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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: October 31, 2007
Last updated: October 29, 2015
Last verified: October 2015
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].

Condition Intervention Phase
Crohn Disease
Biological: Cimzia
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 402
Study Start Date: May 2008
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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)

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552344

  Show 100 Study Locations
Sponsors and Collaborators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT00552344     History of Changes
Other Study ID Numbers: C87088, 2007-002716-26
Study First Received: October 31, 2007
Last Updated: October 29, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: Ministry of Health
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: National Institute of Health
Latvia: State Agency of Medicines
New Zealand: Health Research Council
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
United States: Food and Drug Administration
Ukraine: Ministry of Health

Keywords provided by UCB Pharma:
CDP 870
Certolizumab Pegol
Crohn's Disease
Crohn Disease
CD Induction
Clinical response
Clinical remission

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Certolizumab pegol
Immunoglobulin Fab Fragments
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 30, 2015