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:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00552344
First received: October 31, 2007
Last updated: March 8, 2013
Last verified: March 2013
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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:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
Drug Information available for:
Certolizumab pegol
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 400 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | October 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552344
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Hide Study LocationsLocations
| 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: | March 8, 2013 |
| 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 Publica 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 Immunoglobulin Fab Fragments Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013