Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)
2019년 3월 18일 업데이트: Merck Sharp & Dohme LLC
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial With a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate (MTX) in participants with active rheumatoid arthritis (RA) despite MTX therapy.
The primary hypothesis is that at least 1 dose of MK-8457 + MTX will be superior to placebo + MTX as measured by the percentage of participants who achieve American College of Rheumatology 20 (ACR 20) response after 12 weeks of treatment.
연구 개요
상세 설명
In Base Study Phase IIa, participants were to receive blinded MK-8457 100 mg or matched placebo for up to 24 weeks. At Week 12 and 18 of Phase IIa, efficacy evaluation was conducted to assess eligibility for early escape, defined as <20% reduction in both tender and swollen joint counts. The study plan included Base Study Phase IIb in which dose range finding or dose-response was to be evaluated, depending on the outcome of Phase IIa. Participants who completed Phase IIa or Phase IIb and those eligible for early escape could enroll in Period 3, a 2-year Safety Extension.
All participants must have been treated with MTX for at least 3 months prior to screening and have been receiving a stable dose of MTX for at least 4 weeks prior to screening.
연구 유형
중재적
등록 (실제)
82
단계
- 2 단계
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:
- Diagnosis of rheumatoid arthritis for at least 6 months prior to screening
- Active rheumatoid arthritis as defined by the presence of >= 6 swollen joints (of 66 count) and >= 6 tender joints (of 68 joint count)
- C-reactive protein blood level >0.9 mg/dL
- Anti-citrullinated protein antibody positive and/or rheumatoid factor positive at screening
- American College of Rheumatology Functional Class I, II, or III
- Received methotrexate for a minimum of 3 months prior to screening with a regionally appropriate stable weekly dose for at least 4 weeks prior to screening
- If using oral corticosteroids, the participant must be on a stable dose of 10 mg prednisone
- No history of either untreated, latent, or active tuberculosis prior to baseline
- Participants of reproductive potential must agree to remain abstinent or use 2 acceptable methods of birth control
Exclusion Criteria:
- Presence of inflammatory disease other than rheumatoid arthritis, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
- Positive hepatitis B surface antigen or hepatitis C test result or the presence of Human immunodeficiency virus (HIV) infection
- HIV positive
- User of recreational or illicit drugs or has had a history (within the previous 2 years) of drug or alcohol abuse or dependence
- Females of childbearing potential who are pregnant, intend to become pregnant, or are lactating;
- Severe opportunistic infection within 6 months prior to study start.
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Base Study Phase IIa: MK-8457
Participants received MK-8457 100 mg dosed twice daily (BID) orally with MTX at the stable dose received upon study enrollment.
Phase IIa lasted up to 24 weeks.
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MK-8457 100 mg 경구 투여 BID
MTX dosed at the stable dose receive upon study entry
다른 이름들:
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위약 비교기: Base Study Phase IIa: Placebo
Participants received placebo dosed BID orally with MTX at the stable dose received upon study enrollment.
Phase IIa lasted up to 24 weeks.
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MTX dosed at the stable dose receive upon study entry
다른 이름들:
Dose-matched placebo dosed orally BID
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실험적: Safety Extension Period 3: MK-8457
Participants received MK-8457 100 mg BID orally with MTX at the stable dose received upon study enrollment.
Period 3 was to last up to 2 years.
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MK-8457 100 mg 경구 투여 BID
MTX dosed at the stable dose receive upon study entry
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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12주차에 American College of Rheumatology(ACR) 20 반응을 달성한 참가자의 비율
기간: 12주차
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ACR 응답은 여러 질병 평가 기준의 개선을 수치로 측정한 것입니다.
ACR20 반응은 1) 종창 관절 수(66개 관절) 및 압통 관절 수(68개 관절)에서 ≥20% 개선(0 = 부재, 1 = 존재) 및 2) 다음 중 3개에서 ≥20% 개선으로 정의됩니다. 5 평가: a) 시각적 아날로그 척도(VAS, 통증 없음 =0 내지 극심한 통증 =100)에서 통증에 대한 참가자의 전반적인 평가; b) 질병 활동 VAS의 환자의 전반적인 평가(매우 잘함 =0 내지 매우 나쁨 =100); c) 질병 활동에 대한 연구자의 전반적인 평가 VAS(매우 잘함 =0 ~ 매우 나쁨 =100; d) 건강 평가 설문지(HAQ)에 의해 측정된 8개 기능 영역에 걸친 참가자의 기능 평가, 어려움 없음에서 총 점수 범위 =0 작업을 수행할 수 없음 = 24; 및 e) 혈청 C-반응성 단백질(감소는 개선을 나타냄).
