Clinical Trial Results:
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with Active Rheumatoid Arthritis Despite Standard Therapy
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Summary
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EudraCT number |
2021-000510-42 |
Trial protocol |
ES DE |
Global end of trial date |
10 Aug 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Aug 2023
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First version publication date |
24 Aug 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
80202135ARA2001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04991753 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Janssen Research & Development, LLC
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Sponsor organisation address |
Welsh & McKean Roads, P.O. Box 776, Spring House, United States, PA 19477
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Public contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Aug 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Aug 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of this trial was to evaluate the efficacy of nipocalimab versus placebo in subjects with moderate to severe active rheumatoid arthritis (RA).
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Aug 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 14
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Country: Number of subjects enrolled |
Spain: 3
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Country: Number of subjects enrolled |
United Kingdom: 4
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Country: Number of subjects enrolled |
Poland: 23
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Country: Number of subjects enrolled |
United States: 9
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Worldwide total number of subjects |
53
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EEA total number of subjects |
40
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
40
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From 65 to 84 years |
13
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
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Pre-assignment
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Screening details |
Total of 53 subjects were enrolled and randomised in this study and treated with nipocalimab or placebo. Randomization (3:2 ratio) was stratified based on baseline was methotrexate (MTX) use, anti-tumor necrosis factor (anti-TNF) inadequate response (IR)/intolerance and swollen and tender joint counts level. | |||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Investigator, Subject | |||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1: Placebo | |||||||||||||||
Arm description |
Subjects received placebo (matched to nipocalimab) as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care (SOC) background therapy. | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subjects received placebo q2w from Week 0 through Week 10 along with SOC background therapy.
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Arm title
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Group 2: Nipocalimab | |||||||||||||||
Arm description |
Subjects received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with SOC background therapy. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nipocalimab
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Investigational medicinal product code |
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Other name |
JNJ-80202135
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subjects received nipocalimab 15 mg/kg q2w from Week 0 through Week 10 along with SOC background therapy.
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Baseline characteristics reporting groups
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Reporting group title |
Group 1: Placebo
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Reporting group description |
Subjects received placebo (matched to nipocalimab) as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care (SOC) background therapy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2: Nipocalimab
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Reporting group description |
Subjects received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with SOC background therapy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1: Placebo
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Reporting group description |
Subjects received placebo (matched to nipocalimab) as intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 10 along with standard-of-care (SOC) background therapy. | ||
Reporting group title |
Group 2: Nipocalimab
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Reporting group description |
Subjects received nipocalimab 15 milligrams per kilogram (mg/kg) as IV infusion q2w from Week 0 through Week 10 along with SOC background therapy. | ||
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End point title |
Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 | ||||||||||||
End point description |
The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity. It included 4 components: tender joint count with 28 joints assessed; swollen joint count with 28 joints assessed; high-sensitivity CRP (in milligrams per litre [mg/L]) and general health assessment by the subject using patient global assessment (measured on a visual analog scale [VAS] score ranged from 0 [no arthritis activity] to 100 millimeters [mm; maximal arthritis activity]). DAS28-CRP score ranges from 0 to 10, where higher scores indicated greater disease activity. Negative changes from baseline indicate improvement of arthritis. The full analysis set (FAS) included all randomised subjects who received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Primary
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End point timeframe |
Baseline and Week 12
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Statistical analysis title |
Placebo versus Nipocalimab | ||||||||||||
Comparison groups |
Group 1: Placebo v Group 2: Nipocalimab
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Number of subjects included in analysis |
53
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Analysis specification |
Pre-specified
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Analysis type |
superiority [1] | ||||||||||||
P-value |
= 0.224 [2] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Least Squares (LS) Mean Difference | ||||||||||||
Point estimate |
-0.45
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.17 | ||||||||||||
upper limit |
0.28 | ||||||||||||
| Notes [1] - Results were obtained from analysis of covariance (ANCOVA) model which included baseline DAS28 (CRP) score, treatment group, and the random stratification factor: Baseline MTX use. [2] - The threshold for statistical significance was 0.05. |
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End point title |
Percentage of Subjects Who Achieved American College of Rheumatology (ACR) 20 Response at Week 12 | ||||||||||||
End point description |
ACR 20 response: greater than or equal to(>=)20% improvement from baseline in both swollen joint count(66 joints) and tender joint count(68 joints), >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using VAS(0 [no pain] -100 [worst possible pain]), patient's global assessment of disease activity(arthritis measured on VAS 0 [no arthritis activity] - 100 [maximal arthritis activity]), physician's global assessment of disease activity measured on VAS(0 [no arthritis activity]- 100 [extremely active arthritis]),patient's assessment of physical function measured by Health Assessment Questionnaire disability index(HAQ-DI)with 20-question assessing 8 functional area(dressing,arising,eating,walking,hygiene,reaching,gripping, activities of daily living) with score range of 0(better physical function) to 3(worst physical function), CRP level(mg/L). Higher score=worse outcome. FAS included all randomised subjects who received at least 1 dose of any study drug.
