A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease
- Conditions
- Crohn's Disease
- Interventions
- Biological: Certolizumab Pegol (CDP870)
- Registration Number
- NCT00160706
- Lead Sponsor
- UCB Pharma SA
- Brief Summary
A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] due to an exacerbation of Crohn's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
-
Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] clinical studies in which the subject completed the Week 2 assessment in CDP870-031 [NCT00152490] or the Week 6 randomization in CDP870-032 [NCT00152425] but whose Crohn's Disease was significantly worse as determined by the investigator and whose Clinical Disease Activity Index (CDAI) score at entry to this study is either (subjects may have received active or placebo treatment):
- At least 70 points higher then Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870 032 [NCT00152425] responders) OR
- Higher than Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870-032 [NCT00152425] responders) with an absolute score of at least 350 points
-
Subjects must be able to understand the information provided to them and give written informed consent
- Any exclusion criterion that would have prevented the subject's participation in the qualifying pivotal study (CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]), although the upper limit of 450 in the CDAI score is not applicable. In addition the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Certolizumab Pegol Certolizumab Pegol (CDP870) 3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
- Primary Outcome Measures
Name Time Method Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months) Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372) 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.
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months) Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit Study Completion Visit (Week 362) / (Early) Withdrawal Visit 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.
Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256 Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256 Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034 From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months) Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. 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.
Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit Study Completion Visit (Week 362) / (Early) Withdrawal Visit Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032 From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months) Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. 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 With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034 From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months) Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] to the last Visit in this study. A positive result is defined as Anti-CZP antibody levels \> 2.4 units/mL.
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Trial Locations
- Locations (141)
45141
🇺🇸Seattle, Washington, United States
45022
🇺🇸Houston, Texas, United States
39004
🇿🇦PORT Elisabeth, South Africa
45028
🇺🇸Huntsville, Alabama, United States
45044
🇺🇸Little Rock, Arkansas, United States
45095
🇺🇸Orange, California, United States
45130
🇺🇸Colorado Springs, Colorado, United States
45094
🇺🇸Gainesville, Florida, United States
45087
🇺🇸Miami, Florida, United States
45005
🇺🇸Hialeah, Florida, United States
45016
🇺🇸Chicago, Illinois, United States
45037
🇺🇸Indianapolis, Indiana, United States
45004
🇺🇸North Miami Beach, Florida, United States
45013
🇺🇸Laurel, Maryland, United States
45033
🇺🇸Chevy Chase, Maryland, United States
45009
🇺🇸Great Neck, New York, United States
45035
🇺🇸Berlin, New Jersey, United States
45108
🇺🇸Jefferson City, Missouri, United States
45070
🇺🇸New York, New York, United States
