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| ID | Type | Description | Link |
|---|---|---|---|
| 80202135ARA2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2021-000510-42 | EudraCT Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Placebo | Placebo Comparator | Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 10 along with standard-of-care background therapy. |
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| Group 2: Nipocalimab | Experimental | Participants will receive nipocalimab IV q2w through Week 10 along with standard-of-care background therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Placebo infusion will be administered intravenously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 | Change from baseline in DAS28-CRP at Week 12 were reported. The DAS28 is a composite index used to assess rheumatoid arthritis 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 C-reactive protein (CRP; in milligrams per liter [mg/L]). The set of 28 joint count was based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to 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. Score on the DAS28 ranged from 0 to 10, where higher scores indicated more disease activity. Negative changes from baseline indicated improvement of arthritis. | Baseline (Week 0), Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 at Week 12 | Percentage of participants who achieved ACR20 at Week 12 were reported. ACR20 response is defined as: greater than or equal to (>=)20% 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 assessment of pain using visual analog scale (VAS; 0-100 millimeters [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 as measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Associates PC | Glendale | Arizona | 85306 | United States | ||
| Arizona Arthritis & Rheumatology Research, PLLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42084498 | Derived | Yu F, Myshkin E, Nguyen B, Bobadilla Mendez C, Cossu M, Fei K, Wang Q, Hubbard JJ, Campbell K, Ramchandren S, Rojo Cella R, Edwards R, Taylor PC, Gottenberg JE, Noaiseh G, Vu T, Antozzi C, Winthrop KL, Cuff CA, Loza MJ, Dimitrova D, Gao S. Effect of nipocalimab on IgG responses to vaccinations and viral infections in patients with IgG autoantibody-mediated diseases: Post hoc analyses of three randomized, placebo-controlled trials. Hum Vaccin Immunother. 2026 Dec;22(1):2664331. doi: 10.1080/21645515.2026.2664331. Epub 2026 May 5. | |
| 38942592 |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Placebo | Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2022 | Aug 4, 2025 |
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| Nipocalimab |
| Drug |
Nipocalimab infusions will be administered intravenously. |
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| Week 12 |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 at Week 12 | Percentage of participants who achieved ACR50 at Week 12 were reported. ACR50 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 assessment of pain using 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 as measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. | Week 12 |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 at Week 12 | Percentage of participants who achieved ACR70 at Week 12 were 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 assessment of pain using 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 as measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. | Week 12 |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 at Week 12 | Percentage of participants who achieved ACR90 at Week 12 were reported. ACR90 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 assessment of pain using 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 as measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. | Week 12 |
| Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12 | Percentage of participants who achieved DAS28-CRP remission at Week 12 were reported. The DAS28 remission is defined as DAS28 -CRP value of less than (<) 2.6 at Week 12. The DAS28 is a composite index used to assess rheumatoid arthritis 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; in mg/L). The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, MCP1 to MCP5, PIP1 to 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. Score on the DAS28 ranged from 0 to 10, where higher scores indicated more disease activity. Negative changes from baseline indicated improvement of arthritis. | Week 12 |
| Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Low Disease Activity (LDA) European League Against Rheumatism (EULAR) at Week 12 | Percentage of participants who achieved DAS28-CRP LDA EULAR at Week 12 were reported. The DAS28 LDA EULAR is defined as DAS28 -CRP value of less than or equal to (<=) 3.2 at Week 12. The DAS28 is a composite index used to assess rheumatoid arthritis 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 C-reactive protein (CRP; in mg/L). The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, MCP1 to MCP5, PIP1 to 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. Score on the DAS28 ranged from 0 to 10, where higher scores indicated more disease activity. Negative changes from baseline indicated improvement of arthritis. | Week 12 |
| 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 were reported. The HAQ-DI is a patient-reported questionnaire that measures 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, over the past week. Responses in each functional area were scored on a scale from 0 (indicating no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of category scores and divided by the number of categories answered and ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. | Baseline (Week 0), Week 12 |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Percentage of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AE occurring at or after the initial administration of study intervention through the safety follow-up visit (8 weeks after the last administration of study intervention). | From Week 0 up to 8 weeks post last dose at Week 10 (up to Week 18) |
| Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | Percentage of participants with TESAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, or resulted in congenital anomaly/birth defect. TESAEs were defined as any SAE occurring at or after the initial administration of study intervention through the safety follow-up visit (8 weeks after the last administration of study intervention). | From Week 0 up to 8 weeks post last dose at Week 10 (up to Week 18) |
| Percentage of Participants With AEs Leading to Discontinuation of Study Intervention | Percentage of participants with AEs leading to discontinuation of study intervention were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. | From Week 0 up to Week 10 |
| Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs) | Percentage of participants with TEAEs of special interest were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AE occurring at or after the initial administration of study intervention through the safety follow-up visit (8 weeks after the last administration of study intervention). TEAEs associated with the following situations were considered to be AESIs: (a) Infections that were severe or require IV anti-infective or operative/invasive intervention; (b) Hypoalbuminemia with albumin <20 grams per liter (g/L) (<2.0 grams per deciliter [g/dL]). | From Week 0 up to 8 weeks post last dose at Week 10 (up to Week 18) |
| Mesa |
| Arizona |
| 85210 |
| United States |
| Arizona Arthritis & Rheumatology Research, PLLC | Tucson | Arizona | 85704 | United States |
| Desert Medical Advances | Palm Desert | California | 92260 | United States |
| Arthritis Care and Research Center Inc.: Smitha Reddy, MD | Poway | California | 92064 | United States |
| TriWest Research Associates, LLC | San Diego | California | 92108 | United States |
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | 91786 | United States |
| DJL Clinical Research, PLLC | Charlotte | North Carolina | 28210 | United States |
| STAT Research, Inc. | Vandalia | Ohio | 45377 | United States |
| Low Country Rheumatology PA | Summerville | South Carolina | 29486 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Accurate Clinical Research, Inc. | Houston | Texas | 77089 | United States |
| Southwest Rheumatology Research LLC | Mesquite | Texas | 75150 | United States |
| Hamburger Rheuma Forschungszentrum II | Hamburg | 20095 | Germany |
| Rheumazentrum Ratingen | Ratingen | 40878 | Germany |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy | Bydgoszcz | 85-168 | Poland |
| NZOZ Lecznica Mak-Med sc | Nadarzyn | 05-830 | Poland |
| Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj | Poznan | 61 397 | Poland |
| Centrum Medyczne AMED Targowek | Warsaw | 03 291 | Poland |
| Hosp Univ A Coruna | A Coruña | 15006 | Spain |
| Hosp. Univ. de Basurto | Bilbao | 48013 | Spain |
| Hosp. Clinico Univ. de Santiago | Santiago de Compostela | 15706 | Spain |
| Hosp. Virgen Macarena | Seville | 41009 | Spain |
| Hosp. Do Meixoeiro | Vigo | 36214 | Spain |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Kings College Hospital NHS Trust | London | SE5 9RS | United Kingdom |
| North Tyneside General Hospital | Newcastle | NE29 8NH | United Kingdom |
| Haywood Hospital | Stoke-on-Trent | ST6 7AG | United Kingdom |
| Derived |
| Taylor PC, Schett G, Huizinga TW, Wang Q, Ibrahim F, Zhou B, Liva SG, Shaik JSB, Xiong Y, Leu JH, Panchakshari RA, Loza MJ, Ma K, Dhatt H, Rojo Cella R, Karyekar CS, Cuff CA, Gao S, Fei K. Nipocalimab, an anti-FcRn monoclonal antibody, in participants with moderate to severe active rheumatoid arthritis and inadequate response or intolerance to anti-TNF therapy: results from the phase 2a IRIS-RA study. RMD Open. 2024 Jun 28;10(2):e004278. doi: 10.1136/rmdopen-2024-004278. |
| Group 2: Nipocalimab |
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Placebo | Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. |
| BG001 | Group 2: Nipocalimab | Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 | Change from baseline in DAS28-CRP at Week 12 were reported. The DAS28 is a composite index used to assess rheumatoid arthritis 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 C-reactive protein (CRP; in milligrams per liter [mg/L]). The set of 28 joint count was based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to 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. Score on the DAS28 ranged from 0 to 10, where higher scores indicated more disease activity. Negative changes from baseline indicated improvement of arthritis. | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline (Week 0), Week 12 |
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| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 at Week 12 | Percentage of participants who achieved ACR20 at Week 12 were reported. ACR20 response is defined as: greater than or equal to (>=)20% 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 assessment of pain using visual analog scale (VAS; 0-100 millimeters [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 as measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Posted | Number | Percentage of Participants | Week 12 |
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| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 at Week 12 | Percentage of participants who achieved ACR50 at Week 12 were reported. ACR50 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 assessment of pain using 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 as measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Posted | Number | Percentage of Participants | Week 12 |
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| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 at Week 12 | Percentage of participants who achieved ACR70 at Week 12 were 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 assessment of pain using 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 as measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Posted | Number | Percentage of Participants | Week 12 |
