Trial · NCT04991753
A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
NCT04991753, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2025-08-22
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis. Trials, record NCT04991753. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04991753
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
- NCT number
- NCT04991753
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Placebo, Nipocalimab
- First posted
- 2021-08-05
- Last updated
- 2025-08-22
- Other registries' IDs
- eudract:2021-000510-42
- Results first posted
- 2025-08-22
Source ClinicalTrials.gov
Registered outcomes12
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) 20 at Week 12 | 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. |
| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 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 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. |
| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 at Week 12 | 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. |
| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 at Week 12 | 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. |
| Secondary | Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12 | 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. |
| 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 | 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. |
| 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 and ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From Week 0 up to 8 weeks post last dose at Week 10 (up to Week 18) | 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). |
| Secondary | Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | From Week 0 up to 8 weeks post last dose at Week 10 (up to Week 18) | 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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) 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 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 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 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) European League Against Rheumatism (EULAR) 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 | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From Week 0 up to 8 weeks post last dose at Week 10 (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. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | From Week 0 up to 8 weeks post last dose at Week 10 (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. | Percentage of Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
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: Placebo | -0.58 | 95% Confidence Interval -1.24 to 0.07 | Score on a scale | |
| Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 | Group 2: Nipocalimab | -1.03 | 95% Confidence Interval -1.66 to -0.40 | Score on a scale | |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 at Week 12 | Group 1: Placebo | 20.0 | -1.24 to 0.07 | Percentage of Participants | |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 at Week 12 | Group 2: Nipocalimab | 45.5 | -1.66 to -0.40 | Percentage of Participants | |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 at Week 12 | Group 1: Placebo | 5.0 | -1.24 to 0.07 | Percentage of Participants | |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 at Week 12 | Group 2: Nipocalimab | 15.2 | -1.66 to -0.40 | Percentage of Participants | |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 at Week 12 | Group 1: Placebo | 0 | -1.24 to 0.07 | Percentage of Participants | |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 at Week 12 | Group 2: Nipocalimab | 12.1 | -1.66 to -0.40 | Percentage of Participants | |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 at Week 12 | Group 1: Placebo | 0 | -1.24 to 0.07 | Percentage of Participants | |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 at Week 12 | Group 2: Nipocalimab | 6.1 | -1.66 to -0.40 | Percentage of Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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: Placebo | 20 | |
| Overall Study | STARTED | Group 2: Nipocalimab | 33 | |
| Overall Study | COMPLETED | Group 1: Placebo | 20 | |
| Overall Study | COMPLETED | Group 2: Nipocalimab | 32 | |
| Overall Study | NOT COMPLETED | Group 1: Placebo | 0 | |
| Overall Study | NOT COMPLETED | Group 2: Nipocalimab | 1 |
Source ClinicalTrials.gov
Adverse events46
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 | Nausea | Gastrointestinal disorders | Group 1: Placebo | 2 | 20 | |
| other | Nausea | Gastrointestinal disorders | Group 2: Nipocalimab | 0 | 33 | |
| other | Paraesthesia Oral | Gastrointestinal disorders | Group 1: Placebo | 1 | 20 | |
| other | Paraesthesia Oral | Gastrointestinal disorders | Group 2: Nipocalimab | 0 | 33 | |
| other | Chills | General disorders | Group 1: Placebo | 0 | 20 | |
| other | Chills | General disorders | Group 2: Nipocalimab | 2 | 33 | |
| other | Fatigue | General disorders | Group 1: Placebo | 0 | 20 | |
| other | Fatigue | General disorders | Group 2: Nipocalimab | 2 | 33 | |
| other | Seasonal Allergy | Immune system disorders | Group 1: Placebo | 1 | 20 | |
| other | Seasonal Allergy | Immune system disorders | Group 2: Nipocalimab | 0 | 33 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Placebo | 0 | 20 |
| Total, all-cause mortality | Group 2: Nipocalimab | 0 | 33 |
| Total, other adverse events | Group 1: Placebo | 12 | 20 |
| Total, other adverse events | Group 2: Nipocalimab | 20 | 33 |
| Total, serious adverse events | Group 1: Placebo | 0 | 20 |
| Total, serious adverse events | Group 2: Nipocalimab | 3 | 33 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 2: Nipocalimab vs Group 1: Placebo: deaths from any cause | Trial comparisons |
| Group 2: Nipocalimab vs Group 1: Placebo: 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/NCT04991753
GET https://conductscience.org/api/trials/v1/NCT04991753/results?page=2