A Study of JNJ-67484703 in Participants With Active Rheumatoid Arthritis
Completed · Phase 1 · Has a placebo group
Conditions studied: Rheumatoid Arthritis
In brief
The purpose of this study is to evaluate safety and tolerability of JNJ-67484703 administrations in participants with active rheumatoid arthritis (RA).
Key facts
- Study ID
- NCT04985812
- Run by
- Janssen Research & Development, LLC
- People needed
- 44
- Starts
- 2021-10-18
- Expected to finish
- 2023-05-18
- Last updated by the study team
- 2025-05-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Demonstrated an inadequate response to, or loss of response or intolerance to: at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) and/or up to 2 biologic DMARD (bDMARD)/targeted synthetic DMARD (tsDMARD)
- Have C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening
- 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
You may not qualify if…
- 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
Where it is running
- Pinnacle Research Group, LLC — Anniston, Alabama, United States
- GCSP/CIS Orland Park — Orland Park, Illinois, United States
- Arensia Exploratory Medicine — Tbilisi, Georgia
- Budai Irgalmasrendi Korhaz — Budapest, Hungary
- Clinexpert Kft — Gyöngyös, Hungary
- CRU Hungary Kft. — Kistarcsa, Hungary
- Arensia Exploratory Medicine — Chisinau, Moldova
- Hosp Univ A Coruna — A Coruña, Spain
- Hosp. Clinico San Carlos — Madrid, Spain
- Hosp. Univ. 12 de Octubre — Madrid, Spain
- ARENSIA Exploratory Medicine Unit — Kiev, Ukraine
Full record on ClinicalTrials.gov
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