A Phase 3 interventional study of Placebo and tocilizumab [RoActemra/Actemra] in Sclerosis, Systemic, sponsored by Hoffmann-La Roche. Completed at 50 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-23.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's enrollment of 87 is above the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo · Drug: tocilizumab [RoActemra/Actemra]
Drug: tocilizumab [RoActemra/Actemra]
Subcutaneously weekly, Weeks 0-48
162 mg subcutaneously weekly, Weeks 0-48
162 mg subcutaneously weekly, Week 48-96
Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
Time frame: Baseline, Week 24
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to Week 8 after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Week 48
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
SHAQ-DI assessed five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant's disease. These items were developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant's daily activities. Each VAS item was rated separately (0-100 millimeters \[mm\]), with higher scores indicating more severe disease. The five items were: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.
Time frame: Baseline, Weeks 24 and 48
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 48
The HAQ-DI scale consisted of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicated the participant's self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI was the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.
Time frame: Baseline, Weeks 24 and 48
Change From Baseline in Clinician's Global Assessment at Week 24 and Week 48
The Clinician's Global Assessment evaluated the overall impact of SSc on the participant as assessed by the physician on a VAS with scores ranging from 0 to 100 mm, with higher scores indicating worse disease in terms of severity, damage, or overall disease, but there was no standardization for the scale.
Time frame: Baseline, Weeks 24 and 48
Change From Baseline in Patient's Global Assessment at Week 24 and Week 48
The Patient's Global Assessment was a patient's reported outcome that represented the participant's overall assessment of his or her current SSc on a 100 mm horizontal VAS scale (0 mm to 100 mm), with higher scores indicating worsening disease.
Time frame: Baseline, Weeks 24 and 48
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 and Week 48
This FACIT-Fatigue Scale was a 13-item measure with participants scoring each item on a 5-point scale (0 to 4) up to 52 points. The endpoint measured was fatigue. On this scale, a numerical increase indicated an improvement in the participant's condition.
Time frame: Baseline, Weeks 24 and 48
Change From Baseline in 5-D Itch Scale at Week 24 and Week 48
The 5-D Itch Scale contained five domains of duration, degree, direction, disability, and distribution. The endpoint of the scale was pruritus. Each domain was scored on a 5-point scale, the scores of each of the five domains were achieved separately and then summed together to obtain a total 5-D score. 5-D scores ranged between 5 (no pruritus) and 25 (most severe pruritus).
Time frame: Baseline, Weeks 24 and 48
Change From Baseline in mRSS at Week 48
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
Time frame: Baseline, Week 48
Percentage of Participants Who Maintained or Improved in mRSS From Week 24 to Week 48
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. Percentage of participants with an improvement in mRSS at Week 24 (change from baseline \<0) that maintained or further improved at Week 48 were reported as "Yes" and "No" with Yes = improvers at week 24 that had a change from baseline in mRSS at Week 48 \<= change from baseline at Week 24.
Time frame: Week 48
Change From Baseline in Tender Joint Count 28 (TJC28)
Joint tenderness was evaluated as per assessment of 28 joints. Joints on both sides of the body, including shoulders, elbows, wrists, 10 metacarpal phalangeal (MCP) joints, 10 proximal interphalangeal joint (PIP) joints, and both knees, were assessed. Joints were classified as not tender = 0 or tender = 1. Observed data was presented for this outcome measure.
Time frame: Baseline, Weeks 3, 8, 16, 24, 32, 40, and 48
Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hour (AUC0-168)
AUC was a measure of the serum concentration of the drug over time which was measured in micrograms times (\*) hour per milliliters (µg\*hr/mL). It is used to characterize drug absorption.
Time frame: Pre-dose, 24, 48, 72, 96, 120 or 144, and 168 hours post dose for Baseline and Week 16
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Observed data was presented for this outcome measure.
Time frame: Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Observed data was presented for this outcome measure.
