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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
  Purpose
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: 403
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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Hide Study Locations
Locations
United States, Colorado
284
Lakewood, Colorado, United States
285
Littleton, Colorado, United States
United States, Florida
278
New Port Richey, Florida, United States
300
Winter Park, Florida, United States
United States, Illinois
276
Chicago, Illinois, United States
United States, Kentucky
279
Louisville, Kentucky, United States
United States, Louisiana
275
Metairie, Louisiana, United States
307
Monroe, Louisiana, United States
United States, Maryland
281
Annapolis, Maryland, United States
295
Towson, Maryland, United States
United States, Michigan
310
Chesterfield, Michigan, United States
United States, Minnesota
298
Rochester, Minnesota, United States
United States, North Carolina
272
Raleigh, North Carolina, United States
United States, Ohio
296
Cincinnati, Ohio, United States
289
Cleveland, Ohio, United States
United States, Pennsylvania
280
Lancaster, Pennsylvania, United States
United States, Tennessee
305
Germantown, Tennessee, United States
306
Germantown, Tennessee, United States
United States, Virginia
308
Norfolk, Virginia, United States
United States, Washington
290
Seattle, Washington, United States
Australia, New South Wales
15
Concord, New South Wales, Australia
Australia, Victoria
20
Box Hill, Victoria, Australia
12
Footscray, Victoria, Australia
16
Parkville, Victoria, Australia
Australia
14
Bankstown, Australia
11
Fitzroy, Australia
13
Fremantle, Australia
18
Garran, Australia
Austria
270
Wien, Austria
Belgium
32
Bonheiden, Belgium
31
Gent, Belgium
35
Leuven, Belgium
34
Liege, Belgium
30
Roeselare, Belgium
Brazil
52
Porto Alegre, RS, Brazil
45
Belo-Horizonte, Brazil
41
Curitiba, Brazil
51
Rio de Janeiro, Brazil
53
Santos, Brazil
55
Sao Paulo, Brazil
Canada, Alberta
64
Edmonton, Alberta, Canada
Canada, Manitoba
60
Winnepeg, Manitoba, Canada
Canada, Ontario
67
Hamilton, Ontario, Canada
62
Kingston, Ontario, Canada
63
London, Ontario, Canada
70
London, Ontario, Canada
66
Toronto, Ontario, Canada
68
Toronto, Ontario, Canada
Czech Republic
95
Hradec Kralove, Czech Republic
97
Hradek Kralove, Czech Republic
98
Praha 7, Czech Republic
Estonia
100
Tallin, Estonia
101
Tartu, Estonia
Germany
140
Homburg, Germany
137
Kiel, Germany
144
Ulm, Germany
130
Wilhelmshaven, Germany
Hungary
151
Budapest, Hungary
155
Budapest, Hungary
156
Budapest, Hungary
154
Gyor, Hungary
150
Nagykanizsa, Hungary
153
Szeged, Hungary
152
Szombathely, Hungary
Israel
161
Beer Sheva, Israel
164
Haifa, Israel
167
Holon, Israel
163
Kfar Saba, Israel
166
Petha Tikva, Israel
160
Tel Aviv, Israel
169
Zerifin, Israel
Italy
176
Padova, Italy
171
Roma, Italy
174
Roma, Italy
Latvia
191
Riga, Latvia
192
Riga, Latvia
193
Riga, Latvia
New Zealand
202
Milford, Auckland, New Zealand
204
Newton, Wellington, New Zealand
201
Auckland, New Zealand
200
Christchurch, New Zealand
203
Hamilton, New Zealand
Poland
217
Czestochowa, Poland
218
Czestochowa, Poland
210
Lodz, Poland
211
Warszawa, Poland
212
Warszawa, Poland
213
Wroclaw, Poland
Romania
221
Cluj Napoca, Romania
225
Constanta, Romania
Russian Federation
232
Kazan, Russian Federation
230
Moscow, Russian Federation
234
Moscow, Russian Federation
233
St Petersburg, Russian Federation
Ukraine
258
Dniepropetrovsk, Ukraine
251
Donetsk, Ukraine
256
Kiev, Ukraine
259
Kiev, Ukraine
257
Lviv, Ukraine
254
Simferopol, Ukraine
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
PPD
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Responsible Party: UCB BIOSCIENCES GmbH
ClinicalTrials.gov Identifier: NCT00552344     History of Changes
Other Study ID Numbers: C87088  2007-002716-26 
Study First Received: October 31, 2007
Results First Received: December 14, 2015
Last Updated: January 29, 2016
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
CIMZIA
Crohn's Disease
Crohn Disease
CD Induction
Induction
Clinical response
Clinical remission

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on December 06, 2016