,22,21,21,23) | 22 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Decreased (Day 1-85) (n=92,48,49,48,47) | 2 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Decreased (Day 86-169) (n=85,45,46,48,45) | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: No change (Day 86-169) (n=46,21,21,22,23) | 23 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Decreased (Day 86-169) (n=46,21,21,22,23) | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Increased (Day 1-85) (n=46,22,21,21,23) | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: No change (Day 1-85) (n=92,48,49,48,47) | 45 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Increased (Day 86-169) (n=85,45,46,48,45) | 1 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Low dose (Baseline) (n=92,48,49,48,47) | 21 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: Increased (Day 86-169) (n=46,21,21,22,23) | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | CST: No change (Day 1-85) (n=46,22,21,21,23) | 23 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Increased (Day 1-85) (n=92,48,49,48,47) | 0 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: Medium dose (Baseline) (n=92,48,49,48,47) | 25 participants |
| Mavrilimumab 100 mg | Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose | MTX: No change (Day 86-169) (n=85,45,46,48,45) | 44 participants |
Secondary
Patient Global Assessment of Disease Activity Score
Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Patient Global Assessment of Disease Activity Score | 45.1 mm | Standard Deviation 24.2 |
| Mavrilimumab 10 mg | Patient Global Assessment of Disease Activity Score | 40.0 mm | Standard Deviation 22.8 |
| Mavrilimumab 30 mg | Patient Global Assessment of Disease Activity Score | 37.2 mm | Standard Deviation 21.1 |
| Mavrilimumab 50 mg | Patient Global Assessment of Disease Activity Score | 41.1 mm | Standard Deviation 23.2 |
| Mavrilimumab 100 mg | Patient Global Assessment of Disease Activity Score | 35.5 mm | Standard Deviation 19.3 |
Secondary
Patient Global Assessment of Disease Activity Score by Region
Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly. Data for European and Japanese regions were reported.
Time frame: Day 85
Population: ITT population. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Patient Global Assessment of Disease Activity Score by Region | European region (n=69,36,39,39,38) | 45.9 mm | Standard Deviation 23.8 |
| Placebo | Patient Global Assessment of Disease Activity Score by Region | Japanese region (n=16,9,8,9,8) | 41.5 mm | Standard Deviation 26.2 |
| Mavrilimumab 10 mg | Patient Global Assessment of Disease Activity Score by Region | European region (n=69,36,39,39,38) | 39.5 mm | Standard Deviation 22.2 |
| Mavrilimumab 10 mg | Patient Global Assessment of Disease Activity Score by Region | Japanese region (n=16,9,8,9,8) | 41.9 mm | Standard Deviation 26.5 |
| Mavrilimumab 30 mg | Patient Global Assessment of Disease Activity Score by Region | European region (n=69,36,39,39,38) | 39.0 mm | Standard Deviation 20.6 |
| Mavrilimumab 30 mg | Patient Global Assessment of Disease Activity Score by Region | Japanese region (n=16,9,8,9,8) | 28.8 mm | Standard Deviation 22.7 |
| Mavrilimumab 50 mg | Patient Global Assessment of Disease Activity Score by Region | Japanese region (n=16,9,8,9,8) | 35.0 mm | Standard Deviation 21.4 |
| Mavrilimumab 50 mg | Patient Global Assessment of Disease Activity Score by Region | European region (n=69,36,39,39,38) | 42.5 mm | Standard Deviation 23.6 |
| Mavrilimumab 100 mg | Patient Global Assessment of Disease Activity Score by Region | European region (n=69,36,39,39,38) | 37.3 mm | Standard Deviation 19.2 |
| Mavrilimumab 100 mg | Patient Global Assessment of Disease Activity Score by Region | Japanese region (n=16,9,8,9,8) | 26.9 mm | Standard Deviation 18.7 |
Secondary
Patient Pain Assessment Score
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Patient Pain Assessment Score | 44.5 mm | Standard Deviation 24.9 |
| Mavrilimumab 10 mg | Patient Pain Assessment Score | 38.7 mm | Standard Deviation 24.1 |
| Mavrilimumab 30 mg | Patient Pain Assessment Score | 38.1 mm | Standard Deviation 24.2 |
| Mavrilimumab 50 mg | Patient Pain Assessment Score | 40.1 mm | Standard Deviation 24.2 |
| Mavrilimumab 100 mg | Patient Pain Assessment Score | 34.4 mm | Standard Deviation 21.6 |
Secondary
Patient Pain Assessment Score by Region
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. Data for European and Japanese regions were reported.
