An observational study in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 3 sites in Estonia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-10.
Sponsored by Hoffmann-La Roche · Observational
This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the local label will be followed for 12 months.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 23 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis 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.
Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra (tocilizumab)
Exclusion Criteria:
Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation
Time frame: 6 Months
Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation
Time frame: Month 12
Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity
Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (\>=) 75 days between two consecutive doses of study drug.
Time frame: Up to Month 12
Number of Participants With Comorbidities at Baseline
Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.
Time frame: Baseline
Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)
Time frame: Baseline
Number of Participants With Prior Exposure of Biologics
Time frame: Baseline
Disease Activity Score Based on 28-joints Count (DAS28)
DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (\<=) 2.6 meant clinical remission; DAS28 \<=3.2 meant low disease activity; DAS28 greater than (\>) 3.2 to 5.1 implied moderate disease activity; and DAS28 \>5.1 implied high disease activity.
Time frame: Baseline, Month 3, 6, and 12
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline \>1.2 with DAS28 \<= 3.2; moderate responders: decrease from baseline \>1.2 with DAS28 \>3.2 or decrease from baseline \>0.6 to \<=1.2 with DAS28 \<=5.1; non-responders: decrease from baseline \<= 0.6 or decrease from baseline \>0.6 and \<=1.2 with DAS28 \>5.1.
Time frame: Month 3, 6, and 12
Physician Global Assessment (PGA) of Disease Activity
PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.
Time frame: Baseline, Month 6, and 12
Patient Global Assessment (PtGA) of Disease Activity Score
PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.
Time frame: Baseline, Month 6, and 12
Health Assessment 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 was scored on a 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 divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Baseline, Month 6, and 12
Visual Analog Scale (VAS)-Pain
Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.
Time frame: Baseline, Month 6, and 12
Visual Analog Fatigue Scale (VAFS)
Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Time frame: Baseline, Month 6, and 12
Visual Analog Scale-Morning Stiffness (VAS-MS)
Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.
Time frame: Baseline, Month 6, and 12
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. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time frame: Baseline, Month 6, and 12
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. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Month 6, and 12
Number of Swollen and Tender Joints Based on 66 and 68 Joints
Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) 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 at each visit, 0 = no tenderness, 1 = tenderness.
Time frame: Baseline, Month 6, and 12
Number of Swollen and Tender Joints Based on 28 Joints
Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) 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 at each visit, 0 = no tenderness, 1 = tenderness.
Time frame: Baseline, Month 6, and 12
Simplified Disease Activity Index (SDAI) Score
The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
Time frame: Baseline, Month 6, and 12
Clinical Disease Activity Index (CDAI) Score
The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
Time frame: Baseline, Month 6, and 12
Number of Participants Who Received Tocilizumab as Monotherapy
Time frame: Baseline, Study end (at Month 12 or at time of study discontinuation)
Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)
Time frame: Baseline, Study end (at Month 12 or at time of study discontinuation)
Number of Participants Receiving Oral Corticosteroids
Time frame: Baseline, Month 3, 6, and 12
Number of Participants With Disease Activity Status Based on DAS28 Score
Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score \<= 2.6; low disease activity: DAS28 \<=3.2; moderate disease activity: DAS28 \<=5.1; and high disease activity: DAS28 \>5.1.
Time frame: Baseline, Month 3, 6, and 12
Number of Participants With Disease Activity Status Based on SDAI Score
Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score \<= 3.3; low disease activity: SDAI \<=11.0; moderate disease activity: SDAI \<=26.0; and high disease activity: SDAI \>26.0.
Time frame: Baseline, Month 3, 6, and 12
Number of Participants With Disease Activity Status Based on CDAI Score
Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score \<= 2.8; low disease activity: CDAI \<=10.0; moderate disease activity: CDAI \<=22.0; and high disease activity: CDAI \>22.0.
