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

An adverse event (AEs) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.

A serious adverse event based on International Council for Harmonization (ICH) and European Union (EU) guidelines on pharmacovigilance for medicinal products for human use is any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (the participant was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe.); c) requires inpatient hospitalization or prolongation of existing hospitalization; d) results in persistent or significant disability/incapacity; e) Is a congenital anomaly/birth defect; f) is a suspected transmission of any infectious agent via a medicinal product.

Percentage of participants with TEAEs by SOC with a frequency threshold of 5% or more by study intervention will be reported. TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.

Percentage of participants with abnormalities in vital signs (temperature [oral or tympanic], pulse/heart rate, respiratory rate and blood pressure [systolic and diastolic]) will be reported.

Percentage of participants with abnormalities in physical examination will be reported.

Percentage of participants with abnormalities in laboratory parameters (hematology, serum chemistry, and urinalysis) will be reported.

Serum concentration of JNJ-67484703 over time will be reported using a validated, specific, and sensitive method.

Percentage of participants with antibodies to JNJ-67484703 in participants receiving active study intervention will be reported.

DAS28-CRP is a derived score combining tender joints (28 joints), swollen joints (28 joints), CRP, and patient's global assessment of disease activity (GH). The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP)1, MCP2, MCP3, MCP4, MCP5, proximal interphalangeal (PIP)1, PIP2, PIP3, PIP4, PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. Scores below 3.2 indicate best disease control and scores above 5.1 indicate worse disease control.

ACR responses are presented as numerical measurement of improvement in multiple disease assessment criteria. For example, ACR20 response is defined as percent improvement of 20 or higher from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), combined with a percent improvement of 20 or higher from baseline in 3 of the following 5 assessments: patient's assessment of pain by visual analog scale (VAS), patient's global assessment of disease activity by VAS, physician's global assessment of disease activity by VAS, patient's assessment of physical function measured by health assessment questionnaire-disability index (HAQ-DI, a 20-question instrument assessing 8 functional areas), and CRP. ACR50 and ACR70 are similarly defined except percent improvement threshold from baseline is 50 and 70, respectively.

Percentage of participants achieving DAS28-CRP remission < 2.6 at Week 12 will be reported.

Percentage of participants achieving DAS28-CRP low disease activity (defined as DAS28-CRP less than or equal to [<=] 3.2) at week 12 will be reported.

Change in number of T-lymphocytes in blood will be reported. T-lymphocyte populations in blood will be assessed by flow cytometry.

Change in magnitude and duration of cell surface expression level of receptors will be assessed by flow cytometry will be reported.