Time frame: Day 85
Population: ITT population. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Patient Pain Assessment Score by Region | European region (n=69,36,39,39,38) | 44.9 mm | Standard Deviation 24.4 |
| Placebo | Patient Pain Assessment Score by Region | Japanese region (n=16,9,8,9,8) | 42.6 mm | Standard Deviation 27.8 |
| Mavrilimumab 10 mg | Patient Pain Assessment Score by Region | European region (n=69,36,39,39,38) | 38.1 mm | Standard Deviation 24.1 |
| Mavrilimumab 10 mg | Patient Pain Assessment Score by Region | Japanese region (n=16,9,8,9,8) | 41.1 mm | Standard Deviation 25.5 |
| Mavrilimumab 30 mg | Patient Pain Assessment Score by Region | European region (n=69,36,39,39,38) | 39.1 mm | Standard Deviation 24 |
| Mavrilimumab 30 mg | Patient Pain Assessment Score by Region | Japanese region (n=16,9,8,9,8) | 33.3 mm | Standard Deviation 26.1 |
| Mavrilimumab 50 mg | Patient Pain Assessment Score by Region | Japanese region (n=16,9,8,9,8) | 34.1 mm | Standard Deviation 23.6 |
| Mavrilimumab 50 mg | Patient Pain Assessment Score by Region | European region (n=69,36,39,39,38) | 41.4 mm | Standard Deviation 24.4 |
| Mavrilimumab 100 mg | Patient Pain Assessment Score by Region | European region (n=69,36,39,39,38) | 36.0 mm | Standard Deviation 22 |
| Mavrilimumab 100 mg | Patient Pain Assessment Score by Region | Japanese region (n=16,9,8,9,8) | 27.0 mm | Standard Deviation 19.4 |
Secondary
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85
ACR20, ACR50, and ACR70, were defined as greater than or equal to (\>=) 20 percent (%),\>=50%, or \>=70% improvement, respectively, in: swollen joint count and tender joint count and \>=20%, \>=50%, or \>=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR20 | 37.0 percentage of participants | 0.11 |
| Placebo | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR70 | 5.4 percentage of participants | — |
| Placebo | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR50 | 12.0 percentage of participants | 0.12 |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR50 | 20.8 percentage of participants | 0.166 |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR20 | 41.7 percentage of participants | 0.16 |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR70 | 4.2 percentage of participants | — |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR50 | 30.6 percentage of participants | 0.163 |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR20 | 57.1 percentage of participants | 0.139 |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR70 | 10.2 percentage of participants | — |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR20 | 37.5 percentage of participants | 0.146 |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR70 | 6.3 percentage of participants | — |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR50 | 16.7 percentage of participants | 0.162 |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR50 | 34.0 percentage of participants | 0.165 |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR20 | 70.2 percentage of participants | 0.115 |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 | ACR70 | 14.9 percentage of participants | — |
Comparison: ACR20: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.58995% CI: [-12.1, 22]Fisher Exact
Comparison: ACR20: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.03295% CI: [2.8, 36.7]Fisher Exact
Comparison: ACR20: p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-16, 18]Fisher Exact
Comparison: ACR20: p-value was calculated using a two-tailed Fisher's exact test.p-value: <0.00195% CI: [15.6, 48.6]Fisher Exact
Comparison: ACR50: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.21295% CI: [-3.5, 23.6]Fisher Exact
Comparison: ACR50: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.01195% CI: [4.8, 34]Fisher Exact
Comparison: ACR50: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.44695% CI: [-7, 19.1]Fisher Exact
Comparison: ACR50: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.00395% CI: [7.6, 37.8]Fisher Exact
Comparison: ACR70: p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-8.9, 9.7]Fisher Exact
Comparison: ACR70: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.31795% CI: [-4.1, 17.5]Fisher Exact
Comparison: ACR70: p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-7.2, 12.1]Fisher Exact
Comparison: ACR70: p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.10695% CI: [-0.5, 23.5]Fisher Exact
Secondary
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region
ACR20, ACR50, and ACR70, were defined as \>=20%, \>=50%, or \>=70% improvement, respectively, in: SJC and TJC and \>=20%, \>=50%, or \>=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Data for the European and Japanese regions were reported.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR20 (n=75,39,41,39,39) | 40.0 percentage of participants | 0.11 |
| Placebo | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR20 (n=17,9,8,9,8) | 23.5 percentage of participants | 0.12 |
| Placebo | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR50 (n=75,39,41,39,39) | 12.0 percentage of participants | — |
| Placebo | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR50 (n=17,9,8,9,8) | 11.8 percentage of participants | — |
| Placebo | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR70 (n=75,39,41,39,39) | 4.0 percentage of participants | — |
| Placebo | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR70 (n=17,9,8,9,8) | 11.8 percentage of participants | — |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR70 (n=75,39,41,39,39) | 5.1 percentage of participants | — |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR70 (n=17,9,8,9,8) | 0.0 percentage of participants | — |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR20 (n=75,39,41,39,39) | 41.0 percentage of participants | 0.16 |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR50 (n=75,39,41,39,39) | 23.1 percentage of participants | — |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR50 (n=17,9,8,9,8) | 11.1 percentage of participants | — |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR20 (n=17,9,8,9,8) | 44.4 percentage of participants | 0.166 |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR50 (n=17,9,8,9,8) | 37.5 percentage of participants | — |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR70 (n=75,39,41,39,39) | 9.8 percentage of participants | — |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR20 (n=75,39,41,39,39) | 56.1 percentage of participants | 0.139 |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR50 (n=75,39,41,39,39) | 29.3 percentage of participants | — |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR20 (n=17,9,8,9,8) | 62.5 percentage of participants | 0.163 |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR70 (n=17,9,8,9,8) | 12.5 percentage of participants | — |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR50 (n=17,9,8,9,8) | 0.0 percentage of participants | — |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR20 (n=17,9,8,9,8) | 22.2 percentage of participants | 0.162 |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR50 (n=75,39,41,39,39) | 20.5 percentage of participants | — |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR70 (n=17,9,8,9,8) | 0.0 percentage of participants | — |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR70 (n=75,39,41,39,39) | 7.7 percentage of participants | — |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR20 (n=75,39,41,39,39) | 41.0 percentage of participants | 0.146 |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR70 (n=75,39,41,39,39) | 17.9 percentage of participants | — |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR50 (n=75,39,41,39,39) | 30.8 percentage of participants | — |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR20 (n=17,9,8,9,8) | 75.0 percentage of participants | 0.165 |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR70 (n=17,9,8,9,8) | 0.0 percentage of participants | — |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | Japanese: ACR50 (n=17,9,8,9,8) | 50.0 percentage of participants | — |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region | European: ACR20 (n=75,39,41,39,39) | 69.2 percentage of participants | 0.115 |
Comparison: European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-17.7, 20.4]Fisher Exact
Comparison: European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.1295% CI: [-3.1, 34.4]Fisher Exact
Comparison: European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-17.7, 20.4]Fisher Exact
Comparison: European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.00595% CI: [9.7, 46.1]Fisher Exact
Comparison: Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.38295% CI: [-16.4, 55.9]Fisher Exact
Comparison: Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.08795% CI: [-2.7, 69.6]Fisher Exact
Comparison: Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-33.7, 35.7]Fisher Exact
Comparison: Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.02895% CI: [8.2, 77]Fisher Exact
Comparison: European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.17595% CI: [-2.9, 27.9]Fisher Exact
Comparison: European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.02695% CI: [2.4, 34.1]Fisher Exact
Comparison: European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.27195% CI: [-5.1, 24.9]Fisher Exact
Comparison: European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.02195% CI: [3.4, 36]Fisher Exact
Comparison: Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-27, 34.8]Fisher Exact
Comparison: Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.28395% CI: [-8.8, 63.2]Fisher Exact
Comparison: Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.52995% CI: [-35, 22.7]Fisher Exact
Comparison: Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.05995% CI: [1.6, 71.2]Fisher Exact
Comparison: European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-7, 14.2]Fisher Exact
Comparison: European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.24295% CI: [-3.7, 19.4]Fisher Exact
Comparison: European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.4195% CI: [-5.1, 16.9]Fisher Exact
Comparison: European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.0395% CI: [2.7, 29.5]Fisher Exact
Comparison: Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.52995% CI: [-35, 22.7]Fisher Exact
Comparison: Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-26.7, 39.5]Fisher Exact
Comparison: Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-37.5, 22.6]Fisher Exact
Secondary
Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85
DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 | DAS28(CRP) | 7.6 percentage of participants | 0.11 |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 | DAS28(ESR) | 3.3 percentage of participants | 0.12 |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 | DAS28(CRP) | 14.6 percentage of participants | 0.16 |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 | DAS28(ESR) | 6.3 percentage of participants | 0.166 |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 | DAS28(CRP) | 22.4 percentage of participants | 0.139 |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 | DAS28(ESR) | 8.2 percentage of participants | 0.163 |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 | DAS28(ESR) | 8.3 percentage of participants | 0.162 |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 | DAS28(CRP) | 18.8 percentage of participants | 0.146 |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 | DAS28(CRP) | 23.4 percentage of participants | 0.115 |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 | DAS28(ESR) | 6.4 percentage of participants | 0.165 |
Comparison: DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.23895% CI: [-3.3, 20.5]Fisher Exact
Comparison: DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.01795% CI: [2.8, 29.7]Fisher Exact
Comparison: DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.0995% CI: [0, 25.4]Fisher Exact
Comparison: DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.01595% CI: [2.9, 31]Fisher Exact
Comparison: DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.41295% CI: [-4.2, 14]Fisher Exact
Comparison: DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.23795% CI: [-2.9, 16.4]Fisher Exact
Comparison: DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.23195% CI: [-2.8, 16.8]Fisher Exact
Comparison: DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.40695% CI: [-4.1, 14.4]Fisher Exact
Secondary
Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region
DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | European: DAS28(CRP):(n=75,39,41,39,39) | 6.7 percentage of participants | 0.11 |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | European: DAS28(ESR):(n=75,39,41,39,39) | 1.3 percentage of participants | 0.12 |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | Japanese: DAS28(CRP) (n=17,9,8,9,8) | 11.8 percentage of participants | — |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | Japanese: DAS28(ESR) (n=17,9,8,9,8) | 11.8 percentage of participants | — |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | European: DAS28(CRP):(n=75,39,41,39,39) | 15.4 percentage of participants | 0.16 |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | Japanese: DAS28(ESR) (n=17,9,8,9,8) | 0.0 percentage of participants | — |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | European: DAS28(ESR):(n=75,39,41,39,39) | 7.7 percentage of participants | 0.166 |
| Mavrilimumab 10 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | Japanese: DAS28(CRP) (n=17,9,8,9,8) | 11.1 percentage of participants | — |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | Japanese: DAS28(ESR) (n=17,9,8,9,8) | 0.0 percentage of participants | — |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | European: DAS28(ESR):(n=75,39,41,39,39) | 9.8 percentage of participants | 0.163 |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | Japanese: DAS28(CRP) (n=17,9,8,9,8) | 50.0 percentage of participants | — |
