Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00552058
Registration number
NCT00552058
Ethics application status
Date submitted
18/10/2007
Date registered
1/11/2007
Date last updated
9/08/2018
Titles & IDs
Public title
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
Query!
Scientific title
Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.
Query!
Secondary ID [1]
0
0
2007-001913-41
Query!
Secondary ID [2]
0
0
C87085
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Crohn Disease
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Inflammatory bowel disease
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Crohn's disease
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Other interventions - certolizumab pegol (CDP870, CZP)
Other interventions - Placebo
Experimental: Certolizumab pegol - Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo Comparator: Placebo - Placebo, saline solution for sc injection
Other interventions: certolizumab pegol (CDP870, CZP)
Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
Other interventions: Placebo
Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Subjects in Clinical Remission at Week 6
Query!
Assessment method [1]
0
0
The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [1]
0
0
Week 6
Query!
Secondary outcome [1]
0
0
Percentage of Subjects Achieving a Clinical Response at Week 6
Query!
Assessment method [1]
0
0
The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [1]
0
0
Week 0, Week 6
Query!
Secondary outcome [2]
0
0
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6
Query!
Assessment method [2]
0
0
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Query!
Timepoint [2]
0
0
Week 6
Query!
Secondary outcome [3]
0
0
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6
Query!
Assessment method [3]
0
0
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [3]
0
0
Week 0 to Week 6
Query!
Secondary outcome [4]
0
0
Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6
Query!
Assessment method [4]
0
0
The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. 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 (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.
Query!
Timepoint [4]
0
0
Week 0 to Week 6
Query!
Secondary outcome [5]
0
0
Percentage of Subjects in Clinical Remission at Week 2
Query!
Assessment method [5]
0
0
The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [5]
0
0
Week 2
Query!
Secondary outcome [6]
0
0
Percentage of Subjects in Clinical Remission at Week 4
Query!
Assessment method [6]
0
0
The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [6]
0
0
Week 4
Query!
Secondary outcome [7]
0
0
Percentage of Subjects Achieving a Clinical Response at Week 2
Query!
Assessment method [7]
0
0
The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [7]
0
0
Week 0, Week 2
Query!
Secondary outcome [8]
0
0
Percentage of Subjects Achieving a Clinical Response at Week 4
Query!
Assessment method [8]
0
0
The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [8]
0
0
Week 0, Week 4
Query!
Secondary outcome [9]
0
0
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2
Query!
Assessment method [9]
0
0
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [9]
0
0
Week 0 to Week 2
Query!
Secondary outcome [10]
0
0
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4
Query!
Assessment method [10]
0
0
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [10]
0
0
Week 0, Week 4
Query!
Secondary outcome [11]
0
0
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2
Query!
Assessment method [11]
0
0
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Query!
Timepoint [11]
0
0
Week 2
Query!
Secondary outcome [12]
0
0
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4
Query!
Assessment method [12]
0
0
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Query!
Timepoint [12]
0
0
Week 4
Query!
Secondary outcome [13]
0
0
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
Query!
Assessment method [13]
0
0
The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [13]
0
0
Week 6
Query!
Secondary outcome [14]
0
0
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
Query!
Assessment method [14]
0
0
The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [14]
0
0
Week 6
Query!
Secondary outcome [15]
0
0
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Query!
Assessment method [15]
0
0
The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [15]
0
0
Week 0, Week 6
Query!
Secondary outcome [16]
0
0
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Query!
Assessment method [16]
0
0
The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Query!
Timepoint [16]
0
0
Week 0, Week 6
Query!
Eligibility
Key inclusion criteria
- male/female
- 18 - 75 years inclusive
- diagnosis of Crohn's disease confirmed
- moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
- no previous treatment with anti-tumor necrosis factor (anti-TNF) medications
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- previous participation in a certolizumab pegol study
- general exclusion criteria as common for studies in this indication
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
439
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
- Concord
Query!
Recruitment hospital [2]
0
0
- Box Hill
Query!
Recruitment hospital [3]
0
0
- Footscray
Query!
Recruitment hospital [4]
0
0
- Parkville
Query!
Recruitment hospital [5]
0
0
- Adelaide
Query!
Recruitment hospital [6]
0
0
- Bankstown
Query!
Recruitment hospital [7]
0
0
- Clayton
Query!
Recruitment hospital [8]
0
0
- Fitzroy
Query!
Recruitment hospital [9]
0
0
- Fremantle
Query!
Recruitment hospital [10]
0
0
- Garran
Query!
Recruitment postcode(s) [1]
0
0
- Concord
Query!
Recruitment postcode(s) [2]
0
0
- Box Hill
Query!
Recruitment postcode(s) [3]
0
0
- Footscray
Query!
Recruitment postcode(s) [4]
0
0
- Parkville
Query!
Recruitment postcode(s) [5]
0
0
- Adelaide
Query!
Recruitment postcode(s) [6]
0
0
- Bankstown
Query!
Recruitment postcode(s) [7]
0
0
- Clayton
Query!
Recruitment postcode(s) [8]
0
0
- Fitzroy
Query!
Recruitment postcode(s) [9]
0
0
- Fremantle
Query!
Recruitment postcode(s) [10]
0
0
- Garran
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kentucky
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Louisiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Minnesota
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Tennessee
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Virginia
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Washington
Query!
Country [16]
0
0
Austria
Query!
