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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01683604
Registration number
NCT01683604
Ethics application status
Date submitted
5/09/2012
Date registered
12/09/2012
Date last updated
21/07/2016
Titles & IDs
Public title
Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia
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Scientific title
A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (ACT-UP)
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Secondary ID [1]
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ML28144
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Observational study
Rheumatoid Arthritis (RA) Participants (All Groups) - Participants with severe RA were prescribed with tocilizumab in accordance with routine clinic practice, and were observed for 6 months.
Other interventions: Observational study
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
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Assessment method [1]
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Percentage of participants on tocilizumab treatment at Month 6 was calculated as: [(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100.
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Timepoint [1]
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Month 6
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Primary outcome [2]
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Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
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Assessment method [2]
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Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.
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Timepoint [2]
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Baseline
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Primary outcome [3]
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Patient Global Assessment of Disease Activity Using VAS at Baseline
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Assessment method [3]
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The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.
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Timepoint [3]
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Baseline
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Primary outcome [4]
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Physician Global Assessment of Disease Activity Using VAS at Baseline
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Assessment method [4]
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Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.
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Timepoint [4]
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Baseline
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Primary outcome [5]
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Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline
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Assessment method [5]
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The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.
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Timepoint [5]
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Baseline
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Primary outcome [6]
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Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline
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Assessment method [6]
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TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.
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Timepoint [6]
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Baseline
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Primary outcome [7]
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Erythrocyte Sedimentation Rate (ESR) at Baseline
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Assessment method [7]
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ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.
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Timepoint [7]
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Baseline
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Primary outcome [8]
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C-Reactive Protein (CRP) at Baseline
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Assessment method [8]
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The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
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Timepoint [8]
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Baseline
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Secondary outcome [1]
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Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs
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Assessment method [1]
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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Median Dose at Month 6
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Assessment method [2]
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Timepoint [2]
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Month 6
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Secondary outcome [3]
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Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change
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Assessment method [3]
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Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported.
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Timepoint [3]
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Baseline up to Month 6
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Secondary outcome [4]
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Mean Dosing Interval at Month 6
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Assessment method [4]
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The time interval between two successive doses in days was reported.
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Timepoint [4]
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Month 6
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Secondary outcome [5]
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Percentage of Participants With Reasons Who Discontinued Tocilizumab
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Assessment method [5]
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Timepoint [5]
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Baseline up to Month 6
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Secondary outcome [6]
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Time to Restoration of Initial Dosing Regimen
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Assessment method [6]
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Timepoint [6]
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Baseline up to Month 6
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Secondary outcome [7]
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Percentage of Participants by Reason for Choice of Monotherapy at Baseline
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Assessment method [7]
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Timepoint [7]
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Baseline up to Month 6
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Secondary outcome [8]
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Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6
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Assessment method [8]
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Timepoint [8]
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Baseline, Month 6
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Secondary outcome [9]
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Duration of Tocilizumab Treatment
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Assessment method [9]
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Timepoint [9]
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Baseline up to Month 6
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Secondary outcome [10]
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Percentage of Participants by Duration of Morning Stiffness
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Assessment method [10]
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Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (<) 30 minutes, between 30 and 240 minutes, greater than (>) 240 minutes and whole day.
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Timepoint [10]
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Baseline, Month 3, Month 6
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Secondary outcome [11]
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Percentage of Participants With and Without Morning Stiffness
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Assessment method [11]
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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 able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:
Presence of participant's joints stiff when woke up that day, measured as yes or no
Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: < 30 minutes, between 30 and 240 minutes, > 240 minutes, and the whole day.
Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness.
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Timepoint [11]
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Baseline, Month 3, Month 6
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Secondary outcome [12]
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Percentage of Participants Adhering to Local Label for Adverse Events
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Assessment method [12]
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Percentage of participants who adhered to local label/protocol for the management of adverse events is reported.
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Timepoint [12]
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Baseline up to Month 6
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Secondary outcome [13]
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Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit
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Assessment method [13]
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The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x vTJC28 + 0.28 x vSJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease.
