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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00552344
First received: October 31, 2007
Last updated: August 20, 2014
Last verified: August 2014
  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.


Condition Intervention Phase
Crohn Disease
Biological: Certolizumab Pegol
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, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, 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, Inc.:

Primary Outcome Measures:
  • 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: 262 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Obtain long term efficacy data. [ Time Frame: 262 weeks ] [ Designated as safety issue: No ]
  • Obtain data on plasma concentration of certolizumab pegol. [ Time Frame: 262 weeks ] [ Designated as safety issue: No ]
  • Obtain data on plasma concentration of ds-DNA and ANA. [ Time Frame: 262 weeks ] [ Designated as safety issue: No ]

Enrollment: 402
Study Start Date: May 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDP870 Biological: Certolizumab Pegol
200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
Other Name: Cimzia

  Eligibility

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

Inclusion Criteria:

  • Subjects participated in study C87085

Exclusion Criteria:

  • General exclusion criteria as common for open-label extension studies
  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
174
Roma, Italy
171
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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00552344     History of Changes
Other Study ID Numbers: C87088, 2007-002716-26
Study First Received: October 31, 2007
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: Ministry of Health
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
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
Ukraine: Ministry of Health

Keywords provided by UCB, Inc.:
CDP 870
Certolizumab Pegol
CIMZIA
Crohn Disease
Crohn's disease
Induction
Clinical response
Clinical remission

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 28, 2014