Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)
18 de março de 2019 atualizado por: 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.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
82
Estágio
- Fase 2
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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 administrado por via oral BID
MTX dosed at the stable dose receive upon study entry
Outros nomes:
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Comparador de Placebo: 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
Outros nomes:
Dose-matched placebo dosed orally BID
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Experimental: 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 administrado por via oral BID
MTX dosed at the stable dose receive upon study entry
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Porcentagem de participantes que obtiveram uma resposta do American College of Rheumatology (ACR) 20 na semana 12
Prazo: Semana 12
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As respostas ACR são medidas numéricas de melhora em vários critérios de avaliação de doenças.
Uma resposta ACR20 é definida como uma melhoria ≥20% em 1) contagem de articulações edemaciadas (66 articulações) e contagem de articulações sensíveis (68 articulações) (0 = ausente; 1 = presente) e 2) melhoria ≥20% em 3 dos seguintes 5 avaliações: a) avaliação geral da dor de um participante em uma escala analógica visual (VAS, sem dor =0 a dor extrema =100); b) EVA de Avaliação Global da Atividade da Doença do Paciente (indo muito bem =0 a muito mal =100); c) Avaliação global do investigador da atividade da doença VAS (indo muito bem = 0 a indo muito mal = 100; d) avaliação do participante da função em 8 áreas funcionais, conforme medido pelo Health Assessment Questionnaire (HAQ), pontuações totais variando de nenhuma dificuldade = 0 à incapacidade de realizar tarefas =24; e e) Proteína C Reativa sérica (diminuição indica melhora).
Esta medida de resultado se aplica apenas aos participantes do Estudo de Base.
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Semana 12
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in Disease Activity Score (DAS28) as Measured by Erythrocyte Sedimentation Rate (ESR) at Week 12
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Week 12
|
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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Alteração da linha de base no Questionário de Avaliação de Saúde Incapacidade (Índice de Incapacidade HAQ) na Semana 12
Prazo: Linha de base e Semana 12
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O estado funcional do participante foi avaliado por meio do Índice de Incapacidade do HAQ em escala Likert.
Este instrumento de 20 questões avalia o grau de dificuldade que uma pessoa tem em realizar tarefas em 8 áreas funcionais (vestir-se, levantar-se, comer, caminhar, higiene, alcançar, agarrar e atividades da vida diária).
As respostas em cada área funcional são pontuadas de 0, indicando nenhuma dificuldade, a 3, indicando incapacidade de realizar uma tarefa nessa área.
A pontuação geral para o Índice de Incapacidade é a média das 8 pontuações da área funcional e também varia de 0 a 3, com uma pontuação mais baixa indicando menos incapacidade.
Uma mudança negativa da linha de base indica melhora.
Esta medida de resultado se aplica apenas aos participantes do Estudo de Base.
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Linha de base e Semana 12
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Change From Baseline in Serum C-Reactive Protein (CRP) at Week 12
Prazo: 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
Prazo: 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
Prazo: 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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Porcentagem de participantes que alcançaram uma resposta ACR50 na semana 12
Prazo: Semana 12
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As respostas ACR são medidas numéricas de melhora em vários critérios de avaliação de doenças.
Uma resposta ACR50 é definida como uma melhoria ≥50% em 1) contagem de articulações edemaciadas (66 articulações) e contagem de articulações sensíveis (68 articulações) (0 = ausente; 1 = presente) e 2) melhoria ≥50% em 3 dos seguintes 5 avaliações: a) avaliação geral da dor de um participante em uma escala analógica visual (VAS, sem dor =0 a dor extrema =100); b) EVA de Avaliação Global da Atividade da Doença do Paciente (indo muito bem =0 a muito mal =100); c) Avaliação global do investigador da atividade da doença VAS (indo muito bem = 0 a indo muito mal = 100; d) avaliação do participante da função em 8 áreas funcionais, conforme medido pelo Health Assessment Questionnaire (HAQ), pontuações totais variando de nenhuma dificuldade = 0 à incapacidade de realizar tarefas =24; e e) Proteína C Reativa sérica (diminuição indica melhora).
Esta medida de resultado se aplica apenas aos participantes do Estudo de Base.
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Semana 12
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Percentage of Participants With an ACR20 Response Over Time
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
22 de maio de 2012
Conclusão Primária (Real)
3 de outubro de 2013
Conclusão do estudo (Real)
3 de outubro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
30 de março de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de março de 2012
Primeira postagem (Estimativa)
2 de abril de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de março de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de março de 2019
Última verificação
1 de março de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do sistema imunológico
- Doenças autoimunes
- Doenças articulares
- Doenças musculoesqueléticas
- Doenças Reumáticas
- Doenças do Tecido Conjuntivo
- Artrite
- Artrite, Reumatóide
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores da Síntese de Ácido Nucleico
- Inibidores Enzimáticos
- Agentes Antirreumáticos
- Antimetabólitos, Antineoplásicos
- Antimetabólitos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Agentes dermatológicos
- Agentes de Controle Reprodutivo
- Agentes abortivos, não esteróides
- Agentes abortivos
- Antagonistas do ácido fólico
- Metotrexato
Outros números de identificação do estudo
- P08683 (Outro identificador: Merck)
- MK-8457-008 (Outro identificador: Merck)
- 2012-000439-17 (Número EudraCT)
- 132235 (Identificador de registro: JAPIC-CTI)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
Descrição do plano IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Artrite Reumatoide (AR)
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Citryll BVRecrutamento
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Beijing Boren HospitalAinda não está recrutando
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Chong Kun Dang PharmaceuticalConcluídoImunossupressor (Transplante de Órgãos, RA)
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University of Medicine and Pharmacy at Ho Chi Minh...Ainda não está recrutando
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Amrita Vishwa VidyapeethamAinda não está recrutandoRinite Alérgica (RA)
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Liaquat National Hospital & Medical CollegeAinda não está recrutandoRinite Alérgica (RA)Paquistão
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Assiut UniversityAinda não está recrutandoRelacionamento RA e OP
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Region SkaneConcluídoSíndrome | Vasculite | LES | Esclerodermia | RA | SjögrensSuécia
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SanofiRegeneron PharmaceuticalsConcluídoRAEstados Unidos, Chile, México, Polônia, Federação Russa, África do Sul
Ensaios clínicos em MK-8457 100 mg
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Merck Sharp & Dohme LLCConcluídoHipertensãoEstados Unidos
-
Merck Sharp & Dohme LLCConcluído
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