| Mavrilimumab 30 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | European: DAS28(CRP):(n=75,39,41,39,39) | 17.1 percentage of participants | 0.139 |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | European: DAS28(CRP):(n=75,39,41,39,39) | 17.9 percentage of participants | 0.146 |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | European: DAS28(ESR):(n=75,39,41,39,39) | 7.7 percentage of participants | 0.162 |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | Japanese: DAS28(ESR) (n=17,9,8,9,8) | 11.1 percentage of participants | — |
| Mavrilimumab 50 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | Japanese: DAS28(CRP) (n=17,9,8,9,8) | 22.2 percentage of participants | — |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | Japanese: DAS28(ESR) (n=17,9,8,9,8) | 0.0 percentage of participants | — |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | Japanese: DAS28(CRP) (n=17,9,8,9,8) | 25.0 percentage of participants | — |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | European: DAS28(ESR):(n=75,39,41,39,39) | 7.7 percentage of participants | 0.165 |
| Mavrilimumab 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region | European: DAS28(CRP):(n=75,39,41,39,39) | 23.1 percentage of participants | 0.115 |
Comparison: European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.18295% CI: [-2.7, 24.4]Fisher Exact
Comparison: European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.1195% CI: [-1.2, 25.5]Fisher Exact
Comparison: European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.10495% CI: [-0.6, 26.9]Fisher Exact
Comparison: European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.01695% CI: [3.5, 32.7]Fisher Exact
Comparison: European region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.11595% CI: [-1, 19.3]Fisher Exact
Comparison: European region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.05295% CI: [0.6, 21.6]Fisher Exact
Comparison: Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-27, 34.8]Fisher Exact
Comparison: Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.05995% CI: [1.6, 71.2]Fisher Exact
Comparison: Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.59195% CI: [-18.2, 46.2]Fisher Exact
Comparison: Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.5795% CI: [-16.6, 51.4]Fisher Exact
Comparison: Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 0.52995% CI: [-35, 22.7]Fisher Exact
Comparison: Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-37.5, 22.6]Fisher Exact
Comparison: Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.p-value: 195% CI: [-27, 34.8]Fisher Exact
Secondary
Physician Global Assessment of Disease Activity Score
Physician Global Assessment of Arthritis was measured on a 0 to 10 centimeter (cm) Visual Analogue Scale (VAS), where 0 cm = very good and 10 cm = very bad.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Physician Global Assessment of Disease Activity Score | 3.82 cm | Standard Deviation 2.05 |
| Mavrilimumab 10 mg | Physician Global Assessment of Disease Activity Score | 3.30 cm | Standard Deviation 2.16 |
| Mavrilimumab 30 mg | Physician Global Assessment of Disease Activity Score | 3.13 cm | Standard Deviation 1.8 |
| Mavrilimumab 50 mg | Physician Global Assessment of Disease Activity Score | 3.45 cm | Standard Deviation 1.97 |
| Mavrilimumab 100 mg | Physician Global Assessment of Disease Activity Score | 2.95 cm | Standard Deviation 1.7 |
Secondary
Physician Global Assessment of Disease Activity Score by Region
Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad. Data for European and Japanese regions were reported.
Time frame: Day 85
Population: ITT population. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Physician Global Assessment of Disease Activity Score by Region | European region (n=69,36,39,39,38) | 3.93 cm | Standard Deviation 2.06 |
| Placebo | Physician Global Assessment of Disease Activity Score by Region | Japanese region (n=16,9,8,9,8) | 3.31 cm | Standard Deviation 1.99 |
| Mavrilimumab 10 mg | Physician Global Assessment of Disease Activity Score by Region | European region (n=69,36,39,39,38) | 3.29 cm | Standard Deviation 2.21 |
| Mavrilimumab 10 mg | Physician Global Assessment of Disease Activity Score by Region | Japanese region (n=16,9,8,9,8) | 3.37 cm | Standard Deviation 2.05 |
| Mavrilimumab 30 mg | Physician Global Assessment of Disease Activity Score by Region | European region (n=69,36,39,39,38) | 3.20 cm | Standard Deviation 1.79 |
| Mavrilimumab 30 mg | Physician Global Assessment of Disease Activity Score by Region | Japanese region (n=16,9,8,9,8) | 2.79 cm | Standard Deviation 1.91 |
| Mavrilimumab 50 mg | Physician Global Assessment of Disease Activity Score by Region | Japanese region (n=16,9,8,9,8) | 3.08 cm | Standard Deviation 2.03 |
| Mavrilimumab 50 mg | Physician Global Assessment of Disease Activity Score by Region | European region (n=69,36,39,39,38) | 3.54 cm | Standard Deviation 1.98 |
| Mavrilimumab 100 mg | Physician Global Assessment of Disease Activity Score by Region | European region (n=69,36,39,39,38) | 3.12 cm | Standard Deviation 1.74 |
| Mavrilimumab 100 mg | Physician Global Assessment of Disease Activity Score by Region | Japanese region (n=16,9,8,9,8) | 2.18 cm | Standard Deviation 1.37 |
Secondary
Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA)
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA) | 295.90 units per milliliter | Standard Deviation 920.92 |
| Mavrilimumab 10 mg | Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA) | 232.22 units per milliliter | Standard Deviation 469.86 |
| Mavrilimumab 30 mg | Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA) | 211.77 units per milliliter | Standard Deviation 250.5 |
| Mavrilimumab 50 mg | Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA) | 330.82 units per milliliter | Standard Deviation 549.05 |
| Mavrilimumab 100 mg | Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA) | 221.18 units per milliliter | Standard Deviation 333.28 |
Secondary
Serum Concentration of C-Reactive Protein (CRP)
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Serum Concentration of C-Reactive Protein (CRP) | 11.49 mg/L | Standard Deviation 4.67 |
| Mavrilimumab 10 mg | Serum Concentration of C-Reactive Protein (CRP) | 9.62 mg/L | Standard Deviation 4.15 |
| Mavrilimumab 30 mg | Serum Concentration of C-Reactive Protein (CRP) | 9.35 mg/L | Standard Deviation 3.92 |
| Mavrilimumab 50 mg | Serum Concentration of C-Reactive Protein (CRP) | 5.71 mg/L | Standard Deviation 2.97 |
| Mavrilimumab 100 mg | Serum Concentration of C-Reactive Protein (CRP) | 6.12 mg/L | Standard Deviation 2.9 |
Secondary
Serum Concentration of C-Reactive Protein (CRP) by Region
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for European and Japanese regions were reported.
Time frame: Day 85
Population: ITT population. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Concentration of C-Reactive Protein (CRP) by Region | European region (n=69,36,38,39,38) | 11.89 mg/L | Standard Deviation 18.57 |
| Placebo | Serum Concentration of C-Reactive Protein (CRP) by Region | Japanese region (n=16,9,8,9,8) | 9.75 mg/L | Standard Deviation 11.93 |
| Mavrilimumab 10 mg | Serum Concentration of C-Reactive Protein (CRP) by Region | European region (n=69,36,38,39,38) | 8.86 mg/L | Standard Deviation 13.1 |
| Mavrilimumab 10 mg | Serum Concentration of C-Reactive Protein (CRP) by Region | Japanese region (n=16,9,8,9,8) | 12.67 mg/L | Standard Deviation 18.47 |
| Mavrilimumab 30 mg | Serum Concentration of C-Reactive Protein (CRP) by Region | European region (n=69,36,38,39,38) | 10.24 mg/L | Standard Deviation 16.68 |
| Mavrilimumab 30 mg | Serum Concentration of C-Reactive Protein (CRP) by Region | Japanese region (n=16,9,8,9,8) | 5.13 mg/L | Standard Deviation 6.83 |
| Mavrilimumab 50 mg | Serum Concentration of C-Reactive Protein (CRP) by Region | Japanese region (n=16,9,8,9,8) | 2.28 mg/L | Standard Deviation 1.92 |
| Mavrilimumab 50 mg | Serum Concentration of C-Reactive Protein (CRP) by Region | European region (n=69,36,38,39,38) | 6.50 mg/L | Standard Deviation 7.6 |
| Mavrilimumab 100 mg | Serum Concentration of C-Reactive Protein (CRP) by Region | European region (n=69,36,38,39,38) | 5.84 mg/L | Standard Deviation 9.68 |
| Mavrilimumab 100 mg | Serum Concentration of C-Reactive Protein (CRP) by Region | Japanese region (n=16,9,8,9,8) | 7.44 mg/L | Standard Deviation 12.26 |
Secondary
Serum Concentration of Erythrocyte Sedimentation Rate (ESR)
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) | 34.4 mm/hr | Standard Deviation 26.5 |
| Mavrilimumab 10 mg | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) | 31.3 mm/hr | Standard Deviation 19 |
| Mavrilimumab 30 mg | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) | 34.1 mm/hr | Standard Deviation 23.6 |
| Mavrilimumab 50 mg | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) | 29.7 mm/hr | Standard Deviation 19.1 |
| Mavrilimumab 100 mg | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) | 23.6 mm/hr | Standard Deviation 14.6 |
Secondary
Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Data for European and Japanese regions were reported.
Time frame: Day 85
Population: ITT population. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region | European region (n=69,36,39,39,38) | 33.9 mm/hr | Standard Deviation 27.8 |
| Placebo | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region | Japanese region (n=16,9,8,9,8) | 36.6 mm/hr | Standard Deviation 20.8 |
| Mavrilimumab 10 mg | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region | European region (n=69,36,39,39,38) | 30.3 mm/hr | Standard Deviation 18.3 |
| Mavrilimumab 10 mg | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region | Japanese region (n=16,9,8,9,8) | 35.0 mm/hr | Standard Deviation 22.5 |
| Mavrilimumab 30 mg | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region | European region (n=69,36,39,39,38) | 33.2 mm/hr | Standard Deviation 23.9 |
| Mavrilimumab 30 mg | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region | Japanese region (n=16,9,8,9,8) | 38.8 mm/hr | Standard Deviation 22.6 |
| Mavrilimumab 50 mg | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region | Japanese region (n=16,9,8,9,8) | 16.3 mm/hr | Standard Deviation 13.6 |
| Mavrilimumab 50 mg | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region | European region (n=69,36,39,39,38) | 32.7 mm/hr | Standard Deviation 19 |
| Mavrilimumab 100 mg | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region | European region (n=69,36,39,39,38) | 23.1 mm/hr | Standard Deviation 14.3 |
| Mavrilimumab 100 mg | Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region | Japanese region (n=16,9,8,9,8) | 25.9 mm/hr | Standard Deviation 16.7 |
Secondary
Serum Concentration of Rheumatoid Factor (RF)
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Serum Concentration of Rheumatoid Factor (RF) | 109.82 units per milliliter | Standard Deviation 135.39 |
| Mavrilimumab 10 mg | Serum Concentration of Rheumatoid Factor (RF) | 79.62 units per milliliter | Standard Deviation 93.21 |
| Mavrilimumab 30 mg | Serum Concentration of Rheumatoid Factor (RF) | 177.84 units per milliliter | Standard Deviation 352.16 |
| Mavrilimumab 50 mg | Serum Concentration of Rheumatoid Factor (RF) | 85.15 units per milliliter | Standard Deviation 81.47 |
| Mavrilimumab 100 mg | Serum Concentration of Rheumatoid Factor (RF) | 83.26 units per milliliter | Standard Deviation 118.14 |
Secondary
Swollen and Tender Joint Count
Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1.