Time frame: Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48
Percentage of Participants With Anti-Tocilizumab Antibody
Time frame: Baseline, and post-baseline (up to Week 48)
| Milestone | Placebo | Tocilizumab |
|---|---|---|
| Started | 44 | 43 |
| Completed | 36 | 35 |
| Not completed | 8 | 8 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Adverse event | 2 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Non-compliance | 1 | 0 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Withdrawal by subject | 4 | 2 |
| Milestone | Placebo | Tocilizumab |
|---|---|---|
| Started | 44 | 43 |
| Completed | 33 | 30 |
| Not completed | 11 | 13 |
| Withdrew: Death | 0 | 3 |
| Withdrew: Adverse event | 4 | 5 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Non-compliance | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Withdrawal by subject | 5 | 3 |
| Withdrew: Physician decision | 1 | 0 |
| Milestone | Placebo | Tocilizumab |
|---|---|---|
| Started | 31 | 30 |
| Completed | 24 | 27 |
| Not completed | 7 | 3 |
| Withdrew: Adverse event | 4 | 1 |
| Withdrew: Non-compliance | 1 | 0 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
| unit on a scale | Placebo | Tocilizumab |
|---|---|---|
| Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 | -1.22 (-3.42 to 0.98) | -3.92 (-6.17 to -1.67) |
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to Week 8 after last dose that were absent before treatment or that worsened relative to pretreatment state.
| percentage of participants | Placebo | Tocilizumab |
|---|---|---|
| Treatment-emergent adverse events | 90.9 | 97.7 |
| Treatment-emergent serious adverse events | 34.1 | 32.6 |
SHAQ-DI assessed five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant's disease. These items were developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant's daily activities. Each VAS item was rated separately (0-100 millimeters \[mm\]), with higher scores indicating more severe disease. The five items were: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.
| mm | Placebo | Tocilizumab |
|---|---|---|
| Week 24: Intestinal VAS Score (n=42, 41) | 5.81 (-1.43 to 13.06) | 5.38 (-1.98 to 12.74) |
| Week 24: Breathing VAS Scores (n=42, 41) | 8.54 (0.81 to 16.27) | 4.42 (-3.47 to 12.31) |
| Week 24: Raynaud syndrome (n=42, 41) | 2.41 (-6.96 to 11.78) | 1.13 (-8.47 to 10.73) |
| Week 24: Finger ulcers VAS Score (n=42, 41) | 9.20 (-0.22 to 18.61) | 14.09 (4.45 to 23.73) |
| Week 24: Overall disease (n=42, 41) | 1.89 (-4.99 to 8.77) | 1.81 (-5.21 to 8.84) |
| Week 48: Intestinal VAS Score (n=41, 41) | 7.91 (-0.37 to 16.18) | 1.11 (-6.88 to 9.10) |
| Week 48: Breathing VAS Scores (n=41, 41) | 0.55 (-7.09 to 8.19) | 2.09 (-5.39 to 9.57) |
| Week 48: Raynaud syndrome (n=41, 41) | 0.30 (-9.51 to 10.12) | -4.18 (-13.87 to 5.51) |
| Week 48: Finger ulcers VAS Score (n=41, 41) | 4.97 (-3.15 to 13.10) | -0.83 (-8.83 to 7.17) |
| Week 48: Overall disease (n=41, 41) | 3.46 (-4.50 to 11.41) | -4.36 (-12.27 to 3.55) |
The HAQ-DI scale consisted of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicated the participant's self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI was the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.
| units on a scale | Placebo | Tocilizumab |
|---|---|---|
| Week 24 (n=42, 41) | 0.118 (-0.026 to 0.262) | 0.137 (-0.010 to 0.285) |
| Week 48 (n=41, 41) | 0.205 (0.017 to 0.393) | -0.002 (-0.188 to 0.183) |
The Clinician's Global Assessment evaluated the overall impact of SSc on the participant as assessed by the physician on a VAS with scores ranging from 0 to 100 mm, with higher scores indicating worse disease in terms of severity, damage, or overall disease, but there was no standardization for the scale.
| mm | Placebo | Tocilizumab |
|---|---|---|
| Week 24 (n=41, 39) | -7.25 (-12.99 to -1.51) | -8.24 (-14.06 to -2.41) |
| Week 48 (n=41, 40) | -9.39 (-16.66 to -2.12) | -18.41 (-25.30 to -11.52) |
The Patient's Global Assessment was a patient's reported outcome that represented the participant's overall assessment of his or her current SSc on a 100 mm horizontal VAS scale (0 mm to 100 mm), with higher scores indicating worsening disease.