Time frame: Baseline, Month 3, 6, and 12
| Milestone | Tocilizumab |
|---|---|
| Started | 23 |
| Completed | 15 |
| Not completed | 8 |
| Withdrew: Lack of efficacy | 3 |
| Withdrew: Consent withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Switched to subcutaneous tocilizumab | 2 |
| percentage of participants | Tocilizumab |
|---|---|
| Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation | 73.9 (51.6 to 89.9) |
| percentage of participants | Tocilizumab |
|---|---|
| Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation | 69.6 (47.1 to 86.8) |
Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (\>=) 75 days between two consecutive doses of study drug.
| percentage of participants | Tocilizumab |
|---|---|
| Dose Modification | 26.1 |
| Dose Modification + Interruption | 39.1 |
| Dose Modification + Interruption + Irregularity | 39.1 |
Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.
| participants | Tocilizumab |
|---|---|
| Anemia | 1 |
| Iron deficiency anemia | 1 |
| Atrial fibrillation | 1 |
| Hypothyroidism | 3 |
| Chronic gastritis | 2 |
| Duodenitis | 1 |
| Duodenal ulcer perforation | 1 |
| Dyspepsia | 1 |
| Gastric disorder | 2 |
| Inguinal hernia | 1 |
| Large intestine polyp | 1 |
| Cholelithiasis | 1 |
| Hepatic steatosis | 1 |
| Latent tuberculosis | 1 |
| Pulmonary tuberculosis | 1 |
| Hyperlipidaemia | 2 |
| Spinal osteoarthritis | 2 |
| Osteoarthritis | 5 |
| Osteopenia | 2 |
| Osteoporosis | 2 |
| Rotator cuff syndrome | 1 |
| Scoliosis | 1 |
| Spondyloarthropathy | 1 |
| Spondylolisthesis | 1 |
| Spinal column stenosis | 1 |
| Haemangioma of liver | 1 |
| Ovarian cancer | 1 |
| Radiculopathy | 1 |
| Cervical radiculopathy | 1 |
| Gynaecomastia | 1 |
| Chronic obstructive pulmonary disease | 1 |
| Hypertension | 9 |
| participants | Tocilizumab |
|---|---|
| No Prior DMARDs | 1 |
| 1 Prior DMARD | 1 |
| 2 Prior DMARDs | 5 |
| 3 Prior DMARDs | 7 |
| 4 Prior DMARDs | 5 |
| 5 Prior DMARDs | 4 |
| participants | Tocilizumab |
|---|---|
| No Prior Biologics | 12 |
| 1 Prior Biologic | 8 |
| 2 Prior Biologics | 3 |
DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (\<=) 2.6 meant clinical remission; DAS28 \<=3.2 meant low disease activity; DAS28 greater than (\>) 3.2 to 5.1 implied moderate disease activity; and DAS28 \>5.1 implied high disease activity.
| units on a scale | Tocilizumab |
|---|---|
| Baseline (n=22) | 5.35 ± 1.21 |
| Month 3 (n=19) | 3.54 ± 1.20 |
| Month 6 (n=17) | 2.91 ± 1.59 |
| Month 12 (n=11) | 2.29 ± 1.11 |
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline \>1.2 with DAS28 \<= 3.2; moderate responders: decrease from baseline \>1.2 with DAS28 \>3.2 or decrease from baseline \>0.6 to \<=1.2 with DAS28 \<=5.1; non-responders: decrease from baseline \<= 0.6 or decrease from baseline \>0.6 and \<=1.2 with DAS28 \>5.1.
| participants | Tocilizumab |
|---|---|
| Month 3: Good responders (n=18) | 6 |
| Month 3: Moderate responders (n=18) | 8 |
| Month 3: Non-responders (n=18) | 4 |
| Month 6: Good responders (n=16) | 11 |
| Month 6: Moderate responders (n = 16) | 2 |
| Month 6: Non-responders (n=16) | 3 |
| Month 12: Good responders (n=11) | 8 |
| Month 12: Moderate responders (n=11) | 2 |
| Month 12: Non-responders (n=11) | 1 |
PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.