이 결과 측정은 기본 연구 참가자에게만 적용되었습니다.
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12주차
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Disease Activity Score (DAS28) as Measured by Erythrocyte Sedimentation Rate (ESR) at Week 12
기간: Baseline and Week 12
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The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR (an inflammatory marker), and Patient's Global Assessment of Disease Activity VAS (GH).
It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH.
SQRT = square root.
The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater rheumatoid arthritis (RA) disease activity.
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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Change From Baseline in DAS28 as Measured by C-Reactive Protein (CRP) at Week 12
기간: Baseline and Week 12
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The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), CRP (an inflammatory marker), and Patient's Global Assessment of Disease Activity VAS (GH).
It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96.
The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity.
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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Percentage of Participants Achieving an ACR70 Response at Week 12
기간: Week 12
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ACR responses are numerical measurements of improvement in multiple disease assessment criteria.
An ACR70 response is defined as a ≥70% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥70% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement).
This outcome measure applied to Base Study participants only.
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Week 12
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Percentage of Participants Achieving Hybrid ACR Response at Week 12
기간: Week 12
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Hybrid ACR Response evaluates the improvement in active RA by combining elements of the ACR20/50/70 with a categorical score of the mean change in the core set measures (tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, disability index of the HAQ, and CRP).
The mean percentage improvement from Baseline in the core set measures was computed and used with the participant's ACR20, ACR50, and ACR70 status to determine the hybrid ACR response in a lookup table.
The range of values was -100 to 100, with a positive change indicating improvement.
This outcome measure applied to Base Study participants only.
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Week 12
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Percentage of Participants Achieving an ACR-N Response at Week 12
기간: Week 12
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The ACR-N response is the minimum of the following: 1) the percent decrease from Baseline in tender joint counts (68 joints, 0 = absent, 1 = present); 2) the percent decrease from Baseline in swollen joint counts (66 joints, 0 = absent, 1 = present); and 3) the median percent decrease from Baseline for the following: a) Patient's Global Assessment of Pain (VAS, 0 mm = "no pain" and 100 mm = "extreme pain"); b) Patient's Global Assessment of Disease Activity (VAS, 0 mm = doing very well to 100 mm = doing very poor); c) Investigator's Global Assessment of Disease Activity (VAS, 0 mm = doing very well to 100 mm = doing very poor); d. physical function as measured by the HAQ (Likert scale, 0 to 3 with a lower score indicating less disability); and e) CRP.
This outcome measure applied to Base Study participants only.
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Week 12
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Percentage of Participants Achieving a DAS28-ESR Response at Week 12
기간: Week 12
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The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR, and Patient's Global Assessment of Disease Activity VAS (GH).
It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH.
SQRT = square root.
The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity.
Depending upon the DAS28-ESR value for a given visit, change in DAS28-ESR is categorized as follows: No Response (reduction from Baseline ≤0.6),
No response or Moderate Response (reduction >0.6 - 1.2), and Moderate or Good Response (reduction >1.2).
The percentage of participants with a Moderate or Good change in DAS28-ESR was reported.
This outcome measure applied to Base Study participants only.
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Week 12
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Percentage of Participants Achieving a DAS28-CRP Response at Week 12
기간: Week 12
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The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), CRP, and Patient's Global Assessment of Disease Activity VAS (GH).
It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96.
The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity.
Depending upon the DAS28-CRP value for a given visit, change in DAS28-CRP is categorized as follows: No Response (reduction from Baseline ≤0.6),
No response or Moderate Response (reduction >0.6 - 1.2), and Moderate or Good Response (reduction >1.2).
The percentage of participants with a Moderate or Good change in DAS28-CRP was reported.
This outcome measure applied to Base Study participants only.
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Week 12
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Percentage of Participants Achieving DAS28-ESR Remission at Week 12
기간: Week 12
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The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR, and Patient's Global Assessment of Disease Activity VAS (GH).
It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH.
SQRT = square root.
The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity.
DAS28-ESR remission is defined as a value <2.6 at the visit.
This outcome measure applied to Base Study participants only.
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Week 12
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Percentage of Participants Achieving DAS28-CRP Remission at Week 12
기간: Week 12
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The DAS28-CRP is a continuous parameter derived from the formula: 0.56 × the square root of the tender joint count (0-28) + 0.28 × the square root of the swelling joint count (0-28) + 0.36 × the C reactive protein value (in mg/L +1) + 0.014 × Patient's Global Assessment of Disease Activity VAS of 0-100 mm + 0.96.
The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity.
DAS28-CRP remission is defined as a value <2.6 at the visit.
This outcome measure applied to Base Study participants only.
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Week 12
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DAS28-ESR Area Under the Curve (AUC)
기간: Up to 12 weeks
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DAS28-ESR AUC was to be calculated from the DAS28-ESR score versus time curve, which provided an assessment of changes in disease activity over time.
The DAS28-ESR AUC was to be calculated using the trapezoidal rule as the DAS28-ESR multiplied by the duration of the assessment period (in weeks) and was to be expressed as %-weeks.
A higher calculated AUC value indicates higher disease activity (worse).
This outcome measure applied to Base Study participants only.
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Up to 12 weeks
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DAS28-CRP Area Under the Curve (AUC)
기간: Up to 12 weeks
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DAS28-CRP AUC was to be calculated from the DAS28-CRP score versus time curve, which provided an assessment of changes in disease activity over time.
The DAS28-CRP AUC was to be calculated using the trapezoidal rule as the DAS28-CRP multiplied by the duration of the assessment period (in weeks) and was to be expressed as %-weeks.
A higher calculated AUC value indicates higher disease activity (worse).
This outcome measure applied to Base Study participants only.
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Up to 12 weeks
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Change From Baseline in Tender Joint Count at Week 12
기간: Baseline and Week 12
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Tender Joint Count was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points.
Joint pain was scored as 0 = Absent; 1 = Present for each joint.
The overall Tender Joint Count ranged from 0 to 68.
A higher score indicated greater disease severity.
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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Change From Baseline in Swollen Joint Count at Week 12
기간: Baseline and Week 12
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Swollen joint count included 66 joints (same joints as for tender joint count except this excluded evaluation of hips) that were assessed for the presence of swelling.
Soft tissue swelling was considered to be present if there was palpable or visible evidence of capsular distention considered to be due to either synovial thickening and/or a joint effusion.
Bony swelling, nodule formation, and joint deformity were excluded from consideration.
A swollen joint was scored as 0 = Absent; 1 = Present for each joint.
The overall swollen joint count ranged from 0 to 66.
A higher score indicated greater disease severity.
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12
기간: Baseline and Week 12
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SDAI is the simple linear sum of the following parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, Patient's Global Assessment of Disease Activity [PGA, VAS 0 to 10 cm], Investigator's Global Assessment of Disease Activity (MDGA, VAS 0 to 10 cm) and CRP levels (mg/dL).
SDAI =TJC + SJC + PGA + MDGA + CRP.
Overall scores can range from 0.0 to 86.0.
A higher score indicated greater disease severity.
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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Change From Baseline in the Short Form Health Survey (SF-36) at Week 12
기간: Baseline and Week 12
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The SF-36 is a health-related quality of life instrument that consists of 8 multi-item scales: limitations in physical functioning due to health problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to personal or emotional problems, limitations in social functioning due to physical or mental health problems, vitality (energy and fatigue), and general health perception.
Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight.
The lower the score the greater the disability i.e., a score of 0 corresponds to maximum disability and a score of 100 corresponds to no disability.
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 12
기간: Baseline and Week 12
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The FACIT-F is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue.
FACIT-F is a 13-item questionnaire.
Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much).
The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
The higher the participant's response to the questions the greater the participant's fatigue.
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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Change From Baseline in the Patient's Global Assessment of Disease Status/Activity (PGADSA) at Week 12
기간: Baseline and Week 12
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A participant's overall assessment of pain was assessed from the amount of pain due to arthritis experienced during the past 48 hours on a VAS, where 0 mm = doing very well to 100 mm = doing very poor.
A negative change from Baseline indicates improvement.
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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Change From Baseline in the Investigator's Global Assessment of Disease Status/Activity (IGADSA) at Week 12
기간: Baseline and Week 12
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The Investigator's Global Assessment of Disease Status/Activity (IGADSA) is measured with scores ranging from 0 to 100 mm (VAS, 0 mm = doing very well to 100 mm = doing very poor).
A negative change from Baseline indicates improvement.
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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Change From Baseline in the Patient's Global Assessment of Pain (PGAP) at Week 12
기간: Baseline and Week 12
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A participant's overall assessment of pain was assessed from the amount of pain due to arthritis experienced during the past 48 hours on a VAS where 0 mm = "no pain" and 100 mm = "extreme pain".
A negative change from Baseline indicates improvement.
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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12주차에 건강 평가 설문지 장애(HAQ 장애 지수)의 기준선에서 변경
기간: 기준선 및 12주차
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참가자의 기능적 상태는 리커트 척도에서 HAQ의 장애 지수를 사용하여 평가되었습니다.
