Trial · NCT06028438
A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
NCT06028438, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2025-10-16
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis. Trials, record NCT06028438. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06028438
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
- NCT number
- NCT06028438
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 103 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Placebo, Nipocalimab, Certolizumab
- First posted
- 2023-09-08
- Last updated
- 2025-10-16
- Results first posted
- 2025-10-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 | Baseline (Week 0), 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. |
| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) Response 20 at Week 12 | 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. |
| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 12 | 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. |
| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 Response at Week 12 | 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. |
| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 Response at Week 12 | 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. |
| Secondary | Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12 | 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. |
| Secondary | Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Low Disease Activity (LDA) at Week 12 | 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. |
| Secondary | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 | Baseline (Week 0), 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. |
| Secondary | Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12 | Baseline (Week 0), 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 | Baseline (Week 0), Week 12 | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved American College of Rheumatology (ACR) Response 20 at Week 12 | Week 12 | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 12 | Week 12 | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 Response at Week 12 | Week 12 | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 Response at Week 12 | Week 12 | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12 | Week 12 | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Low Disease Activity (LDA) at Week 12 | Week 12 | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 | Baseline (Week 0), Week 12 | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12 | Baseline (Week 0), Week 12 | The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention. | Score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 | Group 1: Certolizumab and Placebo | -1.86 | 95% Confidence Interval -2.55 to -1.17 | Score on a Scale | |
| Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 | Group 2: Certolizumab and Nipocalimab | -1.92 | 95% Confidence Interval -2.59 to -1.25 | Score on a Scale | |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) Response 20 at Week 12 | Group 1: Certolizumab and Placebo | 63.4 | Percentage of participants | ||
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) Response 20 at Week 12 | Group 2: Certolizumab and Nipocalimab | 62.9 | Percentage of participants | ||
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 12 | Group 1: Certolizumab and Placebo | 31.71 | Percentage of participants | ||
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 12 | Group 2: Certolizumab and Nipocalimab | 40.32 | Percentage of participants | ||
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 Response at Week 12 | Group 1: Certolizumab and Placebo | 12.20 | Percentage of participants | ||
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 Response at Week 12 | Group 2: Certolizumab and Nipocalimab | 14.52 | Percentage of participants | ||
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 Response at Week 12 | Group 1: Certolizumab and Placebo | 2.44 | Percentage of participants | ||
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 Response at Week 12 | Group 2: Certolizumab and Nipocalimab | 3.23 | Percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Certolizumab and Placebo | 41 | |
| Overall Study | STARTED | Group 2: Certolizumab and Nipocalimab | 62 | |
| Overall Study | COMPLETED | Group 1: Certolizumab and Placebo | 32 | |
| Overall Study | COMPLETED | Group 2: Certolizumab and Nipocalimab | 49 | |
| Overall Study | NOT COMPLETED | Group 1: Certolizumab and Placebo | 9 | |
| Overall Study | NOT COMPLETED | Group 2: Certolizumab and Nipocalimab | 13 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | Group 1: Certolizumab and Placebo | 0 | 41 | |
| other | Bronchitis | Infections and infestations | Group 2: Certolizumab and Nipocalimab | 4 | 62 | |
| other | Nasopharyngitis | Infections and infestations | Group 1: Certolizumab and Placebo | 2 | 41 | |
| other | Nasopharyngitis | Infections and infestations | Group 2: Certolizumab and Nipocalimab | 5 | 62 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Group 1: Certolizumab and Placebo | 1 | 41 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Group 2: Certolizumab and Nipocalimab | 4 | 62 | |
| other | Urinary Tract Infection | Infections and infestations | Group 1: Certolizumab and Placebo | 1 | 41 | |
| other | Urinary Tract Infection | Infections and infestations | Group 2: Certolizumab and Nipocalimab | 4 | 62 | |
| other | Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | Group 1: Certolizumab and Placebo | 0 | 41 | |
| other | Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | Group 2: Certolizumab and Nipocalimab | 4 | 62 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Certolizumab and Placebo | 0 | 41 |
| Total, all-cause mortality | Group 2: Certolizumab and Nipocalimab | 0 | 62 |
| Total, other adverse events | Group 1: Certolizumab and Placebo | 7 | 41 |
| Total, other adverse events | Group 2: Certolizumab and Nipocalimab | 23 | 62 |
| Total, serious adverse events | Group 1: Certolizumab and Placebo | 1 | 41 |
| Total, serious adverse events | Group 2: Certolizumab and Nipocalimab | 7 | 62 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41781163 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1: Certolizumab and Placebo vs Group 2: Certolizumab and Nipocalimab: deaths from any cause | Trial comparisons |
| Group 1: Certolizumab and Placebo vs Group 2: Certolizumab and Nipocalimab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06028438
GET https://conductscience.org/api/trials/v1/NCT06028438/events?page=2