Trial Outcomes & Findings for Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis (NCT NCT01579006)
NCT ID: NCT01579006
Last Updated: 2016-03-07
Results Overview
COMPLETED
184 participants
6 months
2016-03-07
Participant Flow
Participant milestones
| Measure |
Rheumatoid Arthritis Participants
Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), who have had an inadequate response (or were intolerant) to treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
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|---|---|
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Overall Study
STARTED
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184
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Overall Study
COMPLETED
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151
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Overall Study
NOT COMPLETED
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33
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Reasons for withdrawal
| Measure |
Rheumatoid Arthritis Participants
Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), who have had an inadequate response (or were intolerant) to treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
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|---|---|
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Overall Study
Lack of Efficacy
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10
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Overall Study
Adverse Event
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13
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Overall Study
Withdrawal by Subject
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5
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Overall Study
Non-compliance
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3
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Overall Study
Due to participant's health fund
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1
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Overall Study
Scheduled surgery
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1
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Baseline Characteristics
Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Rheumatoid Arthritis Participants
n=184 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
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|---|---|
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Age, Continuous
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54.8 years
STANDARD_DEVIATION 13.7 • n=5 Participants
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Sex: Female, Male
Female
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141 Participants
n=5 Participants
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Sex: Female, Male
Male
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43 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 monthsPopulation: FAS population
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=184 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
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|---|---|
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Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation
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42.4 percentage of participants
Interval 35.1542 to 49.8776
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PRIMARY outcome
Timeframe: 5-6 monthsPopulation: FAS population
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=184 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
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|---|---|
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Percentage of Participants on TCZ Treatment at 5-6 Months After Treatment Initiation
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85.9 percentage of participants
Interval 79.985 to 90.5573
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SECONDARY outcome
Timeframe: BaselinePopulation: FAS population.
Systemic manifestations included fibromyalgia, osteoporosis, sjogren's syndrome, anemia, rheumatoid nodules, pulmonary fibrosis, vasculitis, peripheral neuropathy or mononeuropathy, scleritis, episcleritis, hypertension, hyperlipidemia, low high-density lipoproteins, diabetes type 1 and type 2, metabolic syndrome, carotid artery disease, transient ischemic attacks, embolic stroke, atherothrombotic stroke, atrial fibrillation, heart failure New York Heart Association (NYHA) Class l/ll, coronary heart disease(angina pectoris/myocardial), aortic aneurism, peripheral arterial occlusive disease, percutaneous coronary interventions, coronary artery bypass, carotid endarterectomy and peripheral arterial bypass.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=184 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
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|---|---|
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Fibromyalgia
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8.7 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Osteoporosis
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22.3 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Sjogren's syndrome
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6.5 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Anemia
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21.8 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Rheumatoid nodules
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8.1 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Pulmonary fibrosis
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3.2 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Vasculitis
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0.5 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Peripheral neuropathy or mononeuropathy
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4.3 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Scleritis
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1.6 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Episcleritis
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0.5 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Hypertension
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32.1 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Hyperlipidemia
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38.0 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Low high-density lipoproteins
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8.7 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Diabetes type 1 and type 2
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15.2 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Metabolic syndrome
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10.3 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Carotid artery disease
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1.1 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Transient ischemic attacks
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3.3 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Embolic stroke
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0.5 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Atherothrombotic stroke
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2.7 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Atrial fibrillation
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1.1 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Heart Failure NYHA class l/ll
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1.6 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Coronary heart disease(angina pectoris/myocardial)
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6.0 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Aortic aneurism
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0.5 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Peripheral arterial occlusive disease
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0.5 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Percutaneous coronary interventions
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4.4 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Coronary artery bypass
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1.6 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Carotid Endarterectomy
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0.5 percentage of participants
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Percentage of Participants With Systemic Manifestations of RA at Baseline
Peripheral arterial bypass
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2.1 percentage of participants
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SECONDARY outcome
Timeframe: Prior to study start (8 weeks) and Baseline up to 6 monthsPopulation: FAS population.
