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

Primary Purpose

Crohn Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cimzia
Sponsored by
UCB BIOSCIENCES GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring CDP 870, Certolizumab Pegol, CIMZIA, Crohn's Disease, Crohn Disease, CD Induction, Induction, Clinical response, Clinical remission

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 284
  • 285
  • 278
  • 300
  • 276
  • 279
  • 275
  • 307
  • 281
  • 295
  • 310
  • 298
  • 272
  • 296
  • 289
  • 280
  • 305
  • 306
  • 308
  • 290
  • 15
  • 20
  • 12
  • 16
  • 14
  • 11
  • 13
  • 18
  • 270
  • 32
  • 31
  • 35
  • 34
  • 30
  • 52
  • 45
  • 41
  • 51
  • 53
  • 55
  • 64
  • 60
  • 67
  • 62
  • 63
  • 70
  • 66
  • 68
  • 95
  • 97
  • 98
  • 100
  • 101
  • 140
  • 137
  • 144
  • 130
  • 151
  • 155
  • 156
  • 154
  • 150
  • 153
  • 152
  • 161
  • 164
  • 167
  • 163
  • 166
  • 160
  • 169
  • 176
  • 171
  • 174
  • 191
  • 192
  • 193
  • 202
  • 204
  • 201
  • 200
  • 203
  • 217
  • 218
  • 210
  • 211
  • 212
  • 213
  • 221
  • 225
  • 232
  • 230
  • 234
  • 233
  • 258
  • 251
  • 256
  • 259
  • 257
  • 254

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Certolizumab Pegol

Arm Description

Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)
HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)
IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.
Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)
Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
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
Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 [NCT00552058] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.