Time frame: Day 85
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Swollen and Tender Joint Count | Swollen joint count | 9.2 joints | Standard Deviation 10 |
| Placebo | Swollen and Tender Joint Count | Tender joint count | 14.8 joints | Standard Deviation 13.1 |
| Mavrilimumab 10 mg | Swollen and Tender Joint Count | Swollen joint count | 8.0 joints | Standard Deviation 8.4 |
| Mavrilimumab 10 mg | Swollen and Tender Joint Count | Tender joint count | 11.2 joints | Standard Deviation 10.9 |
| Mavrilimumab 30 mg | Swollen and Tender Joint Count | Swollen joint count | 5.4 joints | Standard Deviation 6.8 |
| Mavrilimumab 30 mg | Swollen and Tender Joint Count | Tender joint count | 9.8 joints | Standard Deviation 10.1 |
| Mavrilimumab 50 mg | Swollen and Tender Joint Count | Tender joint count | 13.9 joints | Standard Deviation 11.8 |
| Mavrilimumab 50 mg | Swollen and Tender Joint Count | Swollen joint count | 5.8 joints | Standard Deviation 7.4 |
| Mavrilimumab 100 mg | Swollen and Tender Joint Count | Swollen joint count | 4.4 joints | Standard Deviation 4.3 |
| Mavrilimumab 100 mg | Swollen and Tender Joint Count | Tender joint count | 9.1 joints | Standard Deviation 8.8 |
Secondary
Swollen and Tender Joint Count by Region
Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Data for the European and Japanese regions were reported.
Time frame: Day 85
Population: ITT population. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Swollen and Tender Joint Count by Region | European: Swollen joint count (n=69,36,39,39,38) | 9.6 joints | Standard Deviation 10.4 |
| Placebo | Swollen and Tender Joint Count by Region | Japanese: Swollen joint count (n=16,9,8,9,8) | 7.6 joints | Standard Deviation 8 |
| Placebo | Swollen and Tender Joint Count by Region | Japanese: Tender joint count (n=16,9,8,9,8) | 9.6 joints | Standard Deviation 11.9 |
| Placebo | Swollen and Tender Joint Count by Region | European: Tender joint count (n=69,36,39,39,38) | 15.9 joints | Standard Deviation 13.1 |
| Mavrilimumab 10 mg | Swollen and Tender Joint Count by Region | European: Tender joint count (n=69,36,39,39,38) | 11.0 joints | Standard Deviation 11.4 |
| Mavrilimumab 10 mg | Swollen and Tender Joint Count by Region | European: Swollen joint count (n=69,36,39,39,38) | 8.0 joints | Standard Deviation 8.2 |
| Mavrilimumab 10 mg | Swollen and Tender Joint Count by Region | Japanese: Swollen joint count (n=16,9,8,9,8) | 7.8 joints | Standard Deviation 9.5 |
| Mavrilimumab 10 mg | Swollen and Tender Joint Count by Region | Japanese: Tender joint count (n=16,9,8,9,8) | 12.1 joints | Standard Deviation 9.1 |
| Mavrilimumab 30 mg | Swollen and Tender Joint Count by Region | Japanese: Tender joint count (n=16,9,8,9,8) | 2.8 joints | Standard Deviation 2.4 |
| Mavrilimumab 30 mg | Swollen and Tender Joint Count by Region | European: Tender joint count (n=69,36,39,39,38) | 11.2 joints | Standard Deviation 10.5 |
| Mavrilimumab 30 mg | Swollen and Tender Joint Count by Region | European: Swollen joint count (n=69,36,39,39,38) | 5.6 joints | Standard Deviation 7.2 |
| Mavrilimumab 30 mg | Swollen and Tender Joint Count by Region | Japanese: Swollen joint count (n=16,9,8,9,8) | 4.6 joints | Standard Deviation 4.1 |
| Mavrilimumab 50 mg | Swollen and Tender Joint Count by Region | European: Swollen joint count (n=69,36,39,39,38) | 6.4 joints | Standard Deviation 8 |
| Mavrilimumab 50 mg | Swollen and Tender Joint Count by Region | Japanese: Swollen joint count (n=16,9,8,9,8) | 3.1 joints | Standard Deviation 2.9 |
| Mavrilimumab 50 mg | Swollen and Tender Joint Count by Region | European: Tender joint count (n=69,36,39,39,38) | 14.8 joints | Standard Deviation 12 |
| Mavrilimumab 50 mg | Swollen and Tender Joint Count by Region | Japanese: Tender joint count (n=16,9,8,9,8) | 9.6 joints | Standard Deviation 10.1 |
| Mavrilimumab 100 mg | Swollen and Tender Joint Count by Region | Japanese: Swollen joint count (n=16,9,8,9,8) | 4.9 joints | Standard Deviation 4.3 |
| Mavrilimumab 100 mg | Swollen and Tender Joint Count by Region | European: Swollen joint count (n=69,36,39,39,38) | 4.2 joints | Standard Deviation 4.4 |
| Mavrilimumab 100 mg | Swollen and Tender Joint Count by Region | Japanese: Tender joint count (n=16,9,8,9,8) | 5.5 joints | Standard Deviation 7.2 |
| Mavrilimumab 100 mg | Swollen and Tender Joint Count by Region | European: Tender joint count (n=69,36,39,39,38) | 9.9 joints | Standard Deviation 9 |
Secondary
Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Data for European and Japanese regions were reported.