DMARDs exposure was evaluated for all participants. "Prior DMARDs treatment" included participants, who were treated with DMARDs 8 weeks and according to physician's discretion before being included in the study. "DMARDs treatment at baseline" included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ. Only those participants who received DMARDs prior to start of study and at Baseline up to 6 months were reported.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=184 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
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|---|---|
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Leflunomide: Adm 1 to 6
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25.0 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Azathioprine: Prior to study
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0.6 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Gold Compounds: Prior to study
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2.2 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Hydroxychloroquine: Prior to study
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33.3 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Leflunomide: Prior to study
|
7.9 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Methotrexate: Prior to study
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24.5 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Sulfasalazine: Prior to study
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29.2 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Other DMARD: Prior to study
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2.2 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Azathioprine: Adm 1 to 6
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1.1 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Gold Compounds: Adm 1 to 6
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3.3 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Hydroxychloroquine: Adm 1 to 6
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84.8 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Methotrexate: Adm 1 to 6
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96.2 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Other DMARD: Adm 1 to 6
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20.7 percentage of participants
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Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
Sulfasalazine: Adm 1 to 6
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69.0 percentage of participants
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SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: FAS population.
Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=184 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
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|---|---|
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Percentage of Participants With Reason for DMARD Withdrawal
Methotrexate: Lack of efficacy
|
27.3 percentage of participants
Interval 19.217 to 36.5911
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Percentage of Participants With Reason for DMARD Withdrawal
Methotrexate: Intolerance,Objective
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22.7 percentage of participants
Interval 15.2801 to 31.6955
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Percentage of Participants With Reason for DMARD Withdrawal
Methotrexate: Intolerance,Subjective
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17.3 percentage of participants
Interval 10.7316 to 25.652
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Percentage of Participants With Reason for DMARD Withdrawal
Methotrexate: Other
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32.7 percentage of participants
Interval 24.0832 to 42.3279
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Percentage of Participants With Reason for DMARD Withdrawal
Hydroxychloroquine: Lack of efficacy
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60.0 percentage of participants
Interval 50.4498 to 69.0222
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Percentage of Participants With Reason for DMARD Withdrawal
Hydroxychloroquine: Intolerance,Objective
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14.8 percentage of participants
Interval 8.8536 to 22.6102
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Percentage of Participants With Reason for DMARD Withdrawal
Hydroxychloroquine: Intolerance,Subjective
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12.2 percentage of participants
Interval 6.8181 to 19.5816
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Percentage of Participants With Reason for DMARD Withdrawal
Hydroxychloroquine: Other
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13.0 percentage of participants
Interval 7.4878 to 20.5993
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Percentage of Participants With Reason for DMARD Withdrawal
Sulfasalazine: Lack of efficacy
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60.6 percentage of participants
Interval 50.7331 to 69.7795
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Percentage of Participants With Reason for DMARD Withdrawal
Sulfasalazine: Intolerance,Objective
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11.9 percentage of participants
Interval 6.5057 to 19.5311
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Percentage of Participants With Reason for DMARD Withdrawal
Sulfasalazine: Intolerance,Subjective
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9.2 percentage of participants
Interval 4.4876 to 16.2252
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Percentage of Participants With Reason for DMARD Withdrawal
Sulfasalazine: Other
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18.3 percentage of participants
Interval 11.5831 to 26.9055
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Percentage of Participants With Reason for DMARD Withdrawal
Leflunomide: Lack of efficacy
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63.2 percentage of participants
Interval 45.9943 to 78.1875
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Percentage of Participants With Reason for DMARD Withdrawal
Leflunomide: Intolerance,Objective
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5.3 percentage of participants
Interval 0.6439 to 17.7491
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Percentage of Participants With Reason for DMARD Withdrawal
Leflunomide: Intolerance,Subjective
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10.5 percentage of participants
Interval 2.9435 to 24.8049
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Percentage of Participants With Reason for DMARD Withdrawal
Leflunomide: Other
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21.1 percentage of participants
Interval 9.5541 to 37.3188
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Percentage of Participants With Reason for DMARD Withdrawal
Gold compounds: Lack of efficacy
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100 percentage of participants
Interval 66.3733 to 100.0
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Percentage of Participants With Reason for DMARD Withdrawal
Azathioprine: Lack of efficacy
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66.7 percentage of participants
Interval 9.4299 to 99.1596
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Percentage of Participants With Reason for DMARD Withdrawal
Azathioprine: Intolerance, Subjective
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33.3 percentage of participants
Interval 0.8404 to 90.5701
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Percentage of Participants With Reason for DMARD Withdrawal
Other: Lack of efficacy
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44.0 percentage of participants
Interval 24.4024 to 65.0718
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Percentage of Participants With Reason for DMARD Withdrawal
Other: Intolerance,Objective
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8.0 percentage of participants
Interval 0.984 to 26.0306
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Percentage of Participants With Reason for DMARD Withdrawal
Other: Intolerance,Subjective
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16.0 percentage of participants
Interval 4.5379 to 36.0828
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Percentage of Participants With Reason for DMARD Withdrawal
Other: Unspecified
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32.0 percentage of participants
Interval 14.9495 to 53.5001
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SECONDARY outcome
Timeframe: Prior to study start (8 weeks)Population: FAS population.
