Trial Outcomes & Findings for Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA) (NCT NCT01181050)

Results Overview

DAS28-CRP=0.56×sqrt(tender joints \[count:1-28\])+0.28×sqrt(swollen joints \[count:1-28\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \[100=most severe\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

Week 0, Week 12

Results posted on

2016-10-03

Participant Flow

The trial was conducted at 8 trial sites in 3 different countries (Germany, the Russian Federation and Ukraine) as follows: Germany: 1 site, the Russian Federation: 6 sites and Ukraine: 1 site. All sites enrolled, randomised and dosed at least 1 subject.

Participant milestones

Participant milestones
Measure	4.0 mg/kg Subjects received a single dose of 4 mg/kg NNC0142-0002	Placebo Subjects received a single dose of placebo
Overall Study STARTED	41	22
Overall Study COMPLETED	41	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4.0 mg/kg n=41 Participants Subjects received a single dose of 4 mg/kg NNC0142-0002	Placebo n=22 Participants Subjects received a single dose of placebo	Total n=63 Participants Total of all reporting groups
Age, Continuous	52.6 years STANDARD_DEVIATION 10.8 • n=5 Participants	52.0 years STANDARD_DEVIATION 10.8 • n=7 Participants	52.4 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	19 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
DAS28-CRP (Disease Activity Score based on count of 28 joints and the C-reactive protein)	5.4 scores STANDARD_DEVIATION 0.9 • n=5 Participants	5.4 scores STANDARD_DEVIATION 1.0 • n=7 Participants	5.4 scores STANDARD_DEVIATION 0.9 • n=5 Participants

PRIMARY outcome

Timeframe: Week 0, Week 12

Population: Change in DAS28-CRP was calculated by using last observation carried forward method.

DAS28-CRP=0.56×sqrt(tender joints \[count:1-28\])+0.28×sqrt(swollen joints \[count:1-28\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \[100=most severe\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.

Outcome measures

Outcome measures
Measure	4.0 mg/kg n=41 Participants Subjects received a single dose of 4 mg/kg NNC0142-0002	Placebo n=22 Participants Subjects received a single dose of placebo
Change in DAS28-CRP After 12 Weeks of Treatment	-1.0 scores Standard Deviation 1.0	-1.0 scores Standard Deviation 1.0

SECONDARY outcome

Timeframe: Week 0, Week 6

Population: Change in DAS28-CRP was calculated by using last observation carried forward method.

DAS28-CRP=0.56×sqrt(tender joints \[count:1-28\])+0.28×sqrt(swollen joints \[count:1-28\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \[100=most severe\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment.

Outcome measures

Outcome measures
Measure	4.0 mg/kg n=41 Participants Subjects received a single dose of 4 mg/kg NNC0142-0002	Placebo n=22 Participants Subjects received a single dose of placebo
Change in DAS28-CRP After 6 Weeks of Treatment.	-0.9 scores Standard Deviation 1.1	-1.0 scores Standard Deviation 0.8

SECONDARY outcome

Timeframe: Week 0, Week 24

Population: Change in DAS28-CRP was calculated by using last observation carried forward method.

DAS28-CRP=0.56×sqrt(tender joints \[count:1-28\])+0.28×sqrt(swollen joints \[count:1-28\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \[100=most severe\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment.

Outcome measures

Outcome measures
Measure	4.0 mg/kg n=41 Participants Subjects received a single dose of 4 mg/kg NNC0142-0002	Placebo n=22 Participants Subjects received a single dose of placebo
Change in DAS28-CRP After 24 Weeks of Treatment.	-1.3 scores Standard Deviation 1.1	-1.3 scores Standard Deviation 1.1

Adverse Events

4.0 mg/kg

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	4.0 mg/kg n=41 participants at risk Subjects received a single dose of 4 mg/kg NNC0142-0002	Placebo n=22 participants at risk Subjects received a single dose of placebo
Gastrointestinal disorders Gastritis erosive	2.4% 1/41 • Number of events 1 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator	0.00% 0/22 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator
Gastrointestinal disorders Pancreatitis chronic	2.4% 1/41 • Number of events 1 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator	0.00% 0/22 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator
Hepatobiliary disorders Portal hypertension	0.00% 0/41 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator	4.5% 1/22 • Number of events 1 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.4% 1/41 • Number of events 1 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator	0.00% 0/22 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	2.4% 1/41 • Number of events 1 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator	0.00% 0/22 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator

Other adverse events

Other adverse events
Measure	4.0 mg/kg n=41 participants at risk Subjects received a single dose of 4 mg/kg NNC0142-0002	Placebo n=22 participants at risk Subjects received a single dose of placebo
Infections and infestations Respiratory tract infection viral	2.4% 1/41 • Number of events 2 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator	9.1% 2/22 • Number of events 2 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator
Investigations Alanine aminotransferase increased	0.00% 0/41 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator	9.1% 2/22 • Number of events 3 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	9.8% 4/41 • Number of events 4 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator	4.5% 1/22 • Number of events 1 • The adverse events were collected from dosing until end of trial (a total of 24 weeks) Safety analysis set includes all subjects who received one dose of the investigational product or its comparator

Additional Information

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Email: [email protected]

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