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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00552344




Registration number
NCT00552344
Ethics application status
Date submitted
31/10/2007
Date registered
1/11/2007
Date last updated
9/08/2018

Titles & IDs
Public title
A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
Scientific title
A Phase IIIb, Multinational, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-TNF-alpha Monoclonal Antibody, Administered at Weeks 0, 2 and 4, and Then Every 4 Weeks Thereafter, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085
Secondary ID [1] 0 0
2007-002716-26
Secondary ID [2] 0 0
C87088
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Other interventions - Cimzia

Experimental: Certolizumab Pegol - Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.


Other interventions: Cimzia
Active substance: Certolizumab Pegol
Pharmaceutical form:first reconstituted, lyophilized powder formulation of CZP and after implementation of Amendment 2 (after 401 subjects were enrolled) prefilled syringe
Concentration: 200 mg/ml
Route of Administration: Subcutaneous use

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks) - 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.
Timepoint [1] 0 0
From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Primary outcome [2] 0 0
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks) - 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.
Timepoint [2] 0 0
From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Secondary outcome [1] 0 0
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI = 4) at Study Completion Visit (Week 262) - 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.
Timepoint [1] 0 0
Week 262
Secondary outcome [2] 0 0
Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ = 170) at Study Completion Visit (Week 262) - IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.
Timepoint [2] 0 0
Week 262
Secondary outcome [3] 0 0
Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52) - Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088 - Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 [NCT00552058] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.
Timepoint [4] 0 0
From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)

Eligibility
Key inclusion criteria
- Subject participated in study C87085 [NCT00552058] in which the subject completed the
study at Week 6

- Subject is capable of providing informed consent, which must be obtained prior to any
study related procedures

- Have a chest X-ray taken at Visit 1 that is read by a qualified radiologist or
pulmonary physician, with no evidence of current active Tuberculosis (TB) or old
inactive TB

- Subject has taken a TB survey and is committed to comply with TB prophylaxis if
applicable
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject is experiencing an ongoing serious adverse event assessed as being related to
study medication or is experiencing a serious adverse event that is still not
assessable

- Subject has an intercurrent illness that requires termination of treatment, such as a
serious infection (e.g. TB, pneumonia, sepsis, pyelonephritis, fistula abscess)

- Subject is non-compliant with TB prophylactic treatment (if applicable)

- Subject has had a chest X-ray at Visit 1 that shows an abnormality suggestive of a
malignancy or active infection, including TB

- Female who is pregnant or breast feeding

- Female of child bearing age or post puberty males not practicing effective birth
control

- Subject is expecting to receive any live virus or bacterial vaccination within 3
months of first Study Medication administration, during the trial or 3 months after
last dose of study drug

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
15 - Concord
Recruitment hospital [2] 0 0
20 - Box Hill
Recruitment hospital [3] 0 0
12 - Footscray
Recruitment hospital [4] 0 0
16 - Parkville
Recruitment hospital [5] 0 0
14 - Bankstown
Recruitment hospital [6] 0 0
11 - Fitzroy
Recruitment hospital [7] 0 0
13 - Fremantle
Recruitment hospital [8] 0 0
18 - Garran
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Footscray
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- Bankstown
Recruitment postcode(s) [6] 0 0
- Fitzroy
Recruitment postcode(s) [7] 0 0
- Fremantle
Recruitment postcode(s) [8] 0 0
- Garran
Recruitment outside Australia
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United States of America
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Colorado
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Florida
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Tennessee
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Washington
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Austria
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Wien
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Belgium
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Bonheiden
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Gent
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Leuven
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Liege
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Roeselare
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RS
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Brazil
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Belo-Horizonte
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Curitiba
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Gyor
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Holon
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Israel
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Kfar Saba
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Israel
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Petha Tikva
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Israel
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Tel Aviv
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Israel
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Zerifin
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Padova
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Roma
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Riga
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Auckland
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Wellington
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Christchurch
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Kiev
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Lviv
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Ukraine
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Simferopol

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB BIOSCIENCES GmbH
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
PPD
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to assess the safety of long term therapy with
Certolizumab Pegol in those subjects participating in study C87085 [NCT00552058].
Trial website
https://clinicaltrials.gov/show/NCT00552344
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications