Trial Outcomes & Findings for A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis (NCT NCT04991753)
NCT ID: NCT04991753
Last Updated: 2025-08-22
Results Overview
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.
COMPLETED
PHASE2
53 participants
Baseline (Week 0), Week 12
2025-08-22
Participant Flow
Participant milestones
| Measure |
Group 1: Placebo
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
33
|
|
Overall Study
COMPLETED
|
20
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1: Placebo
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 8.57 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 12.30 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Week 12Population: The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
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.
Outcome measures
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12
|
-0.58 Score on a scale
Interval -1.24 to 0.07
|
-1.03 Score on a scale
Interval -1.66 to -0.4
|
SECONDARY outcome
Timeframe: Week 12Population: 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 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.
Outcome measures
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 at Week 12
|
20.0 Percentage of Participants
Interval -1.24 to 0.07
|
45.5 Percentage of Participants
Interval -1.66 to -0.4
|
SECONDARY outcome
Timeframe: Week 12Population: 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 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.
Outcome measures
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 at Week 12
|
5.0 Percentage of Participants
Interval -1.24 to 0.07
|
15.2 Percentage of Participants
Interval -1.66 to -0.4
|
SECONDARY outcome
Timeframe: Week 12Population: 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 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.
Outcome measures
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 at Week 12
|
0 Percentage of Participants
Interval -1.24 to 0.07
|
12.1 Percentage of Participants
Interval -1.66 to -0.4
|
SECONDARY outcome
Timeframe: Week 12Population: 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 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.
Outcome measures
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 at Week 12
|
0 Percentage of Participants
Interval -1.24 to 0.07
|
6.1 Percentage of Participants
Interval -1.66 to -0.4
|
SECONDARY outcome
Timeframe: Week 12Population: 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 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.
Outcome measures
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12
|
10.0 Percentage of Participants
Interval -1.24 to 0.07
|
21.2 Percentage of Participants
Interval -1.66 to -0.4
|
SECONDARY outcome
Timeframe: Week 12Population: 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 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.
Outcome measures
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
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
|
10.0 Percentage of Participants
Interval -1.24 to 0.07
|
21.2 Percentage of Participants
Interval -1.66 to -0.4
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 12Population: The full analysis set (FAS) included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
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.
Outcome measures
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
|
-0.21 Score on a scale
Interval -0.45 to 0.04
|
-0.42 Score on a scale
Interval -0.66 to -0.19
|
SECONDARY outcome
Timeframe: From Week 0 up to 8 weeks post last dose at Week 10 (up to Week 18)Population: The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
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).
Outcome measures
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
60.0 Percentage of Participants
Interval -1.24 to 0.07
|
81.8 Percentage of Participants
Interval -1.66 to -0.4
|
SECONDARY outcome
Timeframe: From Week 0 up to 8 weeks post last dose at Week 10 (up to Week 18)Population: The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
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).
Outcome measures
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
|
0 Percentage of Participants
Interval -1.24 to 0.07
|
9.1 Percentage of Participants
Interval -1.66 to -0.4
|
SECONDARY outcome
Timeframe: From Week 0 up to Week 10Population: The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
Percentage of participants with AEs leading to discontinuation of study intervention were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Outcome measures
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
|
30.0 Percentage of Participants
Interval -1.24 to 0.07
|
18.2 Percentage of Participants
Interval -1.66 to -0.4
|
SECONDARY outcome
Timeframe: From Week 0 up to 8 weeks post last dose at Week 10 (up to Week 18)Population: The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
Percentage of participants with TEAEs of special interest were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AE occurring at or after the initial administration of study intervention through the safety follow-up visit (8 weeks after the last administration of study intervention). TEAEs associated with the following situations were considered to be AESIs: (a) Infections that were severe or require IV anti-infective or operative/invasive intervention; (b) Hypoalbuminemia with albumin \<20 grams per liter (g/L) (\<2.0 grams per deciliter \[g/dL\]).
Outcome measures
| Measure |
Group 1: Placebo
n=20 Participants
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 Participants
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs)
|
0 Percentage of Participants
Interval -1.24 to 0.07
|
3.0 Percentage of Participants
Interval -1.66 to -0.4
|
Adverse Events
Group 1: Placebo
Group 2: Nipocalimab
Serious adverse events
| Measure |
Group 1: Placebo
n=20 participants at risk
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 participants at risk
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Infections and infestations
Burn Infection
|
0.00%
0/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
3.0%
1/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
3.0%
1/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
3.0%
1/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
Other adverse events
| Measure |
Group 1: Placebo
n=20 participants at risk
Participants received placebo matched to nipocalimab as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
Group 2: Nipocalimab
n=33 participants at risk
Participants received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with standard-of-care background therapy. Participants were followed up for safety up to 8 weeks after administration of last study intervention at Week 10.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
General disorders
Chills
|
0.00%
0/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
6.1%
2/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
6.1%
2/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Immune system disorders
Seasonal Allergy
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Abscess Limb
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Covid-19
|
0.00%
0/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
12.1%
4/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Cystitis
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
6.1%
2/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Oral Herpes
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
6.1%
2/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Injury, poisoning and procedural complications
Synovial Rupture
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
30.0%
6/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
27.3%
9/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
12.1%
4/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Renal and urinary disorders
Nocturia
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
6.1%
2/33 • All cause mortality: From screening (Week -6) up to Week 18; Serious and non-serious AEs: From Week 0 up to Week 18
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
Additional Information
Medical Director Rheumatology
Janssen Research & Development
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER