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A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]

A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00160524
Acronym
PRECiSE 3
Enrollment
596
Registered
2005-09-12
Start date
2004-07-31
Completion date
2012-08-31
Last updated
2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Certolizumab Pegol, Cimzia, CDP870, CZP

Brief summary

An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\]).

Interventions

Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Sponsors

UCB Pharma SA
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participation in either of the CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] clinical studies in which the subject completed the trial at Week 26. Subjects may have received active or placebo or both treatments in the prior study * Subjects must be able to understand the information provided to them and give written informed consent

Exclusion criteria

* Any exclusion criterion that would have prevented the subject's participation in the qualifying pivotal study CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\], although the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply. In addition there are no limits on the Clinical Disease Activity Index (CDAI) score at entry

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)An AE is defined as 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.
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.

Secondary

MeasureTime frameDescription
Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal VisitStudy Completion Visit (Week 364) / (Early) Withdrawal VisitPlasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels \> 2.4 units/mL.
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal VisitStudy Completion Visit (Week 364) / (Early) Withdrawal VisitHBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal VisitStudy Completion Visit (Week 364) / (Early) Withdrawal Visit
Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change >=3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal VisitResponse is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well-being. The first three parameters are scored for the previous day.

Countries

Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Czechia, Denmark, Estonia, Georgia, Germany, Hong Kong, Hungary, Israel, Italy, Latvia, Lithuania, New Zealand, Norway, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Ukraine, United States

Participant flow

Recruitment details

This multicenter study started to enroll subjects in July 2004 in order to end up with 206 centers in 29 countries with enrolled subjects. Participant Flow refers to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].

Pre-assignment details

All subjects who completed the Week 26 assessment in feeder studies C87031 and C87032 were eligible to enter this open-label follow-on study C87033.

Participants by arm

ArmCount
Certolizumab Pegol
400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
595
Total595

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event119
Overall StudyAdverse Event and Other94
Overall StudyLack of Efficacy21
Overall StudyLack of Efficacy and Other1
Overall StudyLost to Follow-up13
Overall StudyLost to Follow-up and Other1
Overall StudyOther20
Overall StudyPhysician Decision27
Overall StudyPhysician Decision and Other6
Overall StudyProtocol Violation16
Overall StudyProtocol Violation and Other2
Overall StudyWithdrawal by Subject141
Overall StudyWithdrawal by Subject and Other17

Baseline characteristics

CharacteristicCertolizumab Pegol
Age, Categorical
<=18 years
7 Participants
Age, Categorical
>=65 years
14 Participants
Age, Categorical
Between 18 and 65 years
574 Participants
Age, Continuous38.1 years
STANDARD_DEVIATION 11.87
Region of Enrollment
Australia
30 participants
Region of Enrollment
Austria
4 participants
Region of Enrollment
Belarus
12 participants
Region of Enrollment
Belgium
6 participants
Region of Enrollment
Bulgaria
20 participants
Region of Enrollment
Canada
17 participants
Region of Enrollment
Czech Republic
54 participants
Region of Enrollment
Denmark
21 participants
Region of Enrollment
Estonia
4 participants
Region of Enrollment
Georgia
1 participants
Region of Enrollment
Germany
21 participants
Region of Enrollment
Hong Kong
2 participants
Region of Enrollment
Hungary
48 participants
Region of Enrollment
Israel
13 participants
Region of Enrollment
Italy
14 participants
Region of Enrollment
Latvia
4 participants
Region of Enrollment
Lithuania
1 participants
Region of Enrollment
New Zealand
10 participants
Region of Enrollment
Norway
7 participants
Region of Enrollment
Poland
72 participants
Region of Enrollment
Russian Federation
22 participants
Region of Enrollment
Serbia
29 participants
Region of Enrollment
Singapore
2 participants
Region of Enrollment
Slovenia
15 participants
Region of Enrollment
South Africa
45 participants
Region of Enrollment
Spain
1 participants
Region of Enrollment
Sweden
4 participants
Region of Enrollment
Ukraine
18 participants
Region of Enrollment
United States
98 participants
Sex: Female, Male
Female
307 Participants
Sex: Female, Male
Male
288 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
410 / 595
serious
Total, serious adverse events
240 / 595

Outcome results

Primary

Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)

An AE is defined as 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.

Time frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)

Population: All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].

ArmMeasureValue (NUMBER)
Certolizumab PegolPercentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)88.2 percentage of subjects
Primary

Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)

An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.

Time frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)

Population: All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].

ArmMeasureValue (NUMBER)
Certolizumab PegolPercentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)40.3 percentage of subjects
Secondary

C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit

Time frame: Study Completion Visit (Week 364) / (Early) Withdrawal Visit

Population: Of the 594 subjects in the Intention-To-Treat (ITT) Population, 593 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

ArmMeasureValue (GEOMETRIC_MEAN)
Certolizumab PegolC-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit7.93 mg/L
Secondary

Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258

Time frame: Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258

Population: Of the 594 subjects in the Intention-To-Treat (ITT) Population, 567 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

ArmMeasureValue (GEOMETRIC_MEAN)
Certolizumab PegolFaecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258302.540 μg/g stool
Secondary

Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit

HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.

Time frame: Study Completion Visit (Week 364) / (Early) Withdrawal Visit

Population: Of the 594 subjects in the Intention-To-Treat (ITT) Population, 592 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

ArmMeasureValue (NUMBER)
Certolizumab PegolPercentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit54.7 percentage of subjects
Secondary

Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change >=3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032

Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well-being. The first three parameters are scored for the previous day.

Time frame: From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit

Population: All 594 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

ArmMeasureValue (NUMBER)
Certolizumab PegolPercentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change >=3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-03221.7 percentage of subjects
Secondary

Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033

Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels \> 2.4 units/mL.

Time frame: From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)

Population: Of the 595 subjects in the Safety Population, 593 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].

ArmMeasureValue (NUMBER)
Certolizumab PegolPercentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-03322.6 percentage of subjects
Secondary

Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit

Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.

Time frame: Study Completion Visit (Week 364) / (Early) Withdrawal Visit

Population: Of the 595 subjects in the Safety Population, 590 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].

ArmMeasureValue (GEOMETRIC_MEAN)
Certolizumab PegolPlasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit5.578 μg/mL

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026