Rheumatoid Arthritis
Conditions
Brief summary
This observational study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis. Data will be collected from patients for the 12 months following the first infusion of RoActemra/Actemra.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria * Initiated on RoActemra/Actemra treatment according to the Summary of Product Characteristics not more than 6 months before opening of study center
Exclusion criteria
* Current serious infection * Hypersensitivity to the active component or any of the excipients * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment | Up to 12 months | Low disease activity is defined as a disease activity score based on 28 joint count (DAS28) score lesser or equal to (\</=) 3.2. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. Erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) measurement, 4. Participant's judgement on his own overall health status expressed by a visual analogue scale (VAS). The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. Percentage of participants with low disease activity was reported. |
| Percentage of Participants Achieving Disease Remission After 6 Months of Treatment | Up to 12 months | Disease remission is defined as a DAS28 score \< 2.6. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. Percentage of participants with disease remission was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab | Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 | The health assessment questionnaire (HAQ) is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, the participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score of minimum/maximum i.e., 0 (best) to 3 (worst). |
| Number of Participants With Concomitant Medications | Up to 12 months | Number of participants treated with at least one concomitant medication i.e., corticosteroid (Prednisone, Methyl prednisolone) was reported. |
| Percentage of Participants Discontinuing Treatment With Tocilizumab | Up to 12 months | The percentage of participants who prematurely discontinued treatment with TCZ during the study period was reported. |
| Number of Participants With Any Adverse Events and Serious Adverse Events | Up to 12 months | An adverse event (AE) was defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. |
| Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion | Up to 12 months | Percentage of participants who continued treatment till 12 months after the first infusion with TCZ was reported. |
| Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 | The presence and severity of synovial hyperplasia (SH) and joint effusion (JE) of second metacarpo-phalangeal (MCP) joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, synovial hyperplasia and joint effusion were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra articular surface). |
| Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab | Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12 | The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3.ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. |
| Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 | The presence and severity of SH and JE of second MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of second MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface). |
| Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 | The presence and severity of SH and JE of third MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface). |
| Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 | The DAS28 index applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints) 3. ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. The mean DAS28 scores were evaluated after the first infusion of TCZ in two different sub populations: participants with inadequate response (IR) to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of DAS28 was available for 81 participants in DMARD-IR group and 203 participants in DMARD + anti-TNF-IR group. |
| Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 | VAS for fatigue is a 100 mm scale for participant's assessment of their current level of fatigue: 0 mm corresponds to no perception of fatigue; 100 mm is the maximum that may be perceived. The mean VAS fatigue scores were evaluated after the first infusion of TCZ in two different sub populations, classified according to the previous pharmacological treatment: participants with inadequate response to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of fatigue (VAS) was available for 45 participants in DMARD-IR group and 113 participants in DMARD + anti-TNF-IR group. |
| Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 | The HAQ is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). Data allowing the evaluation of HAQ was available for 73 participants in DMARD-IR group and 157 participants in DMARD + anti-TNF-IR group. |
| Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 | The presence and severity of SH and JE of third MCP joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of right hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intraarticular surface). |
| Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab | Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 | VAS for fatigue is a 100 mm scale for participant's assessment of their current level of fatigue. The '0 'mm corresponds to no perception of fatigue, '100 mm' is the maximum level of fatigue that may be perceived. Mean score of VAS fatigue in participants were reported. |
Countries
Italy
Participant flow
Recruitment details
A total of 322 participants were enrolled across 59 study centers in Italy from 31 May 2011 to 24 April 2013.
Participants by arm
| Arm | Count |
|---|---|
| Tocilizumab Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC. | 322 |
| Total | 322 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Insufficient compliance | 9 |
| Overall Study | Insufficient therapeutic effect | 17 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Not related AEs | 9 |
| Overall Study | Participant moved to another site | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Related Adverse event (AEs) | 15 |
| Overall Study | Remission of disease | 2 |
| Overall Study | Symptoms of concurrent diseases | 1 |
| Overall Study | unavailability of drug at the Hospital | 2 |
Baseline characteristics
| Characteristic | Tocilizumab |
|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 260 Participants |
| Sex: Female, Male Male | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 99 / 322 |
| serious Total, serious adverse events | 28 / 322 |
Outcome results
Primary
Percentage of Participants Achieving Disease Remission After 6 Months of Treatment
Disease remission is defined as a DAS28 score \< 2.6. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. Percentage of participants with disease remission was reported.