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End point type |
Secondary
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End point timeframe |
Week 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects Who Achieved ACR50 Response at Week 12 | ||||||||||||
End point description |
ACR 50 response: >=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 VAS (0 [no pain] to 100 [worst possible pain]), patient's global assessment of disease activity (arthritis measured on VAS 0 [no arthritis activity] to 100 [maximal arthritis activity]), physician's global assessment of disease activity measured on VAS (0 [no arthritis activity] to 100 [extremely active arthritis]), patient's assessment of physical function measured by HAQ-DI with 20-question assessing 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living) with scoring range of 0 (better physical function) to 3 (worst physical function) and CRP level (mg/L).Higher score=worst outcome. The FAS included all randomised subjects who received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Week 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects Who Achieved ACR70 Response at Week 12 | ||||||||||||
End point description |
ACR 70 response: >=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 [no pain] to 100 [worst possible pain]), patient's global assessment of disease activity (arthritis measured on VAS 0 [no arthritis activity] to 100 [maximal arthritis activity]), physician's global assessment of disease activity measured on VAS (0 [no arthritis activity] to 100 [extremely active arthritis]), patient's assessment of physical function measured by HAQ-DI with 20-question assessing 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living) with scoring range of 0 (better physical function) to 3 (worst physical function) and CRP level (mg/L). Higher score = worse outcomes. The FAS included all randomised subjects who received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Week 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects Who Achieved ACR90 Response at Week 12 | ||||||||||||
End point description |
ACR 90 response: >=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 [no pain] to 100 [worst possible pain]), patient's global assessment of disease activity (arthritis measured on VAS 0 [no arthritis activity] to 100 [maximal arthritis activity]), physician's global assessment of disease activity measured on VAS (0 [no arthritis activity] to 100 [extremely active arthritis]), patient's assessment of physical function measured by HAQ-DI with 20-question assessing 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living) with scoring range of 0 (better physical function) to 3 (worst physical function) and CRP level (mg/L). Higher score = worse outcomes. The FAS included all randomised subjects who received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Week 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects Who Achieved DAS28-CRP Remission at Week 12 | ||||||||||||
End point description |
DAS28 remission was defined as a DAS28-CRP value of <2.6 at Week 12. The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity. It included 4 components: tender joint count with 28 joints assessed; swollen joint count with 28 joints assessed; high-sensitivity CRP (in mg/L) and general health assessment by the subject using patient global assessment (measured on a VAS score ranged from 0 [no arthritis activity] to 100 mm [maximal arthritis activity]). DAS28-CRP score ranges from 0 to 10, where higher scores indicated greater disease activity. The FAS included all randomised subjects who received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Week 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects Who Achieved DAS28 (CRP) Low Disease Activity (LDA) at Week 12 | ||||||||||||
End point description |
The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity. It included 4 components: tender joint count with 28 joints assessed; swollen joint count with 28 joints assessed; high-sensitivity CRP (in mg/L) and general health assessment by the subject using patient global assessment (measured on a VAS score ranged from 0 [no arthritis activity] to 100 mm [maximal arthritis activity]). DAS28-CRP score ranges from 0 to 10, where higher scores indicated greater disease activity. DAS28 (CRP) LDA was defined as DAS28 (CRP) value less than or equal to (<=) 3.2 at Week 12. The FAS included all randomised subjects who received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Week 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | ||||||||||||
End point description |
HAQ-DI was 20-question instrument that assesses 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). Each functional category consisted of 2-3 items. For each items, level of difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Overall score was computed as the sum of functional area scores and divided by the number of functional area answered. Total possible score range 0 (least difficulty in physical function) to 3 (extreme difficulty in physical function), where higher scores indicate more difficulty while performing daily living activities. The FAS included all randomised subjects who received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects with Treatment-emergent Adverse Events (TEAEs) | ||||||||||||
End point description |
An adverse event (AE) was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily had a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention through the safety follow-up visit was considered to be treatment-emergent. The safety analysis set included all randomised subjects who received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Up to 18 weeks
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects with Treatment-emergent Serious Adverse Events (TESAEs) | ||||||||||||
End point description |
