An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis
2015年10月21日 更新者：Hoffmann-La Roche
HAQIMONO a Non-interventional National Multicenter Study, Observing RA Patients Treated With Tocilizumab in Mono-therapy, i.e. Without Combination With DMARD
This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use methotrexate.
Eligible patients initiated on RoActemra/Actemra treatment will be followed for 6 months.
調査の概要
状態
完了
条件
研究の種類
観察的
入学 (実際)
107
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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Falun、スウェーデン、SE-791 82
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Farsta、スウェーデン、541 85
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Goteborg、スウェーデン、413 45
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Helsingborg、スウェーデン、251 87
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Hudiksvall、スウェーデン、824 81
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Jönköping、スウェーデン、551 85
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Karlskrona、スウェーデン、37185
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Karlstad、スウェーデン、65185
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Kristianstad、スウェーデン、29185
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Malmo、スウェーデン、205 02
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Simrishamn、スウェーデン、272 81
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Skoevde、スウェーデン、54185
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Trelleborg、スウェーデン、231 85
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Uppsala、スウェーデン、75185
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Västerås、スウェーデン、72189
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Esbjerg、デンマーク、6700
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Holbæk、デンマーク、4300
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Kolding、デンマーク、6000
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Køge、デンマーク、4600
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Svendborg、デンマーク、5700
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Vejle、デンマーク、7100
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Bergen、ノルウェー、5053
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Gjettum、ノルウェー、1346
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Moss、ノルウェー、1535
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Skien、ノルウェー、3722
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Trondheim、ノルウェー、7030
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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
Patients with active moderate to severe rheumatoid arthritis unable to use methotrexate
説明
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
- Patients who for any reason do not take methotrexate and for whom the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy; patients who commenced RoActemra/Actemra as monotherapy within 8 weeks prior to the enrolment visit may be included
- Concomitant treatment with non-steroidal anti-inflammatory drug (NSAID) or corticosteroids (orally or intra-articularly) is allowed
Exclusion Criteria:
- Patients who have received RoActemra/Actemra more than 8 weeks prior to enrolment visit
- Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
- Concomitant DMARD treatment for rheumatoid arthritis (e.g. hyroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting RoActemra/Actemra treatment
- History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
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
コホートと介入
グループ/コホート |
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コホート
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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 |
時間枠 |
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Percentage of Participants on Tocilizumab Treatment at Month 6
時間枠：Month 6
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Month 6
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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 With Dose Modifications of Tocilizumab
時間枠：Baseline to Month 6
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Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.
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Baseline to Month 6
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Swollen Joint Count (SJC)
時間枠：Baseline, Month 3, Month 6
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Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present.
The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28.
A reduction in number of swollen joints compared to baseline indicates improvement.
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Baseline, Month 3, Month 6
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Tender Joint Count (TJC)
時間枠：Baseline, Month 3, Month 6
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Number of tender joints was determined by examining 28 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 each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.
A reduction in number of tender joints compared to baseline indicates improvement.
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Baseline, Month 3, Month 6
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Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
時間枠：Baseline, Month 3, Month 6
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DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter [mg/L]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter [mm] Visual Analog Scale [VAS]) where 0=no disease activity and 100=worst disease activity).
DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96.
Total score range: 0 to 10, higher score indicated more disease activity.
DAS28-4 (CRP) less than or equal to (<= 3.2) implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (<) 2.6 = clinical remission.
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Baseline, Month 3, Month 6
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Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)
時間枠：Month 3 and Month 6
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DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity).
DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96.
Total score range: 0 to 10, higher score indicated more disease activity.
DAS28-4 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) < 2.6 = clinical remission.
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Month 3 and Month 6
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Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
時間枠：Baseline, Month 3, Month 6
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DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour [mm/hour]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity).
DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA.
Total score range: 0-10, higher score=more disease activity.
DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.
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Baseline, Month 3, Month 6
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Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)
時間枠：Month 3 and Month 6
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DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity).
DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA.
Total score range: 0-10, higher score=more disease activity.
DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.
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Month 3 and Month 6
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Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)
時間枠：Month 3 and Month 6
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The DAS28-4 (CRP) [described in Outcome Measure 5] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached.
Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.
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Month 3 and Month 6
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Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)
時間枠：Month 3 and Month 6
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The DAS28-4 (ESR) [described in Outcome Measure 7] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached.
Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.
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Month 3 and Month 6
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Simplified Disease Activity Index (SDAI)
時間枠：Baseline, Month 3, Month 6
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The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL).
SDAI total score = 0-86.
SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.
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Baseline, Month 3, Month 6
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Percentage of Participants Achieving Clinical Remission Based on SDAI
時間枠：Month 3 and Month 6
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The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL).
SDAI total score = 0-86.
SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.
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Month 3 and Month 6
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Clinical Disease Activity Index (CDAI)
時間枠：Baseline, Month 3, Month 6
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The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity.
CDAI total score = 0-76.
CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.
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Baseline, Month 3, Month 6
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Percentage of Participants Achieving Clinical Remission Based on CDAI
時間枠：Month 3 and Month 6
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The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity.
CDAI total score = 0-76.
CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.
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Month 3 and Month 6
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Number of Participants With an American College of Rheumatology (ACR) Response
時間枠：Baseline to Month 6
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ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.
ACR response is based on 66/68 total joint count.
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Baseline to Month 6
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Patient Global Assessment (PtGA) of Disease Activity Score
時間枠：Baseline, Month 3, Month 6
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Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.
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Baseline, Month 3, Month 6
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Physician Global Assessment (PGA) of Disease Activity
時間枠：Baseline, Month 3, Month 6
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Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.
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Baseline, Month 3, Month 6
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Percentage of Participants in a PGA of Disease Activity Score Category
時間枠：Baseline, Month 3, Month 6
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A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.
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Baseline, Month 3, Month 6
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Patient Global Assessment of Pain
時間枠：Baseline, Month 3, Month 6
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Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.
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Baseline, Month 3, Month 6
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Percentage of Participants With Morning Stiffness
時間枠：Baseline, Month 3, Month 6
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The percentage of participants with morning stiffness ("yes", "no", or "do not know") was assessed at each visit.
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Baseline, Month 3, Month 6
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Percentage of Participants With 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 when participant woke up in the morning and was able to resume normal activities without stiffness.
Duration was recorded as less than (<) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (>) 240 minutes, or whole day.
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Baseline, Month 3, Month 6
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6
時間枠：Baseline, Month 3 and Month 6
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HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week.
Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
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Baseline, Month 3 and Month 6
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Percentage of Participants With Concomitant Corticosteroids Treatment
時間枠：Baseline to Month 6
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Baseline to Month 6
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Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study
時間枠：Baseline to Month 6
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Baseline to 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4月1日
一次修了 (実際)
2014年9月1日
研究の完了 (実際)
2014年9月1日
試験登録日
最初に提出
2012年8月13日
QC基準を満たした最初の提出物
2012年8月17日
最初の投稿 (見積もり)
2012年8月21日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年11月23日
QC基準を満たした最後の更新が送信されました
2015年10月21日
最終確認日
2015年10月1日
詳しくは
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