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Timepoint [13]
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Baseline, Month 3, Month 6
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Secondary outcome [14]
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Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
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Assessment method [14]
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Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x vTJC28 + 0.28 x vSJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2.
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Timepoint [14]
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Month 3 and Month 6
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Secondary outcome [15]
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Clinical Disease Activity Index (CDAI) Score by Visit
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Assessment method [15]
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The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease.
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Timepoint [15]
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Baseline, Month 3, Month 6
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Secondary outcome [16]
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Change From Baseline in TJC and SJC at Month 3 and Month 6
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Assessment method [16]
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TJC was determined by examining 28 and 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.
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Timepoint [16]
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Baseline, Month 3, Month 6
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Secondary outcome [17]
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Simplified Disease Activity Index (SDAI) Score by Visit
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Assessment method [17]
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The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease.
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Timepoint [17]
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Baseline, Month 3, Month 6
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Secondary outcome [18]
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Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment
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Assessment method [18]
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ACR 20,50 or 70 response=an improvement of = 20%, = 50% or = 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity.
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Timepoint [18]
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Month 3 and Month 6
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Secondary outcome [19]
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Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6
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Assessment method [19]
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The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease.
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Timepoint [19]
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Baseline, Month 3, Month 6
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Secondary outcome [20]
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Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6
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Assessment method [20]
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The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly.
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Timepoint [20]
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Baseline, Month 3, Month 6
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Secondary outcome [21]
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Change From Baseline in HAQ-DI Score at Months 3 and 6
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Assessment method [21]
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The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ-D1 score reported at baseline and the HAQ-D1 score reported at Month 3 and Month 6.
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Timepoint [21]
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Baseline, Month 3, Month 6
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Secondary outcome [22]
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Change From Baseline in VAS-Fatigue at Months 3 and 6
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Assessment method [22]
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Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue.
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Timepoint [22]
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Baseline, Month 3, Month 6
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Secondary outcome [23]
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Change From Baseline in Patient's Assessment of Pain at Months 3 and 6
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Assessment method [23]
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Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.
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Timepoint [23]
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Baseline, Month 3, Month 6
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Secondary outcome [24]
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Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6
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Assessment method [24]
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The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness.
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Timepoint [24]
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Baseline, Month 3, Month 6
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Eligibility
Key inclusion criteria
- Severe RA.
- Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
- Participants initiating treatment with tocilizumab on their physician's decision (in
accordance with the local label), including participants who started treatment with
tocilizumab within the 8 weeks prior to the enrolment visit.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Tocilizumab treatment more than 8 weeks prior to the enrolment visit.
- Previous tocilizumab treatment in a clinical trial or for compassionate use.
- Enrolled in an ongoing clinical trial and/or treatment with any investigational agent
within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer)
before starting treatment with tocilizumab.
- History of autoimmune disease or any joint inflammatory disease other than RA.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2014
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Sample size
Target
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Accrual to date
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Final
37
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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- Campsie
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Recruitment hospital [2]
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- Coffs Harbour
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Recruitment hospital [3]
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- New Lambton
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Recruitment hospital [4]
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- Woodville
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Recruitment hospital [5]
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- Heidelberg
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Recruitment hospital [6]
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- Morwell
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Recruitment hospital [7]
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- Shenton Park
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Recruitment postcode(s) [1]
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2194 - Campsie
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Recruitment postcode(s) [2]
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2450 - Coffs Harbour
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Recruitment postcode(s) [3]
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2305 - New Lambton
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Recruitment postcode(s) [4]
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5011 - Woodville
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment postcode(s) [6]
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3842 - Morwell
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Recruitment postcode(s) [7]
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6008 - Shenton Park
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This multi-center, observational study will evaluate the treatment patterns in clinical
practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA)
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. Data will be
collected from each eligible participant initiated on tocilizumab treatment by their treating
physician according to approved label for 6 months from start of treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01683604
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01683604
Download to PDF