search
Back to results

A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Nipocalimab
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)/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 swollen and 6 tender joints out of the 66/68-swollen and tender joint count at the time of screening and at baseline
  • Is positive for anti-citrullinated protein antibodies (ACPA) and/or rheumatoid factor (RF) at screening
  • Screening C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram per deciliter (mg/dL) by the central laboratory
  • A woman of childbearing potential must have a negative highly sensitive urine pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine (beta-hCG) pregnancy test at Week 0 prior to administration of study intervention

Exclusion Criteria:

  • Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her RA or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
  • Currently has a malignancy or has a history of malignancy within 3 years before screening (with the exception of localized basal cell carcinoma and/or squamous cell carcinoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks before the first administration of study intervention or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first administration of study intervention)
  • Is (anatomically or functionally) asplenic
  • Has experienced myocardial infarction (MI), unstable ischemic heart disease, or stroke within 12 weeks of screening
  • Has other known inflammatory diseases that might confound the evaluations of benefit from nipocalimab therapy, including but not limited to ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, Lyme disease
  • Is currently taking immunoglobulin (Ig)G fragment crystallizable (Fc)-related protein therapeutics

Sites / Locations

  • Arizona Arthritis & Rheumatology Associates PC
  • Arizona Arthritis & Rheumatology Research, PLLC
  • Arizona Arthritis & Rheumatology Research, PLLC
  • Desert Medical Advances
  • Arthritis Care and Research Center Inc.: Smitha Reddy, MD
  • TriWest Research Associates, LLC
  • Inland Rheumatology Clinical Trials, Inc.
  • DJL Clinical Research, PLLC
  • STAT Research, Inc.
  • Low Country Rheumatology PA
  • West Tennessee Research Institute
  • Accurate Clinical Research, Inc.
  • Southwest Rheumatology Research LLC
  • Hamburger Rheuma Forschungszentrum II
  • Rheumazentrum Ratingen
  • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
  • NZOZ Lecznica Mak-Med sc
  • Prywatna Praktyka Lekarska, Prof. UM dr hab. med. Paweł Hrycaj
  • Centrum Medyczne FutureMeds Targowek
  • Hosp. Univ. A Coruña
  • Hosp. Univ. de Basurto
  • Hosp. Clinico Univ. de Santiago
  • Hosp. Virgen Macarena
  • Hosp. Do Meixoeiro
  • Western General Hospital
  • Kings College Hospital NHS Trust
  • North Tyneside General Hospital
  • Haywood Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Group 1: Placebo

Group 2: Nipocalimab

Arm Description

Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 10 along with standard-of-care background therapy.

Participants will receive nipocalimab IV q2w through Week 10 along with standard-of-care background therapy.

Outcomes

Primary Outcome Measures

Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12
DAS28-CRP is a composite 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, and CRP. Change from baseline in DAS28-CRP measures the change in disease activity, where a negative change indicates an improvement, and a positive change indicates a worsening.

Secondary Outcome Measures

Percentage of Participants who Achieve American College of Rheumatology (ACR) 20 at Week 12
ACR20 response is defined greater than or equal to (>=) 20 percent (%) 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 assessment of pain by visual analog scale (VAS; 0-100 millimeter [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by health assessment questionnaire-disability index (HAQ-DI, a 20-question instrument assessing 8 functional areas), range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Percentage of Participants who Achieve ACR50 at Week 12
ACR50 response is defined >=50% 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 assessment of pain by VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Percentage of Participants who Achieve ACR70 at Week 12
ACR70 response is defined >=70% 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 assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Percentage of Participants who Achieve ACR90 at Week 12
ACR90 response is defined >=90% 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 assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Percentage of Participants Achieving DAS28-CRP Remission at Week 12
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
DAS28 LDA is defined as a DAS28 value of >=2.6 and <=3.2 at the analysis visit.
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
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.
Percentage 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/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Percentage 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, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.
Percentage of Participants with TEAEs Leading to Discontinuation of Study Intervention
Percentage of participants with TEAEs leading to discontinuation of study intervention will be reported.
Percentage of Participants with Adverse Events of Special interests (AESIs)
Percentage of participants with AESIs will be reported.
Percentage of Participants with Change from Baseline in Clinical Laboratory Abnormalities Over Time
Percentage of participants with change from baseline in clinical laboratory abnormalities over time will be reported.
Percentage of Participants with Change from Baseline in Vital Signs Abnormalities Over Time
Percentage of participants with change from baseline in vital signs abnormalities (including temperature, pulse/heart rate, respiratory rate, and blood pressure) over time will be reported.
Serum Concentration of Nipocalimab Over Time
Serum concentration of nipocalimab over time in participants receiving active study intervention will be reported.
Percentage of Participants with Antibodies to Nipocalimab (Anti-drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])
Percentage of participants with antibodies to nipocalimab (ADAs and NAbs) in participants receiving active study intervention will be reported.

Full Information

First Posted
August 2, 2021
Last Updated
August 9, 2023
Sponsor
Janssen Research & Development, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT04991753
Brief Title
A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
Official Title
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants With Active Rheumatoid Arthritis Despite Standard Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
August 10, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

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 and safety of nipocalimab versus placebo in participants with moderate to severe active rheumatoid arthritis (RA).
Detailed Description
RA is a chronic autoimmune inflammatory disorder of unknown etiology that occurs in approximately 1 percent (%) of the population. Nipocalimab (also referred to as JNJ-80202135 and M281) is a fully human aglycosylated immunoglobulin (Ig)G1 monoclonal antibody designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal fragment crystallizable (Fc) receptor (FcRn). Nipocalimab has a unique mechanism of action whereby it blocks the IgG binding site on endogenous FcRn and is expected to decrease pathogenic IgG antibody concentrations. A significant involvement of pathogenic IgG antibodies has been demonstrated in autoimmune diseases including RA. The primary hypothesis is that treatment with nipocalimab intravenously (IV) every 2 weeks (q2w) is superior to placebo in participants with moderate to severe active rheumatoid arthritis (RA) as assessed by the mean change from baseline in the disease activity index score 28 using C-reactive Protein (DAS28-CRP) at Week 12. The study consists of a Screening Period (less than or equal to [<=] 6 Weeks), Double-blind Treatment Period (12 Weeks), and a Safety Follow-up Period (6 Weeks). Key safety assessments will include adverse events (AEs), serious adverse events (SAEs), adverse events of special interests (AESIs), clinical laboratory safety tests (hematology, chemistry, and lipid profile), vital signs, and physical examination. The total duration of the study is up to 24 weeks.

