A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease (PRECiSE 4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT00160706
First received: September 8, 2005
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an exacerbation of Crohn's Disease.


Condition Intervention Phase
Crohn's Disease
Biological: Certolizumab Pegol (CDP870)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months) [ Time Frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372) ] [ 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 This Study CDP870-034 (up to 84 Months) [ Time Frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372) ] [ 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 or (Early) Withdrawal Visit [ Time Frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit ] [ 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 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 [ Time Frame: From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034 [ Time Frame: From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months) ] [ Designated as safety issue: No ]
    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.

  • Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit [ Time Frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit ] [ 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 Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034 [ Time Frame: From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months) ] [ 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 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.

  • C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit [ Time Frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit ] [ Designated as safety issue: No ]
  • Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256 [ Time Frame: Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256 ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: February 2004
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Certolizumab Pegol
3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Biological: Certolizumab Pegol (CDP870)

Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.

Up to 84 months of therapy in this study.

Other Names:
  • Cimzia
  • CDP870
  • CZP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] clinical studies in which the subject completed the Week 2 assessment in CDP870-031 [NCT00152490] or the Week 6 randomization in CDP870-032 [NCT00152425] but whose Crohn's Disease was significantly worse as determined by the investigator and whose Clinical Disease Activity Index (CDAI) score at entry to this study is either (subjects may have received active or placebo treatment):

    1. At least 70 points higher then Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870 032 [NCT00152425] responders) OR
    2. Higher than Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870-032 [NCT00152425] responders) with an absolute score of at least 350 points
  • 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 upper limit of 450 in the CDAI score is not applicable. In addition the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply
  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: NCT00160706

  Show 141 Study Locations
Sponsors and Collaborators
UCB Pharma SA
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications:
Responsible Party: UCB, Inc. ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT00160706     History of Changes
Other Study ID Numbers: C87034, 2005-002623-13
Study First Received: September 8, 2005
Results First Received: May 16, 2013
Last Updated: May 16, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Ministry for Health and Women
Belarus: Ministry of Health
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
New Zealand: Food Safety Authority
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Singapore: Health Sciences Authority
Slovenia: Agency for Medicinal Products - Ministry of Health
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 20, 2014