Trial Outcomes & Findings for An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST) (NCT NCT01394276)
NCT ID: NCT01394276
Last Updated: 2025-09-11
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
322 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2025-09-11
Participant Flow
A total of 322 participants were enrolled across 59 study centers in Italy from 31 May 2011 to 24 April 2013.
Participant milestones
| Measure |
Tocilizumab
Participants with moderate to severe Rheumatoid arthritis (RA) who had received RoActemra \[Tocilizumab (TCZ)\] treatment for 6 months prior to initiation of study and are inadequate responders to Disease Modifying Anti-Rheumatic Drugs (DMARDs) and anti-Tumor Necrosis Factors (anti-TNFs) agents were observed. Participants received treatment with TCZ with dose of 8 milligrams per kilogram (mg/kg) body weight, intravenously once every 4 weeks for 12 months according to European Union (EU) approved dosage, and Summary of Product Characteristics (SmPC).
|
|---|---|
|
Overall Study
STARTED
|
322
|
|
Overall Study
COMPLETED
|
260
|
|
Overall Study
NOT COMPLETED
|
62
|
Reasons for withdrawal
| Measure |
Tocilizumab
Participants with moderate to severe Rheumatoid arthritis (RA) who had received RoActemra \[Tocilizumab (TCZ)\] treatment for 6 months prior to initiation of study and are inadequate responders to Disease Modifying Anti-Rheumatic Drugs (DMARDs) and anti-Tumor Necrosis Factors (anti-TNFs) agents were observed. Participants received treatment with TCZ with dose of 8 milligrams per kilogram (mg/kg) body weight, intravenously once every 4 weeks for 12 months according to European Union (EU) approved dosage, and Summary of Product Characteristics (SmPC).
|
|---|---|
|
Overall Study
Related Adverse event (AEs)
|
15
|
|
Overall Study
Not related AEs
|
9
|
|
Overall Study
Remission of disease
|
2
|
|
Overall Study
Insufficient therapeutic effect
|
17
|
|
Overall Study
Insufficient compliance
|
9
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Participant moved to another site
|
1
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
unavailability of drug at the Hospital
|
2
|
|
Overall Study
Symptoms of concurrent diseases
|
1
|
Baseline Characteristics
An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)
Baseline characteristics by cohort
| Measure |
Tocilizumab
n=322 Participants
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.
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|---|---|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
260 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Tocilizumab
n=226 Participants
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.
|
DMARD + Anti-TNF-IR
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.
|
|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment
|
57.52 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Tocilizumab
n=226 Participants
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.
|
DMARD + Anti-TNF-IR
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.
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|---|---|---|
|
Percentage of Participants Achieving Disease Remission After 6 Months of Treatment
|
38.05 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12Population: 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.
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.
Outcome measures
| Measure |
Tocilizumab
n=93 Participants
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.
|
DMARD + Anti-TNF-IR
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.
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|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12Population: 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.
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.
Outcome measures
| Measure |
Tocilizumab
n=50 Participants
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.
|
DMARD + Anti-TNF-IR
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12Population: 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.
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).
Outcome measures
| Measure |
Tocilizumab
n=66 Participants
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.
|
DMARD + Anti-TNF-IR
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
Number of participants treated with at least one concomitant medication i.e., corticosteroid (Prednisone, Methyl prednisolone) was reported.
Outcome measures
| Measure |
Tocilizumab
n=322 Participants
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.
|
DMARD + Anti-TNF-IR
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.
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|---|---|---|
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Number of Participants With Concomitant Medications
Prednisone
|
142 participants
|
—
|
|
Number of Participants With Concomitant Medications
Methylprednisolone
|
130 participants
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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 percentage of participants who prematurely discontinued treatment with TCZ during the study period was reported.
Outcome measures
| Measure |
Tocilizumab
n=322 Participants
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.
|
DMARD + Anti-TNF-IR
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.
|
|---|---|---|
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Percentage of Participants Discontinuing Treatment With Tocilizumab
|
19.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Tocilizumab
n=322 Participants
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.
|
DMARD + Anti-TNF-IR
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.
|
|---|---|---|
|
Number of Participants With Any Adverse Events and Serious Adverse Events
Any AE
|
214 participants
|
—
|
|
Number of Participants With Any Adverse Events and Serious Adverse Events
Any SAE
|
28 participants
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
Percentage of participants who continued treatment till 12 months after the first infusion with TCZ was reported.
