이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy

2018년 8월 30일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

관찰

등록 (실제)

71

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 벨기에
      • Aalst, 벨기에, 9300
        • ASZ Aalst
      • Ath, 벨기에, 7800
        • CH EpiCURA Site Ath
      • Bruxelles, 벨기에, 1020
        • CHU Brugmann (Victor Horta)
      • Bruxelles, 벨기에, 1070
        • Hospital Erasme; Neurologie
      • Genk, 벨기에, 3600
        • ReumaClinic
      • Gilly (Charleroi), 벨기에, 6000
        • GHdC Site Saint-Joseph
      • Gosselies, 벨기에, 6041
        • Clinique Notre Dame de Grâce
      • Haine-Saint-Paul, 벨기에, 7100
        • CH Jolimont - Lobbes (Jolimont)
      • Kortrijk, 벨기에, 8500
        • AZ Groeninge
      • Liège, 벨기에, 4000
        • CHR de la Citadelle
      • Liège, 벨기에, 4000
        • Clinique Saint-Joseph
      • Mons, 벨기에, 7000
        • CHU Ambroise Paré
      • Oostende, 벨기에, 8400
        • AZ Damiaan
      • Ottignies, 벨기에, 1340
        • Clinique St Pierre asbl
      • Roeselare, 벨기에, 8800
        • AZ Delta (Campus Wilgenstraat)
      • Turnhout, 벨기에, 2300
        • AZ Turnhout Sint Jozef
      • Wilrijk, 벨기에, 2610
        • Sint Augustinus Wilrijk

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

Participants with rheumatoid arthritis initiating treatment with RoActemra/Actemra in monotherapy

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Tocilizumab
Participants with rheumatoid arthritis (RA) received tocilizumab monotherapy according to individualized physician-prescribed regimens.
의약품: tocilizumab
Participants received tocilizumab monotherapy according to individualized physician-prescribed regimens.
다른 이름들:
  • 악템라

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
기간: Month 6 after treatment initiation
Month 6 after treatment initiation

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Systemic Manifestations of RA at Baseline
기간: Baseline
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.
Baseline
Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response
기간: Baseline
Baseline
Number of Participants With Inadequate Response to Other Biologics
기간: Baseline
Baseline
Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)
기간: Month 6
The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.
Month 6
Percentage of Participants Who Had DMARDs During Study
기간: Month 6
Month 6
Number of Participants With Dose Reductions
기간: 6 months
6 months
Number of Participants With Starting Tocilizumab After Failing DMARDs
기간: Baseline
Baseline
Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents
기간: Baseline
Baseline
Time to Reduction/Withdrawal of Corticosteroids
기간: Month 6
Month 6
Number of Dose Modifications Per Participant at Month 6
기간: Month 6
Number of dose modification per participant at Month 6 was reported.
Month 6
Mean Dosing Interval Per Participant at Month 6
기간: Month 6
Month 6
Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy
기간: Month 6
Month 6
Time for Restoration of Initial Dosing Regimen
기간: Month 6
Month 6
Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen
기간: Month 6
Month 6
Number of Participants Who Were Not Adhering to Recommended Management of AEs
기간: Month 6
Month 6
Percentage of Participants Still on Tocilizumab Monotherapy at Month 6
기간: Month 6
Month 6
Percentage of Participants With Reason for Choice of Monotherapy at Baseline
기간: Baseline
Baseline
Tender Joint Count (TJC)
기간: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Swollen Joint Count (SJC)
기간: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Percentage of Participants With Disease Activity Score-28 (DAS28)
기간: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
기간: Month 3, 6
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.
Month 3, 6
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6
기간: Month 3, 6
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.
Month 3, 6
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response
기간: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response
기간: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6
기간: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6
기간: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6
기간: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Change From Baseline in VAS-Fatigue at Month 3 and Month 6
기간: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6
기간: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6
기간: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)
기간: Month 6
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.
Month 6
Percentage of Participants With AEs Leading to Dose Modifications
기간: Month 6
Month 6
C-reactive Protein (CRP]) Level
기간: Baseline, Month 3, 6
CRP is an acute phase reactant and is a measure of inflammation.
Baseline, Month 3, 6
Erythrocyte Sedimentation Rate (ESR) Level
기간: Baseline, Month 3, 6
ESR is an acute phase reactant and is a measure of inflammation.
Baseline, Month 3, 6

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

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 (실제)

2012년 7월 31일

기본 완료 (실제)

2014년 12월 12일

연구 완료 (실제)

2014년 12월 12일

연구 등록 날짜

최초 제출

2012년 10월 10일

QC 기준을 충족하는 최초 제출

2012년 10월 10일

처음 게시됨 (추정)

2012년 10월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 9월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 8월 30일

마지막으로 확인됨

2018년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ML28269

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. .

tocilizumab에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Philippines

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다