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PRECiSE 3: 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]

Sponsor
UCB Pharma SA (Industry)
Overall Status
Completed
CT.gov ID
NCT00160524
Collaborator
(none)
596
Enrollment
206
Locations
1
Arm
97
Duration (Months)
2.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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]).

Condition or Disease Intervention/Treatment Phase
  • Biological: Certolizumab Pegol (CDP870)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
596 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032
Study Start Date :
Jul 1, 2004
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Certolizumab Pegol

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Biological: Certolizumab Pegol (CDP870)
Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Other Names:
  • Cimzia
  • CDP870
  • CZP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit [Study Completion Visit (Week 364) / (Early) Withdrawal Visit]

    6. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 45102 Birmingham Alabama United States
    2 45028 Huntsville Alabama United States
    3 45144 Tucson Arizona United States
    4 45095 Orange California United States
    5 45006 San Diego California United States
    6 45131 San Diego California United States
    7 45130 Colorado Springs Colorado United States
    8 45094 Gainesville Florida United States
    9 45029 Jacksonville Florida United States
    10 45087 Miami Florida United States
    11 45085 Plantation Florida United States
    12 45143 Atlanta Georgia United States
    13 45064 Savannah Georgia United States
    14 45138 Columbus Indiana United States
    15 45111 Louisville Kentucky United States
    16 45105 Annapolis Maryland United States
    17 45033 Chevy Chase Maryland United States
    18 45013 Laurel Maryland United States
    19 45057 Plymouth Minnesota United States
    20 45108 Jefferson City Missouri United States
    21 45031 Lincoln Nebraska United States
    22 45035 Berlin New Jersey United States
    23 45124 Florham Park New Jersey United States
    24 45018 New Brunswick New Jersey United States
    25 45009 Great Neck New York United States
    26 45070 New York New York United States
    27 45117 Rochester New York United States
    28 45003 Raleigh North Carolina United States
    29 45040 Winston-Salem North Carolina United States
    30 45081 Cincinnati Ohio United States
    31 45091 Cincinnati Ohio United States
    32 45054 Dayton Ohio United States
    33 45039 Oklahoma City Oklahoma United States
    34 45041 Tulsa Oklahoma United States
    35 45048 Portland Oregon United States
    36 45084 Chattanooga Tennessee United States
    37 45113 Germantown Tennessee United States
    38 45071 Nashville Tennessee United States
    39 45119 Nashville Tennessee United States
    40 45022 Houston Texas United States
    41 45073 San Antonio Texas United States
    42 45020 Salt Lake City Utah United States
    43 45139 Salt Lake City Utah United States
    44 45052 South Ogden Utah United States
    45 45078 Christiansburg Virginia United States
    46 45109 Norfolk Virginia United States
    47 45135 Tacoma Washington United States
    48 11001 Adelaide Australia
    49 11016 Ballarat Australia
    50 11011 Bankstown Australia
    51 11007 Box Hill Australia
    52 11013 Frankston Australia
    53 11010 Fremantle Australia
    54 11015 Garran Australia
    55 11017 Herston Australia
    56 11014 Lauceston Australia
    57 11003 Melbourne Australia
    58 11004 Melbourne Australia
    59 11005 New Lambton Australia
    60 11018 Newtown Australia
    61 11012 Parkville Australia
    62 46005 Graz Austria
    63 46006 Linz Austria
    64 46002 Wien Austria
    65 12001 Minsk Belarus
    66 12003 Minsk Belarus
    67 12002 Vitebsk Belarus
    68 13004 Brussels Belgium
    69 13001 Gent Belgium
    70 13002 Liege Belgium
    71 15001 Sofia Bulgaria
    72 15002 Sofia Bulgaria
    73 16014 Halifax Canada
    74 16021 Ottawa Canada
    75 16013 Toronto Canada
    76 16001 Vancouver Canada
    77 16010 Vancouver Canada
