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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04985812
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Georgia, Hungary, Moldova, Republic of, Spain, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: JNJ-67484703

Participants will receive multiple doses of JNJ-67484703.

Placebo Comparator: Placebo

Participants will receive multiple doses of placebo.

Interventions

Drug: - JNJ-67484703

Participants will receive JNJ-67484703.

Drug: - Placebo

Participants will receive placebo to JNJ-67484703.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pinnacle Research Group, LLC, Anniston, Alabama

Status

Completed

Address

Pinnacle Research Group, LLC

Anniston, Alabama, 36207

Clinical Research of West Florida, Clearwater, Florida

Status

Withdrawn

Address

Clinical Research of West Florida

Clearwater, Florida, 33765

GCSP/CIS Orland Park, Orland Park, Illinois

Status

Active, not recruiting

Address

GCSP/CIS Orland Park

Orland Park, Illinois, 60467

Arthritis Associates, Hattiesburg, Mississippi

Status

Withdrawn

Address

Arthritis Associates

Hattiesburg, Mississippi, 39402

Tekton Research Inc., Austin, Texas

Status

Withdrawn

Address

Tekton Research Inc.

Austin, Texas, 78745

International Sites

Arensia Exploratory Medicine, Tbilisi, Georgia

Status

Active, not recruiting

Address

Arensia Exploratory Medicine

Tbilisi, , 0112

Budai Irgalmasrendi Korhaz, Budapest, Hungary

Status

Active, not recruiting

Address

Budai Irgalmasrendi Korhaz

Budapest, , 1023

Clinexpert Kft., Gyöngyös, Hungary

Status

Active, not recruiting

Address

Clinexpert Kft.

Gyöngyös, , 3200

CRU Hungary Kft., Kistarcsa, Hungary

Status

Completed

Address

CRU Hungary Kft.

Kistarcsa, , 2143

Arensia Exploratory Medicine, Chisinau, Moldova, Republic of

Status

Active, not recruiting

Address

Arensia Exploratory Medicine

Chisinau, , MD-2025

Hosp. Univ. A Coruña, A Coruña, Spain

Status

Recruiting

Address

Hosp. Univ. A Coruña

A Coruña, , 15006

Hosp. Clinico San Carlos, Madrid, Spain

Status

Completed

Address

Hosp. Clinico San Carlos

Madrid, , 28040

Hosp. Univ. 12 de Octubre, Madrid, Spain

Status

Completed

Address

Hosp. Univ. 12 de Octubre

Madrid, , 28041

ARENSIA Exploratory Medicine Unit, Kiev, Ukraine

Status

Completed

Address

ARENSIA Exploratory Medicine Unit

Kiev, , 2000