SAE was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. An AE was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily had a causal relationship with the intervention. Any SAE occurring at or after the initial administration of study intervention through the safety follow-up visit was considered treatment-emergent. The safety analysis set included all randomised subjects who received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Up to 18 weeks
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects with Treatment-emergent AEs Leading to Discontinuation of Study Intervention | ||||||||||||
End point description |
Percentage of subjects with treatment-emergent AE leading to discontinuation of study intervention was reported. An AE was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily had a causal relationship with the intervention. The safety analysis set included all randomised subjects who received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Up to 18 weeks
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects with Adverse Events of Special interests (AESIs) | ||||||||||||
End point description |
Treatment-emergent AEs associated with the following situations were considered as AESIs: Infections that were severe or required IV anti-infective or operative/invasive intervention; Hypoalbuminemia with albumin less than (<) 20 grams per litre (g/L) (<2.0 grams per deciliter [g/dL]). The safety analysis set included all randomised subjects who received at least 1 dose (partial or complete) of any study intervention.
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End point type |
Secondary
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End point timeframe |
Up to 18 weeks
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Serum Concentration of Nipocalimab Over Time [3] | ||||||||||||||||||||||||||
End point description |
Serum concentration of nipocalimab overtime was reported. The pharmacokinetic (PK) analysis set was defined as all randomised subjects who received at least 1 complete dose of nipocalimab and had at least 1 valid post-dose blood sample drawn for PK analysis. Here, 'N' (number of subjects analysed) signifies who were evaluable for this endpoint and 'n' (number analysed) signifies subjects who were evaluated at each specified timepoint.
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End point type |
Secondary
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End point timeframe |
Weeks 0, 2, 4, 8 (pre-infusion), Weeks 0, 2 and 8 (post-infusion [45 minutes after the end of infusion]), and Weeks 12, 18
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| Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arm only. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Percentage of Subjects with Treatment-emergent Anti-drug Antibodies (ADA) Against Nipocalimab [4] | ||||||||
End point description |
Percentage of subjects with treatment-emergent ADA against nipocalimab was reported. ADA responses were categorised as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined an ADA positive sample prior to nipocalimab administration and at least one ADA positive sample after nipocalimab with a 2-fold increase in titer over baseline. Treatment-induced ADA was defined an ADA negative sample prior to nipocalimab administration and at least one ADA positive sample after nipocalimab. Treatment-emergent antibodies to nipocalimab included all subjects who were positive (treatment-boosted or treatment-induced) at any time after their first nipocalimab administration through Week 18. The immunogenicity analysis set was defined as all randomised subjects who received at least 1 dose (partial or complete) of nipocalimab and had appropriate samples for ADA detection.
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End point type |
Secondary
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End point timeframe |
Up to Week 18
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| Notes [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arm only. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to 18 weeks
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Adverse event reporting additional description |
The safety analysis set included all randomised subjects who received at least 1 dose (partial or complete) of any study intervention.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.0
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Reporting groups
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Reporting group title |
Group 1: Placebo
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Reporting group description |
Subjects received placebo (matched to nipocalimab) intravenous (IV) infusion every 2 weeks (q2w) from Week0 through Week 10 along with standard-of-care (SOC) background therapy. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2: Nipocalimab
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Reporting group description |
Subjects received nipocalimab 15 milligrams per kilogram (mg/kg) IV infusion q2w from Week 0 through Week 10 along with SOC background therapy. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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19 May 2021 |
The purpose of this amendment-1 was to include additional safety criteria related to hypogammaglobulinemia, hyperlipidemia, and anaphylaxis. |
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30 Jun 2021 |
The purpose of this amendment-2 was to include additional stopping criteria for the study and for individual subjects. |
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12 Jan 2022 |
The purpose of this amendment-3 was to include additional biomarker samples for the study to better understand the molecular effects of nipocalimab in rheumatoid arthritis. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