    78 18003 Brno Czechia
    79 18011 Ceske Budejovice Czechia
    80 18006 Hradek Kralove Czechia
    81 18009 Melnik Czechia
    82 18007 Olomouc Czechia
    83 18008 Olomouc Czechia
    84 18010 Pardubice Czechia
    85 18005 Plzen - Lochotin Czechia
    86 18012 Praha 10 Czechia
    87 18004 Praha 2 Czechia
    88 18002 Praha 4 Czechia
    89 19004 Aalborg Denmark
    90 19002 Aarhus Denmark
    91 19008 Copenhagen Denmark
    92 19009 Copenhagen Denmark
    93 19001 Glostrup Denmark
    94 19010 Herlev Denmark
    95 19007 Hvidovre Denmark
    96 19005 Odense C Denmark
    97 20001 Tallin Estonia
    98 20002 Tartu Estonia
    99 48001 Tbilisi Georgia
    100 22002 Berlin Germany
    101 22006 Berlin Germany
    102 22009 Berlin Germany
    103 22021 Cologne Germany
    104 22026 Dresden Germany
    105 22013 Göttingen Germany
    106 22017 Hannover Germany
    107 22015 Kiel Germany
    108 22024 Leipzig Germany
    109 22003 Magdeburg Germany
    110 22001 Minden Germany
    111 22008 Münster Germany
    112 22005 Wilhelmshaven Germany
    113 23002 Shatin Hong Kong
    114 24002 Budapest Hungary
    115 24012 Budapest Hungary
    116 24015 Budapest Hungary
    117 24001 Debrecen Hungary
    118 24014 Dunaujvaros Hungary
    119 24010 Gyor Hungary
    120 24005 Gyula Hungary
    121 24009 Pecs Hungary
    122 24008 Szeged Hungary
    123 24011 Szekszard Hungary
    124 24007 Veszprem Hungary
    125 26004 Beer Sheva Israel
    126 26007 Haifa Israel
    127 26006 Jerusalem Israel
    128 27002 Bologna Italy
    129 27001 Milano Italy
    130 27004 Palermo Italy
    131 27006 Roma Italy
    132 27007 Roma Italy
    133 28001 Riga Latvia
    134 28003 Riga Latvia
    135 29001 Kaunas Lithuania
    136 31002 Auckland New Zealand
    137 31001 Christchurch New Zealand
    138 31005 Hamilton New Zealand
    139 31003 Tauranga New Zealand
    140 31004 Tauranga New Zealand
    141 32009 Hamar Norway
    142 32001 Haugesund Norway
    143 32005 Oslo Norway
    144 32008 Oslo Norway
    145 32004 Tromso Norway
    146 33022 Bialystok Poland
    147 33004 Bydgoszcz Poland
    148 33002 Cracow Poland
    149 33010 Krakow Poland
    150 33011 Lodz Poland
    151 33012 Lodz Poland
    152 33019 Lublin Poland
    153 33020 Opole Poland
    154 33003 Sopot Poland
    155 33013 Szczecin Poland
    156 33007 Warsaw Poland
    157 33001 Warszawa Poland
    158 33009 Warszawa Poland
    159 33016 Warszawa Poland
    160 33006 Wroclaw Poland
    161 33021 Wroclaw Poland
    162 34017 Lipetsk Russian Federation
    163 34006 Moscow Russian Federation
    164 34015 Moscow Russian Federation
    165 34016 Nizhny Novgorod Russian Federation
    166 34001 St. Petersburg Russian Federation
    167 34005 St. Petersburg Russian Federation
    168 34007 St. Petersburg Russian Federation
    169 34013 St. Petersburg Russian Federation
    170 34008 Volgograd Russian Federation
    171 35001 Belgrade Serbia
    172 35002 Belgrade Serbia
    173 35004 Belgrade Serbia
    174 35005 Belgrade Serbia
    175 35003 Nis Serbia
    176 36001 Singapore Singapore
    177 36002 Singapore Singapore
    178 38001 Celje Slovenia
    179 38003 Ljubljana Slovenia
    180 38004 Novo Mesto Slovenia
    181 39003 Cape Town South Africa
    182 39016 Cape Town South Africa
    183 39017 Cape Town South Africa
    184 39011 Durban South Africa
    185 39012 Goodwood South Africa
    186 39002 Johannesburg South Africa
    187 39007 Johannesburg South Africa
    188 39010 Johannesburg South Africa
    189 39013 Johannesburg South Africa
    190 39008 Midrand South Africa
    191 39004 PORT Elisabeth South Africa
    192 39006 Pretoria South Africa
    193 39014 Pretoria South Africa
    194 39019 Pretoria South Africa
    195 40009 Barcelona Spain
    196 41001 Stockholm Sweden
    197 41004 Stockholm Sweden
    198 41002 Umea Sweden
    199 43005 Crimean Autonomy Ukraine
    200 43002 Dniepropetrovsk Ukraine
    201 43008 Dniepropetrovsk Ukraine
    202 43004 Donetsk Ukraine
    203 43001 Kharkov Ukraine
    204 43007 Kiev Ukraine
    205 43003 Lviv Ukraine
    206 43006 Odessa Ukraine