Time frame: Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169
Population: The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here N signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 5.56 days | Standard Deviation 4.08 |
| Placebo | Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 6.96 days | Standard Deviation 4.61 |
| Mavrilimumab 10 mg | Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 7.23 days | Standard Deviation 5.67 |
| Mavrilimumab 10 mg | Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 4.37 days | Standard Deviation 2.88 |
| Mavrilimumab 30 mg | Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 6.33 days | Standard Deviation 3.07 |
| Mavrilimumab 30 mg | Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 7.38 days | Standard Deviation 1.65 |
| Mavrilimumab 50 mg | Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 6.84 days | Standard Deviation 3 |
| Mavrilimumab 50 mg | Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 7.08 days | Standard Deviation 2.19 |
Secondary
Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission
DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score.
Time frame: Baseline up to Day 169 (follow-up)
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (ESR) Response | 85.0 days | — |
| Placebo | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (CRP) Remission | NA days | 95% Confidence Interval 0.12 |
| Placebo | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (CRP) Response | 88.0 days | 95% Confidence Interval 0.11 |
| Placebo | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (ESR) Remission | NA days | — |
| Mavrilimumab 10 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (CRP) Remission | NA days | 95% Confidence Interval 0.166 |
| Mavrilimumab 10 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (CRP) Response | 84.0 days | 95% Confidence Interval 0.16 |
| Mavrilimumab 10 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (ESR) Response | 58.0 days | — |
| Mavrilimumab 10 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (ESR) Remission | NA days | — |
| Mavrilimumab 30 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (ESR) Response | 30.0 days | — |
| Mavrilimumab 30 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (CRP) Response | 43.0 days | 95% Confidence Interval 0.139 |
| Mavrilimumab 30 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (CRP) Remission | NA days | 95% Confidence Interval 0.163 |
| Mavrilimumab 30 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (ESR) Remission | NA days | — |
| Mavrilimumab 50 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (CRP) Remission | NA days | 95% Confidence Interval 0.162 |
| Mavrilimumab 50 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (ESR) Remission | NA days | — |
| Mavrilimumab 50 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (ESR) Response | 57.0 days | — |
| Mavrilimumab 50 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (CRP) Response | 71.0 days | 95% Confidence Interval 0.146 |
| Mavrilimumab 100 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (ESR) Remission | NA days | — |
| Mavrilimumab 100 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (CRP) Remission | NA days | 95% Confidence Interval 0.165 |
| Mavrilimumab 100 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (CRP) Response | 42.0 days | 95% Confidence Interval 0.115 |
| Mavrilimumab 100 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission | DAS28 (ESR) Response | 29.0 days | — |
Comparison: Analysis reported for DAS28 (CRP) response.p-value: 0.604Log Rank
Comparison: Analysis reported for DAS28 (CRP) response.p-value: <0.001Log Rank
Comparison: Analysis reported for DAS28 (CRP) response.p-value: 0.145Log Rank
Comparison: Analysis reported for DAS28 (ESR) response.p-value: 0.282Log Rank
Comparison: Analysis reported for DAS28 (ESR) response.p-value: <0.001Log Rank
Comparison: Analysis reported for DAS28 (ESR) response.p-value: 0.047Log Rank
Secondary
Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region
DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 \<3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Time to response for DAS28 (CRP) and DAS28 (ESR) by region were reported. Time to remission for DAS28 (CRP) and DAS28 (ESR) by region were not analyzed because time to remission for the overall study population could not be achieved.