Time frame: Up to 12 months
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of disease remission was available for 226 participants in TCZ group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab | Percentage of Participants Achieving Disease Remission After 6 Months of Treatment | 38.05 percentage of participants |
p-value: 0.0003Exact binomial proportion test
Primary
Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment
Low disease activity is defined as a disease activity score based on 28 joint count (DAS28) score lesser or equal to (\</=) 3.2. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. Erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) measurement, 4. Participant's judgement on his own overall health status expressed by a visual analogue scale (VAS). The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. Percentage of participants with low disease activity was reported.
Time frame: Up to 12 months
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of low disease activity was available for 226 participants in TCZ group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab | Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment | 57.52 percentage of participants |
p-value: 0.0237Exact binomial proportion test
Secondary
Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents
The DAS28 index applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints) 3. ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. The mean DAS28 scores were evaluated after the first infusion of TCZ in two different sub populations: participants with inadequate response (IR) to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of DAS28 was available for 81 participants in DMARD-IR group and 203 participants in DMARD + anti-TNF-IR group.
Time frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Baseline; n = 81, 203 | 5.3 units on a scale | Standard Deviation 1.1 |
| Tocilizumab | Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 1; n = 54, 150 | 3.6 units on a scale | Standard Deviation 1.2 |
| Tocilizumab | Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 2; n = 62, 144 | 3.1 units on a scale | Standard Deviation 1.3 |
| Tocilizumab | Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 4; n = 64, 127 | 3.0 units on a scale | Standard Deviation 1.4 |
| Tocilizumab | Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 6; n = 65, 158 | 3.0 units on a scale | Standard Deviation 1.2 |
| Tocilizumab | Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 12; n = 60, 125 | 2.7 units on a scale | Standard Deviation 1.2 |
| DMARD + Anti-TNF-IR | Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 6; n = 65, 158 | 3.0 units on a scale | Standard Deviation 1.2 |
| DMARD + Anti-TNF-IR | Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Baseline; n = 81, 203 | 5.3 units on a scale | Standard Deviation 1.3 |
| DMARD + Anti-TNF-IR | Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 4; n = 64, 127 | 3.1 units on a scale | Standard Deviation 1.2 |
| DMARD + Anti-TNF-IR | Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 1; n = 54, 150 | 3.7 units on a scale | Standard Deviation 1.3 |
| DMARD + Anti-TNF-IR | Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 12; n = 60, 125 | 2.6 units on a scale | Standard Deviation 1.1 |
| DMARD + Anti-TNF-IR | Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 2; n = 62, 144 | 3.4 units on a scale | Standard Deviation 1.3 |
Comparison: At Baseline: mean difference of scores of DAS28 between the two groups was calculated.p-value: 0.80895% CI: [-0.3, 0.4]t-test, 2 sided
Comparison: At Month 1: mean difference of scores of DAS28 between the two groups was calculated.p-value: 0.488495% CI: [-0.5, 0.3]t-test, 2 sided
Comparison: At Month 2: mean difference of scores of DAS28 between the two groups was calculated.p-value: 0.094795% CI: [-0.7, 0.1]t-test, 2 sided
Comparison: At Month 4: mean difference of scores of DAS28 between the two groups was calculated.p-value: 0.818195% CI: [-0.4, 0.3]t-test, 2 sided
Comparison: At Month 6: mean difference of scores of DAS28 between the two groups was calculated.p-value: 0.972195% CI: [-0.4, 0.3]t-test, 2 sided
Comparison: At Month 12: mean difference of scores of DAS28 between the two groups was calculated.p-value: 0.583295% CI: [-0.3, 0.5]t-test, 2 sided
Secondary
Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab
The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3.ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation.
