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

• Status: Recruiting
• Trial end date: 2023-04-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

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