First-in-man Trial of NNC0142-0002 in Patients With Rheum... | NCT00927927 | Trialant
NCT00927927
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
Oct 3, 2016Estimated
Enrollment
65Actual
Phase
Phase 1
Conditions
Inflammation
Rheumatoid Arthritis
Interventions
NNC0142-0002
NNC0142-0002
NNC0142-0002
NNC0142-0002
NNC0142-0002
NNC0142-0002
NNC0142-0002
NNC0142-0002
placebo
NNC0142-0002
NNC0142-0002
NNC0142-0002
NNC0142-0002
NNC0142-0002
placebo
Countries
Germany
Protocol Section
Identification Module
NCT ID
NCT00927927
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NN8555-3618
Secondary IDs
ID
Type
Description
Link
2008-008703-18
EudraCT Number
Brief Title
First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
Official Title
A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Aug 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2009
Primary Completion Date
Dec 2011Actual
Completion Date
Dec 2011Actual
First Submitted Date
Jun 24, 2009
First Submission Date that Met QC Criteria
Jun 24, 2009
First Posted Date
Jun 25, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 25, 2013
Results First Submitted that Met QC Criteria
Oct 8, 2013
Results First Posted Date
Oct 21, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 24, 2016
Last Update Posted Date
Oct 3, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.
Detailed Description
Not provided
Conditions Module
Conditions
Inflammation
Rheumatoid Arthritis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
65Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
SD 0.0002 mg/kg
Experimental
Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg
Drug: NNC0142-0002
SD 0.0012 mg/kg
Experimental
Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg
Drug: NNC0142-0002
SD 0.007 mg/kg
Experimental
Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg
Drug: NNC0142-0002
SD 0.035 mg/kg
Experimental
Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg
Drug: NNC0142-0002
SD 0.175 mg/kg
Experimental
Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg
Drug: NNC0142-0002
SD 0.7 mg/kg
Experimental
Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
NNC0142-0002
Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
SD 0.0002 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Frequency of Adverse Events
Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.
Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Concentration-time Curve (AUC)
Systemic exposure to NNC0142-0002.
Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Active rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration
Aged between 18 and 75 years (both inclusive)
Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
Use of highly effective contraception during the trial (both males and females)
Exclusion Criteria:
A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)
An active or latent tuberculosis
Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
A known significant cardio-vascular disease
Vaccination against live virus or bacteria within 4 weeks prior to randomization
The use of concomitant medications that are prohibited in the trial (e.g., certain DMARDs (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B and/or hepatitis C, or tuberculosis skin test
Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry
A total of 65 subjects were randomised, but only 64 subjects were exposed to trial product. One subject withdrew consent after being randomised but before receiving any trial product.
Recruitment Details
The trial was conducted at one site in Germany.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
SD 0.0002 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
FG001
SD 0.0012 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: NNC0142-0002
SD 2.5 mg/kg
Experimental
Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg
Drug: NNC0142-0002
SD 7.5 mg/kg
Experimental
Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg
Drug: NNC0142-0002
SD Placebo
Experimental
Subjects were injected once with placebo
Drug: placebo
MD 0.02 mg/kg
Experimental
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
Drug: NNC0142-0002
MD 0.3 mg/kg
Experimental
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
Drug: NNC0142-0002
MD 1.0 mg/kg
Experimental
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
Drug: NNC0142-0002
MD 1.6 mg/kg
Experimental
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
Drug: NNC0142-0002
MD 4.0 mg/kg
Experimental
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
Drug: NNC0142-0002
MD Placebo
Experimental
Subjects were injected biweekly four times with placebo
Drug: placebo
NNC0142-0002
Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
SD 0.0012 mg/kg
NNC0142-0002
Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
SD 0.007 mg/kg
NNC0142-0002
Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
SD 0.035 mg/kg
NNC0142-0002
Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
SD 0.175 mg/kg
NNC0142-0002
Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
SD 0.7 mg/kg
NNC0142-0002
Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
SD 2.5 mg/kg
NNC0142-0002
Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
SD 7.5 mg/kg
placebo
Drug
Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
SD Placebo
NNC0142-0002
Drug
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
MD 0.02 mg/kg
NNC0142-0002
Drug
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
