A Study of JNJ-67484703 in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Название протокола
Клинические исследование Rheumatoid Arthritis: JNJ-67484703, Placebo - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Janssen Research & Development, LLC

Источник Janssen Research & Development, LLC
Краткое содержание

The purpose of this study is to evaluate safety and tolerability of JNJ-67484703 administrations in participants with active rheumatoid arthritis (RA) despite receiving methotrexate (MTX) therapy.

Подробное описание

JNJ-67484703 is a humanized immunoglobulin G1 kappa (huIgG1κ) antibody that is being developed as a treatment for systemic autoimmune disorders. The primary hypothesis of this study is that treatment with JNJ-67484703 as compared to placebo will result in a similar tolerability and safety profile, as a measure of participants with abnormalities in vital signs, physical examinations, and laboratory safety tests. This study will be conducted in 3 phases: screening phase (up to 6 weeks), treatment phase (up to 10 weeks), and follow-up phase (up to 14 weeks). The duration of study participation will be approximately 30 weeks. Safety assessment like electrocardiogram (ECG), adverse events will be performed during the study. Efficacy assessment like joint assessments, pain assessments, RA joint pain severity assessment, patient's and physician's global assessment of disease activity, health assessment questionnaires, duration of morning stiffness, functional assessment of chronic illness therapy-fatigue will be performed during the study.

Общий статус Recruiting
Дата начала 2021-10-18
Дата завершения 2023-04-18
Дата первичного завершения 2022-11-17
Фаза Phase 1
Тип исследования Interventional
Первичный результат
Мера Временное ограничение
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Up to 24 weeks
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs) Up to 24 weeks
Percentage of Participants with TEAEs by System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More Up to 24 weeks
Percentage of Participants with Abnormalities in Vital Signs Up to 24 weeks
Percentage of Participants with Abnormalities in Physical Examination Up to 24 weeks
Percentage of Participants with Abnormalities in Laboratory Parameters Up to 24 weeks
Вторичный результат
Мера Временное ограничение
Plasma Concentration of JNJ-67484703 Up to 24 weeks
Percentage of Participants with Antibodies to JNJ-67484703 in Participants Receiving Active Study Intervention Up to 24 weeks
Change from Baseline in Disease Activity Index Score 28 using C-reactive Protein (DAS28-CRP) at Week 12 Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 Response Up to 24 weeks
Percentage of Participants Achieving DAS28-CRP Remission (less than [<] 2.6) at Week 12 Week 12
Percentage of Participants Achieving DAS28-CRP Low Disease Activity (<=3.2) at Week 12 Week 12
Change in Number of T-lymphocyte Populations in Blood Up to 24 weeks
Change in Magnitude and Duration of Cell Surface Expression Level of Receptors Up to 24 weeks
Регистрация 42
Состояние
  • Rheumatoid Arthritis
Вмешательство

Тип вмешательства: Drug

Название вмешательства: JNJ-67484703

Описание: Participants will receive JNJ-67484703.

Этикетка Arm Group: JNJ-67484703

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Participants will receive placebo to JNJ-67484703.

Этикетка Arm Group: Placebo

Приемлемость

Критерии:

Inclusion Criteria: - Participants have an inadequate response to receiving methotrexate (MTX) therapy - Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening - Have a diagnosis of rheumatoid arthritis (RA) (American College of Rheumatology [ACR]/ European League Against Rheumatism [EULAR] criteria 2010) - Body weight within the range of 50.0 kilograms (kg) to 120.0 kg, inclusive, and have a body mass index (BMI) of 19.0 kilograms per meter square (kg/m^2) to 32.0 kg/m^2, inclusive - All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening Exclusion Criteria: - Known allergies, hypersensitivity, or intolerance to any biologic medication or excipients of JNJ-67484703 - Has a diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances - Have other known inflammatory diseases that might confound the evaluations of benefit from JNJ-67484703 therapy - Have a history of any clinically significant adverse reaction to murine or chimeric proteins, including, but not limited to, allergic reactions - Have a history of or currently have felty's syndrome

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

65 Years

Здоровые волонтеры:

No

Общий Официальный
Фамилия Роль Присоединение
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Общий контакт

Фамилия: Study Contact

Телефон: 844-434-4210

Расположение
Объект: Положение дел:
Pinnacle Research Group, LLC | Anniston, Alabama, 36207, United States Not yet recruiting
Clinical Research of West Florida | Clearwater, Florida, 33765, United States Withdrawn
GCSP/CIS Orland Park | Orland Park, Illinois, 60467, United States Recruiting
Arthritis Associates | Hattiesburg, Mississippi, 39402, United States Withdrawn
Tekton Research Inc. | Austin, Texas, 78745, United States Withdrawn
Arensia Exploratory Medicine | Tbilisi, 0112, Georgia Recruiting
Budai Irgalmasrendi Korhaz | Budapest, 1023, Hungary Recruiting
Arensia Exploratory Medicine | Chisinau, MD-2025, Moldova, Republic of Recruiting
Hosp. Univ. A Coruña | A Coruña, 15006, Spain Recruiting
Hosp. Clinico San Carlos | Madrid, 28040, Spain Recruiting
Hosp. Univ. 12 de Octubre | Madrid, 28041, Spain Recruiting
ARENSIA Exploratory Medicine Unit | Kiev, 2000, Ukraine Recruiting
Расположение Страны

Georgia

Hungary

Moldova, Republic of

Spain

Ukraine

United States

Дата проверки

2022-01-01

Ответственная сторона

Тип: Sponsor

Имеет расширенный доступ No
Состояние Просмотр
  • Arthritis
  • Arthritis, Rheumatoid
Количество рук 2
Группа вооружений

Метка: JNJ-67484703

Тип: Experimental

Описание: Participants will receive multiple doses of JNJ-67484703.

Метка: Placebo

Тип: Placebo Comparator

Описание: Participants will receive multiple doses of placebo.

Данные пациента Yes
Информация о дизайне исследования

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: Triple (Participant, Investigator, Outcomes Assessor)