NCT01550003 · FLOW

Participant flow

Pediatric Arthritis Study of Certolizumab Pegol · Source last updated 2024-10-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

description
Participants received Certolizumab Pegol (CZP) subcutaneously (sc) as a fixed dose based on their body weight every 2 weeks (Q2W) or every 4 weeks (Q4W) throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study (maximum up to 12 years).
id
FG000
title
Any CZP Dose - Weight Group: 10 - < 20 kg
description
Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
id
FG001
title
Any CZP Dose - Weight Group: 20 - <40 kg
description
Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
id
FG002
title
Any CZP Dose - Weight Group: >= 40 kg

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
9
group Id
FG002
num Subjects
15
type
Adverse Event
reasons
group Id
FG000
num Subjects
4
group Id
FG001
num Subjects
11
group Id
FG002
num Subjects
15
type
Lack of Efficacy
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
3
group Id
FG002
num Subjects
2
type
Protocol Violation
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
4
group Id
FG002
num Subjects
8
type
Lost to Follow-up
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
11
group Id
FG002
num Subjects
23
type
Consent withdrawn
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
2
type
Missing
reasons
group Id
FG000
num Subjects
7
group Id
FG001
num Subjects
6
group Id
FG002
num Subjects
24
type
Study closure as announced by sponsor
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
type
Protocol Noncompliance
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
group Id
FG002
num Subjects
1
type
Study closure
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
group Id
FG002
num Subjects
0
type
Patient reached adulthood
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
2
group Id
FG002
num Subjects
4
type
Early discontinuation at request of sponsor
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
3
group Id
FG002
num Subjects
3
type
Sponsor's order
milestones
achievements
group Id
FG000
num Subjects
18
group Id
FG001
num Subjects
63
group Id
FG002
num Subjects
112
type
STARTED
achievements
group Id
FG000
num Subjects
7
group Id
FG001
num Subjects
34
group Id
FG002
num Subjects
64
type
Original CZP Dose
achievements
group Id
FG000
num Subjects
11
group Id
FG001
num Subjects
29
group Id
FG002
num Subjects
48
type
Reduced CZP Dose
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
18
group Id
FG001
num Subjects
63
group Id
FG002
num Subjects
112
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

Participant Flow refers to the Safety Set.

recruitment Details

The study started to enroll participants in March 2012 and concluded in April 2024.

Complete source fields