Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia
2016년 6월 10일 업데이트: Hoffmann-La Roche
A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (ACT-UP)
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.
연구 개요
연구 유형
관찰
등록 (실제)
37
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New South Wales
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Campsie, New South Wales, 호주, 2194
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Coffs Harbour, New South Wales, 호주, 2450
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New Lambton, New South Wales, 호주, 2305
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South Australia
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Woodville, South Australia, 호주, 5011
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Victoria
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Heidelberg, Victoria, 호주, 3084
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Morwell, Victoria, 호주, 3842
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Western Australia
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Shenton Park, Western Australia, 호주, 6008
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
RA participants treated with tocilizumab
설명
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.
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
기간: Month 6
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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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Month 6
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Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
기간: Baseline
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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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Baseline
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Patient Global Assessment of Disease Activity Using VAS at Baseline
기간: Baseline
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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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Baseline
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Physician Global Assessment of Disease Activity Using VAS at Baseline
기간: Baseline
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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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Baseline
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Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline
기간: Baseline
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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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Baseline
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Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline
기간: Baseline
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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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Baseline
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Erythrocyte Sedimentation Rate (ESR) at Baseline
기간: Baseline
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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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Baseline
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C-Reactive Protein (CRP) at Baseline
기간: Baseline
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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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Baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs
기간: Baseline
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Baseline
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Median Dose at Month 6
기간: Month 6
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Month 6
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Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change
기간: Baseline up to Month 6
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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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Baseline up to Month 6
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Mean Dosing Interval at Month 6
기간: Month 6
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The time interval between two successive doses in days was reported.
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Month 6
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Percentage of Participants With Reasons Who Discontinued Tocilizumab
기간: Baseline up to Month 6
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Baseline up to Month 6
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Time to Restoration of Initial Dosing Regimen
기간: Baseline up to Month 6
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Baseline up to Month 6
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Percentage of Participants by Reason for Choice of Monotherapy at Baseline
기간: Baseline up to Month 6
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Baseline up to Month 6
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Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6
기간: Baseline, Month 6
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Baseline, Month 6
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Duration of Tocilizumab Treatment
기간: Baseline up to Month 6
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Baseline up to Month 6
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Percentage of Participants by Duration of Morning Stiffness
기간: Baseline, Month 3, Month 6
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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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Baseline, Month 3, Month 6
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Percentage of Participants With and Without Morning Stiffness
기간: Baseline, Month 3, Month 6
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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:
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Baseline, Month 3, Month 6
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Percentage of Participants Adhering to Local Label for Adverse Events
기간: Baseline up to Month 6
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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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Baseline up to Month 6
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Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit
기간: Baseline, Month 3, Month 6
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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 √TJC28 + 0.28 x √SJC28 + 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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Baseline, Month 3, Month 6
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Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
기간: Month 3 and Month 6
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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 √TJC28 + 0.28 x √SJC28 + 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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Month 3 and Month 6
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Clinical Disease Activity Index (CDAI) Score by Visit
기간: Baseline, Month 3, Month 6
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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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Baseline, Month 3, Month 6
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Change From Baseline in TJC and SJC at Month 3 and Month 6
기간: Baseline, Month 3, Month 6
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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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Baseline, Month 3, Month 6
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Simplified Disease Activity Index (SDAI) Score by Visit
기간: Baseline, Month 3, Month 6
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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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Baseline, Month 3, Month 6
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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
기간: Month 3 and Month 6
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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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Month 3 and Month 6
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Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6
기간: Baseline, Month 3, Month 6
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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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Baseline, Month 3, Month 6
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Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6
기간: Baseline, Month 3, Month 6
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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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Baseline, Month 3, Month 6
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Change From Baseline in HAQ-DI Score at Months 3 and 6
기간: Baseline, Month 3, Month 6
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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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Baseline, Month 3, Month 6
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Change From Baseline in VAS-Fatigue at Months 3 and 6
기간: Baseline, Month 3, Month 6
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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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Baseline, Month 3, Month 6
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Change From Baseline in Patient's Assessment of Pain at Months 3 and 6
기간: Baseline, Month 3, Month 6
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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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Baseline, Month 3, Month 6
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Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6
기간: Baseline, Month 3, Month 6
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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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Baseline, Month 3, Month 6
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 7월 1일
기본 완료 (실제)
2014년 6월 1일
연구 완료 (실제)
2014년 6월 1일
연구 등록 날짜
최초 제출
2012년 9월 5일
QC 기준을 충족하는 최초 제출
2012년 9월 7일
처음 게시됨 (추정)
2012년 9월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 7월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 6월 10일
마지막으로 확인됨
2016년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
류마티스 관절염에 대한 임상 시험
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Azienda Unita Sanitaria Locale di PiacenzaUniversity of Parma모병특발성 폐 섬유증(IPF) | 전신 질환으로 인한 간질성 폐질환(장애) | Reumatoid Arthritis | 결합 조직 질환 (CTD)체코, 이탈리아
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