이 20개 질문 도구는 8가지 기능 영역(옷 입기, 일어나기, 먹기, 걷기, 위생, 뻗기, 잡기 및 일상 생활 활동)에서 작업을 수행하는 데 있어 어려움의 정도를 평가합니다.
각 기능 영역의 응답은 어려움이 없음을 나타내는 0에서 해당 영역에서 작업을 수행할 수 없음을 나타내는 3까지 점수가 매겨집니다.
장애 지수의 전체 점수는 8가지 기능 영역 점수의 평균이며 범위도 0에서 3까지이며 점수가 낮을수록 장애가 적음을 나타냅니다.
기준선에서 음의 변화는 개선을 나타냅니다.
이 결과 측정은 기본 연구 참가자에게만 적용되었습니다.
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기준선 및 12주차
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Change From Baseline in Serum C-Reactive Protein (CRP) at Week 12
기간: Baseline and Week 12
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C-Reactive Protein is an inflammatory marker with a normal reference range of less than 0.9 mg/dL.
Change from Baseline in CRP at Week 12 (Week 12 concentration minus Baseline concentration).
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12
기간: Baseline and Week 12
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The ESR is the rate at which red blood cells sediment in a period of one hour, and is a non-specific measure of inflammation.
Change from Baseline is ESR at Week 12 minus ESR at Baseline.
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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Change From Baseline in Hemoglobin at Week 12
기간: Baseline and Week 12
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Hemoglobin is the iron-containing oxygen-transport metalloprotein in red blood cells.
Change from Baseline is hemoglobin at Week 12 minus hemoglobin at Baseline.
This outcome measure applied to Base Study participants only.
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Baseline and Week 12
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12주차에 ACR50 응답을 달성한 참가자 비율
기간: 12주차
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ACR 응답은 여러 질병 평가 기준의 개선을 수치로 측정한 것입니다.
ACR50 반응은 1) 종창 관절 수(66개 관절) 및 압통 관절 수(68개 관절)에서 ≥50% 개선(0 = 부재, 1 = 존재) 및 2) 다음 중 3개에서 ≥50% 개선으로 정의됩니다. 5 평가: a) 시각적 아날로그 척도(VAS, 통증 없음 =0 내지 극심한 통증 =100)에서 통증에 대한 참가자의 전반적인 평가; b) 질병 활동 VAS의 환자의 전반적인 평가(매우 잘함 =0 내지 매우 나쁨 =100); c) 질병 활동에 대한 연구자의 전반적인 평가 VAS(매우 잘함 =0 ~ 매우 나쁨 =100; d) 건강 평가 설문지(HAQ)에 의해 측정된 8개 기능 영역에 걸친 참가자의 기능 평가, 어려움 없음에서 총 점수 범위 =0 작업을 수행할 수 없음 = 24; 및 e) 혈청 C-반응성 단백질(감소는 개선을 나타냄).
이 결과 측정은 기본 연구 참가자에게만 적용되었습니다.
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12주차
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Percentage of Participants With an ACR20 Response Over Time
기간: Week 1, Week 2, Week 4, Week 6, Week 18 and Week 24
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ACR responses are numerical measurements of improvement in multiple disease assessment criteria.
An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement).
This outcome measure applied to Base Study participants only.
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Week 1, Week 2, Week 4, Week 6, Week 18 and Week 24
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 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)
2012년 5월 22일
기본 완료 (실제)
2013년 10월 3일
연구 완료 (실제)
2013년 10월 3일
연구 등록 날짜
최초 제출
2012년 3월 30일
QC 기준을 충족하는 최초 제출
2012년 3월 30일
처음 게시됨 (추정)
2012년 4월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 3월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 3월 18일
마지막으로 확인됨
2019년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- P08683 (기타 식별자: Merck)
- MK-8457-008 (기타 식별자: Merck)
- 2012-000439-17 (EudraCT 번호)
- 132235 (레지스트리 식별자: JAPIC-CTI)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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. .
류마티스 관절염(RA)에 대한 임상 시험
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Sequenom, Inc.Laboratory Corporation of America모병
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AbbVie모집하지 않고 적극적으로
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AbbVie완전한
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AbbVie완전한류마티스 관절염(RA)미국, 벨기에, 캐나다, 체코, 헝가리, 폴란드, 푸에르토 리코, 스페인, 영국
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Dr. Larry W. MorelandBristol-Myers Squibb; Genentech, Inc.종료됨
MK-8457 100mg에 대한 임상 시험
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MiMedx Group, Inc.Rho, Inc.; NBCD A/S; United BioSource, LLC종료됨
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Kirby Institute모병
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OrthoTrophix, Inc완전한
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Fondazione Policlinico Universitario Agostino Gemelli...완전한