Outcome measures
| Measure |
Tocilizumab
n=322 Participants
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.
|
DMARD + Anti-TNF-IR
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.
|
|---|---|---|
|
Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion
|
80.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12Population: 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 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).
Outcome measures
| Measure |
Tocilizumab
n=322 Participants
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.
|
DMARD + Anti-TNF-IR
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12Population: 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 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).
Outcome measures
| Measure |
Tocilizumab
n=322 Participants
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.
|
DMARD + Anti-TNF-IR
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12Population: 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 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).
Outcome measures
| Measure |
Tocilizumab
n=322 Participants
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.
|
DMARD + Anti-TNF-IR
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12Population: 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 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).
Outcome measures
| Measure |
Tocilizumab
n=322 Participants
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.
|
DMARD + Anti-TNF-IR
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12Population: 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.
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.
Outcome measures
| Measure |
Tocilizumab
n=81 Participants
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.
|
DMARD + Anti-TNF-IR
n=203 Participants
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.
|
|---|---|---|
|
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
|
5.3 units on a scale
Standard Deviation 1.3
|
|
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
|
3.7 units on a scale
Standard Deviation 1.3
|
|
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
|
3.4 units on a scale
Standard Deviation 1.3
|
|
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
|
3.1 units on a scale
Standard Deviation 1.2
|
|
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
|
3.0 units on a scale
Standard Deviation 1.2
|
|
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
|
2.6 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12Population: 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.
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.
Outcome measures
| Measure |
Tocilizumab
n=45 Participants
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.
|
DMARD + Anti-TNF-IR
n=113 Participants
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.
|
|---|---|---|
|
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
|
58.7 units on a scale
Standard Deviation 25.2
|
|
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
|
48.0 units on a scale
Standard Deviation 25.4
|
|
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 24.0
|
44.1 units on a scale
Standard Deviation 25.0
|
|
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
|
40.0 units on a scale
Standard Deviation 24.8
|
|
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
|
34.7 units on a scale
Standard Deviation 25.4
|
|
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
|
31.0 units on a scale
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12Population: 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.
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.
Outcome measures
| Measure |
Tocilizumab
n=73 Participants
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.
|
DMARD + Anti-TNF-IR
n=157 Participants
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.
|
|---|---|---|
|
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
|
1.5 units on a scale
Standard Deviation 0.7
|
|
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
|
1.3 units on a scale
Standard Deviation 0.7
|
|
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
|
1.2 units on a scale
Standard Deviation 0.8
|
|
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
|
1.1 units on a scale
Standard Deviation 0.7
|
|
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
|
1.0 units on a scale
Standard Deviation 0.7
|
|
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
|
0.9 units on a scale
Standard Deviation 0.7
|
Adverse Events
Tocilizumab
Serious events: 28 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tocilizumab
n=322 participants at risk
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.
|
|---|---|
|
Psychiatric disorders
Major depression
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Investigations
Fibrin D dimer increased
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Renal abscess
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Bronchitis
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Diarrhoea infectious
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Pyelonephritis
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Tuberculosis
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Urosepsis
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Cardiac disorders
Atrial fibrillation
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Leucopenia
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Hypocomplementaemia
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Nervous system disorders
Polyneuropathy
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Eye disorders
Retinal detachment
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Endocrine disorders
Goitre
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.62%
2/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Renal and urinary disorders
Renal failure acute
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.62%
2/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Vascular disorders
Hypertensive crisis
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.31%
1/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
Other adverse events
| Measure |
Tocilizumab
n=322 participants at risk
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.
|
|---|---|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.1%
23/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Bronchitis
|
7.1%
23/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Influenza
|
5.0%
16/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Leucopenia
|
6.2%
20/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.3%
17/322 • Up to 12 months
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER