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A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis (DAISY)

Primary Purpose

Arthritis, Rheumatoid

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Nipocalimab
Certolizumab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of rheumatoid arthritis (RA) and meeting the 2010 American college of rheumatology (ACR) or European League Against Rheumatism (EULAR) criteria for RA for at least 3 months before screening Has moderate to severe active RA as defined by persistent disease activity with at least 6 of 66 swollen joints and 6 of 68 tender joints at the time of screening and at baseline Is positive for anti-citrullinated protein antibodies (ACPA) or rheumatoid factor (RF) by the central laboratory at the time of screening Has C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram per deciliter (mg/dL) by the central laboratory at the time of screening If has received prior biological disease-modifying antirheumatic drugs (bDMARDs) (or biosimilars) other than anti-tumor necrosis factor (anti-TNF) agent in RA, has demonstrated inadequate response (IR) or intolerance to the therapy based on one of the following: IR to at least 1bDMARD (or the biosimilars) other than anti-TNF agents, as assessed by the treating physician, after at least 12 weeks of therapy including but not limited to abatacept, anakinra, tocilizumab, and sarilumab or at least 16 weeks of therapy with rituximab Documented IR may include inadequate improvement or loss in response after initial improvement in joint counts or other parameters of disease activity Intolerance to bDMARD (or biosimilars) other than anti-TNF agent, as assessed by the treating physician. Documented intolerance includes side effects and injection or infusion reactions If has received prior anti-TNF agent (including biosimilars), has demonstrated IR to >=1 anti-TNF agent (including biosimilars), as assessed by the treating physician: After at least 12 weeks dosage of etanercept, adalimumab, golimumab (including biosimilars), and/or After at least 14 weeks dosage (example, at least 4 doses) of infliximab (including biosimilars) Documented IR may include inadequate improvement or loss in response after initial improvement in joint counts or other parameters of disease activity Exclusion Criteria: Has a confirmed or suspected clinical immunodeficiency syndrome not related to treatment of RA or has a family history of congenital or hereditary immunodeficiency unless confirmed absent Is (anatomically or functionally) asplenic Has experienced myocardial infarction, unstable ischemic heart disease, or stroke less than or equal to (<=) 12 weeks of screening Has a diagnosis of congestive heart failure including medically controlled, asymptomatic congestive heart failure Has a history of known demyelinating disease such as multiple sclerosis or optic neuritis

Sites / Locations

  • Arizona Arthritis and Rheumatology Research, PLLCRecruiting
  • Inland Rheumatology Clinical Trials Inc.Recruiting
  • Integral Rheumatology & Immunology SpecialistsRecruiting
  • Southwest Rheumatology Research LLCRecruiting
  • ARCIS Salud SRL (Aprillus asistencia e investigacion)Recruiting
  • Centro de Investigaciones Medicas TucumanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Certolizumab + Placebo

Certolizumab + Nipocalimab

Arm Description

Participants will receive placebo intravenously (IV) and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by placebo IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.

Participants will receive nipocalimab IV and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by nipocalimab IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.

Outcomes

Primary Outcome Measures

Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12
Change from baseline in DAS28-CRP score at Week 12 will be reported. DAS28-CRP is combined index used to assess rheumatoid arthritis (RA) disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), CRP, and patient's global assessment of disease activity. 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. Lower scores indicate better disease control and higher scores indicate worse disease control.

Secondary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 12
Percentage of participants achieving ACR 20 response at Week 12 will be reported. ACR 20 response is defined as greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >= 20% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, visual analog scale [VAS]; 0-100 mm, 0=excellent and 100=poor), patient's assessment of pain by VAS (VAS; 0-100 millimeter [mm], 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by health assessment questionnaire-disability index (HAQ-DI), defined as a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity, and 100=extremely active arthritis), and CRP.
Percentage of Participants Achieving ACR 50 Response at Week 12
Percentage of participants achieving ACR 50 response at Week 12 will be reported. ACR 50 response is defined as >= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >= 50% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), patient's assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and CRP.
Percentage of Participants Achieving ACR 70 Response at Week 12
Percentage of participants achieving ACR 70 response at Week 12 will be reported. ACR70 response is defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), patient's assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas), range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and CRP.
Percentage of Participants Achieving ACR90 Response at Week 12
Percentage of participants achieving ACR 90 response at Week 12 will be reported. ACR 90 response is defined as >= 90% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >= 90% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), patient's assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas), range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and CRP.
Percentage of Participants Achieving DAS28-CRP Remission at Week 12
Percentage of participants achieving DAS28-CRP level for remission at Week 12 will be reported. DAS28-CRP remission is defined as DAS28-CRP value less than (<) 2.6 at the analysis visit.
Percentage of Participants Achieving DAS28-CRP Low Disease Activity (LDA) at Week 12
Percentage of participants achieving DAS28-CRP level for LDA at Week 12 will be reported. DAS28 LDA is defined as a DAS28 value of less than or equal to (<=) 3.2 at the analysis visit.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
Change from baseline in HAQ-DI score at Week 12 will be reported. The functional status of the participant will be assessed using the HAQ-DI. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Lower scores are indicative of better functioning.
Change From Baseline in Clinical Disease Activity Index Score (CDAI) at Week 12
Change from baseline in CDAI score to Week 12 will be reported. The CDAI score is a derived combined index used to assess rheumatoid arthritis (RA) disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient's global assessment of disease activity (arthritis, VAS; 0-10 centimeter (cm), 0=excellent and 10= poor), and physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis). CDAI total score ranges from 0 to 76.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical or biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that at any dose results in death, 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 was more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants With TEAEs Leading to Discontinuation of Study Intervention
Number of participants with TEAEs leading to discontinuation of study intervention will be reported. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants With Adverse Events of Special interests (AESIs)
Number of participants with AESIs will be reported. TEAEs associated with the following situations are considered to be AESIs: Infections that are severe or require intravenous (IV) anti-infective or operative or invasive intervention, clinically significant opportunistic infection (for example, active TB, invasive fungal infections), hypoalbuminemia with albumin level <20 gram per liter (g/L), and any newly identified malignancies. An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.

Full Information

First Posted
September 1, 2023
Last Updated
October 9, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT06028438
Brief Title
A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
Acronym
DAISY
Official Title
A Phase 2a Multicenter, Randomized, Double Blind, Parallel, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis Despite Prior Treatment With Advanced Therapies (bDMARD or tsDMARD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Certolizumab + Placebo
Arm Type
Active Comparator
Arm Description
Participants will receive placebo intravenously (IV) and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by placebo IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.
Arm Title
Certolizumab + Nipocalimab
Arm Type
Experimental
Arm Description
Participants will receive nipocalimab IV and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by nipocalimab IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Nipocalimab
Other Intervention Name(s)
JNJ-80202135, M281
Intervention Description
Nipocalimab will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Certolizumab
Other Intervention Name(s)
Cimzia
Intervention Description
Certolizumab will be administered subcutaneously.
Primary Outcome Measure Information:
Title
Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12
Description
Change from baseline in DAS28-CRP score at Week 12 will be reported. DAS28-CRP is combined index used to assess rheumatoid arthritis (RA) disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), CRP, and patient's global assessment of disease activity. 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. Lower scores indicate better disease control and higher scores indicate worse disease control.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 12
Description
Percentage of participants achieving ACR 20 response at Week 12 will be reported. ACR 20 response is defined as greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >= 20% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, visual analog scale [VAS]; 0-100 mm, 0=excellent and 100=poor), patient's assessment of pain by VAS (VAS; 0-100 millimeter [mm], 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by health assessment questionnaire-disability index (HAQ-DI), defined as a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity, and 100=extremely active arthritis), and CRP.
Time Frame
At Week 12
Title
Percentage of Participants Achieving ACR 50 Response at Week 12
Description
Percentage of participants achieving ACR 50 response at Week 12 will be reported. ACR 50 response is defined as >= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >= 50% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), patient's assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and CRP.
Time Frame
At Week 12
Title
Percentage of Participants Achieving ACR 70 Response at Week 12
Description
Percentage of participants achieving ACR 70 response at Week 12 will be reported. ACR70 response is defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), patient's assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas), range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and CRP.
Time Frame
At Week 12
Title
Percentage of Participants Achieving ACR90 Response at Week 12
Description
Percentage of participants achieving ACR 90 response at Week 12 will be reported. ACR 90 response is defined as >= 90% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >= 90% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), patient's assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas), range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and CRP.
Time Frame
At Week 12
Title
Percentage of Participants Achieving DAS28-CRP Remission at Week 12
Description
Percentage of participants achieving DAS28-CRP level for remission at Week 12 will be reported. DAS28-CRP remission is defined as DAS28-CRP value less than (<) 2.6 at the analysis visit.
Time Frame
At Week 12
Title
Percentage of Participants Achieving DAS28-CRP Low Disease Activity (LDA) at Week 12
Description
Percentage of participants achieving DAS28-CRP level for LDA at Week 12 will be reported. DAS28 LDA is defined as a DAS28 value of less than or equal to (<=) 3.2 at the analysis visit.
Time Frame
At Week 12
Title
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
Description
Change from baseline in HAQ-DI score at Week 12 will be reported. The functional status of the participant will be assessed using the HAQ-DI. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Lower scores are indicative of better functioning.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Clinical Disease Activity Index Score (CDAI) at Week 12
Description
Change from baseline in CDAI score to Week 12 will be reported. The CDAI score is a derived combined index used to assess rheumatoid arthritis (RA) disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient's global assessment of disease activity (arthritis, VAS; 0-10 centimeter (cm), 0=excellent and 10= poor), and physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis). CDAI total score ranges from 0 to 76.
Time Frame
Baseline, Week 12
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical or biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time Frame
Up to Week 30
Title
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Description
SAE is any untoward medical occurrence that at any dose results in death, 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 was more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.
Time Frame
Up to Week 30
Title
Number of Participants With TEAEs Leading to Discontinuation of Study Intervention
Description
Number of participants with TEAEs leading to discontinuation of study intervention will be reported. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time Frame
Up to Week 30
Title
Number of Participants With Adverse Events of Special interests (AESIs)
Description
Number of participants with AESIs will be reported. TEAEs associated with the following situations are considered to be AESIs: Infections that are severe or require intravenous (IV) anti-infective or operative or invasive intervention, clinically significant opportunistic infection (for example, active TB, invasive fungal infections), hypoalbuminemia with albumin level <20 gram per liter (g/L), and any newly identified malignancies. An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
Time Frame
Up to Week 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of rheumatoid arthritis (RA) and meeting the 2010 American college of rheumatology (ACR) or European League Against Rheumatism (EULAR) criteria for RA for at least 3 months before screening Has moderate to severe active RA as defined by persistent disease activity with at least 6 of 66 swollen joints and 6 of 68 tender joints at the time of screening and at baseline Is positive for anti-citrullinated protein antibodies (ACPA) or rheumatoid factor (RF) by the central laboratory at the time of screening Has C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram per deciliter (mg/dL) by the central laboratory at the time of screening If has received prior biological disease-modifying antirheumatic drugs (bDMARDs) (or biosimilars) other than anti-tumor necrosis factor (anti-TNF) agent in RA, has demonstrated inadequate response (IR) or intolerance to the therapy based on one of the following: IR to at least 1bDMARD (or the biosimilars) other than anti-TNF agents, as assessed by the treating physician, after at least 12 weeks of therapy including but not limited to abatacept, anakinra, tocilizumab, and sarilumab or at least 16 weeks of therapy with rituximab Documented IR may include inadequate improvement or loss in response after initial improvement in joint counts or other parameters of disease activity Intolerance to bDMARD (or biosimilars) other than anti-TNF agent, as assessed by the treating physician. Documented intolerance includes side effects and injection or infusion reactions If has received prior anti-TNF agent (including biosimilars), has demonstrated IR to >=1 anti-TNF agent (including biosimilars), as assessed by the treating physician: After at least 12 weeks dosage of etanercept, adalimumab, golimumab (including biosimilars), and/or After at least 14 weeks dosage (example, at least 4 doses) of infliximab (including biosimilars) Documented IR may include inadequate improvement or loss in response after initial improvement in joint counts or other parameters of disease activity Exclusion Criteria: Has a confirmed or suspected clinical immunodeficiency syndrome not related to treatment of RA or has a family history of congenital or hereditary immunodeficiency unless confirmed absent Is (anatomically or functionally) asplenic Has experienced myocardial infarction, unstable ischemic heart disease, or stroke less than or equal to (<=) 12 weeks of screening Has a diagnosis of congestive heart failure including medically controlled, asymptomatic congestive heart failure Has a history of known demyelinating disease such as multiple sclerosis or optic neuritis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
Inland Rheumatology Clinical Trials Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Name
Integral Rheumatology & Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Name
Southwest Rheumatology Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Name
ARCIS Salud SRL (Aprillus asistencia e investigacion)
City
Caba
ZIP/Postal Code
C1406AGA
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Medicas Tucuman
City
San Miguel De Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis

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