    Sponsors and Collaborators

    • UCB Pharma SA

    Investigators

    • Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    UCB Pharma SA
    ClinicalTrials.gov Identifier:
    NCT00160524
    Other Study ID Numbers:
    • C87033
    • 2005-002622-60
    First Posted:
    Sep 12, 2005
    Last Update Posted:
    Aug 1, 2018
    Last Verified:
    Aug 1, 2013
    Keywords provided by UCB Pharma SA
    Certolizumab Pegol
    Cimzia
    CDP870
    CZP
    Additional relevant MeSH terms:
    Crohn Disease
    Certolizumab Pegol

    Study Results

    Participant Flow

    Recruitment Details This multicenter study started to enroll subjects in July 2004 in order to end up with 206 centers in 29 countries with enrolled subjects. Participant Flow refers to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].
    Pre-assignment Detail All subjects who completed the Week 26 assessment in feeder studies C87031 and C87032 were eligible to enter this open-label follow-on study C87033.
    Arm/Group Title Certolizumab Pegol
    Arm/Group Description 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
    Period Title: Overall Study
    STARTED 595
    COMPLETED 117
    NOT COMPLETED 478

    Baseline Characteristics

    Arm/Group Title Certolizumab Pegol
    Arm/Group Description 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
    Overall Participants 595
    Age (Count of Participants)
    <=18 years
    7
    1.2%
    Between 18 and 65 years
    574
    96.5%
    >=65 years
    14
    2.4%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    38.1
    (11.87)
    Sex: Female, Male (Count of Participants)
    Female
    307
    51.6%
    Male
    288
    48.4%
    Region of Enrollment (participants) [Number]
    Belarus
    12
    2%
    United States
    98
    16.5%
    Serbia
    29
    4.9%
    Estonia
    4
    0.7%
    Hong Kong
    2
    0.3%
    Spain
    1
    0.2%
    Ukraine
    18
    3%
    Israel
    13
    2.2%
    Russian Federation
    22
    3.7%
    Italy
    14
    2.4%
    Denmark
    21
    3.5%
    Australia
    30
    5%
    South Africa
    45
    7.6%
    Latvia
    4
    0.7%
    Slovenia
    15
    2.5%
    Lithuania
    1
    0.2%
    Austria
    4
    0.7%
    Czech Republic
    54
    9.1%
    Hungary
    48
    8.1%
    Canada
    17
    2.9%
    Belgium
    6
    1%
    Poland
    72
    12.1%
    Singapore
    2
    0.3%
    Georgia
    1
    0.2%
    Bulgaria
    20
    3.4%
    Germany
    21
    3.5%
    Norway
    7
    1.2%
    New Zealand
    10
    1.7%
    Sweden
    4
    0.7%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)
    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 Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)

    Outcome Measure Data

    Analysis Population Description
    All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].
    Arm/Group Title Certolizumab Pegol
    Arm/Group Description 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
    Measure Participants 595
    Number [percentage of subjects]
    88.2
    2. Primary Outcome
    Title Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)
    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 Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)

    Outcome Measure Data

    Analysis Population Description
    All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].
    Arm/Group Title Certolizumab Pegol
    Arm/Group Description 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
    Measure Participants 595
    Number [percentage of subjects]
    40.3
    3. Secondary Outcome
    Title Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit
    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 Study Completion Visit (Week 364) / (Early) Withdrawal Visit

