A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]
- Conditions
- Crohn's Disease
- Interventions
- Biological: Certolizumab Pegol (CDP870)
- Registration Number
- NCT00160524
- Lead Sponsor
- UCB Pharma SA
- Brief Summary
An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 596
- Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] clinical studies in which the subject completed the trial at Week 26. Subjects may have received active or placebo or both treatments in the prior study
- 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 criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply. In addition there are no limits on the Clinical Disease Activity Index (CDAI) score at entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Certolizumab Pegol Certolizumab Pegol (CDP870) 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
- Primary Outcome Measures
Name Time Method Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months) Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374) 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 This Study CDP870-033 (up to 84 Months) Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374) 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
Name Time Method Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit Study Completion Visit (Week 364) / (Early) Withdrawal Visit 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 CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033 From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of CDP870-033 (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 364) / (Early) Withdrawal Visit 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 Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit 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 Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit Study Completion Visit (Week 364) / (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.
Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258 Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258
Trial Locations
- Locations (206)
18009
🇨🇿Melnik, Czechia
33009
🇵🇱Warszawa, Poland
35005
🇷🇸Belgrade, Serbia
45102
🇺🇸Birmingham, Alabama, United States
45087
🇺🇸Miami, Florida, United States
45035
🇺🇸Berlin, New Jersey, United States
45009
🇺🇸Great Neck, New York, United States
45109
🇺🇸Norfolk, Virginia, United States
45064
🇺🇸Savannah, Georgia, United States
45041
🇺🇸Tulsa, Oklahoma, United States
45095
🇺🇸Orange, California, United States
45138
🇺🇸Columbus, Indiana, United States
45013
🇺🇸Laurel, Maryland, United States
45144
🇺🇸Tucson, Arizona, United States
45105
🇺🇸Annapolis, Maryland, United States
11015
🇦🇺Garran, Australia
11001
🇦🇺Adelaide, Australia
45085
🇺🇸Plantation, Florida, United States
45111
🇺🇸Louisville, Kentucky, United States
45033
🇺🇸Chevy Chase, Maryland, United States
45057
🇺🇸Plymouth, Minnesota, United States
45108
🇺🇸Jefferson City, Missouri, United States
11014
🇦🇺Lauceston, Australia
45070
🇺🇸New York, New York, United States
11011
🇦🇺Bankstown, Australia
45031
🇺🇸Lincoln, Nebraska, United States
45084
🇺🇸Chattanooga, Tennessee, United States
45117
🇺🇸Rochester, New York, United States
45040
🇺🇸Winston-Salem, North Carolina, United States
45054
🇺🇸Dayton, Ohio, United States
45052
🇺🇸South Ogden, Utah, United States
11005
🇦🇺New Lambton, Australia
27001
🇮🇹Milano, Italy
31005
🇳🇿Hamilton, New Zealand
45113
🇺🇸Germantown, Tennessee, United States
22002
🇩🇪Berlin, Germany
24010
🇭🇺Gyor, Hungary
24009
🇭🇺Pecs, Hungary
18004
🇨🇿Praha 2, Czechia
24012
🇭🇺Budapest, Hungary
18002
🇨🇿Praha 4, Czechia
18003
🇨🇿Brno, Czechia
11010
🇦🇺Fremantle, Australia
22013
🇩🇪Göttingen, Germany
22024
🇩🇪Leipzig, Germany
22009
🇩🇪Berlin, Germany
18010
🇨🇿Pardubice, Czechia
26004
🇮🇱Beer Sheva, Israel
22021
🇩🇪Cologne, Germany
11013
🇦🇺Frankston, Australia
11018
🇦🇺Newtown, Australia
22003
🇩🇪Magdeburg, Germany
22001
🇩🇪Minden, Germany
18006
🇨🇿Hradek Kralove, Czechia
27007
🇮🇹Roma, Italy
24002
🇭🇺Budapest, Hungary
19001
🇩🇰Glostrup, Denmark
34016
🇷🇺Nizhny Novgorod, Russian Federation
22015
🇩🇪Kiel, Germany
31003
🇳🇿Tauranga, New Zealand
24005
🇭🇺Gyula, Hungary
27006
🇮🇹Roma, Italy
34008
🇷🇺Volgograd, Russian Federation
18005
🇨🇿Plzen - Lochotin, Czechia
18007