| mm | Placebo | Tocilizumab |
|---|---|---|
| Week 24 (n=42, 42) | 1.53 (-4.93 to 7.98) | -2.33 (-8.87 to 4.22) |
| Week 48 (n=41, 42) | -2.70 (-10.56 to 5.16) | -11.00 (-18.69 to -3.31) |
This FACIT-Fatigue Scale was a 13-item measure with participants scoring each item on a 5-point scale (0 to 4) up to 52 points. The endpoint measured was fatigue. On this scale, a numerical increase indicated an improvement in the participant's condition.
| units on a scale | Placebo | Tocilizumab |
|---|---|---|
| Week 24 (n=41, 42) | 1.26 (-1.85 to 4.37) | 2.68 (-0.41 to 5.77) |
| Week 48 (n=40, 42) | 0.36 (-2.64 to 3.37) | 3.11 (0.28 to 5.95) |
The 5-D Itch Scale contained five domains of duration, degree, direction, disability, and distribution. The endpoint of the scale was pruritus. Each domain was scored on a 5-point scale, the scores of each of the five domains were achieved separately and then summed together to obtain a total 5-D score. 5-D scores ranged between 5 (no pruritus) and 25 (most severe pruritus).
| units on a scale | Placebo | Tocilizumab |
|---|---|---|
| Week 24 (n=41, 41) | -1.73 (-2.95 to -0.50) | -0.94 (-2.15 to 0.28) |
| Week 48 (n=40, 41) | -1.08 (-2.60 to 0.43) | -2.19 (-3.58 to -0.80) |
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
| unit on a scale | Placebo | Tocilizumab |
|---|---|---|
| Change From Baseline in mRSS at Week 48 | -2.77 (-5.44 to -0.11) | -6.33 (-8.86 to -3.79) |
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. Percentage of participants with an improvement in mRSS at Week 24 (change from baseline \<0) that maintained or further improved at Week 48 were reported as "Yes" and "No" with Yes = improvers at week 24 that had a change from baseline in mRSS at Week 48 \<= change from baseline at Week 24.
| percentage of participants | Placebo | Tocilizumab |
|---|---|---|
| Percentage of Participants Who Maintained or Improved in mRSS From Week 24 to Week 48 | 44.4 | 68.2 |
Joint tenderness was evaluated as per assessment of 28 joints. Joints on both sides of the body, including shoulders, elbows, wrists, 10 metacarpal phalangeal (MCP) joints, 10 proximal interphalangeal joint (PIP) joints, and both knees, were assessed. Joints were classified as not tender = 0 or tender = 1. Observed data was presented for this outcome measure.
| joint count | Placebo | Tocilizumab |
|---|---|---|
| Week 3 (n=20, 19) | -2.75 ± 4.27 | -2.32 ± 5.55 |
| Week 8 (n=18, 19) | -3.06 ± 6.67 | -4.00 ± 6.16 |
| Week 16 (n=18, 17) | -3.50 ± 6.00 | -3.65 ± 7.59 |
| Week 24 (n=17, 16) | -2.06 ± 6.28 | -4.31 ± 7.34 |
| Week 32 (n=12, 11) | -3.33 ± 6.62 | -3.18 ± 7.40 |
| Week 40 (n=10, 10) | -3.80 ± 6.76 | -4.30 ± 8.23 |
| Week 48 (n=12, 10) | -2.92 ± 7.08 | -5.10 ± 7.29 |
AUC was a measure of the serum concentration of the drug over time which was measured in micrograms times (\*) hour per milliliters (µg\*hr/mL). It is used to characterize drug absorption.
| µg*hr/mL | Tocilizumab |
|---|---|
| Baseline (n=7) | 686 ± 455 |
| Week 16 (n=4) | 7508 ± 2369 |
Observed data was presented for this outcome measure.