    Outcome Measure Data

    Analysis Population Description
    Of the 594 subjects in the Intention-To-Treat (ITT) Population, 592 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.
    Arm/Group Title Certolizumab Pegol
    Arm/Group Description 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
    Measure Participants 592
    Number (95% Confidence Interval) [percentage of subjects]
    54.7
    4. Secondary Outcome
    Title 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
    Description 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.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    All 594 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.
    Arm/Group Title Certolizumab Pegol
    Arm/Group Description 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
    Measure Participants 594
    Number (95% Confidence Interval) [percentage of subjects]
    21.7
    5. Secondary Outcome
    Title Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit
    Description Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
    Time Frame Study Completion Visit (Week 364) / (Early) Withdrawal Visit

    Outcome Measure Data

    Analysis Population Description
    Of the 595 subjects in the Safety Population, 590 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].
    Arm/Group Title Certolizumab Pegol
    Arm/Group Description 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
    Measure Participants 590
    Geometric Mean (95% Confidence Interval) [μg/mL]
    5.578
    6. Secondary Outcome
    Title 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
    Description 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.
    Time Frame 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)

    Outcome Measure Data

    Analysis Population Description
    Of the 595 subjects in the Safety Population, 593 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].
    Arm/Group Title Certolizumab Pegol
    Arm/Group Description 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
    Measure Participants 593
    Number [percentage of subjects]
    22.6
    7. Secondary Outcome
    Title C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
    Description
    Time Frame Study Completion Visit (Week 364) / (Early) Withdrawal Visit

    Outcome Measure Data

    Analysis Population Description
    Of the 594 subjects in the Intention-To-Treat (ITT) Population, 593 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.
    Arm/Group Title Certolizumab Pegol
    Arm/Group Description 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
    Measure Participants 593
    Geometric Mean (95% Confidence Interval) [mg/L]
    7.93
    8. Secondary Outcome
    Title Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258
    Description
    Time Frame Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258

    Outcome Measure Data

    Analysis Population Description
    Of the 594 subjects in the Intention-To-Treat (ITT) Population, 567 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.
    Arm/Group Title Certolizumab Pegol
    Arm/Group Description 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
    Measure Participants 567
    Geometric Mean (95% Confidence Interval) [μg/g stool]
    302.540

    Adverse Events

    Time Frame Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374).
    Adverse Event Reporting Description Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].
    Arm/Group Title Certolizumab Pegol
    Arm/Group Description 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
    All Cause Mortality
    Certolizumab Pegol
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Certolizumab Pegol
    Affected / at Risk (%) # Events
    Total 240/595 (40.3%)
    Blood and lymphatic system disorders
    Anaemia 6/595 (1%) 6
    Neutropenia 3/595 (0.5%) 3
    Iron deficiency anaemia 2/595 (0.3%) 3
    Lymphadenitis 2/595 (0.3%) 2
    Pancytopenia 2/595 (0.3%) 2
    Leukopenia 1/595 (0.2%) 1
    Thrombocytopenia 1/595 (0.2%) 1
    Cardiac disorders
    Cardiac failure 1/595 (0.2%) 1
    Myocardial ischaemia 1/595 (0.2%) 2
    Gastrointestinal disorders
    Crohn's disease 67/595 (11.3%) 75
    Small intestinal obstruction 13/595 (2.2%) 16
    Intestinal obstruction 10/595 (1.7%) 10
    Abdominal pain 9/595 (1.5%) 9
    Ileal stenosis 7/595 (1.2%) 7
    Perirectal abscess 5/595 (0.8%) 5
    Anal fistula 4/595 (0.7%) 5
    Pancreatitis acute 3/595 (0.5%) 3
    Subileus 3/595 (0.5%) 4
    Vomiting 3/595 (0.5%) 3
    Gastritis 2/595 (0.3%) 2
    Inguinal hernia 2/595 (0.3%) 2
    Intestinal mass 2/595 (0.3%) 2
    Large intestine perforation 2/595 (0.3%) 2
    Nausea 2/595 (0.3%) 2
    Rectovaginal fistula 2/595 (0.3%) 2
    Abdominal hernia 1/595 (0.2%) 1
    Anal haemorrhage 1/595 (0.2%) 1
    Anal inflammation 1/595 (0.2%) 1
    Anal stenosis 1/595 (0.2%) 1
    Colonic stenosis 1/595 (0.2%) 1
    Constipation 1/595 (0.2%) 1
    Dyspepsia 1/595 (0.2%) 1
    Dysphagia 1/595 (0.2%) 2
    Enterovesical fistula 1/595 (0.2%) 1
    Gastric ulcer 1/595 (0.2%) 1
    Gastrointestinal mucosal disorder 1/595 (0.2%) 1
    Gastrooesophageal reflux disease 1/595 (0.2%) 1
    Haemorrhoids 1/595 (0.2%) 1
    Intestinal fistula 1/595 (0.2%) 1
    Intestinal stenosis 1/595 (0.2%) 1
    Jejunal stenosis 1/595 (0.2%) 1
    Mouth ulceration 1/595 (0.2%) 1
    Oesophageal perforation 1/595 (0.2%) 1
    Oesophageal stenosis acquired 1/595 (0.2%) 2
    Pancreatitis 1/595 (0.2%) 1
    Peritoneal adhesions 1/595 (0.2%) 1
    Proctalgia 1/595 (0.2%) 5
    Rectal haemorrhage 1/595 (0.2%) 1
    Small intestinal perforation 1/595 (0.2%) 1
    Small intestinal stricture 1/595 (0.2%) 1
    Stomatitis 1/595 (0.2%) 1
    Upper gastrointestinal haemorrhage 1/595 (0.2%) 1
    General disorders
    General physical health deterioration 1/595 (0.2%) 1
    Impaired healing 1/595 (0.2%) 1
    Pain 1/595 (0.2%) 1
    Hepatobiliary disorders
    Cholelithiasis 2/595 (0.3%) 2
    Autoimmune hepatitis 1/595 (0.2%) 1
    Biliary cirrhosis 1/595 (0.2%) 1
    Biliary colic 1/595 (0.2%) 1
    Gallbladder non-functioning 1/595 (0.2%) 1
    Hepatic cirrhosis 1/595 (0.2%) 1
    Liver disorder 1/595 (0.2%) 1
    Immune system disorders
    Sarcoidosis 1/595 (0.2%) 1
    Infections and infestations
    Perianal abscess 9/595 (1.5%) 10
    Abdominal abscess 8/595 (1.3%) 9
    Pneumonia 7/595 (1.2%) 7
    Gastroenteritis 6/595 (1%) 7
    Cellulitis 3/595 (0.5%) 3
    Disseminated tuberculosis 3/595 (0.5%) 3
    Pulmonary tuberculosis 3/595 (0.5%) 3
    Urinary tract infection 3/595 (0.5%) 3
    Bronchitis 2/595 (0.3%) 2
    Bronchopneumonia 2/595 (0.3%) 2
    Gastroenteritis viral 2/595 (0.3%) 2
    Postoperative abscess 2/595 (0.3%) 4
    Pyelonephritis 2/595 (0.3%) 2
    Sepsis 2/595 (0.3%) 2
