A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
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
2 other identifiers
interventional
403
17 countries
92
Brief Summary
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 \[NCT00552058\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2008
Longer than P75 for phase_3
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2007
CompletedFirst Posted
Study publicly available on registry
November 1, 2007
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
January 21, 2016
CompletedAugust 9, 2018
January 1, 2016
6.6 years
October 31, 2007
December 14, 2015
July 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)
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.
From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)
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.
From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Secondary Outcomes (4)
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)
Week 262
Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)
Week 262
Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)
Week 52
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
From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)
Study Arms (1)
Certolizumab Pegol
EXPERIMENTALCertolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
Interventions
* 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB BIOSCIENCES GmbHlead
- PPD Development, LPcollaborator
Study Sites (100)
284
Lakewood, Colorado, United States
285
Littleton, Colorado, United States
278
New Port Richey, Florida, United States
300
Winter Park, Florida, United States
276
Chicago, Illinois, United States
279
Louisville, Kentucky, United States
275
Metairie, Louisiana, United States
307
Monroe, Louisiana, United States
281
Annapolis, Maryland, United States
295
Towson, Maryland, United States
310
Chesterfield, Michigan, United States
298
Rochester, Minnesota, United States
272
Raleigh, North Carolina, United States
296
Cincinnati, Ohio, United States
289
Cleveland, Ohio, United States
280
Lancaster, Pennsylvania, United States
305
Germantown, Tennessee, United States
306
Germantown, Tennessee, United States
308
Norfolk, Virginia, United States
290
Seattle, Washington, United States
15
Concord, New South Wales, Australia
20
Box Hill, Victoria, Australia
12
Footscray, Victoria, Australia
16
Parkville, Victoria, Australia
14
Bankstown, Australia
11
Fitzroy, Australia
13
Fremantle, Australia
18
Garran, Australia
270
Vienna, Austria
32
Bonheiden, Belgium
31
Ghent, Belgium
35
Leuven, Belgium
34
Liège, Belgium
30
Roeselare, Belgium
52
Porto Alegre, Rio Grande do Sul, Brazil
45
Belo Horizonte, Brazil
41
Curitiba, Brazil
51
Rio de Janeiro, Brazil
53
Santos, Brazil
55
São Paulo, Brazil
64
Edmonton, Alberta, Canada
60
Winnepeg, Manitoba, Canada
67
Hamilton, Ontario, Canada
62
Kingston, Ontario, Canada
63
London, Ontario, Canada
70
London, Ontario, Canada
66
Toronto, Ontario, Canada
68
Toronto, Ontario, Canada
95
Hradec Králové, Czechia
97
Hradek Kralove, Czechia
98
Prague, Czechia
100
Tallinn, Estonia
101
Tartu, Estonia
140
Homburg, Germany
137
Kiel, Germany
144
Ulm, Germany
130
Wilhelmshaven, Germany
151
Budapest, Hungary
155
Budapest, Hungary
156
Budapest, Hungary
154
Győr, Hungary
150
Nagykanizsa, Hungary
153
Szeged, Hungary
152
Szombathely, Hungary
161
Beersheba, Israel
164
Haifa, Israel
167
Holon, Israel
163
Kfar Saba, Israel
166
Petha Tikva, Israel
160
Tel Aviv, Israel
169
Ẕerifin, Israel
176
Padua, Italy
171
Roma, Italy
174
Roma, Italy
191
Riga, Latvia
192
Riga, Latvia
193
Riga, Latvia
202
Milford, Auckland, New Zealand
204
Newton, Wellington Region, New Zealand
201
Auckland, New Zealand
200
Christchurch, New Zealand
203
Hamilton, New Zealand
217
Częstochowa, Poland
218
Częstochowa, Poland
210
Lodz, Poland
211
Warsaw, Poland
212
Warsaw, Poland
213
Wroclaw, Poland
221
Cluj-Napoca, Romania
225
Constanța, Romania
232
Kazan', Russia
230
Moscow, Russia
234
Moscow, Russia
233
Saint Petersburg, Russia
258
Dniepropetrovsk, Ukraine
251
Donetsk, Ukraine
256
Kiev, Ukraine
259
Kiev, Ukraine
257
Lviv, Ukraine
254
Simferopol, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Cares
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 31, 2007
First Posted
November 1, 2007
Study Start
May 1, 2008
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 9, 2018
Results First Posted
January 21, 2016
Record last verified: 2016-01