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| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 at Week 12 | Percentage of participants who achieved ACR90 at Week 12 were reported. ACR90 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 assessment of pain using 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 as measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Posted | Number | Percentage of Participants | Week 12 |
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| Secondary | Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12 | Percentage of participants who achieved DAS28-CRP remission at Week 12 were reported. The DAS28 remission is defined as DAS28 -CRP value of less than (<) 2.6 at Week 12. The DAS28 is a composite index used to assess rheumatoid arthritis 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; in mg/L). The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, MCP1 to MCP5, PIP1 to 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. Score on the DAS28 ranged from 0 to 10, where higher scores indicated more disease activity. Negative changes from baseline indicated improvement of arthritis. | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Posted | Number | Percentage of Participants | Week 12 |
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| Secondary | Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Low Disease Activity (LDA) European League Against Rheumatism (EULAR) at Week 12 | Percentage of participants who achieved DAS28-CRP LDA EULAR at Week 12 were reported. The DAS28 LDA EULAR is defined as DAS28 -CRP value of less than or equal to (<=) 3.2 at Week 12. The DAS28 is a composite index used to assess rheumatoid arthritis 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 C-reactive protein (CRP; in mg/L). The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, MCP1 to MCP5, PIP1 to 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. Score on the DAS28 ranged from 0 to 10, where higher scores indicated more disease activity. Negative changes from baseline indicated improvement of arthritis. | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Posted | Number | Percentage of Participants | Week 12 |
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| Secondary | 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 were reported. The HAQ-DI is a patient-reported questionnaire that measures 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, over the past week. Responses in each functional area were scored on a scale from 0 (indicating no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of category scores and divided by the number of categories answered and ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline (Week 0), Week 12 |
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| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Percentage of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AE occurring at or after the initial administration of study intervention through the safety follow-up visit (8 weeks after the last administration of study intervention). | The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Posted | Number | Percentage of Participants | From Week 0 up to 8 weeks post last dose at Week 10 (up to Week 18) |
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| Secondary | Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | Percentage of participants with TESAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, or resulted in congenital anomaly/birth defect. TESAEs were defined as any SAE occurring at or after the initial administration of study intervention through the safety follow-up visit (8 weeks after the last administration of study intervention). | The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Posted | Number | Percentage of Participants | From Week 0 up to 8 weeks post last dose at Week 10 (up to Week 18) |
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| Secondary | Percentage of Participants With AEs Leading to Discontinuation of Study Intervention | Percentage of participants with AEs leading to discontinuation of study intervention were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. | The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Posted | Number | Percentage of Participants | From Week 0 up to Week 10 |
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| Secondary | Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs) | Percentage of participants with TEAEs of special interest were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AE occurring at or after the initial administration of study intervention through the safety follow-up visit (8 weeks after the last administration of study intervention). TEAEs associated with the following situations were considered to be AESIs: (a) Infections that were severe or require IV anti-infective or operative/invasive intervention; (b) Hypoalbuminemia with albumin <20 grams per liter (g/L) (<2.0 grams per deciliter [g/dL]). | The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Posted | Number | Percentage of Participants | From Week 0 up to 8 weeks post last dose at Week 10 (up to Week 18) |
|
All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Placebo | Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. | 0 | 20 | 0 | 20 | 12 | 20 |
| EG001 | Group 2: Nipocalimab | Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. | 0 | 33 | 3 | 33 | 20 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burn Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Paraesthesia Oral | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Synovial Rupture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director Rheumatology | Janssen Research & Development | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2022 | Aug 4, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. |
|
|
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. |
|
|
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. |
|
|
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. |
|
|
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. |
|
|
| Group 2: Nipocalimab |
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10. |
|
|
|
|
|
|
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|
| Units | Counts |
|---|
| Participants |
|
|
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|