Time frame: Baseline up to Day 169 (follow-up)
Population: The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | European: DAS28 (CRP) Response (n=75,39,41,39,39) | 85.0 days | 95% Confidence Interval 0.11 |
| Placebo | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | Japanese: DAS28 (CRP) Response (n=17,9,8,9,8) | NA days | 95% Confidence Interval 0.12 |
| Placebo | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | European: DAS28 (ESR) Response (n=75,39,41,39,39) | 71.0 days | — |
| Placebo | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | Japanese: DAS28 (ESR) Response (n=17,9,8,9,8) | NA days | — |
| Mavrilimumab 10 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | European: DAS28 (CRP) Response (n=75,39,41,39,39) | 43.0 days | 95% Confidence Interval 0.16 |
| Mavrilimumab 10 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | Japanese: DAS28 (ESR) Response (n=17,9,8,9,8) | 86.0 days | — |
| Mavrilimumab 10 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | Japanese: DAS28 (CRP) Response (n=17,9,8,9,8) | NA days | 95% Confidence Interval 0.166 |
| Mavrilimumab 10 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | European: DAS28 (ESR) Response (n=75,39,41,39,39) | 57.0 days | — |
| Mavrilimumab 30 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | Japanese: DAS28 (ESR) Response (n=17,9,8,9,8) | 29.0 days | — |
| Mavrilimumab 30 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | Japanese: DAS28 (CRP) Response (n=17,9,8,9,8) | 22.5 days | 95% Confidence Interval 0.163 |
| Mavrilimumab 30 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | European: DAS28 (ESR) Response (n=75,39,41,39,39) | 42.0 days | — |
| Mavrilimumab 30 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | European: DAS28 (CRP) Response (n=75,39,41,39,39) | 43.0 days | 95% Confidence Interval 0.139 |
| Mavrilimumab 50 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | European: DAS28 (CRP) Response (n=75,39,41,39,39) | 50.0 days | 95% Confidence Interval 0.146 |
| Mavrilimumab 50 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | Japanese: DAS28 (CRP) Response (n=17,9,8,9,8) | 87.0 days | 95% Confidence Interval 0.162 |
| Mavrilimumab 50 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | Japanese: DAS28 (ESR) Response (n=17,9,8,9,8) | 44.5 days | — |
| Mavrilimumab 50 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | European: DAS28 (ESR) Response (n=75,39,41,39,39) | 52.5 days | — |
| Mavrilimumab 100 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | Japanese: DAS28 (ESR) Response (n=17,9,8,9,8) | 30.0 days | — |
| Mavrilimumab 100 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | European: DAS28 (ESR) Response (n=75,39,41,39,39) | 29.0 days | — |
| Mavrilimumab 100 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | Japanese: DAS28 (CRP) Response (n=17,9,8,9,8) | 37.0 days | 95% Confidence Interval 0.165 |
| Mavrilimumab 100 mg | Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region | European: DAS28 (CRP) Response (n=75,39,41,39,39) | 42.0 days | 95% Confidence Interval 0.115 |
Comparison: European region: Analysis reported for DAS28 (CRP) response.p-value: 0.237Log Rank
Comparison: European region: Analysis reported for DAS28 (CRP) response.p-value: 0.005Log Rank
Comparison: European region: Analysis reported for DAS28 (CRP) response.p-value: 0.134Log Rank
Comparison: European region: Analysis reported for DAS28 (CRP) response.p-value: <0.001Log Rank
Comparison: Japanese region: Analysis reported for DAS28 (CRP) response.p-value: 0.265Log Rank
Comparison: Japanese region: Analysis reported for DAS28 (CRP) response.p-value: 0.013Log Rank
Comparison: Japanese region: Analysis reported for DAS28 (CRP) response.p-value: 0.952Log Rank
Comparison: Japanese region: Analysis reported for DAS28 (CRP) response.p-value: 0.004Log Rank
Comparison: European region: Analysis reported for DAS28 (ESR) response.p-value: 0.246Log Rank
Comparison: European region: Analysis reported for DAS28 (ESR) response.p-value: <0.001Log Rank
Comparison: European region: Analysis reported for DAS28 (ESR) response.p-value: 0.126Log Rank
Comparison: Japanese region: Analysis reported for DAS28 (ESR) response.p-value: 0.831Log Rank
Comparison: Japanese region: Analysis reported for DAS28 (ESR) response.p-value: 0.005Log Rank
Comparison: Japanese region: Analysis reported for DAS28 (ESR) response.p-value: 0.125Log Rank
Comparison: Japanese region: Analysis reported for DAS28 (ESR) response.p-value: <0.001Log Rank
Secondary
Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region
Data for European and Japanese regions were reported.
Time frame: Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169
Population: The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here N signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region | European region (n=37,41,40,37) | 4 days | Full Range 0.16 |
| Placebo | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region | Japanese region (n=9,8,9,8) | 6 days | Full Range 0.166 |
| Mavrilimumab 10 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region | Japanese region (n=9,8,9,8) | 7 days | Full Range 0.163 |
| Mavrilimumab 10 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region | European region (n=37,41,40,37) | 3 days | Full Range 0.139 |
| Mavrilimumab 30 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region | European region (n=37,41,40,37) | 4 days | Full Range 0.146 |
| Mavrilimumab 30 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region | Japanese region (n=9,8,9,8) | 6 days | Full Range 0.162 |
| Mavrilimumab 50 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region | European region (n=37,41,40,37) | 4 days | Full Range 0.115 |
| Mavrilimumab 50 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region | Japanese region (n=9,8,9,8) | 7 days | Full Range 0.165 |
Secondary
Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region
Data for European and Japanese regions were reported.
Time frame: Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169
Population: The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here N signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 3 days | Full Range 0.16 |
| Placebo | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 3 days | Full Range 0.166 |
| Mavrilimumab 10 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 3 days | Full Range 0.163 |
| Mavrilimumab 10 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 3 days | Full Range 0.139 |
| Mavrilimumab 30 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 3 days | Full Range 0.146 |
| Mavrilimumab 30 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 3.5 days | Full Range 0.162 |
| Mavrilimumab 50 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region | European region (n=33,33,37,37) | 3 days | Full Range 0.115 |
| Mavrilimumab 50 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region | Japanese region (n=9,7,8,8) | 2 days | Full Range 0.165 |