Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-67484703 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| JNJ-67484703 | EXPERIMENTAL | Participants will receive multiple doses of JNJ-67484703. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive multiple doses of placebo. |
| Name | Type | Description |
|---|---|---|
| JNJ-67484703 | DRUG | Participants will receive JNJ-67484703. |
| Placebo | DRUG | Participants will receive placebo to JNJ-67484703. |
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 tha...
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JNJ-67484703 is an investigational small molecule being studied for the treatment of active rheumatoid arthritis. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a clinical trial involving participants with active rheumatoid arthritis.
JNJ-67484703 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is an investigational small molecule in Phase 1 clinical development for the treatment of active rheumatoid arthritis.
JNJ-67484703 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 study of JNJ-67484703 in participants with active rheumatoid arthritis has been completed.
JNJ-67484703 has been studied in one clinical trial, identified as NCT04985812. This was a Phase 1, randomized, double-blind, placebo-controlled study in participants with active rheumatoid arthritis. The trial enrolled 44 participants and has been completed.
JNJ-67484703 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of active rheumatoid arthritis. The drug has not yet completed the clinical trials needed to support a marketing application.