Time frame: Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of disease activity based on 28 joints count was available for 93 participants in TCZ group. The n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab | Baseline; n = 93 | 5.4 units on a scale | Standard Deviation 1.3 |
| Tocilizumab | Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab | Month 1; n = 60 | 3.6 units on a scale | Standard Deviation 1.3 |
| Tocilizumab | Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab | Month 2; n = 63 | 3.3 units on a scale | Standard Deviation 1.1 |
| Tocilizumab | Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab | Month 4; n = 64 | 3.2 units on a scale | Standard Deviation 1.3 |
| Tocilizumab | Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab | Month 6; n = 75 | 3.0 units on a scale | Standard Deviation 1.2 |
| Tocilizumab | Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab | Month 12; n = 61 | 2.8 units on a scale | Standard Deviation 1.2 |
Secondary
Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab
VAS for fatigue is a 100 mm scale for participant's assessment of their current level of fatigue. The '0 'mm corresponds to no perception of fatigue, '100 mm' is the maximum level of fatigue that may be perceived. Mean score of VAS fatigue in participants were reported.
Time frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of fatigue based on VAS was available for 50 participants in TCZ group. The n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab | Baseline; n = 50 | 62.8 units on a scale | Standard Deviation 23.2 |
| Tocilizumab | Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab | Month 1; n = 39 | 48.2 units on a scale | Standard Deviation 27.9 |
| Tocilizumab | Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab | Month 12; n = 46 | 33.1 units on a scale | Standard Deviation 24.9 |
| Tocilizumab | Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab | Month 2; n = 36 | 41.8 units on a scale | Standard Deviation 25.6 |
| Tocilizumab | Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab | Month 4; n = 39 | 38.8 units on a scale | Standard Deviation 26.6 |
| Tocilizumab | Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab | Month 6; n = 48 | 38.8 units on a scale | Standard Deviation 26.1 |
Secondary
Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents
VAS for fatigue is a 100 mm scale for participant's assessment of their current level of fatigue: 0 mm corresponds to no perception of fatigue; 100 mm is the maximum that may be perceived. The mean VAS fatigue scores were evaluated after the first infusion of TCZ in two different sub populations, classified according to the previous pharmacological treatment: participants with inadequate response to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of fatigue (VAS) was available for 45 participants in DMARD-IR group and 113 participants in DMARD + anti-TNF-IR group.
Time frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Baseline; n = 42, 113 | 62.3 units on a scale | Standard Deviation 21.6 |
| Tocilizumab | Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 1; n = 34, 90 | 50.1 units on a scale | Standard Deviation 24.2 |
| Tocilizumab | Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 2; n = 38, 88 | 50.6 units on a scale | Standard Deviation 24 |
| Tocilizumab | Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 4; n = 45, 99 | 42.8 units on a scale | Standard Deviation 22.9 |
| Tocilizumab | Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 6; n = 43, 111 | 48.4 units on a scale | Standard Deviation 23.6 |
| Tocilizumab | Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 12; n = 45, 94 | 34.9 units on a scale | Standard Deviation 19.9 |
| DMARD + Anti-TNF-IR | Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 6; n = 43, 111 | 34.7 units on a scale | Standard Deviation 25.4 |
| DMARD + Anti-TNF-IR | Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Baseline; n = 42, 113 | 58.7 units on a scale | Standard Deviation 25.2 |
| DMARD + Anti-TNF-IR | Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 4; n = 45, 99 | 40.0 units on a scale | Standard Deviation 24.8 |
| DMARD + Anti-TNF-IR | Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 1; n = 34, 90 | 48.0 units on a scale | Standard Deviation 25.4 |
| DMARD + Anti-TNF-IR | Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 12; n = 45, 94 | 31.0 units on a scale | Standard Deviation 24.3 |
| DMARD + Anti-TNF-IR | Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 2; n = 38, 88 | 44.1 units on a scale | Standard Deviation 25 |
Comparison: At Baseline: mean difference of scores of fatigue between the two groups was calculated.p-value: 0.421195% CI: [-5.1, 12.2]t-test, 2 sided
Comparison: At Month 1: mean difference of scores of fatigue between the two groups was calculated.p-value: 0.674995% CI: [-7.9, 12.1]t-test, 2 sided
Comparison: At Month 2: mean difference of scores of fatigue between the two groups was calculated.p-value: 0.181795% CI: [-3, 15.9]t-test, 2 sided
Comparison: At Month 4: mean difference of scores of fatigue between the two groups was calculated.p-value: 0.518295% CI: [-5.8, 11.4]t-test, 2 sided
Comparison: At Month 6: mean difference of scores of fatigue between the two groups was calculated.p-value: 0.002595% CI: [4.9, 22.6]t-test, 2 sided
Comparison: At Month 12: mean difference of scores of fatigue between the two groups was calculated.p-value: 0.35495% CI: [-4.4, 12.1]t-test, 2 sided
Secondary
Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab
The health assessment questionnaire (HAQ) is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, the participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score of minimum/maximum i.e., 0 (best) to 3 (worst).
Time frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of HAQ was available for 66 participants in TCZ group. The n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab | Baseline; n = 66 | 1.6 units on a scale | Standard Deviation 0.8 |
| Tocilizumab | Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab | Month 1; n = 50 | 1.2 units on a scale | Standard Deviation 0.7 |
| Tocilizumab | Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab | Month 12; n = 50 | 1.1 units on a scale | Standard Deviation 0.8 |
| Tocilizumab | Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab | Month 2; n = 55 | 1.1 units on a scale | Standard Deviation 0.8 |
| Tocilizumab | Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab | Month 4; n = 54 | 1.0 units on a scale | Standard Deviation 0.9 |
| Tocilizumab | Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab | Month 6; n = 59 | 1.1 units on a scale | Standard Deviation 0.8 |
Secondary
Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents
The HAQ is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). Data allowing the evaluation of HAQ was available for 73 participants in DMARD-IR group and 157 participants in DMARD + anti-TNF-IR group.
Time frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 4; n = 62, 122 | 0.9 units on a scale | Standard Deviation 0.8 |
| Tocilizumab | Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 1; n = 52, 120 | 1.1 units on a scale | Standard Deviation 0.7 |
| Tocilizumab | Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 6; n = 62, 126 | 1.0 units on a scale | Standard Deviation 0.8 |
| Tocilizumab | Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Baseline; n = 73, 157 | 1.5 units on a scale | Standard Deviation 0.8 |
| Tocilizumab | Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 12; n = 54, 102 | 1.0 units on a scale | Standard Deviation 0.8 |
| Tocilizumab | Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 2; n = 58, 123 | 1.2 units on a scale | Standard Deviation 0.8 |
| DMARD + Anti-TNF-IR | Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 12; n = 54, 102 | 0.9 units on a scale | Standard Deviation 0.7 |
| DMARD + Anti-TNF-IR | Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Baseline; n = 73, 157 | 1.5 units on a scale | Standard Deviation 0.7 |
| DMARD + Anti-TNF-IR | Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 1; n = 52, 120 | 1.3 units on a scale | Standard Deviation 0.7 |
| DMARD + Anti-TNF-IR | Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 4; n = 62, 122 | 1.1 units on a scale | Standard Deviation 0.7 |
| DMARD + Anti-TNF-IR | Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 6; n = 62, 126 | 1.0 units on a scale | Standard Deviation 0.7 |
| DMARD + Anti-TNF-IR | Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents | Month 2; n = 58, 123 | 1.2 units on a scale | Standard Deviation 0.8 |
Comparison: At Baseline: mean difference of scores of HAQ between the two groups was calculated.p-value: 0.734395% CI: [-0.2, 0.2]t-test, 2 sided
Comparison: At Month 1: mean difference of scores of HAQ between the two groups was calculated.p-value: 0.109895% CI: [-0.4, 0]t-test, 2 sided
Comparison: At Month 2: mean difference of scores of HAQ between the two groups was calculated.p-value: 0.493295% CI: [-0.3, 0.2]t-test, 2 sided
Comparison: At Month 4: mean difference of scores of HAQ between the two groups was calculated.p-value: 0.246895% CI: [-0.4, 0.1]t-test, 2 sided
Comparison: At Month 6: mean difference of scores of HAQ between the two groups was calculated.p-value: 0.963995% CI: [-0.2, 0.2]t-test, 2 sided
Comparison: At Month 12: mean difference of scores of HAQ between the two groups was calculated.p-value: 0.669695% CI: [-0.2, 0.3]t-test, 2 sided
Secondary
Number of Participants With Any Adverse Events and Serious Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time frame: Up to 12 months
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Number of Participants With Any Adverse Events and Serious Adverse Events | Any AE | 214 participants |
| Tocilizumab | Number of Participants With Any Adverse Events and Serious Adverse Events | Any SAE | 28 participants |
Secondary
Number of Participants With Concomitant Medications
Number of participants treated with at least one concomitant medication i.e., corticosteroid (Prednisone, Methyl prednisolone) was reported.
