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A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)

2014년 7월 8일 업데이트: Hoffmann-La Roche

A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)

This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

121

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 모로코
      • Casablanca, 모로코, 20000
      • Fés, 모로코, 30000
      • Khouribga, 모로코, 14000
      • Kénitra, 모로코, 25000
      • Marrakech, 모로코, 40000
      • Meknés, 모로코, 50000
      • Rabat, 모로코, 10000
      • Salé, 모로코, 15045

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

설명

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe active rheumatoid arthritis (DAS28 > 3.2 at screening)
  • Inadequate response to DMARDs
  • Body weight < 150 kg

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of enrollment
  • Rheumatic autoimmune disease other than RA
  • American College of Rheumatology (ACR) functional class IV
  • Prior history of or current inflammatory joint disease other than RA
  • Previous treatment with any biologic drug that is used in the treatment of RA
  • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
  • Pregnant or lactating women
  • Active current or history of recurrent infection, active TB within the previous 3 years, HIV infection

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 싱글 암
의약품: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, total of 6 infusions

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Adverse Events
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, AEs leading to withdrawal, AEs leading to death, and treatment-related AEs.
Baseline, Weeks 4, 8, 12, 16, 20, and 24

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit
기간: Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants discontinuing study treatment for any reason at every visit; causes of discontinuation in the summary included AEs, deaths, lost to follo-wup, AE and investigator decision and 'not determined'.
Weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value
기간: Baseline through Week 24
The difference between baseline and highest values until Week 24 of ALT and AST. The values are measures as international units per liter (UI/L). The change was calculated as the value (highest) at a later timepoint up to Week 24, minus the value at Baseline.
Baseline through Week 24
Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values
기간: Baseline through Week 24
Levels of LDL and TC were measured in milligrams/deciliter (mg/dL). Change in LDL and TC were calculated as the value (highest) through Week 24, minus the value at Baseline.
Baseline through Week 24
Percentage of Participants With Lipid Elevations by Study Visit
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Lipid panel assessed included TC, triglycerides, high-density lipoprotein (HDL), and LDL. Elevations were categorized as follows: LDL cholesterol: Optimal equals (=) less than (<)100 mg/dL, Near optimal=100-129 mg/dL, Borderline high 130-159 mg/dL, High 160-189 mg/dL, Very High ≥190 mg/dL; Total cholesterol: Desirable <200 mg/dL, Borderline high 200-239 mg/dL, High ≥240 mg/dL; HDL cholesterol: Low <40 mg/dL, High ≥60 mg/dL; Triglycerides: Normal <150 mg/dL, Borderline high 150-199 mg/dL, High 200-499 mg/dL, and Very high ≥500 mg/dL.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Disease Activity Score Based on 28-Joint Count (DAS28)
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to less than or equal to (≤) 5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants by DAS28 Response Category
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 =low disease activity, DAS28 >3.2 to ≤5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A reduction in DAS28 of at least 1.2 units was considered a clinically meaningful improvement.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Time to Achieve Clinically Meaningful Reduction in DAS28
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
A clinically meaningful improvement in DAS28 was defined as a reduction of at least 1.2 units. Time to achieving clinically meanigful improvement was calculated as the number of days from the first infusion to the first achievement of reduction of 1.2 units in DAS28.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants Achieving Remission (DAS28 <2.6)
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants with a DAS28 score <2.6 were considered to have achieved remission.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
기간: Weeks 4, 8, 12, 16, 20, and 24
The ACR response rates ACR20, ACR50, ACR70 are defined as ≥20%, ≥50%, ≥70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the following 5 assessments: Patient assessment of pain (VAS); Patient global assessment of disease activity (VAS); Investigator global assessment of disease activity (VAS); and acute phase response (ESR or CRP)
Weeks 4, 8, 12, 16, 20, and 24
Swollen and Tender Joint Counts
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). The following 28 joints were assessed by the physician for tenderness : metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). The change in SJC and TJC was determined as the difference in values from baseline at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Health Assessment Questionnaire (HAQ)
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
HAQ was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple-choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The change in HAQ was determined as the difference in values from baseline at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Patient Global Assessment of Disease Activity (VAS)
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as "no disease activity" (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as "maximum disease activity" (maximum arthritis disease activity). The change in Patient Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Physician's Global Assessment of Disease Activity (VAS)
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as "maximum disease activity". The Physician's Global Assessment of Disease Activity was completed by the Efficacy Assessor who could or could not be a physician. The change in Physician's Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Patient Assessment of of Pain (VAS)
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
The participant's assessment of their current level of pain was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as "no pain" and the right-hand extreme of the line (100 mm) was described as "unbearable pain". The change in participant's perception of pain was determined as the difference in values from baseline at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
C-Reactive Protein (CRP)
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
CRP is an acute phase inflammatory marker. Levels of CRP increase with inflammation. The change in CRP was determined as the difference in values from baseline and at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Erythrocyte Sedimentation Rate (ESR)
기간: Baseline, Weeks 4, 8, 12, 16, 20, and 24
ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. The change in ESR was determined as the difference in values from baseline at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24

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

2010년 3월 1일

기본 완료 (실제)

2011년 8월 1일

연구 완료 (실제)

2011년 8월 1일

연구 등록 날짜

최초 제출

2012년 5월 31일

QC 기준을 충족하는 최초 제출

2012년 6월 1일

처음 게시됨 (추정)

2012년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 7월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 7월 8일

마지막으로 확인됨

2014년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ML22638

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

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. .

tocilizumab [RoActemra/Actemra]에 대한 임상 시험

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