Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia
2016年6月10日 更新者：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.
調査の概要
研究の種類
観察的
入学 (実際)
37
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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New South Wales
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Campsie、New South Wales、オーストラリア、2194
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Coffs Harbour、New South Wales、オーストラリア、2450
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New Lambton、New South Wales、オーストラリア、2305
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South Australia
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Woodville、South Australia、オーストラリア、5011
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Victoria
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Heidelberg、Victoria、オーストラリア、3084
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Morwell、Victoria、オーストラリア、3842
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Western Australia
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Shenton Park、Western Australia、オーストラリア、6008
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
RA participants treated with tocilizumab
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs
時間枠：Baseline
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Baseline
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Median Dose at Month 6
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, Month 6
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Baseline, Month 6
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Duration of Tocilizumab Treatment
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年7月1日
一次修了 (実際)
2014年6月1日
研究の完了 (実際)
2014年6月1日
試験登録日
最初に提出
2012年9月5日
QC基準を満たした最初の提出物
2012年9月7日
最初の投稿 (見積もり)
2012年9月12日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年7月21日
QC基準を満たした最後の更新が送信されました
2016年6月10日
最終確認日
2016年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
観察研究の臨床試験
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University of RoehamptonUniversity of Malaya; Universidad Complutense de Madrid; Saglik Bilimleri Universitesi; University... と他の協力者募集
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