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
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 10 along with standard-of-care background therapy.
Arm Title
Group 2: Nipocalimab
Arm Type
Experimental
Arm Description
Participants will receive nipocalimab IV q2w through Week 10 along with standard-of-care background therapy.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo infusion will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Nipocalimab
Other Intervention Name(s)
JNJ-80202135, M281
Intervention Description
Nipocalimab infusions will be administered intravenously.
Primary Outcome Measure Information:
Title
Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12
Description
DAS28-CRP is a composite 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, and CRP. Change from baseline in DAS28-CRP measures the change in disease activity, where a negative change indicates an improvement, and a positive change indicates a worsening.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve American College of Rheumatology (ACR) 20 at Week 12
Description
ACR20 response is defined greater than or equal to (>=) 20 percent (%) 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 assessment of pain by visual analog scale (VAS; 0-100 millimeter [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by health assessment questionnaire-disability index (HAQ-DI, a 20-question instrument assessing 8 functional areas), range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame
Week 12
Title
Percentage of Participants who Achieve ACR50 at Week 12
Description
ACR50 response is defined >=50% 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 assessment of pain by VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame
Week 12
Title
Percentage of Participants who Achieve ACR70 at Week 12
Description
ACR70 response is defined >=70% 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 assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame
Week 12
Title
Percentage of Participants who Achieve ACR90 at Week 12
Description
ACR90 response is defined >=90% 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 assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time Frame
Week 12
Title
Percentage of Participants Achieving DAS28-CRP Remission at Week 12
Description
DAS28-CRP remission is defined as DAS28-CRP value less than (<) 2.6 at the analysis visit.
Time Frame
Week 12
Title
Percentage of Participants Achieving DAS28-CRP Low Disease Activity (LDA) at Week 12
Description
DAS28 LDA is defined as a DAS28 value of >=2.6 and <=3.2 at the analysis visit.
Time Frame
Week 12
Title
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
Description
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, up to Week 12
Title
Percentage 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/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 24 weeks
Title
Percentage 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, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. 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 24 weeks
Title
Percentage of Participants with TEAEs Leading to Discontinuation of Study Intervention
Description
Percentage of participants with TEAEs leading to discontinuation of study intervention will be reported.
Time Frame
Up to 24 weeks
Title
Percentage of Participants with Adverse Events of Special interests (AESIs)
Description
Percentage of participants with AESIs will be reported.
Time Frame
Up to 24 weeks
Title
Percentage of Participants with Change from Baseline in Clinical Laboratory Abnormalities Over Time
Description
Percentage of participants with change from baseline in clinical laboratory abnormalities over time will be reported.
Time Frame
Up to 24 weeks
Title
Percentage of Participants with Change from Baseline in Vital Signs Abnormalities Over Time
Description
Percentage of participants with change from baseline in vital signs abnormalities (including temperature, pulse/heart rate, respiratory rate, and blood pressure) over time will be reported.
Time Frame
Up to 24 weeks
Title
Serum Concentration of Nipocalimab Over Time
Description
Serum concentration of nipocalimab over time in participants receiving active study intervention will be reported.
Time Frame
Up to Week 18
Title
Percentage of Participants with Antibodies to Nipocalimab (Anti-drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])
Description
Percentage of participants with antibodies to nipocalimab (ADAs and NAbs) in participants receiving active study intervention will be reported.
Time Frame
Up to Week 18

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)/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 swollen and 6 tender joints out of the 66/68-swollen and tender joint count at the time of screening and at baseline Is positive for anti-citrullinated protein antibodies (ACPA) and/or rheumatoid factor (RF) at screening Screening C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram per deciliter (mg/dL) by the central laboratory A woman of childbearing potential must have a negative highly sensitive urine pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine (beta-hCG) pregnancy test at Week 0 prior to administration of study intervention Exclusion Criteria: Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her RA or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant Currently has a malignancy or has a history of malignancy within 3 years before screening (with the exception of localized basal cell carcinoma and/or squamous cell carcinoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks before the first administration of study intervention or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first administration of study intervention) Is (anatomically or functionally) asplenic Has experienced myocardial infarction (MI), unstable ischemic heart disease, or stroke within 12 weeks of screening Has other known inflammatory diseases that might confound the evaluations of benefit from nipocalimab therapy, including but not limited to ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, Lyme disease Is currently taking immunoglobulin (Ig)G fragment crystallizable (Fc)-related protein therapeutics
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 & Rheumatology Associates PC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Arthritis Care and Research Center Inc.: Smitha Reddy, MD
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
TriWest Research Associates, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Inland Rheumatology Clinical Trials, Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
DJL Clinical Research, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
STAT Research, Inc.
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377
Country
United States
Facility Name
Low Country Rheumatology PA
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Accurate Clinical Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Southwest Rheumatology Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Hamburger Rheuma Forschungszentrum II
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Rheumazentrum Ratingen
City
Ratingen
ZIP/Postal Code
40878
Country
Germany
Facility Name
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
NZOZ Lecznica Mak-Med sc
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Prywatna Praktyka Lekarska, Prof. UM dr hab. med. Paweł Hrycaj
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
Centrum Medyczne FutureMeds Targowek
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Hosp. Univ. A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hosp. Univ. de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hosp. Clinico Univ. de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hosp. Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hosp. Do Meixoeiro
City
Vigo
ZIP/Postal Code
36214
Country
Spain
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Kings College Hospital NHS Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
North Tyneside General Hospital
City
Newcastle
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Haywood Hospital
City
Stoke on Trent
ZIP/Postal Code
ST6 7AG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

We'll reach out to this number within 24 hrs