| mm | Tocilizumab |
|---|---|
| Baseline (n=20) | 58.40 ± 10.08 |
| Month 6 (n=15) | 27.00 ± 18.34 |
| Month 12 (n=10) | 13.80 ± 13.83 |
PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.
| mm | Tocilizumab |
|---|---|
| Baseline (n=22) | 62.68 ± 17.67 |
| Month 6 (n=17) | 36.85 ± 24.22 |
| Month 12 (n=11) | 22.27 ± 21.00 |
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 was scored on a 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 divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.
| units on a scale | Tocilizumab |
|---|---|
| Baseline (n=20) | 1.22 ± 0.80 |
| Month 6 (n=10) | 0.98 ± 0.81 |
| Month 12 (n=6) | 0.65 ± 0.52 |
Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.
| mm | Tocilizumab |
|---|---|
| Baseline (n=22) | 56.18 ± 21.64 |
| Month 6 (n=17) | 35.00 ± 23.25 |
| Month 12 (n=11) | 22.91 ± 22.87 |
Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
| mm | Tocilizumab |
|---|---|
| Baseline (n=6) | 67.00 ± 30.66 |
| Month 6 (n=5) | 39.80 ± 30.38 |
| Month 12 (n=3) | 5.67 ± 6.66 |
Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.
| mm | Tocilizumab |
|---|---|
| Baseline (n=6) | 67.00 ± 12.54 |
| Month 6 (n=5) | 23.60 ± 33.22 |
| Month 12 (n=2) | 16.00 ± 19.80 |
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. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
| mm/hr | Tocilizumab |
|---|---|
| Baseline (n=23) | 36.83 ± 27.53 |
| Month 6 (n=16) | 9.81 ± 14.11 |
| Month 12 (n=13) | 6.54 ± 6.77 |
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
| mg/L | Tocilizumab |
|---|---|
| Baseline (n=23) | 30.16 ± 41.14 |
| Month 6 (n=18) | 8.54 ± 17.54 |
| Month 12 (n=14) | 4.07 ± 7.70 |
Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) 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 at each visit, 0 = no tenderness, 1 = tenderness.
| joints count | Tocilizumab |
|---|---|
| SJC66: Baseline (n=7) | 4.29 ± 2.21 |
| TJC68: Baseline (n=7) | 6.86 ± 7.99 |
| SJC66: Month 6 (n=1) | 0 ± NA |
| TJC68: Month 6 (n=1) | 0 ± NA |
| SJC66: Month 12 (n=1) | 1.00 ± NA |
| TJC68: Month 12 (n=1) | 2.00 ± NA |
Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) 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 at each visit, 0 = no tenderness, 1 = tenderness.
| joints count | Tocilizumab |
|---|---|
| SJC28: Baseline (n=23) | 6.78 ± 4.06 |
| TJC28: Baseline (n=23) | 9.13 ± 7.23 |
| SJC28: Month 6 (n=18) | 2.56 ± 2.79 |
| TJC28: Month 6 (n=18) | 4.11 ± 6.03 |
| SJC28: Month 12 (n=13) | 1.54 ± 2.40 |
| TJC28: Month 12 (n=13) | 1.92 ± 1.85 |
The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
| units on a scale | Tocilizumab |
|---|---|
| Baseline (n=20) | 31.99 ± 10.77 |
| Month 6 (n=15) | 13.69 ± 11.60 |
| Month 12 (n=10) | 7.17 ± 6.12 |
The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
| units on a scale | Tocilizumab |
|---|---|
| Baseline (n=20) | 28.68 ± 10.21 |
| Month 6 (n=15) | 13.12 ± 11.55 |
| Month 12 (n=10) | 6.77 ± 5.33 |
| participants | Tocilizumab |
|---|---|
| Baseline | 2 |
| Study end | 9 |
| participants | Tocilizumab |
|---|---|
| Baseline | 21 |
| Study end | 14 |
| Participants | Tocilizumab |
|---|---|
| Baseline (n=23) | 18 |
| Month 3 (n=21) | 14 |
| Month 6 (n=19) | 12 |
| Month 12 (n=15) | 9 |
Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score \<= 2.6; low disease activity: DAS28 \<=3.2; moderate disease activity: DAS28 \<=5.1; and high disease activity: DAS28 \>5.1.
