A Phase 2 interventional study of Placebo and Nipocalimab in Arthritis, Rheumatoid, sponsored by Janssen Research & Development, LLC. Completed at 32 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-10-16.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.
2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.
This study's enrollment of 103 is close to the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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.
Drug: Placebo · Drug: Certolizumab
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.
Drug: Nipocalimab · Drug: Certolizumab
Placebo will be administered intravenously.
Nipocalimab will be administered intravenously.
Also known as: JNJ-80202135, M281
Certolizumab will be administered subcutaneously.
Also known as: Cimzia
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.
Time frame: Baseline (Week 0), Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Week 0), Week 12
| Milestone | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab |
|---|---|---|
| Started | 41 | 62 |
| Completed | 32 | 49 |
| Not completed | 9 | 13 |
| Withdrew: Adverse event | 3 | 9 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Other | 3 | 3 |
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.
| Score on a Scale | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab |
|---|---|---|
| Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 | -1.86 (-2.55 to -1.17) | -1.92 (-2.59 to -1.25) |
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.
| Percentage of participants | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab |
|---|---|---|
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) Response 20 at Week 12 | 63.4 | 62.9 |
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.
| Percentage of participants | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab |
|---|---|---|
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 12 | 31.71 | 40.32 |
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.
| Percentage of participants | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab |
|---|---|---|
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 Response at Week 12 | 12.20 | 14.52 |
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.
| Percentage of participants | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab |
|---|---|---|
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 Response at Week 12 | 2.44 | 3.23 |
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.
| Percentage of participants | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab |
|---|---|---|
| Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12 | 14.63 | 25.81 |
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.
| Percentage of participants | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab |
|---|---|---|
| Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Low Disease Activity (LDA) at Week 12 | 26.83 | 43.55 |
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.
| Score on a scale | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab |
|---|---|---|
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 | -0.33 (-0.62 to -0.04) | -0.30 (-0.58 to -0.02) |
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.
| Score on a scale | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab |
|---|---|---|
| Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12 | -22.51 (-29.23 to -15.78) | -21.36 (-27.89 to -14.83) |
Collected over All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: Certolizumab and Placebo | 0/41 (0%) | 1/41 (2.4%) | 7/41 (17.1%) |
| Group 2: Certolizumab and Nipocalimab | 0/62 (0%) | 7/62 (11.3%) | 23/62 (37.1%) |
| Event | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab |
|---|---|---|
| Myocardial InfarctionCardiac disorders | 0/41 | 2/62 |
| Soft Tissue InfectionInfections and infestations | 1/41 | 0/62 |
| CellulitisInfections and infestations | 0/41 | 1/62 |
| InfluenzaInfections and infestations | 0/41 | 1/62 |
| PneumoniaInfections and infestations | 0/41 | 1/62 |
| Pneumonia Respiratory Syncytial ViralInfections and infestations | 0/41 | 1/62 |
| Rheumatoid ArthritisMusculoskeletal and connective tissue disorders | 0/41 | 1/62 |
| Renal Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/41 | 1/62 |
| Event | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab |
|---|---|---|
| NasopharyngitisInfections and infestations | 2/41 | 5/62 |
| HeadacheNervous system disorders | 3/41 | 4/62 |
| BronchitisInfections and infestations | 0/41 | 4/62 |
| Upper Respiratory Tract InfectionInfections and infestations | 1/41 | 4/62 |
| Urinary Tract InfectionInfections and infestations | 1/41 | 4/62 |
| Rheumatoid ArthritisMusculoskeletal and connective tissue disorders | 0/41 | 4/62 |
| AlopeciaSkin and subcutaneous tissue disorders | 1/41 | 4/62 |
| Age, Categorical(Participants) | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 36 | 53 | 89 |
| >=65 years | 5 | 9 | 14 |
| Age, Continuous(Years) | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab | Total |
|---|---|---|---|
| Mean | 51.9 ± 9.49 | 55 ± 8.96 | 53.8 ± 9.25 |
| Sex: Female, Male(Participants) | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab | Total |
|---|---|---|---|
| Female | 34 | 57 | 91 |
| Male | 7 | 5 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab | Total |
|---|---|---|---|
| Hispanic or Latino | 17 | 20 | 37 |
| Not Hispanic or Latino | 24 | 42 | 66 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 4 | 5 |
| White | 37 | 56 | 93 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(Participants) | Group 1: Certolizumab and Placebo | Group 2: Certolizumab and Nipocalimab | Total |
|---|---|---|---|
| Argentina | 9 | 15 | 24 |
| Germany | 4 | 5 | 9 |
| Hungary | 5 | 12 | 17 |
| Poland | 8 | 12 | 20 |
| United Kingdom | 1 | 0 | 1 |
| United States | 14 | 18 | 32 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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
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