MD 0.3 mg/kg
NNC0142-0002
Drug
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
MD 1.0 mg/kg
NNC0142-0002
Drug
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
MD 1.6 mg/kg
NNC0142-0002
Drug
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
MD 4.0 mg/kg
placebo
Drug
Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
MD Placebo
FG002
SD 0.007 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
FG003
SD 0.035 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
FG004
SD 0.175 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
FG005
SD 0.7 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
FG006
SD 2.5 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
FG007
SD 7.5 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
FG008
SD Placebo
Subjects were dosed once with placebo
FG009
MD 0.02 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
FG010
MD 0.3 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
FG011
MD 1.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
FG012
MD 1.6 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
FG013
MD 4.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
FG014
MD Placebo
Subjects were injected biweekly four times with placebo
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG0073 subjects
FG0088 subjects
FG0093 subjects
FG0105 subjects
FG0116 subjects
FG0125 subjects
FG0135 subjects
FG0149 subjects
Exposed
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG0073 subjects
FG0088 subjects
FG0093 subjects
FG0105 subjects
FG0115 subjects
FG0125 subjects
FG0135 subjects
FG0149 subjects
COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG0071 subjects
FG0088 subjects
FG0093 subjects
FG0105 subjects
FG0114 subjectsOne subject withdrew consent after being randomised but before receiving any trial product.
FG0125 subjects
FG0135 subjects
FG0149 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
SD 0.0002 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
BG001
SD 0.0012 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
BG002
SD 0.007 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
BG003
SD 0.035 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
BG004
SD 0.175 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
BG005
SD 0.7 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
BG006
SD 2.5 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
BG007
SD 7.5 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
BG008
SD Placebo
Subjects were dosed once with placebo
BG009
MD 0.02 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
BG010
MD 0.3 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
BG011
MD 1.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
BG012
MD 1.6 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
BG013
MD 4.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
BG014
MD Placebo
Subjects were injected biweekly four times with placebo
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0033
BG0043
BG0053
BG0063
BG0073
BG0088
BG0093
BG0105
BG0115
BG0125
BG0135
BG0149
BG01564
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
participants
Title
Denominators
Categories
Title
Measurements
BG00063.0± 7.9
BG00160.7± 8.1
BG00266.7± 8.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Frequency of Adverse Events
Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.
All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo.
Posted
Number
events
Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.
ID
Title
Description
OG000
SD 0.0002 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
OG001
SD 0.0012 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
OG002
SD 0.007 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
OG003
SD 0.035 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
OG004
SD 0.175 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
OG005
SD 0.7 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
OG006
SD 2.5 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
OG007
SD 7.5 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
OG008
SD Placebo
Subjects were dosed once with placebo
OG009
MD 0.02 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
OG010
MD 0.3 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
OG011
MD 1.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
OG012
MD 1.6 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
OG013
MD 4.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
OG014
MD Placebo
Subjects were injected biweekly four times with placebo
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Adverse events
Title
Measurements
OG0005
OG0014
OG0023
OG003
Secondary
Area Under the Concentration-time Curve (AUC)
Systemic exposure to NNC0142-0002.
All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo. Serum drug concentrations after dosing with less than 0.175 mg/kg (SD cohorts) and 0.3 mg/kg (MD cohorts) were below the lower limit of quantification.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram×h/mL
Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.
ID
Title
Description
OG000
SD 0.0002 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
OG001
SD 0.0012 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
OG002
SD 0.007 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
OG003
SD 0.035 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
Time Frame
Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.