Full Information

First Posted
October 31, 2007
Last Updated
July 10, 2018
Sponsor
UCB BIOSCIENCES GmbH
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT00552344
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES GmbH
Collaborators
PPD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
CDP 870, Certolizumab Pegol, CIMZIA, Crohn's Disease, Crohn Disease, CD Induction, Induction, Clinical response, Clinical remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
403 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Certolizumab Pegol
Arm Type
Experimental
Arm Description
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
Intervention Type
Biological
Intervention Name(s)
Cimzia
Other Intervention Name(s)
Certolizumab Pegol, CDP870, CZP
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)
Description
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.
Time Frame
From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Title
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)
Description
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.
Time Frame
From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)
Description
HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
Time Frame
Week 262
Title
Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)
Description
IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.
Time Frame
Week 262
Title
Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)
Description
Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
Time Frame
Week 52
Title
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
Description
Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 [NCT00552058] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.
Time Frame
From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
284
City
Lakewood
State/Province
Colorado
Country
United States
Facility Name
285
City
Littleton
State/Province
Colorado
Country
United States
Facility Name
278
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
300
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
276
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
279
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
275
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
307
City
Monroe
State/Province
Louisiana
Country
United States
Facility Name
281
City
Annapolis
State/Province
Maryland
Country
United States
Facility Name
295
City
Towson
State/Province
Maryland
Country
United States
Facility Name
310
City
Chesterfield
State/Province
Michigan
Country
United States
Facility Name
298
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
272
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
296
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
289
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
280
City
Lancaster
State/Province
Pennsylvania
Country
United States
Facility Name
305
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
306
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
308
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
290
City
Seattle
State/Province
Washington
Country
United States
Facility Name
15
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
20
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
12
City
Footscray
State/Province
Victoria
Country
Australia
Facility Name
16
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
14
City
Bankstown
Country
Australia
Facility Name
11
City
Fitzroy
Country
Australia
Facility Name
13
City
Fremantle
Country
Australia
Facility Name
18
City
Garran
Country
Australia
Facility Name
270
City
Wien
Country
Austria
Facility Name
32
City
Bonheiden
Country
Belgium
Facility Name
31
City
Gent
Country
Belgium
Facility Name
35
City
Leuven
Country
Belgium
Facility Name
34
City
Liege
Country
Belgium
Facility Name
30
City
Roeselare
Country
Belgium
Facility Name
52
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
45
City
Belo-Horizonte
Country
Brazil
Facility Name
41
City
Curitiba
Country
Brazil
Facility Name
51
City
Rio de Janeiro
Country
Brazil
Facility Name
53
City
Santos
Country
Brazil
Facility Name
55
City
Sao Paulo
Country
Brazil
Facility Name
64
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
60
City
Winnepeg
State/Province
Manitoba
Country
Canada
Facility Name
67
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
62
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
63
City
London
State/Province
Ontario
Country
Canada
Facility Name
70
City
London
State/Province
Ontario
Country
Canada
Facility Name
66
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
68
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
95
City
Hradec Kralove
Country
Czechia
Facility Name
97
City
Hradek Kralove
Country
Czechia
Facility Name
98
City
Praha 7
Country
Czechia
Facility Name
100
City
Tallin
Country
Estonia
Facility Name
101
City
Tartu
Country
Estonia
Facility Name
140
City
Homburg
Country
Germany
Facility Name
137
City
Kiel
Country
Germany
Facility Name
144
City
Ulm
Country
Germany
Facility Name
130
City
Wilhelmshaven
Country
Germany
Facility Name
151
City
Budapest
Country
Hungary
Facility Name
155
City
Budapest
Country
Hungary
Facility Name
156
City
Budapest
Country
Hungary
Facility Name
154
City
Gyor
Country
Hungary
Facility Name
150
City
Nagykanizsa
Country
Hungary
Facility Name
153
City
Szeged
Country
Hungary
Facility Name
152
City
Szombathely
Country
Hungary
Facility Name
161
City
Beer Sheva
Country
Israel
Facility Name
164
City
Haifa
Country
Israel
Facility Name
167
City
Holon
Country
Israel
Facility Name
163
City
Kfar Saba
Country
Israel
Facility Name
166
City
Petha Tikva
Country
Israel
Facility Name
160
City
Tel Aviv
Country
Israel
Facility Name
169
City
Zerifin
Country
Israel
Facility Name
176
City
Padova
Country
Italy
Facility Name
171
City
Roma
Country
Italy
Facility Name
174
City
Roma
Country
Italy
Facility Name
191
City
Riga
Country
Latvia
Facility Name
192
City
Riga
Country
Latvia
Facility Name
193
City
Riga
Country
Latvia
Facility Name
202
City
Milford
State/Province
Auckland
Country
New Zealand
Facility Name
204
City
Newton
State/Province
Wellington
Country
New Zealand
Facility Name
201
City
Auckland
Country
New Zealand
Facility Name
200
City
Christchurch
Country
New Zealand
Facility Name
203
City
Hamilton
Country
New Zealand
Facility Name
217
City
Czestochowa
Country
Poland
Facility Name
218
City
Czestochowa
Country
Poland
Facility Name
210
City
Lodz
Country
Poland
Facility Name
211
City
Warszawa
Country
Poland
Facility Name
212
City
Warszawa
Country
Poland
Facility Name
213
City
Wroclaw
Country
Poland
Facility Name
221
City
Cluj Napoca
Country
Romania
Facility Name
225
City
Constanta
Country
Romania
Facility Name
232
City
Kazan
Country
Russian Federation
Facility Name
230
City
Moscow
Country
Russian Federation
Facility Name
234
City
Moscow
Country
Russian Federation
Facility Name
233
City
St Petersburg
Country
Russian Federation
Facility Name
258
City
Dniepropetrovsk
Country
Ukraine
Facility Name
251
City
Donetsk
Country
Ukraine
Facility Name
256
City
Kiev
Country
Ukraine
Facility Name
259
City
Kiev
Country
Ukraine
Facility Name
257
City
Lviv
Country
Ukraine
Facility Name
254
City
Simferopol
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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