A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy
2018年8月30日 更新者：Hoffmann-La Roche
Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy
This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in participants with rheumatoid arthritis.
Eligible participants initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.
調査の概要
研究の種類
観察的
入学 (実際)
71
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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Aalst、ベルギー、9300
- ASZ Aalst
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Ath、ベルギー、7800
- CH EpiCURA Site Ath
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Bruxelles、ベルギー、1020
- CHU Brugmann (Victor Horta)
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Bruxelles、ベルギー、1070
- Hospital Erasme; Neurologie
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Genk、ベルギー、3600
- ReumaClinic
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Gilly (Charleroi)、ベルギー、6000
- GHdC Site Saint-Joseph
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Gosselies、ベルギー、6041
- Clinique Notre Dame de Grâce
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Haine-Saint-Paul、ベルギー、7100
- CH Jolimont - Lobbes (Jolimont)
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Kortrijk、ベルギー、8500
- Az Groeninge
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Liège、ベルギー、4000
- CHR de la Citadelle
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Liège、ベルギー、4000
- Clinique Saint-Joseph
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Mons、ベルギー、7000
- CHU Ambroise Paré
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Oostende、ベルギー、8400
- AZ Damiaan
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Ottignies、ベルギー、1340
- Clinique St Pierre asbl
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Roeselare、ベルギー、8800
- AZ Delta (Campus Wilgenstraat)
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Turnhout、ベルギー、2300
- AZ Turnhout Sint Jozef
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Wilrijk、ベルギー、2610
- Sint Augustinus Wilrijk
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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
Participants with rheumatoid arthritis initiating treatment with RoActemra/Actemra in monotherapy
説明
Inclusion Criteria:
- Adult participants, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
- Participants in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy in accordance with the local label and the reimbursement criteria indicating that RoActemra/Actemra can be given in monotherapy in case of methotrexate intolerance or where continued treatment with methotrexate is inappropriate; this can include participants who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
- Concomitant treatment with NSAIDs and/or corticosteroids is allowed
Exclusion Criteria:
- Participants who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
- Participants who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
- Participants receiving concomitant DMARD treatment for rheumatoid arthritis at baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) will be excluded from the study
- Participants who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- Participants with a 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 |
介入・治療 |
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Tocilizumab
Participants with rheumatoid arthritis (RA) received tocilizumab monotherapy according to individualized physician-prescribed regimens.
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Participants received tocilizumab monotherapy according to individualized physician-prescribed regimens.
他の名前：
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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 After Treatment Initiation
時間枠：Month 6 after treatment initiation
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Month 6 after treatment initiation
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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 Systemic Manifestations of RA at Baseline
時間枠：Baseline
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Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease.
Participants were included if they experienced at least any one of the conditions.
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Baseline
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Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response
時間枠：Baseline
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Baseline
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Number of Participants With Inadequate Response to Other Biologics
時間枠：Baseline
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Baseline
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Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)
時間枠：Month 6
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The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.
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Month 6
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Percentage of Participants Who Had DMARDs During Study
時間枠：Month 6
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Month 6
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Number of Participants With Dose Reductions
時間枠：6 months
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6 months
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Number of Participants With Starting Tocilizumab After Failing DMARDs
時間枠：Baseline
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Baseline
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Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents
時間枠：Baseline
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Baseline
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Time to Reduction/Withdrawal of Corticosteroids
時間枠：Month 6
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Month 6
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Number of Dose Modifications Per Participant at Month 6
時間枠：Month 6
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Number of dose modification per participant at Month 6 was reported.
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Month 6
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Mean Dosing Interval Per Participant at Month 6
時間枠：Month 6
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Month 6
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Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy
時間枠：Month 6
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Month 6
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Time for Restoration of Initial Dosing Regimen
時間枠：Month 6
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Month 6
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Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen
時間枠：Month 6
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Month 6
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Number of Participants Who Were Not Adhering to Recommended Management of AEs
時間枠：Month 6
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Month 6
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Percentage of Participants Still on Tocilizumab Monotherapy at Month 6
時間枠：Month 6
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Month 6
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Percentage of Participants With Reason for Choice of Monotherapy at Baseline
時間枠：Baseline
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Baseline
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Tender Joint Count (TJC)
時間枠：Baseline, Month 3, 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.
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Baseline, Month 3, 6
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Swollen Joint Count (SJC)
時間枠：Baseline, Month 3, 6
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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, Month 3, 6
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Percentage of Participants With Disease Activity Score-28 (DAS28)
時間枠：Baseline, Month 3, 6
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DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity).
DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.
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Baseline, Month 3, 6
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Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
時間枠：Month 3, 6
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Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point.
EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant.
EULAR Good response: DAS28 <=3.2 and a CFB <-1.2.
EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2.
EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6.
The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR.
DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control.
A negative CFB indicated clinically meaningful improvement.
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Month 3, 6
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Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6
時間枠：Month 3, 6
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ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments.
A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR).
A reduction in the level of and acute phase reactants was considered an improvement.
ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.
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Month 3, 6
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Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response
時間枠：Baseline, Month 3, 6
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CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) 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, 6
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Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response
時間枠：Baseline, Month 3, 6
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The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP).
SDAI total score = 0-86.
A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.
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Baseline, Month 3, 6
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Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6
時間枠：Baseline, Month 3, 6
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The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly.
A decrease in the score indicates improvement.
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Baseline, Month 3, 6
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Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6
時間枠：Baseline, Month 3, 6
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The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician.
The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).
A negative change from Baseline indicated improvement.
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Baseline, Month 3, 6
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Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6
時間枠：Baseline, Month 3, 6
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The HAQ was a participant self-reported questionnaire for assessing the extent of a participant's functional ability.
It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities).
Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
The HAQ scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.
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Baseline, Month 3, 6
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Change From Baseline in VAS-Fatigue at Month 3 and Month 6
時間枠：Baseline, Month 3, 6
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The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue.
A decrease in the score indicates improvement.
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Baseline, Month 3, 6
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Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6
時間枠：Baseline, Month 3, 6
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The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain.
A decrease in the score indicates improvement.
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Baseline, Month 3, 6
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Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6
時間枠：Baseline, Month 3, 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 as limber as he/she would be during a day involving typical activities.
Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.
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Baseline, Month 3, 6
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Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)
時間枠：Month 6
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An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
AESI included- serious/medically significant infections; myocardial Infarction/acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; serious/medically significant bleeding events; serious/medically significant hepatic events.
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Month 6
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Percentage of Participants With AEs Leading to Dose Modifications
時間枠：Month 6
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Month 6
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C-reactive Protein (CRP]) Level
時間枠：Baseline, Month 3, 6
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CRP is an acute phase reactant and is a measure of inflammation.
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Baseline, Month 3, 6
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Erythrocyte Sedimentation Rate (ESR) Level
時間枠：Baseline, Month 3, 6
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ESR is an acute phase reactant and is a measure of inflammation.
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Baseline, Month 3, 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 (実際)
2012年7月31日
一次修了 (実際)
2014年12月12日
研究の完了 (実際)
2014年12月12日
試験登録日
最初に提出
2012年10月10日
QC基準を満たした最初の提出物
2012年10月10日
最初の投稿 (見積もり)
2012年10月12日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月4日
QC基準を満たした最後の更新が送信されました
2018年8月30日
最終確認日
2018年8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。