State/province [16]
0
0
Wien
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Bonheiden
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Brussels
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Gent
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Leuven
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Liege
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Roeselare
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
MG
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Curitiba
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Goiania
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Porto Alegre
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Rio de Janeiro
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Santo-Andre
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Santos
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Sao Paulo
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
Alberta
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
British Columbia
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Manitoba
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Ontario
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Calgary
Query!
Country [36]
0
0
Chile
Query!
State/province [36]
0
0
Santiago
Query!
Country [37]
0
0
Chile
Query!
State/province [37]
0
0
Vina del Mar
Query!
Country [38]
0
0
Czechia
Query!
State/province [38]
0
0
Hradec Kralove
Query!
Country [39]
0
0
Czechia
Query!
State/province [39]
0
0
Hradek Kralove
Query!
Country [40]
0
0
Czechia
Query!
State/province [40]
0
0
Praha 7
Query!
Country [41]
0
0
Czechia
Query!
State/province [41]
0
0
Usti Nad Orlici
Query!
Country [42]
0
0
Czechia
Query!
State/province [42]
0
0
Zlin
Query!
Country [43]
0
0
Estonia
Query!
State/province [43]
0
0
Tallin
Query!
Country [44]
0
0
Estonia
Query!
State/province [44]
0
0
Tartu
Query!
Country [45]
0
0
Finland
Query!
State/province [45]
0
0
Mikkeli
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Berlin
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Frankfurt
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Freiburg
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Homburg
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Jena
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Kiel
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Munchen
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Ulm
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Wilhelmshaven
Query!
Country [55]
0
0
Hungary
Query!
State/province [55]
0
0
Budapest
Query!
Country [56]
0
0
Hungary
Query!
State/province [56]
0
0
Gyor
Query!
Country [57]
0
0
Hungary
Query!
State/province [57]
0
0
Nagykanizsa
Query!
Country [58]
0
0
Hungary
Query!
State/province [58]
0
0
Szeged
Query!
Country [59]
0
0
Hungary
Query!
State/province [59]
0
0
Szombathely
Query!
Country [60]
0
0
Israel
Query!
State/province [60]
0
0
Beer Sheva
Query!
Country [61]
0
0
Israel
Query!
State/province [61]
0
0
Haifa
Query!
Country [62]
0
0
Israel
Query!
State/province [62]
0
0
Holon
Query!
Country [63]
0
0
Israel
Query!
State/province [63]
0
0
Jerusalem
Query!
Country [64]
0
0
Israel
Query!
State/province [64]
0
0
Kfar Saba
Query!
Country [65]
0
0
Israel
Query!
State/province [65]
0
0
Petha Tikva
Query!
Country [66]
0
0
Israel
Query!
State/province [66]
0
0
Rehovot
Query!
Country [67]
0
0
Israel
Query!
State/province [67]
0
0
Tel Aviv
Query!
Country [68]
0
0
Israel
Query!
State/province [68]
0
0
Zerifin
Query!
Country [69]
0
0
Italy
Query!
State/province [69]
0
0
Bologna
Query!
Country [70]
0
0
Italy
Query!
State/province [70]
0
0
Padova
Query!
Country [71]
0
0
Italy
Query!
State/province [71]
0
0
Roma
Query!
Country [72]
0
0
Latvia
Query!
State/province [72]
0
0
Riga
Query!
Country [73]
0
0
Latvia
Query!
State/province [73]
0
0
Valmiera
Query!
Country [74]
0
0
New Zealand
Query!
State/province [74]
0
0
Auckland
Query!
Country [75]
0
0
New Zealand
Query!
State/province [75]
0
0
Wellington
Query!
Country [76]
0
0
New Zealand
Query!
State/province [76]
0
0
Christchurch
Query!
Country [77]
0
0
New Zealand
Query!
State/province [77]
0
0
Hamilton
Query!
Country [78]
0
0
Poland
Query!
State/province [78]
0
0
Czestochowa
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Lodz
Query!
Country [80]
0
0
Poland
Query!
State/province [80]
0
0
Warszawa
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Wroclaw
Query!
Country [82]
0
0
Romania
Query!
State/province [82]
0
0
Bucharest
Query!
Country [83]
0
0
Romania
Query!
State/province [83]
0
0
Cluj Napoca
Query!
Country [84]
0
0
Romania
Query!
State/province [84]
0
0
Constanta
Query!
Country [85]
0
0
Russian Federation
Query!
State/province [85]
0
0
Kazan
Query!
Country [86]
0
0
Russian Federation
Query!
State/province [86]
0
0
Moscow
Query!
Country [87]
0
0
Russian Federation
Query!
State/province [87]
0
0
St. Petersburg
Query!
Country [88]
0
0
Ukraine
Query!
State/province [88]
0
0
Dniepropetrovsk
Query!
Country [89]
0
0
Ukraine
Query!
State/province [89]
0
0
Donetsk
Query!
Country [90]
0
0
Ukraine
Query!
State/province [90]
0
0
Kiev
Query!
Country [91]
0
0
Ukraine
Query!
State/province [91]
0
0
Kyiv
Query!
Country [92]
0
0
Ukraine
Query!
State/province [92]
0
0
Lviv
Query!
Country [93]
0
0
Ukraine
Query!
State/province [93]
0
0
Simferopol
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
UCB Pharma
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing
clinical remission in patients with moderate to severe Crohn's disease as compared with
placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00552058
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
UCB Clinical Trial Call Center
Query!
Address
0
0
+1 877 822 9493 (UCB)
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00552058
Download to PDF