Time frame: Up to 12 months
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Number of Participants With Concomitant Medications | Prednisone | 142 participants |
| Tocilizumab | Number of Participants With Concomitant Medications | Methylprednisolone | 130 participants |
Secondary
Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand
The presence and severity of SH and JE of second MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of second MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface).
Time frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Absent, Baseline | 24 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Mild, Baseline | 9 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Moderate, Baseline | 16 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Marked, Baseline | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Absent, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Mild, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Moderate, Month 1 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Marked, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Absent, Month 2 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Mild, Month 2 | 7 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Moderate, Month 2 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Marked, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Absent, Month 4 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Mild, Month 4 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Moderate, Month 4 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Marked, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Absent, Month 6 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Mild, Month 6 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Moderate, Month 6 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Marked, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Absent, Month 12 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Mild, Month 12 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Moderate, Month 12 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | SH Marked, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Absent, Baseline | 22 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Mild, Baseline | 13 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Moderate, Baseline | 15 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Marked, Baseline | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Absent, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Mild, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Moderate, Month 1 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Marked, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Absent, Month 2 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Mild, Month 2 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Moderate, Month 2 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Marked, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Absent, Month 4 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Mild, Month 4 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Moderate, Month 4 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Marked, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Absent, Month 6 | 8 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Mild, Month 6 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Moderate, Month 6 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Marked, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Absent, Month 12 | 9 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Mild, Month 12 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Moderate, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | JE Marked, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Absent, Baseline | 26 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Mild, Baseline | 8 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Moderate, Baseline | 11 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Marked, Baseline | 8 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Absent, Month 1 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Mild, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Moderate, Month 1 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Marked, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Absent, Month 2 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Mild, Month 2 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Moderate, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Marked, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Absent, Month 4 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Mild, Month 4 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Moderate, Month 4 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Marked, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Absent, Month 6 | 7 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Mild, Month 6 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Moderate, Month 6 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Marked, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Absent, Month 12 | 12 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Mild, Month 12 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Moderate, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand | Vascularization, Marked, Month 12 | 0 participants |
Secondary
Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand.
The presence and severity of synovial hyperplasia (SH) and joint effusion (JE) of second metacarpo-phalangeal (MCP) joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, synovial hyperplasia and joint effusion were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra articular surface).
Time frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Moderate, Month 1 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Marked, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Absent, Month 4 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Absent, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Mild, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Absent, Month 2 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Absent, Month 6 | 7 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Mild, Month 6 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Absent, Baseline | 25 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Mild, Baseline | 7 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Moderate, Baseline | 16 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Marked, Baseline | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Absent, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Mild, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Absent, Month 2 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH, Mild, Month 2 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Moderate, Month 2 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Marked, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Mild, Month 4 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Moderate, Month 4 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Marked, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Absent, Month 6 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Mild, Month 6 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Moderate, Month 6 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Marked, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Absent, Month 12 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Mild, Month 12 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Moderate, Month 12 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | SH Marked, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Absent, Baseline | 23 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Mild, Baseline | 9 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Moderate, Baseline | 17 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Marked, Baseline | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Moderate, Month 1 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Marked, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Mild, Month 2 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Moderate, Month 2 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Marked, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Absent, Month 4 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Mild, Month 4 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Moderate, Month 4 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Marked, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Moderate, Month 6 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Marked, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Absent, Month 12 | 7 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Mild, Month 12 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Moderate, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | JE Marked, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Absent, Baseline | 26 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Mild, Baseline | 8 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Moderate, Baseline | 8 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Marked, Baseline | 11 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Absent, Month 1 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Mild, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Moderate, Month 1 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Marked, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Absent, Month 2 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Mild, Month 2 | 7 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Moderate, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Marked, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Absent, Month 4 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Mild, Month 4 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Moderate, Month 4 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Marked, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Absent, Month 6 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Mild, Month 6 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Moderate, Month 6 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Marked, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Absent, Month 12 | 12 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Mild, Month 12 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Moderate, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Marked, Month 12 | 0 participants |
Secondary
Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand.
The presence and severity of SH and JE of third MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface).