| picograms per milliliters (pg/mL) | Placebo | Tocilizumab |
|---|---|---|
| Baseline (n=43, 42) | 15.02 ± 18.19 | 13.57 ± 14.69 |
| Week 1: Absolute values (n=43, 43) | 17.24 ± 22.77 | 158.91 ± 326.42 |
| Week 1: Change From Baseline (n=42, 42) | 1.33 ± 27.29 | 147.37 ± 326.20 |
| Week 2: Absolute values (n=43, 41) | 12.60 ± 13.78 | 107.10 ± 73.75 |
| Week 2: Change From Baseline (n=42, 40) | -3.07 ± 17.85 | 94.54 ± 67.99 |
| Week 3: Absolute values (n=42, 40) | 12.47 ± 10.72 | 116.58 ± 75.31 |
| Week 3: Change From Baseline (n=41, 39) | -3.60 ± 15.28 | 104.44 ± 71.84 |
| Week 8: Absolute values (n=42, 39) | 15.39 ± 19.04 | 115.31 ± 66.39 |
| Week 8: Change From Baseline(n=41,38) | 0.15 ± 18.65 | 104.14 ± 62.95 |
| Week 16: Absolute values (n=32,33) | 12.51 ± 14.06 | 98.36 ± 61.65 |
| Week 16: Change From Baseline (n=31,32) | -1.26 ± 11.34 | 88.86 ± 59.77 |
| Week 24: Absolute values (n=36,34) | 10.19 ± 10.55 | 84.67 ± 68.37 |
| Week 24: Change From Baseline(n=35,33) | -2.74 ± 12.43 | 73.61 ± 68.07 |
| Week 48: Absolute values (n=32,27) | 10.50 ± 11.82 | 65.30 ± 35.95 |
| Week 48: Change From Baseline (n=31,26) | -2.61 ± 14.92 | 55.60 ± 35.86 |
Observed data was presented for this outcome measure.
| pg/mL | Placebo | Tocilizumab |
|---|---|---|
| Baseline (n=44, 42) | 37.61 ± 11.12 | 39.39 ± 10.16 |
| Week 1: Absolute values (n=44, 43) | 51.03 ± 59.12 | 237.34 ± 71.38 |
| Week 1: Change From Baseline (n=44, 42) | 13.42 ± 57.91 | 198.39 ± 69.41 |
| Week 2: Absolute values (n=43, 41) | 44.07 ± 42.15 | 329.90 ± 81.93 |
| Week 2: Change From Baseline (n=43, 40) | 6.13 ± 41.60 | 291.38 ± 79.29 |
| Week 3: Absolute values (n=44, 40) | 41.64 ± 27.07 | 384.88 ± 99.41 |
| Week 3: Change From Baseline (n=44, 39) | 4.03 ± 26.00 | 346.68 ± 95.96 |
| Week 8: Absolute values (n=42, 39) | 38.66 ± 11.95 | 486.62 ± 116.41 |
| Week 8: Change From Baseline (n=42, 38) | 0.91 ± 5.07 | 447.77 ± 114.40 |
| Week 16: Absolute values (n=32, 33) | 37.71 ± 10.30 | 525.48 ± 164.90 |
| Week 16: Change From Baseline (n=32, 32) | -0.08 ± 5.71 | 486.43 ± 163.32 |
| Week 24: Absolute values (n=36, 34) | 38.72 ± 13.06 | 520.18 ± 167.97 |
| Week 24: Change From Baseline (n=36, 33) | 1.11 ± 6.47 | 482.10 ± 168.44 |
| Week 48: Absolute values (n=32, 27) | 36.52 ± 9.93 | 491.44 ± 164.82 |
| Week 48: Change From Baseline (n=32, 26) | -0.75 ± 5.20 | 454.19 ± 163.93 |
| percentage of participants | Placebo | Tocilizumab |
|---|---|---|
| Baseline | 7.0 | 2.4 |
| Post-Baseline | 0.0 | 2.4 |
Collected over Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo (up to 24 Weeks) | — | 11/44 (25%) | 26/44 (59.1%) |
| Tocilizumab (up to 24 Weeks) | — | 9/43 (20.9%) | 28/43 (65.1%) |
| Placebo (up to 48 Weeks) | — | 15/44 (34.1%) | 32/44 (72.7%) |
| Tocilizumab (up to 48 Weeks) | — | 14/43 (32.6%) | 34/43 (79.1%) |
| Placebo to Tocilizumab (up to 96 Weeks) | — | 22/44 (50%) | 39/44 (88.6%) |