    Staphylococcal infection 2/595 (0.3%) 2
    Subcutaneous abscess 2/595 (0.3%) 2
    Abscess 1/595 (0.2%) 1
    Abscess intestinal 1/595 (0.2%) 1
    Acute tonsillitis 1/595 (0.2%) 1
    Anal abscess 1/595 (0.2%) 1
    Bronchitis acute 1/595 (0.2%) 1
    Campylobacter gastroenteritis 1/595 (0.2%) 1
    Candidiasis 1/595 (0.2%) 1
    Cellulitis orbital 1/595 (0.2%) 1
    Chronic tonsillitis 1/595 (0.2%) 1
    Clostridial infection 1/595 (0.2%) 1
    Enterocolitis infectious 1/595 (0.2%) 1
    Epiglottitis 1/595 (0.2%) 1
    Erysipelas 1/595 (0.2%) 1
    Fungal infection 1/595 (0.2%) 1
    Gastroenteritis clostridial 1/595 (0.2%) 1
    Groin abscess 1/595 (0.2%) 1
    Herpes Zoster 1/595 (0.2%) 1
    Lobar pneumonia 1/595 (0.2%) 1
    Localised infection 1/595 (0.2%) 1
    Lung abscess 1/595 (0.2%) 1
    Oesophageal candidiasis 1/595 (0.2%) 1
    Osteomyelitis acute 1/595 (0.2%) 1
    Pelvic abscess 1/595 (0.2%) 1
    Pelvic inflammatory disease 1/595 (0.2%) 1
    Perineal abscess 1/595 (0.2%) 1
    Pneumonia bacterial 1/595 (0.2%) 1
    Pneumonia haemophilus 1/595 (0.2%) 1
    Pneumonia streptococcal 1/595 (0.2%) 1
    Rectal abscess 1/595 (0.2%) 2
    Salpingitis 1/595 (0.2%) 1
    Staphylococcal sepsis 1/595 (0.2%) 1
    Streptococcal sepsis 1/595 (0.2%) 1
    Tracheobronchitis 1/595 (0.2%) 1
    Viral infection 1/595 (0.2%) 1
    Wound infection 1/595 (0.2%) 1
    Injury, poisoning and procedural complications
    Postoperative fever 2/595 (0.3%) 3
    Tibia fracture 2/595 (0.3%) 2
    Animal bite 1/595 (0.2%) 1
    Ankle fracture 1/595 (0.2%) 1
    Femur fracture 1/595 (0.2%) 1
    Haemothorax 1/595 (0.2%) 1
    Hand fracture 1/595 (0.2%) 1
    Hip fracture 1/595 (0.2%) 1
    Incisional hernia 1/595 (0.2%) 1
    Joint dislocation 1/595 (0.2%) 1
    Lower limb fracture 1/595 (0.2%) 2
    Meniscus lesion 1/595 (0.2%) 1
    Pelvic fracture 1/595 (0.2%) 1
    Pneumothorax traumatic 1/595 (0.2%) 1
    Polytraumatism 1/595 (0.2%) 1
    Post procedural diarrhoea 1/595 (0.2%) 1
    Post procedural pain 1/595 (0.2%) 1
    Tendon injury 1/595 (0.2%) 1
    Wrist fracture 1/595 (0.2%) 1
    Investigations
    Autoantibody positive 1/595 (0.2%) 1
    International normalised ratio increased 1/595 (0.2%) 1
    Weight decreased 1/595 (0.2%) 1
    Metabolism and nutrition disorders
    Dehydration 1/595 (0.2%) 1
    Hypoalbuminaemia 1/595 (0.2%) 1
    Malnutrition 1/595 (0.2%) 1
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion 3/595 (0.5%) 3
    Arthralgia 1/595 (0.2%) 1
    Bone erosion 1/595 (0.2%) 1
    Chondropathy 1/595 (0.2%) 1
    Fistula 1/595 (0.2%) 1
    Flank pain 1/595 (0.2%) 1
    Sacroiliitis 1/595 (0.2%) 1
    Scleroderma 1/595 (0.2%) 1
    Spondylolisthesis acquired 1/595 (0.2%) 1
    Synovitis 1/595 (0.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma 3/595 (0.5%) 3
    Basal cell carcinoma 2/595 (0.3%) 2
    Small intestine carcinoma 2/595 (0.3%) 2
    Laryngeal cancer 1/595 (0.2%) 1
    Lentigo maligna stage unspecified 1/595 (0.2%) 1
    Lip neoplasm malignant stage unspecified 1/595 (0.2%) 1
    Medullary thyroid cancer 1/595 (0.2%) 1
    Metastatic malignant melanoma 1/595 (0.2%) 1
    Non-small cell lung cancer 1/595 (0.2%) 1
    Prostate cancer 1/595 (0.2%) 1
    Rectal cancer 1/595 (0.2%) 1
    Squamous cell carcinoma 1/595 (0.2%) 1
    Squamous cell carcinoma of skin 1/595 (0.2%) 1
    Nervous system disorders
    Spinal column stenosis 2/595 (0.3%) 2
    Arachnoid cyst 1/595 (0.2%) 1
    Cauda equina syndrome 1/595 (0.2%) 1
