A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF
2017년 7월 6일 업데이트: Hoffmann-La Roche
Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF
This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF.
Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions.
Non-biologic DMARD therapy may be continued throughout the study.
Anticipated time on study treatment is 24 weeks.
연구 개요
연구 유형
중재적
등록 (실제)
28
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Dammam, 사우디 아라비아, 31444
- King Fahad Specialist Hospital; Oncology
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Jeddah, 사우디 아라비아, 21589
- King AbdulAziz University Hospital
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Makkah, 사우디 아라비아
- Heraa General Hospital; Rheumatology
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Riyadh, 사우디 아라비아, 11525
- King Fahad Medical City; Gastroentrology
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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
- Active moderate to severe rheumatoid arthritis of >/= 6 months duration
- >/=1 non-biologic DMARD and/or anti-TNF therapy at stable dose for >/=8 weeks at any time prior to study treatment
- Inadequate clinical response to non-biologic DMARD or anti-TNF therapy
- Oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to first dose of study drug
Exclusion Criteria:
- Pregnant or lactating women
- Major surgery (including joint surgery) within 8 weeks prior to screening or major surgery planned within 6 months of enrolment
- Rheumatic autoimmune disease other than RA
- Functional class IV (ACR classification)
- Prior history of or current joint disease other than RA
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Previous treatment with RoActemra/Actemra
- Known active current or history of recurrent infection
- History of or currently active primary or secondary immunodeficiency
- Active tuberculosis requiring treatment within the previous 3 years
- Positive for HIV
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 싱글 암
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8 mg/kg (max.
800 mg) iv every 4 weeks, 6 infusions
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Disease Activity as Measured by Disease Activity Score 28 (DAS28)
기간: Up to 1 year
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The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA).
The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]), and general health status (participant global assessment of disease activity using visual analog scale [VAS], range 1-100 mm).
DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count.
The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
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Up to 1 year
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Number of Participants Who Achieved Remission (DAS28 < 2.6)
기간: Up to 1 year
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The DAS28 is a combined index for measuring disease activity in RA.
The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm).
DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count.
The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
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Up to 1 year
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Time to Das28 Remission
기간: Up to 1 year
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Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units.
The DAS28 is a combined index for measuring disease activity in RA.
The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm).
DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count.
The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
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Up to 1 year
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Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
기간: Up to 1 year
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DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline.
The DAS28 is a combined index for measuring disease activity in RA.
The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm).
DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count.
The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
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Up to 1 year
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Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
기간: Up to 1 year
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DAS28 low disease activity was defined as a DAS28 score reduction of at least 3.2 units from Baseline.
The DAS28 is a combined index for measuring disease activity in RA.
The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm).
DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count.
The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
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Up to 1 year
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Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
기간: Up to 1 year
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Health Assessment Questionnaire (HAQ) is a self-completed participant questionnaire specific for Rheumatoid Arthritis.
It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities.
Each domain has at least 2 component questions.
There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do.
To calculate HAQ, the participant must have a domain score for at least 6 out of 8 domains.
The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst).
A negative change from baseline indicated improvement.
Clinically meaningful HAQ response was defined as an improvement of at least 0.22 units from baseline in the HAQ Disability Index.
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Up to 1 year
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Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
기간: Up to 1 year
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The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function.
Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much).
The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue.
For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response).
The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
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Up to 1 year
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Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
기간: Up to 1 year
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The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on one end, and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels.
The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue.
Increasing numbers=increasing fatigue.
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Up to 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Any Adverse Event and Serious Adverse Event
기간: Up to 1 year
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An adverse event (AE) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.
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Up to 1 year
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Number of Participants With AE or SAE Related Discontinuation of Tocilizumab
기간: Up to 1 year
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It included participants who discontinued from the study due to occurrence of AE or SAE.
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Up to 1 year
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Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
기간: Up to 1 year
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ACR20, ACR50, ACR70, and ACR90 are defined as greater than or equal to (≥)20 percent (%), ≥50%, ≥70%, or ≥90% improvement, respectively, in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints).
It also comprises ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of the following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]).
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Up to 1 year
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Number of Participants With C-Reactive Protein Abnormality
기간: Up to 1 year
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CRP is a biological marker of inflammation.
A reduction in CRP indicates improvement.
It is measured in milligram per liter (mg/L).
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Up to 1 year
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Number of Participants With Erythrocyte Sedimentation Rate Abnormality
기간: Up to 1 year
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ESR is an acute phase reactant and is a measure of inflammation.
It is measured in millimeter per hour (mm/hr).
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Up to 1 year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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)
2011년 11월 30일
기본 완료 (실제)
2013년 5월 12일
연구 완료 (실제)
2013년 5월 12일
연구 등록 날짜
최초 제출
2011년 3월 7일
QC 기준을 충족하는 최초 제출
2011년 3월 30일
처음 게시됨 (추정)
2011년 3월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 8월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 7월 6일
마지막으로 확인됨
2017년 7월 1일
추가 정보
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. .
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