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A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT00552344
First received: October 31, 2007
Last updated: January 29, 2016
Last verified: January 2016

October 31, 2007
January 29, 2016
May 2008
December 2014   (final data collection date for primary outcome measure)
  • Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks) [ Time Frame: From study start to the end of the Safety Follow-up Period (up to 272 weeks) ] [ Designated as safety issue: No ]
    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 the Study C87088 (up to 272 Weeks) [ Time Frame: From study start to the end of the Safety Follow-up Period (up to 272 weeks) ] [ Designated as safety issue: No ]
    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.
Safety of the long term therapy with certolizumab. All summaries of continuous safety variables will be presented at scheduled time points. Data to be analyzed will be adverse event data, laboratory data, vital signs and urinalysis data. [ Time Frame: 50 weeks ]
Complete list of historical versions of study NCT00552344 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262) [ Time Frame: Week 262 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262) [ Time Frame: Week 262 ] [ Designated as safety issue: No ]
    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.
  • Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Plasma 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 C87085 to the Study Completion Visit in C87088 [ Time Frame: From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks) ] [ Designated as safety issue: No ]
    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.
The absolute and the change from baseline for the HBI, CDAI and IBDQ scores will be summarized over time. [ Time Frame: 50 weeks ]
Not Provided
Not Provided
 
A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
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
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].

This study consisted of:

  • Induction Period (dosing at Weeks 0, 2, and 4)
  • Maintenance Dosing (dosing every 4 weeks up to Week 260)
  • End of Treatment Visit that occurred at Week 262/Withdrawal Visit and a Safety Follow-up Visit (SFU; 12 weeks after final dose)
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn Disease
Biological: 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
Other Names:
  • Certolizumab Pegol
  • CDP870
  • CZP
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.
Intervention: Biological: Cimzia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
403
December 2014
December 2014   (final data collection date for primary outcome measure)

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

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Czech Republic,   Estonia,   Germany,   Hungary,   Israel,   Italy,   Latvia,   New Zealand,   Poland,   Romania,   Russian Federation,   Ukraine
Chile,   Finland
 
NCT00552344
C87088, 2007-002716-26
No
Not Provided
Not Provided
UCB BIOSCIENCES GmbH
UCB BIOSCIENCES GmbH
PPD
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP