Trial Outcomes & Findings for Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006) (NCT NCT01453725)
NCT ID: NCT01453725
Last Updated: 2019-02-06
Results Overview
The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of \>=20% from Baseline and an absolute improvement from Baseline of \>=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a \>=20% worsening and an absolute worsening of \>=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
198 participants
Primary outcome timeframe
Week 16
Results posted on
2019-02-06
Participant Flow
These data are for Parts 1 and 2 of the study.
Participant milestones
| Measure |
Golimumab→Golimumab
In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Placebo→Golimumab
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
100
|
|
Overall Study
COMPLETED
|
85
|
89
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
Reasons for withdrawal
| Measure |
Golimumab→Golimumab
In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Placebo→Golimumab
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Non-compliance With Protocol
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Pregnancy Wish
|
0
|
2
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)
Baseline characteristics by cohort
| Measure |
Golimumab→Golimumab
n=98 Participants
In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Placebo→Golimumab
n=100 Participants
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.7 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
31.7 Years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
31.2 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The Full-Analysis-Set (FAS) population consisted of all randomized participants who received at least one dose of study drug in Part 1.
The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of \>=20% from Baseline and an absolute improvement from Baseline of \>=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a \>=20% worsening and an absolute worsening of \>=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.
Outcome measures
| Measure |
Golimumab→Golimumab
n=97 Participants
In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Placebo→Golimumab
n=100 Participants
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
|---|---|---|
|
Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16
|
71.1 Percentage of Participants
|
40.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)Population: The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.
Outcome measures
| Measure |
Golimumab→Golimumab
n=97 Participants
In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Placebo→Golimumab
n=100 Participants
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
|---|---|---|
|
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
Part 1 (Up to 16 weeks) (n=97, 100)
|
41.2 Percentage of Participants
|
47.0 Percentage of Participants
|
|
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
Part 2 (Up to 60 weeks) (n=93, 96)
|
41.9 Percentage of Participants
|
54.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 16 weeks for Part 1; Week 16 through up to 48 weeks for Part 2Population: The APaT population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study. Participants may have discontinued study drug without discontinuing from the study.
Outcome measures
| Measure |
Golimumab→Golimumab
n=97 Participants
In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Placebo→Golimumab
n=100 Participants
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to an AE
Part 1 (Up to 16 weeks) (n=97, 100)
|
2.1 Percentage of Participants
|
1.0 Percentage of Participants
|
|
Percentage of Participants Who Discontinued Study Drug Due to an AE
Part 2 (Up to 52 weeks) (n=93, 96)
|
1.1 Percentage of Participants
|
2.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 16Population: The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1.
The ASAS consists of 4 domains: participant global assessment, total back pain, function (BASFI), and inflammation (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 100-mm VAS from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of \>=40% from Baseline and an absolute improvement from Baseline of \>=20 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a \>=0% worsening and an absolute worsening of \>=0 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 40 were calculated.
Outcome measures
| Measure |
Golimumab→Golimumab
n=97 Participants
In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Placebo→Golimumab
n=100 Participants
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
|---|---|---|
|
Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16
|
56.7 Percentage of Participants
|
23.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 16Population: The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1 and had a Baseline BASDAI assessement.
The BASDAI is a summary of 6 participant-assessed 100-mm VAS for a) Fatigue, b) Spinal pain (overall), c) Peripheral arthritis, d) Enthesitis, e) Qualitative morning stiffness (intensity) and f) Quantitative morning stiffness (duration). Each VAS is measured as 0=none to 100=very severe, with a higher score indicating more severe symptoms. The BASDAI score is calculated as 0.2 time (a+b+c+d+\[0.5 times e+f\]) and can range from 0 to 100. The BASDAI 50 is defined as improvement by at least 50% from Baseline in the BASDAI score. The percentages of participants who achieved BASDAI 50 were calculated.
Outcome measures
| Measure |
Golimumab→Golimumab
n=97 Participants
In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Placebo→Golimumab
n=100 Participants
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
|---|---|---|
|
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16
|
57.7 Percentage of Participants
|
30.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 16Population: The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1.
ASAS partial remission was defined as a VAS score of less than 20 mm in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.
Outcome measures
| Measure |
Golimumab→Golimumab
n=97 Participants
In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Placebo→Golimumab
n=100 Participants
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
|---|---|---|
|
Percentage of Participants Achieving ASAS Partial Remission at Week 16
|
33.0 Percentage of Participants
|
18.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1, who completed Part 1, and who had Baseline and Week 16 MRI SI joint measurements.
Participants underwent MRI of the SI joints, without contrast, at Screening and Week 16 to assess the presence or absence of active inflammation of the SI joints. Scoring was based on 6 consecutive MRI slices through the SI joint. Each slice was divided into 4 quadrants. Each of the 48 quadrants was scored with respect to the presence of inflammation (0=no, 1=yes), yielding a maximum score of 48. Each slice was also assessed for the presence of a lesion exhibiting either intense signal or a depth \>=1 cm anywhere within the SI joint of the 6 slices (0=no, 1=yes), yielding a maximum score of 24. Total SI joint scores could range from 0 to 72, with a higher score indicating more signs of disease.
Outcome measures
| Measure |
Golimumab→Golimumab
n=74 Participants
In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Placebo→Golimumab
n=87 Participants
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
|---|---|---|
|
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16
Baseline Score
|
9.87 Score on a Scale
Standard Deviation 11.822
|
12.66 Score on a Scale
Standard Deviation 15.619
|
|
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16
Change from Baseline at Week 16
|
-5.25 Score on a Scale
Standard Deviation 7.708
|
-0.95 Score on a Scale
Standard Deviation 8.533
|
Adverse Events
Part 1: Golimumab→Golimumab
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Part 1: Placebo→Golimumab
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Part 2: Golimumab→Golimumab
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Part 2: Placebo→Golimumab
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Golimumab→Golimumab
n=97 participants at risk
In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Part 1: Placebo→Golimumab
n=100 participants at risk
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
Part 2: Golimumab→Golimumab
n=93 participants at risk
In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Part 2: Placebo→Golimumab
n=96 participants at risk
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/97 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
1.0%
1/100 • Number of events 1 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/93 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/96 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/97 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
1.0%
1/100 • Number of events 1 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/93 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/96 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
1.0%
1/97 • Number of events 1 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/100 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/93 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/96 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/97 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/100 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
1.1%
1/93 • Number of events 1 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/96 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/97 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/100 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
1.1%
1/93 • Number of events 1 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/96 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/97 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/100 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/93 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
1.0%
1/96 • Number of events 1 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/97 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/100 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/93 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
1.0%
1/96 • Number of events 1 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/97 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/100 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/93 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
1.0%
1/96 • Number of events 1 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
Other adverse events
| Measure |
Part 1: Golimumab→Golimumab
n=97 participants at risk
In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Part 1: Placebo→Golimumab
n=100 participants at risk
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
Part 2: Golimumab→Golimumab
n=93 participants at risk
In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
|
Part 2: Placebo→Golimumab
n=96 participants at risk
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/97 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
6.0%
6/100 • Number of events 8 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/93 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/96 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
9/97 • Number of events 11 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
9.0%
9/100 • Number of events 11 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
5.4%
5/93 • Number of events 5 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
10.4%
10/96 • Number of events 12 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Nervous system disorders
Headache
|
7.2%
7/97 • Number of events 8 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
6.0%
6/100 • Number of events 11 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
6.5%
6/93 • Number of events 11 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
8.3%
8/96 • Number of events 26 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.2%
5/97 • Number of events 5 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
4.0%
4/100 • Number of events 4 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/93 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/96 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/97 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/100 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
1.1%
1/93 • Number of events 1 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
5.2%
5/96 • Number of events 5 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/97 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/100 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
2.2%
2/93 • Number of events 3 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
7.3%
7/96 • Number of events 7 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/97 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
0.00%
0/100 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
4.3%
4/93 • Number of events 5 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
6.2%
6/96 • Number of events 9 • Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including slides and texts of oral or other public presentations and texts of any transmission through any electronic media) that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER