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

Ведущий спонсор: Janssen Research & Development, LLC

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.

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.

• Rheumatoid Arthritis

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

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

Фамилия: Study Contact

Телефон: 844-434-4210

Georgia

Hungary

Moldova, Republic of

Spain

Ukraine

United States

2022-01-01

Тип: Sponsor

• Arthritis
• Arthritis, Rheumatoid

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.

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: Triple (Participant, Investigator, Outcomes Assessor)