🇨🇿Olomouc, Czechia
22026
🇩🇪Dresden, Germany
22006
🇩🇪Berlin, Germany
16021
🇨🇦Ottawa, Canada
27002
🇮🇹Bologna, Italy
22008
🇩🇪Münster, Germany
24001
🇭🇺Debrecen, Hungary
24011
🇭🇺Szekszard, Hungary
16013
🇨🇦Toronto, Canada
22017
🇩🇪Hannover, Germany
20001
🇪🇪Tallin, Estonia
18012
🇨🇿Praha 10, Czechia
24014
🇭🇺Dunaujvaros, Hungary
26006
🇮🇱Jerusalem, Israel
18011
🇨🇿Ceske Budejovice, Czechia
16010
🇨🇦Vancouver, Canada
18008
🇨🇿Olomouc, Czechia
24008
🇭🇺Szeged, Hungary
34001
🇷🇺St. Petersburg, Russian Federation
39011
🇿🇦Durban, South Africa
28001
🇱🇻Riga, Latvia
34007
🇷🇺St. Petersburg, Russian Federation
34013
🇷🇺St. Petersburg, Russian Federation
34015
🇷🇺Moscow, Russian Federation
33012
🇵🇱Lodz, Poland
39003
🇿🇦Cape Town, South Africa
39002
🇿🇦Johannesburg, South Africa
34005
🇷🇺St. Petersburg, Russian Federation
39017
🇿🇦Cape Town, South Africa
34006
🇷🇺Moscow, Russian Federation
39012
🇿🇦Goodwood, South Africa
39008
🇿🇦Midrand, South Africa
38004
🇸🇮Novo Mesto, Slovenia
40009
🇪🇸Barcelona, Spain
39019
🇿🇦Pretoria, South Africa
43001
🇺🇦Kharkov, Ukraine
43003
🇺🇦Lviv, Ukraine
45143
🇺🇸Atlanta, Georgia, United States
45022
🇺🇸Houston, Texas, United States
45006
🇺🇸San Diego, California, United States
45131
🇺🇸San Diego, California, United States
45091
🇺🇸Cincinnati, Ohio, United States
45039
🇺🇸Oklahoma City, Oklahoma, United States
45071
🇺🇸Nashville, Tennessee, United States
45119
🇺🇸Nashville, Tennessee, United States
45073
🇺🇸San Antonio, Texas, United States
45020
🇺🇸Salt Lake City, Utah, United States
45139
🇺🇸Salt Lake City, Utah, United States
45078
🇺🇸Christiansburg, Virginia, United States
19010
🇩🇰Herlev, Denmark
19008
🇩🇰Copenhagen, Denmark
19004
🇩🇰Aalborg, Denmark
19002
🇩🇰Aarhus, Denmark
19009
🇩🇰Copenhagen, Denmark
19007
🇩🇰Hvidovre, Denmark
19005
🇩🇰Odense C, Denmark
39007
🇿🇦Johannesburg, South Africa
43008
🇺🇦Dniepropetrovsk, Ukraine
45028
🇺🇸Huntsville, Alabama, United States
45130
🇺🇸Colorado Springs, Colorado, United States
45094
🇺🇸Gainesville, Florida, United States
45029
🇺🇸Jacksonville, Florida, United States
45081
🇺🇸Cincinnati, Ohio, United States
45003
🇺🇸Raleigh, North Carolina, United States
11016
🇦🇺Ballarat, Australia
11007
🇦🇺Box Hill, Australia
45135
🇺🇸Tacoma, Washington, United States
11004
🇦🇺Melbourne, Australia
11012
🇦🇺Parkville, Australia
46002
🇦🇹Wien, Austria
12001
🇧🇾Minsk, Belarus
12003
🇧🇾Minsk, Belarus
13004
🇧🇪Brussels, Belgium
12002
🇧🇾Vitebsk, Belarus
13001
🇧🇪Gent, Belgium
15001
🇧🇬Sofia, Bulgaria
13002
🇧🇪Liege, Belgium
15002
🇧🇬Sofia, Bulgaria
16014
🇨🇦Halifax, Canada
16001
🇨🇦Vancouver, Canada
48001
🇬🇪Tbilisi, Georgia
22005
🇩🇪Wilhelmshaven, Germany
24007
🇭🇺Veszprem, Hungary
31002
🇳🇿Auckland, New Zealand
27004
🇮🇹Palermo, Italy
32001
🇳🇴Haugesund, Norway
32005
🇳🇴Oslo, Norway
31004
🇳🇿Tauranga, New Zealand
33013
🇵🇱Szczecin, Poland
33001
🇵🇱Warszawa, Poland
33021
🇵🇱Wroclaw, Poland
34017
🇷🇺Lipetsk, Russian Federation
39016
🇿🇦Cape Town, South Africa
39010
🇿🇦Johannesburg, South Africa
39013
🇿🇦Johannesburg, South Africa
39004
🇿🇦PORT Elisabeth, South Africa
39006
🇿🇦Pretoria, South Africa
39014
🇿🇦Pretoria, South Africa
41001
🇸🇪Stockholm, Sweden
41004
🇸🇪Stockholm, Sweden
41002
🇸🇪Umea, Sweden
43005
🇺🇦Crimean Autonomy, Ukraine
43002
🇺🇦Dniepropetrovsk, Ukraine
43004
🇺🇦Donetsk, Ukraine
43007
🇺🇦Kiev, Ukraine
43006
🇺🇦Odessa, Ukraine
24015
🇭🇺Budapest, Hungary
45048
🇺🇸Portland, Oregon, United States
45018
🇺🇸New Brunswick, New Jersey, United States
11017
🇦🇺Herston, Australia
11003
🇦🇺Melbourne, Australia
26007
🇮🇱Haifa, Israel
31001
🇳🇿Christchurch, New Zealand
28003
🇱🇻Riga, Latvia
32004
🇳🇴Tromso, Norway
33004
🇵🇱Bydgoszcz, Poland
35001
🇷🇸Belgrade, Serbia
36002
🇸🇬Singapore, Singapore
38001
🇸🇮Celje, Slovenia
46005
🇦🇹Graz, Austria
33022
🇵🇱Bialystok, Poland
33002
🇵🇱Cracow, Poland
33007
🇵🇱Warsaw, Poland
38003
🇸🇮Ljubljana, Slovenia
20002
🇪🇪Tartu, Estonia
23002
🇭🇰Shatin, Hong Kong
32009
🇳🇴Hamar, Norway
46006
🇦🇹Linz, Austria
29001
🇱🇹Kaunas, Lithuania
33010
🇵🇱Krakow, Poland
33011
🇵🇱Lodz, Poland
35002
🇷🇸Belgrade, Serbia
35003
🇷🇸Nis, Serbia
32008
🇳🇴Oslo, Norway
33019
🇵🇱Lublin, Poland
33020
🇵🇱Opole, Poland
33003
🇵🇱Sopot, Poland
33016
🇵🇱Warszawa, Poland
33006
🇵🇱Wroclaw, Poland
35004
🇷🇸Belgrade, Serbia
36001
🇸🇬Singapore, Singapore
45124
🇺🇸Florham Park, New Jersey, United States