Description
The safety analysis set included all randomised subjects exposed to at least one dose of NNC0142-0002 or placebo.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
SD 0.0002 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
0
3
2
3
EG001
MD 0.02 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
0
3
1
3
EG002
SD 0.0012 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
0
3
2
3
EG003
SD 0.007 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
0
3
1
3
EG004
SD 0.035 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
0
3
3
3
EG005
SD 0.175 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
0
3
1
3
EG006
SD 0.7 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
1
3
3
3
EG007
SD 2.5 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
0
3
3
3
EG008
SD 7.5 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
1
3
1
3
EG009
SD Placebo
Subjects were dosed once with placebo
0
8
6
8
EG010
MD 0.3 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
0
5
4
5
EG011
MD 1.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
0
5
4
5
EG012
MD 1.6 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
0
5
5
5
EG013
MD 4.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
0
5
3
5
EG014
MD Placebo
Subjects were injected biweekly four times with placebo
0
9
8
9
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected5 at risk
EG0120 events0 affected5 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected9 at risk
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Vertigo
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected5 at risk
EG0120 events0 affected5 at risk
EG0130 events0 affected5 at risk
EG0141 events1 affected9 at risk
Lacrimation increased
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Injection site pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Paronychia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Incorrect dose administered
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Epstein-Barr virus antibody positive
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0004 events2 affected3 at risk
EG0012 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Migraine
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematoma
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Maximum tolerated dose was not reached.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Novo Nordisk reserves the right to defer data release until specified milestones, e.g. availability of a clinical trial report. Novo Nordisk reserves the right to postpone publication and/or communication for short period to protect intellectual property. Novo Nordisk reserves the right to prior review of site-specific publications and to ask for deferment of publication of individual site results until after the primary manuscript is accepted for publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Public Access to Clinical Trials
Novo Nordisk A/S
RA-RNDUS-ClinTriDisc@ITS.JNJ.com
ID
Term
D007249
Inflammation
D001172
Arthritis, Rheumatoid
Ancestor Terms
ID
Term
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000624132
NNC0142-0002 monoclonal antibody
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
58.3
± 5.1
BG00458.7± 3.1
BG00552.7± 11.0
BG00649.0± 10.8
BG00769.0± 4.6
BG00852.8± 7.8
BG00955.3± 5.0
BG01056.4± 9.4
BG01158.4± 5.5
BG01253.0± 17.9
BG01348.2± 7.7
BG01453.7± 11.0
BG01556.0± 9.8
3
BG0033
BG0042
BG0052
BG0063
BG0071
BG0086
BG0092
BG0105
BG0113
BG0124
BG0132
BG0148
BG01549
Male
BG0000
BG0011
BG0020
BG0030
BG0041
BG0051
BG0060
BG0072
BG0082
BG0091
BG0100
BG0112
BG0121
BG0133
BG0141
BG01515
3
OG0043
OG0053
OG0063
OG0073
OG0088
OG0093
OG0105
OG0115
OG0125
OG0135
OG0149
4
OG0041
OG0058
OG0066
OG0073
OG0089
OG0094
OG0108
OG01113
OG01210
OG01314
OG0149
Serious AE
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0071
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG004
SD 0.175 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
OG005
SD 0.7 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
OG006
SD 2.5 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
OG007
SD 7.5 mg/kg
Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
OG008
SD Placebo
Subjects were dosed once with placebo
OG009
MD 0.02 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
OG010
MD 0.3 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
OG011
MD 1.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
OG012
MD 1.6 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
OG013
MD 4.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
OG014
MD Placebo
Subjects were injected biweekly four times with placebo
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG0073
OG0088
OG0093
OG0105
OG0115
OG0125
OG0135
OG0149
Title
Denominators
Categories
Title
Measurements
OG000NA± NAExposure was below lower level of quantification.
OG001NA± NA(NA to NA)Exposure was below lower level of quantification.
OG002NA± NA(NA to NA)Exposure was below lower level of quantification.
OG003NA± NA(NA to NA)Exposure was below lower level of quantification.
OG00491± 306.6(306.6 to )
OG0054229± 12.7(12.7 to )
OG00616616± 35.2(35.2 to )
OG00787461± 29.9(29.9 to )
OG008NA± NA(NA to NA)AUC was not calculated as subjects were not exposed to NNC0142-0002.
OG009NA± NA(NA to NA)Exposure was below lower level of quantification.
OG0104034± 62.8(62.8 to )
OG01121883± 29.6(29.6 to )
OG01230212± 25.4(25.4 to )
OG01383307± 38.3(38.3 to )
OG014NA± NA(NA to )AUC was not calculated as subjects were not exposed to NNC0142-0002.