Clinical trial NCT00552344: A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn Disease
Keywords: CDP 870
Certolizumab Pegol
CIMZIA
Crohn's Disease
Crohn Disease
CD Induction
Induction
Clinical response
Clinical remission
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2007-11-01
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 \[NCT00552058\].

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 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

Primary outcomes:
measure: Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)
timeFrame: From study start to the end of the Safety Follow-up Period (up to 272 weeks)
measure: Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)
timeFrame: From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Secondary outcomes:
measure: Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)
timeFrame: Week 262
measure: Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)
timeFrame: Week 262
measure: Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)
timeFrame: Week 52
measure: 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
timeFrame: From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: 284
state: Colorado
city: Littleton
country: United States
facility: 285
state: Colorado
city: New Port Richey
country: United States
facility: 278
state: Florida
city: Winter Park
country: United States
facility: 300
state: Florida
city: Chicago
country: United States
facility: 276
state: Illinois
city: Louisville
country: United States
facility: 279
state: Kentucky
city: Metairie
country: United States
facility: 275
state: Louisiana
city: Monroe
country: United States
facility: 307
state: Louisiana
city: Annapolis
country: United States
facility: 281
state: Maryland
city: Towson
country: United States
facility: 295
state: Maryland
city: Chesterfield
country: United States
facility: 310
state: Michigan
city: Rochester
country: United States
facility: 298
state: Minnesota
city: Raleigh
country: United States
facility: 272
state: North Carolina
city: Cincinnati
country: United States
facility: 296
state: Ohio
city: Cleveland
country: United States
facility: 289
state: Ohio
city: Lancaster
country: United States
facility: 280
state: Pennsylvania
city: Germantown
country: United States
facility: 305
state: Tennessee
city: Germantown
country: United States
facility: 306
state: Tennessee
city: Norfolk
country: United States
facility: 308
state: Virginia
city: Seattle
country: United States
facility: 290
state: Washington
city: Concord
country: Australia
facility: 15
state: New South Wales
city: Box Hill
country: Australia
facility: 20
state: Victoria
city: Footscray
country: Australia
facility: 12
state: Victoria
city: Parkville
country: Australia
facility: 16
state: Victoria
city: Bankstown
country: Australia
facility: 14
city: Fitzroy
country: Australia
facility: 11
city: Fremantle
country: Australia
facility: 13
city: Garran
country: Australia
facility: 18
city: Wien
country: Austria
facility: 270
city: Bonheiden
country: Belgium
facility: 32
city: Gent
country: Belgium
facility: 31
city: Leuven
country: Belgium
facility: 35
city: Liege
country: Belgium
facility: 34
city: Roeselare
country: Belgium
facility: 30
city: Porto Alegre
country: Brazil
facility: 52
state: RS
city: Belo-Horizonte
country: Brazil
facility: 45
city: Curitiba
country: Brazil
facility: 41
city: Rio de Janeiro
country: Brazil
facility: 51
city: Santos
country: Brazil
facility: 53
city: Sao Paulo
country: Brazil
facility: 55
city: Edmonton
country: Canada
facility: 64
state: Alberta
city: Winnepeg
country: Canada
facility: 60
state: Manitoba
city: Hamilton
country: Canada
facility: 67
state: Ontario
city: Kingston
country: Canada
facility: 62
state: Ontario
city: London
country: Canada
facility: 63
state: Ontario
city: London
country: Canada
facility: 70
state: Ontario
city: Toronto
country: Canada
facility: 66
state: Ontario
city: Toronto
country: Canada
facility: 68
state: Ontario
city: Hradec Kralove
country: Czechia
facility: 95
city: Hradek Kralove
country: Czechia
facility: 97
city: Praha 7
country: Czechia
facility: 98
city: Tallin
country: Estonia
facility: 100
city: Tartu
country: Estonia
facility: 101
city: Homburg
country: Germany
facility: 140
city: Kiel
country: Germany
facility: 137
city: Ulm
country: Germany
facility: 144
city: Wilhelmshaven
country: Germany
facility: 130
city: Budapest
country: Hungary
facility: 151
city: Budapest
country: Hungary
facility: 155
city: Budapest
country: Hungary
facility: 156
city: Gyor
country: Hungary
facility: 154
city: Nagykanizsa
country: Hungary
facility: 150
city: Szeged
country: Hungary
facility: 153
city: Szombathely
country: Hungary
facility: 152
city: Beer Sheva
country: Israel
facility: 161
city: Haifa
country: Israel
facility: 164
city: Holon
country: Israel
facility: 167
city: Kfar Saba
country: Israel
facility: 163
city: Petha Tikva
country: Israel
facility: 166
city: Tel Aviv
country: Israel
facility: 160
city: Zerifin
country: Israel
facility: 169
city: Padova
country: Italy
facility: 176
city: Roma
country: Italy
facility: 171
city: Roma
country: Italy
facility: 174
city: Riga
country: Latvia
facility: 191
city: Riga
country: Latvia
facility: 192
city: Riga
country: Latvia
facility: 193
city: Milford
country: New Zealand
facility: 202
state: Auckland
city: Newton
country: New Zealand
facility: 204
state: Wellington
city: Auckland
country: New Zealand
facility: 201
city: Christchurch
country: New Zealand
facility: 200
city: Hamilton
country: New Zealand
facility: 203
city: Czestochowa
country: Poland
facility: 217
city: Czestochowa
country: Poland
facility: 218
city: Lodz
country: Poland
facility: 210
city: Warszawa
country: Poland
facility: 211
city: Warszawa
country: Poland
facility: 212
city: Wroclaw
country: Poland
facility: 213
city: Cluj Napoca
country: Romania
facility: 221
city: Constanta
country: Romania
facility: 225
city: Kazan
country: Russian Federation
facility: 232
city: Moscow
country: Russian Federation
facility: 230
city: Moscow
country: Russian Federation
facility: 234
city: St Petersburg
country: Russian Federation
facility: 233
city: Dniepropetrovsk
country: Ukraine
facility: 258
city: Donetsk
country: Ukraine
facility: 251
city: Kiev
country: Ukraine
facility: 256
city: Kiev
country: Ukraine
facility: 259
city: Lviv
country: Ukraine
facility: 257
city: Simferopol
country: Ukraine
facility: 254
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: