Rheumatoid ArthritisPhase 1NCT04985812
A Study of JNJ-67484703 in Participants With Active Rheumatoid Arthritis
A Phase 1 study testing JNJ-67484703 in people with Rheumatoid Arthritis, run by Janssen Research & Development, LLC at 11 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate safety and tolerability of JNJ-67484703 administrations in participants with active rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- JNJ-67484703
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 18 Oct 2021to 18 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
Hungary3 sites
Budai Irgalmasrendi Korhaz
Budapest, 1023
Clinexpert Kft
Gyöngyös, 3200
CRU Hungary Kft.
Kistarcsa, 2143
Spain3 sites
Hosp Univ A Coruna
A Coruña, 15006
Hosp. Clinico San Carlos
Madrid, 28040
Hosp. Univ. 12 de Octubre
Madrid, 28041
United States2 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
GCSP/CIS Orland Park
Orland Park, Illinois, 60467
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of JNJ-67484703 in Participants With Active Rheumatoid Arthritis
The purpose of this study is to evaluate safety and tolerability of JNJ-67484703 administrations in participants with active rheumatoid arthritis (RA).
Read the detailed description
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- JNJ-67484703, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-67484703Drug
Participants will receive JNJ-67484703.
PlaceboDrug
Participants will receive placebo to JNJ-67484703.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-67484703 | Experimental | Participants will receive multiple doses of JNJ-67484703. Receives: Drug: JNJ-67484703 |
| Placebo | Placebo comparator | Participants will receive multiple doses of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
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.
Measured: Up to 24 weeks
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)
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.
Measured: Up to 24 weeks
Percentage of Participants with TEAEs by System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More
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.
Measured: Up to 24 weeks
Percentage of Participants with Abnormalities in Vital Signs
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.
Measured: Up to 24 weeks
Percentage of Participants with Abnormalities in Physical Examination
Percentage of participants with abnormalities in physical examination will be reported.
Measured: Up to 24 weeks
Percentage of Participants with Abnormalities in Laboratory Parameters
Percentage of participants with abnormalities in laboratory parameters (hematology, serum chemistry, and urinalysis) will be reported.
Measured: Up to 24 weeks
Secondary outcomes (8)
Serum Concentration of JNJ-67484703 Over Time
Serum concentration of JNJ-67484703 over time will be reported using a validated, specific, and sensitive method.
Measured: Up to 24 weeks
Percentage of Participants with Antibodies to JNJ-67484703 in Participants Receiving Active Study Intervention
Percentage of participants with antibodies to JNJ-67484703 in participants receiving active study intervention will be reported.
Measured: Up to 24 weeks
Change from Baseline in Disease Activity Index Score 28 using C-reactive Protein (DAS28-CRP) at Week 12
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.
Measured: Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 Response
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.
Measured: Up to 24 weeks
Percentage of Participants Achieving DAS28-CRP Remission (less than [<] 2.6) at Week 12
Percentage of participants achieving DAS28-CRP remission < 2.6 at Week 12 will be reported.
Measured: Week 12
Percentage of Participants Achieving DAS28-CRP Low Disease Activity (<=3.2) at Week 12
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.
Measured: Week 12
Change in Number of T-lymphocyte Populations in Blood
Change in number of T-lymphocytes in blood will be reported. T-lymphocyte populations in blood will be assessed by flow cytometry.
Measured: Up to 24 weeks
Change in Magnitude and Duration of Cell Surface Expression Level of Receptors
Change in magnitude and duration of cell surface expression level of receptors will be assessed by flow cytometry will be reported.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start18 Oct 2021
- Primary completion18 May 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985812
- Sponsor's protocol ID
- CR109021
- Other IDs
- 2021-000195-10, 67484703ARA1001
- Status last verified
- May 2025
- First submitted
- 6 Jul 2021
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Publications
Ling ITC, Marciniak SJ, Clarke SH, Lakshminarayanan V, Loza MJ, Liva SG, Wang T, Orillion A, Tikhonov I, Noss EH. Safety, tolerability, and efficacy of the PD-1 agonist antibody JNJ-67484703 in adults with active rheumatoid arthritis: results of a multicenter, double-blind, placebo-controlled, randomized, multiple-dose phase Ib study. Ther Adv Musculoskelet Dis. 2025 Oct 21;17:1759720X251385857. doi: 10.1177/1759720X251385857. eCollection 2025.
PubMed 41146691
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled, Randomized, Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of JNJ-67484703 in Participants With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04985812
- Acronym / sponsor ID
- CR109021
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety and tolerability of JNJ-67484703 administrations in participants with active rheumatoid arthritis (RA).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ-67484703 | Experimental | Drug: JNJ-67484703Participants will receive multiple doses of JNJ-67484703. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive multiple doses of placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-67484703Participants will receive JNJ-67484703. | Drug | JNJ-67484703 |
| PlaceboParticipants will receive placebo to JNJ-67484703. | Drug | Placebo |
Primary outcome
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 24 weeks
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.
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Time frame: Up to 24 weeks
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 System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More
Time frame: Up to 24 weeks
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
Time frame: Up to 24 weeks
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
Time frame: Up to 24 weeks
Percentage of participants with abnormalities in physical examination will be reported.
Percentage of Participants with Abnormalities in Laboratory Parameters
Time frame: Up to 24 weeks
Percentage of participants with abnormalities in laboratory parameters (hematology, serum chemistry, and urinalysis) will be reported.
8 secondary outcomes
Serum Concentration of JNJ-67484703 Over Time
Time frame: Up to 24 weeks
Percentage of Participants with Antibodies to JNJ-67484703 in Participants Receiving Active Study Intervention
Time frame: Up to 24 weeks
Change from Baseline in Disease Activity Index Score 28 using C-reactive Protein (DAS28-CRP) at Week 12
Time frame: Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 Response
Time frame: Up to 24 weeks
Percentage of Participants Achieving DAS28-CRP Remission (less than [<] 2.6) at Week 12
Time frame: Week 12
Percentage of Participants Achieving DAS28-CRP Low Disease Activity (<=3.2) at Week 12
Time frame: Week 12
Change in Number of T-lymphocyte Populations in Blood
Time frame: Up to 24 weeks
Change in Magnitude and Duration of Cell Surface Expression Level of Receptors
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Derived from this study: PubMed 41146691Ling ITC, Marciniak SJ, Clarke SH, Lakshminarayanan V, Loza MJ, Liva SG, Wang T, Orillion A, Tikhonov I, Noss EH. Safety, tolerability, and efficacy of the PD-1 agonist antibody JNJ-67484703 in adults with active rheumatoid arthritis: results of a multicenter, double-blind, placebo-controlled, randomized, multiple-dose phase Ib study. Ther Adv Musculoskelet Dis. 2025 Oct 21;17:1759720X251385857. doi: 10.1177/1759720X251385857. eCollection 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-67484703 in people with Rheumatoid Arthritis, run by Janssen Research & Development, LLC at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Hungary, Spain, United States, Georgia, Moldova and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.