| participants | Tocilizumab |
|---|---|
| Baseline: Remission (n=22) | 1 |
| Baseline: low disease activity (n=22) | 1 |
| Baseline: moderate disease activity (n=22) | 4 |
| Baseline: high disease activity (n=22) | 16 |
| Month 3: Remission (n=19) | 5 |
| Month 3: low disease activity (n=19) | 3 |
| Month 3: moderate disease activity (n=19) | 8 |
| Month 3: high disease activity (n=19) | 3 |
| Month 6: Remission (n=17) | 8 |
| Month 6: low disease activity (n=17) | 3 |
| Month 6: moderate disease activity (n=17) | 4 |
| Month 6: high disease activity (n=17) | 2 |
| Month 12: Remission (n=11) | 9 |
| Month 12: moderate disease activity (n=11) | 2 |
Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score \<= 3.3; low disease activity: SDAI \<=11.0; moderate disease activity: SDAI \<=26.0; and high disease activity: SDAI \>26.0.
| participants | Tocilizumab |
|---|---|
| Baseline: moderate disease activity (n=20) | 5 |
| Baseline: high disease activity (n=20) | 15 |
| Month 3: low disease activity (n=16) | 5 |
| Month 3: moderate disease activity (n=16) | 8 |
| Month 3: high disease activity (n=16) | 3 |
| Month 6: Remission (n=15) | 3 |
| Month 6: low disease activity (n=15) | 4 |
| Month 6: moderate disease activity (n=15) | 7 |
| Month 6: high disease activity (n=15) | 1 |
| Month 12: Remission (n=10) | 2 |
| Month 12: low disease activity (n=10) | 6 |
| Month 12: moderate disease activity (n=10) | 2 |
Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score \<= 2.8; low disease activity: CDAI \<=10.0; moderate disease activity: CDAI \<=22.0; and high disease activity: CDAI \>22.0.
| participants | Tocilizumab |
|---|---|
| Baseline: moderate disease activity (n=20) | 5 |
| Baseline: high disease activity (n=20) | 15 |
| Month 3: low disease activity (n=17) | 4 |
| Month 3: moderate disease activity (n=17) | 9 |
| Month 3: high disease activity (n=17) | 4 |
| Month 6: Remission (n=15) | 3 |
| Month 6: low disease activity (n=15) | 4 |
| Month 6: moderate disease activity (n=15) | 5 |
| Month 6: high disease activity (n=15) | 3 |
| Month 12: Remission (n=10) | 2 |
| Month 12: low disease activity (n=10) | 6 |
| Month 12: moderate disease activity (n=10) | 2 |
Collected over Up to Month 12. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tocilizumab | 0/23 (0%) | 4/23 (17.4%) | 10/23 (43.5%) |
| Event | Tocilizumab |
|---|---|
| Chronic tonsillitisInfections and infestations | 1/23 |
| Post procedural infectionInfections and infestations | 1/23 |
| Femur fractureInjury, poisoning and procedural complications | 1/23 |
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 1/23 |
| Knee arthroplastySurgical and medical procedures | 1/23 |
| Event | Tocilizumab |
|---|---|
| HypertensionVascular disorders | 4/23 |
| NasopharyngitisInfections and infestations | 3/23 |
| Hepatic enzyme increasedInvestigations | 3/23 |
| LeukopeniaBlood and lymphatic system disorders | 2/23 |
| NeutropeniaBlood and lymphatic system disorders | 2/23 |
| Upper respiratory tract infectionInfections and infestations | 2/23 |
Full analysis set (FAS) included all participants who were enrolled in this study.
| Age, Continuous(years) | Tocilizumab |
|---|---|
| Mean | 52.4 ± 12.2 |
| Sex: Female, Male(Participants) | Tocilizumab |
|---|---|
| Female | 20 |
| Male | 3 |
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