Trial Outcomes & Findings for A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis (NCT NCT06028438)
NCT ID: NCT06028438
Last Updated: 2025-10-16
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
103 participants
Baseline (Week 0), Week 12
2025-10-16
Participant Flow
Participant milestones
| Measure |
Group 1: Certolizumab and Placebo
Participants received certolizumab 400 milligram (mg) subcutaneously (SC) at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC every 2 weeks (q2w) from Week 6 up to Week 22 and placebo matching to nipocalimab intravenously (IV) q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
Participants received nipocalimab 30 milligrams per kilogram (mg/kg) IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
62
|
|
Overall Study
COMPLETED
|
32
|
49
|
|
Overall Study
NOT COMPLETED
|
9
|
13
|
Reasons for withdrawal
| Measure |
Group 1: Certolizumab and Placebo
Participants received certolizumab 400 milligram (mg) subcutaneously (SC) at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC every 2 weeks (q2w) from Week 6 up to Week 22 and placebo matching to nipocalimab intravenously (IV) q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
Participants received nipocalimab 30 milligrams per kilogram (mg/kg) IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
9
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Other
|
3
|
3
|
Baseline Characteristics
A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Group 1: Certolizumab and Placebo
n=41 Participants
Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
n=62 Participants
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
51.9 Years
STANDARD_DEVIATION 9.49 • n=5 Participants
|
55 Years
STANDARD_DEVIATION 8.96 • n=7 Participants
|
53.8 Years
STANDARD_DEVIATION 9.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 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
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 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: Certolizumab and Placebo
n=41 Participants
Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
n=62 Participants
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12
|
-1.86 Score on a Scale
Interval -2.55 to -1.17
|
-1.92 Score on a Scale
Interval -2.59 to -1.25
|
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.
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.
Outcome measures
| Measure |
Group 1: Certolizumab and Placebo
n=41 Participants
Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
n=62 Participants
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) Response 20 at Week 12
|
63.4 Percentage of participants
|
62.9 Percentage of participants
|
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 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.
Outcome measures
| Measure |
Group 1: Certolizumab and Placebo
n=41 Participants
Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
n=62 Participants
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 12
|
31.71 Percentage of participants
|
40.32 Percentage of participants
|
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 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.
Outcome measures
| Measure |
Group 1: Certolizumab and Placebo
n=41 Participants
Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
n=62 Participants
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 Response at Week 12
|
12.20 Percentage of participants
|
14.52 Percentage of participants
|
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 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.
Outcome measures
| Measure |
Group 1: Certolizumab and Placebo
n=41 Participants
Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
n=62 Participants
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 Response at Week 12
|
2.44 Percentage of participants
|
3.23 Percentage of participants
|
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.
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.
Outcome measures
| Measure |
Group 1: Certolizumab and Placebo
n=41 Participants
Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
n=62 Participants
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12
|
14.63 Percentage of participants
|
25.81 Percentage of participants
|
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 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.
Outcome measures
| Measure |
Group 1: Certolizumab and Placebo
n=41 Participants
Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
n=62 Participants
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
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 Percentage of participants
|
43.55 Percentage of participants
|
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, score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
Outcome measures
| Measure |
Group 1: Certolizumab and Placebo
n=41 Participants
Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
n=62 Participants
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
|
-0.33 Score on a scale
Interval -0.62 to -0.04
|
-0.30 Score on a scale
Interval -0.58 to -0.02
|
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 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.
Outcome measures
| Measure |
Group 1: Certolizumab and Placebo
n=41 Participants
Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
n=62 Participants
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12
|
-22.51 Score on a scale
Interval -29.23 to -15.78
|
-21.36 Score on a scale
Interval -27.89 to -14.83
|
Adverse Events
Group 1: Certolizumab and Placebo
Group 2: Certolizumab and Nipocalimab
Serious adverse events
| Measure |
Group 1: Certolizumab and Placebo
n=41 participants at risk
Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
n=62 participants at risk
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
3.2%
2/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
1.6%
1/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Influenza
|
0.00%
0/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
1.6%
1/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
1.6%
1/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Pneumonia Respiratory Syncytial Viral
|
0.00%
0/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
1.6%
1/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Soft Tissue Infection
|
2.4%
1/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
0.00%
0/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
1.6%
1/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
1.6%
1/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
Other adverse events
| Measure |
Group 1: Certolizumab and Placebo
n=41 participants at risk
Participants received certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22 and placebo matching to nipocalimab IV q2w starting from Week 0 up to Week 22.
|
Group 2: Certolizumab and Nipocalimab
n=62 participants at risk
Participants received nipocalimab 30 mg/kg IV q2w starting from Week 0 up to Week 22 and certolizumab 400 mg SC at Weeks 0, 2, and 4 followed by certolizumab 200 mg SC q2w from Week 6 up to Week 22.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
6.5%
4/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
2/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
8.1%
5/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.4%
1/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
6.5%
4/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Infections and infestations
Urinary Tract Infection
|
2.4%
1/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
6.5%
4/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
6.5%
4/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Nervous system disorders
Headache
|
7.3%
3/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
6.5%
4/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.4%
1/41 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
6.5%
4/62 • All-cause mortality: From screening (-6 weeks) up to Week 30; Serious and Other AEs: From Week 0 up to Week 30
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of any study intervention.
|
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