| Tocilizumab to Tocilizumab (up to 96 Weeks) | — | 17/43 (39.5%) | 38/43 (88.4%) |
| Event | Placebo (up to 24 Weeks) | Tocilizumab (up to 24 Weeks) | Placebo (up to 48 Weeks) | Tocilizumab (up to 48 Weeks) | Placebo to Tocilizumab (up to 96 Weeks) | Tocilizumab to Tocilizumab (up to 96 Weeks) |
|---|---|---|---|---|---|---|
| Infected skin ulcerInfections and infestations | 0/44 | 1/43 | 0/44 | 1/43 | 2/44 | 2/43 |
| OsteomyelitisInfections and infestations | 0/44 | 2/43 | 1/44 | 2/43 | 2/44 | 2/43 |
| Skin ulcerSkin and subcutaneous tissue disorders | 0/44 | 1/43 | 1/44 | 2/43 | 1/44 | 2/43 |
| Scleroderma renal crisisRenal and urinary disorders | 1/44 | 0/43 | 1/44 | 0/43 | 2/44 | 0/43 |
| Haemolytic uraemic syndromeBlood and lymphatic system disorders | 0/44 | 1/43 | 0/44 | 1/43 | 0/44 | 1/43 |
| ArrhythmiaCardiac disorders | 0/44 | 0/43 | 0/44 | 1/43 | 0/44 | 1/43 |
| GastritisGastrointestinal disorders | 0/44 | 0/43 | 0/44 | 1/43 | 0/44 | 1/43 |
| Impaired healingGeneral disorders | 0/44 | 1/43 | 0/44 | 1/43 | 0/44 | 1/43 |
| Multi-organ failureGeneral disorders | 0/44 | 0/43 | 0/44 | 1/43 | 0/44 | 1/43 |
| BronchitisInfections and infestations | 0/44 | 1/43 | 0/44 | 1/43 | 0/44 | 1/43 |
| Event | Placebo (up to 24 Weeks) | Tocilizumab (up to 24 Weeks) | Placebo (up to 48 Weeks) | Tocilizumab (up to 48 Weeks) | Placebo to Tocilizumab (up to 96 Weeks) | Tocilizumab to Tocilizumab (up to 96 Weeks) |
|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 4/44 | 6/43 | 4/44 | 7/43 | 5/44 | 12/43 |
| PruritusSkin and subcutaneous tissue disorders | 3/44 | 7/43 | 4/44 | 8/43 | 9/44 | 12/43 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 6/44 | 6/43 | 8/44 | 6/43 | 10/44 | 6/43 |
| Skin ulcerSkin and subcutaneous tissue disorders | 6/44 | 6/43 | 7/44 | 7/43 | 9/44 | 8/43 |
| NasopharyngitisInfections and infestations | 2/44 | 3/43 | 4/44 | 5/43 | 5/44 | 8/43 |
| Back painMusculoskeletal and connective tissue disorders | 3/44 | 5/43 | 3/44 | 6/43 | 3/44 | 8/43 |
| HeadacheNervous system disorders | 2/44 | 3/43 | 3/44 | 5/43 | 5/44 | 8/43 |
| Upper respiratory tract infectionInfections and infestations | 0/44 | 0/43 | 6/44 | 1/43 | 8/44 | 3/43 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/44 | 5/43 | 2/44 | 5/43 | 2/44 | 7/43 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 4/44 | 4/43 | 5/44 | 5/43 | 7/44 | 5/43 |
Safety population included all participants who received any study drug and provided at least one post-dose safety assessment (withdrawal, adverse event \[AE\], death, laboratory assessment, vital signs).
| Age, Continuous(years) | Placebo | Tocilizumab | Total |
|---|---|---|---|
| Mean | 48.1 ± 12.9 | 51.2 ± 11.7 | 49.6 ± 12.3 |
| Sex: Female, Male(Participants) | Placebo | Tocilizumab | Total |
|---|---|---|---|
| Female | 35 | 32 | 67 |
| Male | 9 | 11 | 20 |
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