Biological RA treatment exposure was evaluated for all participants. "Prior biological RA treatment" included participants who were treated with biological RA treatment 8 weeks before being included in the study. Percentage of participants who did not receive any biological RA treatment and percentage of participants who received one or more biologic RA treatments were reported.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=184 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
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|---|---|
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Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study
Did not receive any biologic RA treatment
|
53.8 percentage of participants
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Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study
Received 1 biologic RA treatment
|
38.6 percentage of participants
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Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study
Received 2 biologic RA treatments
|
7.1 percentage of participants
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Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study
Received 3 or more biologic RA treatments
|
0.5 percentage of participants
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SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: FAS population.
Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment). Same participants may be counted in more than one previous biologic RA treatment category.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=184 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
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|---|---|
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Percentage of Participants With Type of Previous Biologic RA Treatments
Adalimumab
|
15.2 percentage of participants
|
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Percentage of Participants With Type of Previous Biologic RA Treatments
Infliximab
|
8.2 percentage of participants
|
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Percentage of Participants With Type of Previous Biologic RA Treatments
Golimumab
|
4.3 percentage of participants
|
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Percentage of Participants With Type of Previous Biologic RA Treatments
Etanercept
|
17.4 percentage of participants
|
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Percentage of Participants With Type of Previous Biologic RA Treatments
Certolizumab
|
1.6 percentage of participants
|
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Percentage of Participants With Type of Previous Biologic RA Treatments
Other
|
7.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and "n"= participants who were evaluable for each category.
Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment).
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=85 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
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|---|---|
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Duration of Previous Biologic RA Treatments
Infliximab (n=14)
|
2.5 years
Standard Deviation 2.9
|
|
Duration of Previous Biologic RA Treatments
Golimumab (n=8)
|
1.6 years
Standard Deviation 0.8
|
|
Duration of Previous Biologic RA Treatments
Etanercept (n=31)
|
1.7 years
Standard Deviation 1.9
|
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Duration of Previous Biologic RA Treatments
Certolizumab (n=3)
|
4.9 years
Standard Deviation 1.9
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Duration of Previous Biologic RA Treatments
Other (n=13)
|
1.4 years
Standard Deviation 2.2
|
|
Duration of Previous Biologic RA Treatments
Adalimumab (n=27)
|
0.9 years
Standard Deviation 1.0
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SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and "n"= participants who were evaluable for each category.
Lack of efficacy was determined by physician discretion. Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment).
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=184 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
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|---|---|
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Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Adalimumab: Lack of efficacy (n=28)
|
85.7 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Adalimumab: Adverse event (n=28)
|
10.7 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Adalimumab: Other (n=28)
|
3.6 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Infliximab: Lack of efficacy (n=15)
|
53.3 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Infliximab: Adverse event (n=15)
|
26.7 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Infliximab: Other (n=15)
|
20.0 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Golimumab: Lack of efficacy (n=8)
|
62.5 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Golimumab: Adverse event (n=8)
|
25.0 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Golimumab: Other (n=8)
|
12.5 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Etanercept: Lack of efficacy (n=31)
|
67.7 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Etanercept: Adverse event (n=31)
|
19.4 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Etanercept: Other (n=31)
|
12.9 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Certolizumab: Lack of efficacy (n=3)
|
33.3 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Certolizumab: Adverse event (n=3)
|
33.3 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Certolizumab: Other (n=3)
|
33.3 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Other: Lack of efficacy (n=13)
|
53.8 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Other: Adverse event (n=13)
|
15.4 percentage of participants
|
|
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
Other: Unspecified (n=13)
|
30.8 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and "n"= participants who were evaluable for each category.
TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=183 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Percentage of Participants With Dose Modifications
TCZ Administration 1 (Baseline) (n=183)
|
0.0 percentage of participants
Interval 0.0 to 1.9956
|
|
Percentage of Participants With Dose Modifications
TCZ Administration 2 (Week 4) (n=178)
|
2.8 percentage of participants
Interval 0.9182 to 6.4332
|
|
Percentage of Participants With Dose Modifications
TCZ Administration 3 (Week 8) (n=174)
|
2.3 percentage of participants
Interval 0.6298 to 5.7811
|
|
Percentage of Participants With Dose Modifications
TCZ Administration 4 (Week 12) (n=166)
|
1.8 percentage of participants
Interval 0.3743 to 5.1904
|
|
Percentage of Participants With Dose Modifications
TCZ Administration 5 (Week 16) (n=158)
|
1.9 percentage of participants
Interval 0.3933 to 5.4484
|
|
Percentage of Participants With Dose Modifications
TCZ Administration 6 (Week 20) (n=151)
|
3.3 percentage of participants
Interval 1.0837 to 7.558
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had dose modifications were reported.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=20 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Percentage of Participants With Reasons for Dose Modification
TCZ Administration 2 (Week 4):Adverse event/safety
|
80.0 percentage of participants
Interval 28.3582 to 99.4949
|
|
Percentage of Participants With Reasons for Dose Modification
TCZ Administration 2 (Week 4):Other reason
|
20.0 percentage of participants
Interval 0.5051 to 71.6418
|
|
Percentage of Participants With Reasons for Dose Modification
TCZ Administration 3 (Week 8):Adverse event/safety
|
100.0 percentage of participants
Interval 39.7635 to 100.0
|
|
Percentage of Participants With Reasons for Dose Modification
TCZ Administration 4(Week 12):Adverse event/safety
|
66.7 percentage of participants
Interval 9.4299 to 99.1596
|
|
Percentage of Participants With Reasons for Dose Modification
TCZ Administration 4 (Week 12): Other reason
|
33.3 percentage of participants
Interval 0.8404 to 90.5701
|
|
Percentage of Participants With Reasons for Dose Modification
TCZ Administration 5(Week 16):Adverse event/safety
|
100.0 percentage of participants
Interval 29.2402 to 100.0
|
|
Percentage of Participants With Reasons for Dose Modification
TCZ Administration 6(Week 20):Adverse event/safety
|
40.0 percentage of participants
Interval 5.2745 to 85.3367
|
|
Percentage of Participants With Reasons for Dose Modification
TCZ Administration 6 (Week 20): Other reason
|
60.0 percentage of participants
Interval 14.6633 to 94.7255
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and "n"= participants who were evaluable for each category.
TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=182 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Mean Dose at 6 Months
TCZ Administration 1 (Baseline) (n=182)
|
8.0 milligrams per kilogram (mg/kg)
Standard Deviation 0.0
|
|
Mean Dose at 6 Months
TCZ Administration 2 (Week 4) (n=179)
|
7.9 milligrams per kilogram (mg/kg)
Standard Deviation 0.6
|
|
Mean Dose at 6 Months
TCZ Administration 3 (Week 8) (n=174)
|
7.9 milligrams per kilogram (mg/kg)
Standard Deviation 0.6
|
|
Mean Dose at 6 Months
TCZ Administration 4 (Week 12) (n=166)
|
7.9 milligrams per kilogram (mg/kg)
Standard Deviation 0.5
|
|
Mean Dose at 6 Months
TCZ Administration 5 (Week 16) (n=158)
|
7.9 milligrams per kilogram (mg/kg)
Standard Deviation 0.3
|
|
Mean Dose at 6 Months
TCZ Administration 6 (Week 20) (n=151)
|
7.9 milligrams per kilogram (mg/kg)
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=12 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Mean Number of Dose Modifications at 6 Months
|
1.7 dose modification
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and "n"= participants who were evaluable for each category.
TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. The mean dosing interval between different TCZ administrations (Adm) by participants within 6 months observational period was presented.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=178 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Mean Dosing Interval of Treatment at 6 Months
Between TCZ Adm 1 (Baseline) and 2 (Week 4)(n=178)
|
31.4 days
Standard Deviation 5.7
|
|
Mean Dosing Interval of Treatment at 6 Months
Between TCZ Adm 2 (Week 4) and 3 (Week 8) (n=174)
|
30.8 days
Standard Deviation 4.5
|
|
Mean Dosing Interval of Treatment at 6 Months
Between TCZ Adm 3 (Week 8) and 4 (Week 12) (n=166)
|
31.4 days
Standard Deviation 4.7
|
|
Mean Dosing Interval of Treatment at 6 Months
Between TCZ Adm 4 (Week 12) and 5 (Week 16)(n=158)
|
31.8 days
Standard Deviation 7.2
|
|
Mean Dosing Interval of Treatment at 6 Months
Between TCZ Adm 5 (Week 16) and 6 (Week 20)(n=150)
|
31.9 days
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS population.
The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=184 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy
Lack of efficacy
|
6.0 percentage of participants
Interval 3.0218 to 10.4448
|
|
Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy
Adverse event
|
6.5 percentage of participants
Interval 3.415 to 11.115
|
|
Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy
Other
|
5.4 percentage of participants
Interval 2.6366 to 9.7675
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=7 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Time to Restoration of Initial Dosing Regimen
|
81.6 days
Standard Deviation 34.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=15 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Percentage of Participants Who Adhered to the Dosing Regimen Recommended by Physician
|
8.2 percentage of participants
Interval 4.6345 to 13.0893
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: FAS population. Here, "n"= participants who were evaluable for each category.
TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had TCZ as monotherapy were reported.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=184 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Percentage of Participants on TCZ Monotherapy
TCZ Administration 1 (Baseline) (n=184)
|
32.6 percentage of participants
Interval 25.8944 to 39.894
|
|
Percentage of Participants on TCZ Monotherapy
TCZ Administration 2 (Week 4) (n=178)
|
34.3 percentage of participants
Interval 27.3324 to 41.7408
|
|
Percentage of Participants on TCZ Monotherapy
TCZ Administration 3 (Week 8) (n=174)
|
35.6 percentage of participants
Interval 28.53 to 43.2332
|
|
Percentage of Participants on TCZ Monotherapy
TCZ Administration 4 (Week 12) (n=166)
|
38.0 percentage of participants
Interval 30.5448 to 45.7972
|
|
Percentage of Participants on TCZ Monotherapy
TCZ Administration 5 (Week 16) (n=158)
|
38.6 percentage of participants
Interval 30.9797 to 46.6713
|
|
Percentage of Participants on TCZ Monotherapy
TCZ Administration 6 (Week 20) (n=151)
|
41.7 percentage of participants
Interval 33.7596 to 50.0155
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants with valid data to calculate TJC at the end of study (6 months).
The number of tender joints was recorded on the joint assessment form, with no tenderness = 0, and tenderness = 1, for 68 joints, giving a total possible TJC score of 0 to 68.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=67 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in Tender Joint Count (TJC) (68 Joints) at Month 6
|
-10.7 Tender Joint Count
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
The number of swollen joints was recorded on the joint assessment form, with no swelling = 0, and swelling =1, for 66 joints, giving a total possible SJC score of 0 to 66.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=67 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Month 6
|
-6.7 Swollen Joint Count
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour \[mm/hr\]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale \[VAS\] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=46 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) at Month 6
|
-2.7 Score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores \<2.6 = best disease control and scores \>5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 \<=3.2 and a CFB \<-1.2. EULAR Moderate response: DAS28 \>3.2 to ≤ 5.1 or a CFB \< -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB \>=-0.6, DAS28 \>3.2 to \<=5.1 or CFB \>=-0.6 and DAS28 \>5.1 or CFB \>=-0.6.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=46 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6
Good
|
56.5 percentage of participants
Interval 41.1071 to 71.0657
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6
Moderate
|
28.3 percentage of participants
Interval 15.9867 to 43.4604
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6
No response
|
15.2 percentage of participants
Interval 6.3444 to 28.8691
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter \[mg/dL\]). SDAI total score = 0-86. A SDAI score of \<=3.3 represented clinical remission, a score of \<=11.0 represents low disease activity, a score of \<=26.0 represented moderate disease activity and a score of \>26.0 represented high (or severe) disease.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=52 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 6
|