    Cerebral infarction 1/595 (0.2%) 1
    Cerebrovascular accident 1/595 (0.2%) 1
    Sciatica 1/595 (0.2%) 1
    Transient ischaemic attack 1/595 (0.2%) 1
    Trigeminal neuralgia 1/595 (0.2%) 1
    Pregnancy, puerperium and perinatal conditions
    Pregnancy 2/595 (0.3%) 2
    Unintended pregnancy 2/595 (0.3%) 2
    Pregnancy on oral contraceptive 1/595 (0.2%) 1
    Psychiatric disorders
    Suicide attempt 1/595 (0.2%) 1
    Renal and urinary disorders
    Nephrolithiasis 5/595 (0.8%) 5
    Calculus ureteric 2/595 (0.3%) 3
    Dysuria 1/595 (0.2%) 1
    Glomerulonephritis focal 1/595 (0.2%) 1
    Renal colic 1/595 (0.2%) 1
    Renal tubular acidosis 1/595 (0.2%) 1
    Reproductive system and breast disorders
    Ovarian cyst 3/595 (0.5%) 3
    Azoospermia 1/595 (0.2%) 1
    Dysfunctional uterine bleeding 1/595 (0.2%) 1
    Endometriosis 1/595 (0.2%) 1
    Epididymitis 1/595 (0.2%) 1
    Female genital-digestive tract fistula 1/595 (0.2%) 1
    Menometrorrhagia 1/595 (0.2%) 1
    Metrorrhagia 1/595 (0.2%) 1
    Ovarian disorder 1/595 (0.2%) 1
    Prostatitis 1/595 (0.2%) 1
    Respiratory, thoracic and mediastinal disorders
    Asphyxia 1/595 (0.2%) 1
    Dyspnoea 1/595 (0.2%) 1
    Interstitial lung disease 1/595 (0.2%) 1
    Nasal septum deviation 1/595 (0.2%) 1
    Pneumonia aspiration 1/595 (0.2%) 1
    Skin and subcutaneous tissue disorders
    Alopecia totalis 1/595 (0.2%) 1
    Dermatitis allergic 1/595 (0.2%) 1
    Psoriasis 1/595 (0.2%) 1
    Social circumstances
    Pregnancy of partner 3/595 (0.5%) 3
    Surgical and medical procedures
    Abortion induced 1/595 (0.2%) 1
    Vascular disorders
    Deep vein thrombosis 1/595 (0.2%) 1
    Haematoma 1/595 (0.2%) 1
    Lymphangitis 1/595 (0.2%) 1
    Raynaud's phenomenon 1/595 (0.2%) 2
    Thrombophlebitis superficial 1/595 (0.2%) 1
    Venous thrombosis limb 1/595 (0.2%) 1
    Other (Not Including Serious) Adverse Events
    Certolizumab Pegol
    Affected / at Risk (%) # Events
    Total 410/595 (68.9%)
    Blood and lymphatic system disorders
    Anaemia 34/595 (5.7%) 43
    Gastrointestinal disorders
    Crohn's disease 130/595 (21.8%) 189
    Abdominal pain 89/595 (15%) 152
    Diarrhoea 64/595 (10.8%) 85
    Nausea 50/595 (8.4%) 83
    Dyspepsia 39/595 (6.6%) 46
    Vomiting 33/595 (5.5%) 48
    General disorders
    Pyrexia 56/595 (9.4%) 98
    Infections and infestations
    Nasopharyngitis 91/595 (15.3%) 201
    Urinary tract infection 82/595 (13.8%) 160
    Influenza 72/595 (12.1%) 105
    Upper respiratory tract infection 63/595 (10.6%) 110
    Sinusitis 43/595 (7.2%) 77
    Gastroenteritis 41/595 (6.9%) 52
    Bronchitis 37/595 (6.2%) 52
    Musculoskeletal and connective tissue disorders
    Arthralgia 70/595 (11.8%) 99
    Back pain 41/595 (6.9%) 52
    Nervous system disorders
    Headache 60/595 (10.1%) 99
    Psychiatric disorders
    Insomnia 30/595 (5%) 39
    Respiratory, thoracic and mediastinal disorders
    Cough 35/595 (5.9%) 42
    Skin and subcutaneous tissue disorders
    Rash 40/595 (6.7%) 51
    Vascular disorders
    Hypertension 34/595 (5.7%) 37

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title UCB Clinical Trial Call Center
    Organization UCB
    Phone +1 877 822 9493 (UCB)
    Email
    Responsible Party:
    UCB Pharma SA
    ClinicalTrials.gov Identifier:
    NCT00160524
    Other Study ID Numbers:
    • C87033
    • 2005-002622-60
    First Posted:
    Sep 12, 2005
    Last Update Posted:
    Aug 1, 2018
    Last Verified:
    Aug 1, 2013