A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
NCT ID: NCT00552344
Last Updated: 2018-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
403 participants
INTERVENTIONAL
2008-05-31
2014-12-31
Brief Summary
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Detailed Description
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* 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)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Certolizumab Pegol
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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PPD Development, LP
INDUSTRY
UCB BIOSCIENCES GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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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
Countries
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Other Identifiers
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2007-002716-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C87088
Identifier Type: -
Identifier Source: org_study_id
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