-18.7 Score on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of \<=2.8 represented clinical remission, a score of \<=10.0 represented low disease activity, a score of \<=22.0 represented moderate disease activity and a score of \>22.0 represented high (or severe) disease.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=70 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 6
|
-17.3 Score on a scale
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 \[good\] to 100 mm \[worst\] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=31 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Percentage of Participants Who Achieved 20% Improvement in ACR (ACR20) Response at Month 6
|
54.8 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 \[good\] to 100 mm \[worst\] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=31 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response at Month 6
|
32.3 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 \[good\] to 100 mm \[worst\] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=31 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response at Month 6
|
9.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. The serum concentration of CRP was measured in mg/dL. A reduction in the level was considered an improvement.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=55 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in CRP at Month 6
|
-1.6 mg/dL
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. ESR was measured in mm/hr. A reduction in the level was considered an improvement.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=49 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in ESR at Month 6
|
-34.4 mm/hr
Standard Deviation 26.1
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
The PhGH was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equaled 0 mm, and was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=72 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in PhGH at Month 6
|
-34.0 mm
Standard Deviation 28.2
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
The PGH of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equaled 0 mm, and was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=75 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in PGH of Disease Activity at Month 6
|
-26.5 mm
Standard Deviation 28.4
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from "no difficulty" to "unable to do", corresponding to scores from 0 to 3. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity. A score of \<0.5 represented clinical remission. A participant achieved a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of \>=0.22.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=77 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in HAQ-DI at Month 6
|
-0.3 Score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=74 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in Participant's Assessment of Fatigue Using VAS at Month 6
|
-17.9 mm
Standard Deviation 31.1
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain). A decrease of 10 points was considered clinically meaningful.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=76 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in Participant's Assessment of RA-Related Pain at Month 6
|
-23.7 mm
Standard Deviation 32.6
|
SECONDARY outcome
Timeframe: Administration 1 (Baseline), 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and "n"= participants who were evaluable for each category.
The FACIT Measurement System was a collection of health-related quality of life questionnaires targeted to the management of chronic illness and included questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being and Functional Well-Being. The FACIT Fatigue Scale was a 13-item tool that measured an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue was measured on a five-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score of FACIT ranged from 0 to 160. An increase of 4 points in the FACIT-Fatigue score was considered clinically meaningful. Change from Administration 1 was reported for individual administration schedules. TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=55 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6
Change at Administration 2 (n=38)
|
7.3 Score on a scale
Standard Deviation 12.7
|
|
Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6
Change at Administration 3 (n=39)
|
11.7 Score on a scale
Standard Deviation 18.1
|
|
Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6
Change at Administration 4 (n=35)
|
11.9 Score on a scale
Standard Deviation 18.3
|
|
Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6
Change at Administration 5 (n=31)
|
17.3 Score on a scale
Standard Deviation 20.5
|
|
Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6
Change at Administration 6 (n=33)
|
20.0 Score on a scale
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.
Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=76 Participants
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
|
|---|---|
|
Change From Baseline in Morning Stiffness as Assessed Using VAS at Month 6
|
-26.6 mm
Standard Deviation 34.9
|
Adverse Events
Rheumatoid Arthritis Participants
Serious adverse events
| Measure |
Rheumatoid Arthritis Participants
n=184 participants at risk
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who had been receiving TCZ in the past and in whom the attending physician decided to start treatment with TCZ at the time of recruitment (according to the local label) were observed for 6 months.
