JNJ-67484703 for Rheumatoid Arthritis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rheumatoid ArthritisJNJ-67484703 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for people with rheumatoid arthritis to see if it is safe and has any adverse effects.

Eligible Conditions
  • Rheumatoid Arthritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 9 Secondary · Reporting Duration: Up to 24 weeks

Baseline, Week 12
Change from Baseline in Disease Activity Index Score 28 using C-reactive Protein (DAS28-CRP) at Week 12
Up to 24 weeks
Change in Magnitude and Duration of Cell Surface Expression Level of Receptors
Change in Number of T-lymphocyte Populations in Blood
Percentage of Participants Achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 Response
Percentage of Participants with Abnormalities in Laboratory Parameters
Percentage of Participants with Abnormalities in Physical Examination
Percentage of Participants with Abnormalities in Vital Signs
Percentage of Participants with Antibodies to JNJ-67484703 in Participants Receiving Active Study Intervention
Percentage of Participants with TEAEs by System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Plasma Concentration of JNJ-67484703
Serum Concentration of JNJ-67484703 Over Time
Week 12
Percentage of Participants Achieving DAS28-CRP Low Disease Activity (<=3.2) at Week 12
Percentage of Participants Achieving DAS28-CRP Remission (less than [<] 2.6) at Week 12

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

JNJ-67484703
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

47 Total Participants · 2 Treatment Groups

Primary Treatment: JNJ-67484703 · Has Placebo Group · Phase 1

JNJ-67484703
Drug
Experimental Group · 1 Intervention: JNJ-67484703 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 weeks

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
924 Previous Clinical Trials
6,331,070 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
678 Patients Enrolled for Rheumatoid Arthritis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
710 Previous Clinical Trials
3,904,055 Total Patients Enrolled
2 Trials studying Rheumatoid Arthritis
278 Patients Enrolled for Rheumatoid Arthritis

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have CRP greater than or equal to (>=) 0.3 mg/dL at screening.
You are a woman and you have a negative beta-hCG test.

Who else is applying?

What state do they live in?
Alabama66.7%
Indiana33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Pinnacle Research Group, LLC100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria66.7%
Met criteria33.3%