Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504045-31-00 | Registry Identifier | EUCT number | |
| 80202135ARA2002 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certolizumab + Placebo | Active Comparator | 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. |
|
| Certolizumab + Nipocalimab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo 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) Response 20 at Week 12 | ACR20 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 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 (arthritis, 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. |
Not provided
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:
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arthritis and Rheumatology Research PLLC | Phoenix | Arizona | 85032 | United States | ||
| Newport Huntington Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41781163 | Derived | Taylor PC, Schett G, Huizinga TWJ, Ibrahim F, Zhou B, Huang S, Gambale J, Wang Q, Liva SG, Leu JH, Hubbard JJ, Leonardo S, Panchakshari RA, Loza MJ, Fei K. Nipocalimab and certolizumab combination therapy in participants with active rheumatoid arthritis despite prior treatment with advanced therapies: results from the phase 2a DAISY-RA study. RMD Open. 2026 Mar 4;12(1):e006464. doi: 10.1136/rmdopen-2025-006464. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Certolizumab and Placebo | Participants received certolizumab 400 milligram (mg) subcutaneously (SC) at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC every 2 weeks (q2w) from Week 6 up to Week 22 and placebo matching to nipocalimab intravenously (IV) q2w starting from Week 0 up to Week 22. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 5, 2023 | Sep 29, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nipocalimab |
| Drug |
Nipocalimab will be administered intravenously. |
|
|
| Certolizumab | Drug | Certolizumab will be administered subcutaneously. |
|
|
| Week 12 |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response 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 tender joint count (68 joints) and swollen joint count (66 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 Response at Week 12 | Percentage of participants who achieved ACR70 response 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 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 (arthritis, VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function as measured by (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 Response at Week 12 | Percentage of participants who achieved ACR90 response 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 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 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 | 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 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. | Week 12 |
| Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Low Disease Activity (LDA) at Week 12 | Percentage of participants who achieved DAS28-CRP LDA at Week 12 were reported. DAS28 LDA is defined as a DAS28 value of less than or equal to (<=3.2) at a visit. 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 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. | 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, score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. | Baseline (Week 0), Week 12 |
| Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12 | Change from baseline in CDAI at Week 12 were reported. The CDAI score is a derived score combining 4 disease assessments: tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (PtGA), and Physician's Global Assessment of Disease Activity (PGA). Change from baseline in CDAI score measured the change in disease activity, where a negative change indicated an improvement, and a positive change indicated a worsening. The total score range is 0-76. Score interpretation: Remission <=2.8; Low Disease Activity CDAI > 2.8 and <=10; Moderate Disease Activity CDAI >10 and <=22; High Disease Activity CDAI > 22. | Baseline (Week 0), Week 12 |
| Huntington Beach |
| California |
| 92648 |
| United States |
| Inland Rheumatology Clinical Trials Inc. | Upland | California | 91786 | United States |
| Bay Area Arthritis and Osteoporosis | Brandon | Florida | 33511 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Integral Rheumatology And Immunology Specialists | Plantation | Florida | 33324 | United States |
| Atlanta Research Center for Rheumatology | Marietta | Georgia | 30060 | United States |
| Graves Gilbert Clinic | Bowling Green | Kentucky | 42101 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Southwest Rheumatology Research LLC | Mesquite | Texas | 75150 | United States |
| STAT Research S A | Buenos Aires | C1023AAB | Argentina |
| Centro Privado de Medicina Familiar | Buenos Aires | C1417 | Argentina |
| Sanatorio Agote | Buenos Aires | C1425EOE | Argentina |
| Hospital Central Militar Cirujano Mayor Dr Cosme Argerich | Buenos Aires | C1426BOR | Argentina |
| Mautalen Salud e Investigacion | CABA | C1128AAF | Argentina |
| ARCIS Salud SRL Aprillus asistencia e investigacion | CABA | C1406AGA | Argentina |
| Centro de Investigaciones Medicas Tucuman | San Miguel de Tucumán | T4000AXL | Argentina |
| Hamburger Rheuma Forschungszentrum II | Hamburg | 20095 | Germany |
| Rheumazentrum Ruhrgebiet | Herne | 44649 | Germany |
| Rheumazentrum Ratingen | Ratingen | 40878 | Germany |
| Budai Irgalmasrendi Korhaz | Budapest | H-1027 | Hungary |
| Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Gyula | 5700 | Hungary |
| Porcika Klinika - Vasarhelyi Sarkanyfu Kft. | Hódmezővásárhely | 6800 | Hungary |
| CMed Rehabilitacios es Diagnosztikai Kozpont | Székesfehérvár | 8000 | Hungary |
| Vital Medical Center Orvosi es Fogaszati Kozpont | Veszprém | 8200 | Hungary |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy | Bydgoszcz | 85-168 | Poland |
| NZOZ Lecznica MAK MED S C | Nadarzyn | 05 830 | Poland |
| MICS Centrum Medyczne Warszawa | Warsaw | 00 874 | Poland |
| Centrum Medyczne Reuma Park | Warsaw | 02 665 | Poland |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Medway NHS Foundation Trust | Gillingham | ME7 5NY | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Group 2: Certolizumab and Nipocalimab |
Participants received nipocalimab 30 milligrams per kilogram (mg/kg) IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Certolizumab and Placebo | Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22. |
| BG001 | Group 2: Certolizumab and Nipocalimab | Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) Response 20 at Week 12 | ACR20 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 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 (arthritis, 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response 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 tender joint count (68 joints) and swollen joint count (66 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 Response at Week 12 | Percentage of participants who achieved ACR70 response 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 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 (arthritis, VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function as measured by (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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 Response at Week 12 | Percentage of participants who achieved ACR90 response 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 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 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12 | 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 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 | Number | Percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Low Disease Activity (LDA) at Week 12 | Percentage of participants who achieved DAS28-CRP LDA at Week 12 were reported. DAS28 LDA is defined as a DAS28 value of less than or equal to (<=3.2) at a visit. 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 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 | Number | Percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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, score 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12 | Change from baseline in CDAI at Week 12 were reported. The CDAI score is a derived score combining 4 disease assessments: tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (PtGA), and Physician's Global Assessment of Disease Activity (PGA). Change from baseline in CDAI score measured the change in disease activity, where a negative change indicated an improvement, and a positive change indicated a worsening. The total score range is 0-76. Score interpretation: Remission <=2.8; Low Disease Activity CDAI > 2.8 and <=10; Moderate Disease Activity CDAI >10 and <=22; High Disease Activity CDAI > 22. | 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 |
|
All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
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: Certolizumab and Placebo | Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22. | 0 | 41 | 1 | 41 | 7 | 41 |
| EG001 | Group 2: Certolizumab and Nipocalimab | Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22. | 0 | 62 | 7 | 62 | 23 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Pneumonia Respiratory Syncytial Viral | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Soft Tissue Infection | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | 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_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2024 | Sep 29, 2025 | SAP_003.pdf |
Not provided
| 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
| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| >=65 years |
|
| 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 |
|
| Germany |
|
| Hungary |
|
| Poland |
|
| United Kingdom |
|
| United States |
|
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|
|
|
|
|
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22. |
|
|
|
|
|
|