Time frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Absent, Baseline | 25 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Mild, Baseline | 9 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Moderate, Baseline | 14 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Marked, Baseline | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Absent, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Mild, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Moderate, Month 1 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Marked, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Absent, Month 2 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Mild, Month 2 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Moderate, Month 2 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Marked, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Absent, Month 4 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Mild, Month 4 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Moderate, Month 4 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Marked, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Absent, Month 6 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Mild, Month 6 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Marked, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Moderate, Month 6 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Marked, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Absent, Month 12 | 8 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Mild, Month 12 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | SH Moderate, Month 12 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Absent, Baseline | 25 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Mild, Baseline | 7 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Moderate, Baseline | 18 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Marked, Baseline | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE, Absent, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Mild, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Moderate, Month 1 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Marked, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Absent, Month 2 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Mild, Month 2 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Moderate, Month 2 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Marked, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Absent, Month 4 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Mild, Month 4 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Moderate, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Marked, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Absent, Month 6 | 8 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Mild, Month 6 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Moderate, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Marked, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Absent, Month 12 | 11 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Mild, Month 12 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Moderate, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | JE Marked, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Absent, Baseline | 29 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Mild, Baseline | 8 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Moderate, Baseline | 9 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Marked, Baseline | 7 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Absent, Month 1 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Mild, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Moderate, Month 1 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Marked, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Absent, Month 2 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Mild, Month 2 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Moderate, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Marked, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Absent, Month 4 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Mild, Month 4 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Moderate, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Marked, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Absent, Month 6 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Mild, Month 6 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Moderate, Month 6 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Marked, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Absent, Month 12 | 12 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Mild, Month 12 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Moderate, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. | Vascularization, Marked, Month 12 | 0 participants |
Secondary
Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand.
The presence and severity of SH and JE of third MCP joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of right hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intraarticular surface).
Time frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Moderate, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Moderate, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Mild, Month 2 | 7 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Moderate, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Marked, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Absent, Month 4 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Mild, Month 4 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Moderate, Month 4 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Marked, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Absent, Month 6 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Mild, Month 6 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Moderate, Month 6 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Marked, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Absent, Month 12 | 12 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Mild, Month 12 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Moderate, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Marked, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Absent, Baseline | 26 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Mild, Baseline | 7 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Moderate, Baseline | 17 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Marked, Baseline | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Absent, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Mild, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Moderate, Month 1 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Marked, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Absent, Month 2 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Mild, Month 2 | 3 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Moderate, Month 2 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Marked, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Absent, Month 4 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Mild, Month 4 | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Moderate, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Marked, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Absent, Month 6 | 8 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Mild, Month 6 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Moderate, Month 6 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Marked, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Absent, Month 12 | 9 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Mild, Month 12 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | JE Marked, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Absent, Baseline | 27 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Mild, Baseline | 7 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Moderate, Baseline | 8 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Marked, Baseline | 10 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Absent, Month 1 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Mild, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Moderate, Month 1 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Marked, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Absent, Month 2 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Mild, Month 2 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Moderate, Month 2 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Marked, Month 2 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Absent, Month 4 | 4 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Mild, Month 4 | 5 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Marked, Month 4 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Absent, Month 6 | 8 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Mild, Month 6 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Moderate, Month 6 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Marked, Month 6 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Absent, Month 12 | 12 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Mild, Month 12 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Moderate, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | Vascularization, Marked, Month 12 | 0 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Absent, Baseline | 26 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Mild, Baseline | 9 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Moderate, Baseline | 12 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Marked, Baseline | 6 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Absent, Month 1 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Mild, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Moderate, Month 1 | 2 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Marked, Month 1 | 1 participants |
| Tocilizumab | Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. | SH Absent, Month 2 | 4 participants |
Secondary
Percentage of Participants Discontinuing Treatment With Tocilizumab
The percentage of participants who prematurely discontinued treatment with TCZ during the study period was reported.
Time frame: Up to 12 months
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab | Percentage of Participants Discontinuing Treatment With Tocilizumab | 19.2 percentage of participants |
Secondary
Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion
Percentage of participants who continued treatment till 12 months after the first infusion with TCZ was reported.
Time frame: Up to 12 months
Population: The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab | Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion | 80.8 percentage of participants |