|
|---|---|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.54%
1/184 • Up to 6 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.1%
2/184 • Up to 6 months
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
2/184 • Up to 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.54%
1/184 • Up to 6 months
|
|
Gastrointestinal disorders
Upper abdominal pain
|
0.54%
1/184 • Up to 6 months
|
|
General disorders
Asthenia
|
0.54%
1/184 • Up to 6 months
|
|
General disorders
Chest pain
|
0.54%
1/184 • Up to 6 months
|
|
Infections and infestations
Pneumonia
|
0.54%
1/184 • Up to 6 months
|
|
Infections and infestations
Post procedural sepsis
|
0.54%
1/184 • Up to 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
3/184 • Up to 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.54%
1/184 • Up to 6 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.54%
1/184 • Up to 6 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.54%
1/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
2/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.54%
1/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.54%
1/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.1%
2/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.54%
1/184 • Up to 6 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.54%
1/184 • Up to 6 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.54%
1/184 • Up to 6 months
|
|
Renal and urinary disorders
Acute renal failure
|
0.54%
1/184 • Up to 6 months
|
Other adverse events
| Measure |
Rheumatoid Arthritis Participants
n=184 participants at risk
Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who had been receiving TCZ in the past and in whom the attending physician decided to start treatment with TCZ at the time of recruitment (according to the local label) were observed for 6 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
3/184 • Up to 6 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.7%
5/184 • Up to 6 months
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.54%
1/184 • Up to 6 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.6%
3/184 • Up to 6 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.54%
1/184 • Up to 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.1%
2/184 • Up to 6 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.54%
1/184 • Up to 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
2/184 • Up to 6 months
|
|
Gastrointestinal disorders
Nausea
|
1.6%
3/184 • Up to 6 months
|
|
Gastrointestinal disorders
Oral pain
|
0.54%
1/184 • Up to 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.54%
1/184 • Up to 6 months
|
|
General disorders
Chest pain
|
0.54%
1/184 • Up to 6 months
|
|
General disorders
Malaise
|
0.54%
1/184 • Up to 6 months
|
|
General disorders
Pyrexia
|
0.54%
1/184 • Up to 6 months
|
|
Infections and infestations
Bronchitis
|
0.54%
1/184 • Up to 6 months
|
|
Infections and infestations
Gingival infection
|
0.54%
1/184 • Up to 6 months
|
|
Infections and infestations
Gingivitis
|
0.54%
1/184 • Up to 6 months
|
|
Infections and infestations
Herpes zoster
|
0.54%
1/184 • Up to 6 months
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
2/184 • Up to 6 months
|
|
Infections and infestations
Sinusitis
|
0.54%
1/184 • Up to 6 months
|
|
Infections and infestations
Tracheobronchitis
|
0.54%
1/184 • Up to 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
3/184 • Up to 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.54%
1/184 • Up to 6 months
|
|
Infections and infestations
Viral infection
|
0.54%
1/184 • Up to 6 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.54%
1/184 • Up to 6 months
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
3/184 • Up to 6 months
|
|
Investigations
Arteriogram coronary
|
0.54%
1/184 • Up to 6 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.54%
1/184 • Up to 6 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.54%
1/184 • Up to 6 months
|
|
Investigations
Blood triglycerides increased
|
0.54%
1/184 • Up to 6 months
|
|
Investigations
Full blood count decreased
|
0.54%
1/184 • Up to 6 months
|
|
Investigations
Hepatic enzyme increased
|
3.3%
6/184 • Up to 6 months
|
|
Investigations
Liver function test abnormal
|
1.1%
2/184 • Up to 6 months
|
|
Investigations
Neutrophil count decreased
|
0.54%
1/184 • Up to 6 months
|
|
Investigations
Platelet count decreased
|
0.54%
1/184 • Up to 6 months
|
|
Investigations
Transaminases increased
|
1.1%
2/184 • Up to 6 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.6%
3/184 • Up to 6 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.54%
1/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.54%
1/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.1%
2/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.54%
1/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.54%
1/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
2/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.54%
1/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.54%
1/184 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.54%
1/184 • Up to 6 months
|
|
Nervous system disorders
Dizziness
|
1.1%
2/184 • Up to 6 months
|
|
Nervous system disorders
Headache
|
1.1%
2/184 • Up to 6 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.54%
1/184 • Up to 6 months
|
|
Nervous system disorders
Paraesthesia
|
0.54%
1/184 • Up to 6 months
|
|
Nervous system disorders
Syncope
|
0.54%
1/184 • Up to 6 months
|
|
Psychiatric disorders
Confusional state
|
0.54%
1/184 • Up to 6 months
|
|
Reproductive system and breast disorders
Breast pain
|
0.54%
1/184 • Up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.54%
1/184 • Up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.54%
1/184 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.1%
2/184 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.54%
1/184 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.54%
1/184 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
2/184 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.54%
1/184 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
3/184 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.54%
1/184 • Up to 6 months
|
|
Vascular disorders
Hypertension
|
1.1%
2/184 • Up to 6 months
|
|
Vascular disorders
Hypotension
|
0.54%
1/184 • Up to 6 months
|
Additional Information
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