45145
🇺🇸Greenville, North Carolina, United States
45003
🇺🇸Raleigh, North Carolina, United States
45067
🇺🇸High Point, North Carolina, United States
45091
🇺🇸Cincinnati, Ohio, United States
45054
🇺🇸Dayton, Ohio, United States
45081
🇺🇸Cincinnati, Ohio, United States
45025
🇺🇸Mayfield Heights, Ohio, United States
45093
🇺🇸Hershey, Pennsylvania, United States
45041
🇺🇸Tulsa, Oklahoma, United States
45113
🇺🇸Germantown, Tennessee, United States
45139
🇺🇸Salt Lake City, Utah, United States
45052
🇺🇸South Ogden, Utah, United States
45134
🇺🇸Charlottesville, Virginia, United States
45078
🇺🇸Christiansburg, Virginia, United States
45109
🇺🇸Norfolk, Virginia, United States
11005
🇦🇺New Lambton, New South Wales, Australia
11011
🇦🇺Bankstown, New South Wales, Australia
11017
🇦🇺Herston, Queensland, Australia
11006
🇦🇺South Brisbane, Queensland, Australia
11016
🇦🇺Ballarat, Victoria, Australia
11002
🇦🇺Fitzroy, Victoria, Australia
11007
🇦🇺Box Hill, Victoria, Australia
11013
🇦🇺Frankston, Victoria, Australia
11012
🇦🇺Parkville, Victoria, Australia
11010
🇦🇺Fremantle, Australia
11015
🇦🇺Garran, Australia
11018
🇦🇺Newtown, Australia
46006
🇦🇹Linz, Austria
46002
🇦🇹Wien, Austria
46003
🇦🇹Salzburg, Austria
13004
🇧🇪Brussels, Belgium
12001
🇧🇾Minsk, Belarus
13001
🇧🇪Gent, Belgium
13003
🇧🇪Leuven, Belgium
15001
🇧🇬Sofia, Bulgaria
16005
🇨🇦Winnipeg, Manitoba, Canada
16008
🇨🇦Montreal, Quebec, Canada
16013
🇨🇦Toronto, Ontario, Canada
16014
🇨🇦Halifax, Nova Scotia, Canada
18002
🇨🇿Praha 4, Czechia
18006
🇨🇿Hradek Kralove, Czechia
18001
🇨🇿Ostrava, Czechia
18004
🇨🇿Praha 2, Czechia
19004
🇩🇰Aalborg, Denmark
20001
🇪🇪Tallin, Estonia
20002
🇪🇪Tartu, Estonia
22002
🇩🇪Berlin, Germany
22009
🇩🇪Berlin, Germany
22013
🇩🇪Göttingen, Germany
22019
🇩🇪Frankfurt, Germany
22004
🇩🇪Celle, Germany
26005
🇮🇱Petha Tikva, Israel
22017
🇩🇪Hannover, Germany
22001
🇩🇪Minden, Germany
22016
🇩🇪Leipzig, Germany
22015
🇩🇪Kiel, Germany
22012
🇩🇪Munich, Germany
22008
🇩🇪Münster, Germany
24002
🇭🇺Budapest, Hungary
24009
🇭🇺Pecs, Hungary
26004
🇮🇱Beer Sheva, Israel
24011
🇭🇺Szekszard, Hungary
26007
🇮🇱Haifa, Israel
27007
🇮🇹Roma, Italy
31002
🇳🇿Auckland, New Zealand
31004
🇳🇿Milford, New Zealand
32005
🇳🇴Oslo, Norway
31005
🇳🇿Hamilton, New Zealand
31003
🇳🇿Tauranga, New Zealand
32008
🇳🇴Oslo, Norway
31001
🇳🇿Christchurch, New Zealand
32004
🇳🇴Tromso, Norway
33003
🇵🇱Gdansk, Poland
33008
🇵🇱Bydgoszcz, Poland
33013
🇵🇱Szczecin, Poland
33018
🇵🇱Lublin, Poland
33009
🇵🇱Warszawa, Poland
33007
🇵🇱Warsaw, Poland
34005
🇷🇺St. Petersburg, Russian Federation
34017
🇷🇺Lipetsk, Russian Federation
34006
🇷🇺Moscow, Russian Federation
34016
🇷🇺Nizhny Novgorod, Russian Federation
34001
🇷🇺St. Petersburg, Russian Federation
34007
🇷🇺St. Petersburg, Russian Federation
34013
🇷🇺St. Petersburg, Russian Federation
35002
🇷🇸Belgrade, Serbia
36002
🇸🇬Singapore, Singapore
38001
🇸🇮Celje, Slovenia
38003
🇸🇮Ljubljana, Slovenia
39013
🇿🇦Johannesburg, Gauteng, South Africa
39003
🇿🇦Cape Town, Somerset West, South Africa
39016
🇿🇦Cape Town, South Africa
39018
🇿🇦Cape Town, South Africa
39008
🇿🇦Midrand, South Africa
39010
🇿🇦Johannesburg, South Africa
39012
🇿🇦Goodwood, South Africa
39006
🇿🇦Pretoria, South Africa
39009
🇿🇦Pretoria, South Africa
39019
🇿🇦Pretoria, South Africa
40009
🇪🇸Barcelona, Spain
39014
🇿🇦Pretoria, South Africa
43008
🇺🇦Dniepropetrovsk, Ukraine
43003
🇺🇦Lviv, Ukraine
43006
🇺🇦Odessa, Ukraine
35001
🇷🇸Belgrade, Serbia
11014
🇦🇺Lauceston, Tasmania, Australia
35004
🇷🇸Belgrade, Serbia
11009
🇦🇺Adelaide, Australia
27001
🇮🇹Milano, Italy
27004
🇮🇹Palermo, Italy
19009
🇩🇰Copenhagen, Denmark
19010
🇩🇰Herlev, Denmark
19007
🇩🇰Hvidovre, Denmark
19003
🇩🇰Vejle, Denmark
45102
🇺🇸Birmingham, Alabama, United States
45101
🇺🇸San Francisco, California, United States
45039
🇺🇸Oklahoma City, Oklahoma, United States
45119
🇺🇸Nashville, Tennessee, United States
45073
🇺🇸San Antonio, Texas, United States
45083
🇺🇸Rochester, Minnesota, United States
45040
🇺🇸Winston-Salem, North Carolina, United States
45019
🇺🇸Lexington, Kentucky, United States