Crohn DiseasePhase 3NCT00552058
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
A Phase 3 study testing certolizumab pegol (CDP870, CZP) in people with Crohn Disease, run by UCB Pharma at 116 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- certolizumab pegol (CDP870, CZP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 439 participants
- Where
- 116 sitesin 20 countries
- Study dates
- Mar 2008to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- previous participation in a certolizumab pegol study
- general exclusion criteria as common for studies in this indication
Trial locations and contacts
116 sites in 20 countries.
116 sites in 20 countries
United States24 sites
Study site
Annapolis, Maryland
Study site
Chesterfield, Michigan
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Colorado Springs, Colorado
Study site
Germantown, Tennessee
Study site
Hollywood, Florida
Study site
Jacksonville, Florida
Study site
Lakewood, Colorado
Study site
Lancaster, Pennsylvania
Study site
Littleton, Colorado
Study site
Louisville, Kentucky
Study site
Metairie, Louisiana
Study site
Monroe, Louisiana
Study site
New Port Richey, Florida
Study site
Norfolk, Virginia
Study site
Pell City, Alabama
Study site
Raleigh, North Carolina
Study site
Rochester, Minnesota
Study site
Seattle, Washington
Study site
Towson, Maryland
Study site
West Bloomfield, Michigan
Study site
Winter Park, Florida
Australia10 sites
Study site
Adelaide
Study site
Bankstown
Study site
Box Hill, Victoria
Study site
Clayton
Study site
Concord, New South Wales
Study site
Fitzroy
Study site
Footscray, Victoria
Study site
Fremantle
Study site
Garran
Study site
Parkville, Victoria
Germany9 sites
Study site
Berlin
Study site
Frankfurt
Study site
Freiburg im Breisgau
Study site
Homburg
Study site
Jena
Study site
Kiel
Study site
München
Study site
Ulm
Study site
Wilhelmshaven
Israel9 sites
Study site
Beersheba
Study site
Haifa
Study site
Holon
Study site
Jerusalem
Study site
Kfar Saba
Study site
Petha Tikva
Study site
Rehovot
Study site
Tel Aviv
Study site
Tsrifin
Brazil8 sites
Study site
Belo Horizonte, Minas Gerais
Study site
Curitiba
Study site
Goiânia
Study site
Porto Alegre
Study site
Rio de Janeiro
Study site
Santo André
Study site
Santos
Study site
São Paulo
Canada8 sites
Study site
Calgary
Study site
Edmonton, Alberta
Study site
Hamilton, Ontario
Study site
Kelowna, British Columbia
Study site
Kingston, Ontario
Study site
London, Ontario
Study site
Toronto, Ontario
Study site
Winnipeg, Manitoba
Belgium6 sites
Study site
Bonheiden
Study site
Brussels
Study site
Ghent
Study site
Leuven
Study site
Liège
Study site
Roeselare
Ukraine6 sites
Study site
Dniepropetrovsk
Study site
Donetsk
Study site
Kiev
Study site
Kyiv
Study site
Lviv
Study site
Simferopol
Czechia5 sites
Study site
Hradec Králové
Study site
Hradek Kralove
Study site
Prague
Study site
Ústí nad Orlicí
Study site
Zlín
Hungary5 sites
Study site
Budapest
Study site
Győr
Study site
Nagykanizsa
Study site
Szeged
Study site
Szombathely
New Zealand5 sites
Study site
Auckland
Study site
Christchurch
Study site
Hamilton
Study site
Milford, Auckland
Study site
Newton, Wellington Region
Poland4 sites
Study site
Częstochowa
Study site
Lodz
Study site
Warsaw
Study site
Wroclaw
About this study
Official 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.
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.
- Conditions
- Crohn Disease
- Being tested
- certolizumab pegol (CDP870, CZP), Placebo
- Keywords
- CDP 870, Certolizumab Pegol, CIMZIA ®, Crohn's disease, Induction, Clinical remission, Clinical response
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
certolizumab pegol (CDP870, CZP)Biological
Also called CIMZIA ®, CDP870, CZP
Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
PlaceboOther
Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4
| Study group | Role | What they receive |
|---|---|---|
| Certolizumab pegol | Experimental | Certolizumab pegol 400 mg for subcutaneous (sc) injection Receives: Biological: certolizumab pegol (CDP870, CZP) |
| Placebo | Placebo comparator | Placebo, saline solution for sc injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects in Clinical Remission at Week 6
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.
Measured: Week 6
Secondary outcomes (16)
Percentage of Subjects Achieving a Clinical Response at Week 6
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.
Measured: Week 0, Week 6
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6
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.
Measured: Week 6
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6
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.
Measured: Week 0 to Week 6
Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6
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.
Measured: Week 0 to Week 6
Percentage of Subjects in Clinical Remission at Week 2
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.
Measured: Week 2
Percentage of Subjects in Clinical Remission at Week 4
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.
Measured: Week 4
Percentage of Subjects Achieving a Clinical Response at Week 2
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.
Measured: Week 0, Week 2
Percentage of Subjects Achieving a Clinical Response at Week 4
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.
Measured: Week 0, Week 4
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2
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.
Measured: Week 0 to Week 2
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4
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.
Measured: Week 0, Week 4
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2
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.
Measured: Week 2
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4
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.
Measured: Week 4
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
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.
Measured: Week 6
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
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.
Measured: Week 6
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
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.
Measured: Week 0, Week 6
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
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.
Measured: Week 0, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startMar 2008
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552058
- Sponsor's protocol ID
- C87085
- Other IDs
- 2007-001913-41
- Status last verified
- Oct 2011
- First submitted
- 18 Oct 2007
- Last updated
- 9 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, Younes ZH, Bloomfield R, Coteur G, Guzman JP, D'Haens GR. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug;9(8):670-678.e3. doi: 10.1016/j.cgh.2011.04.031. Epub 2011 May 13.
PubMed 21642014Sandborn WJ, Melmed GY, McGovern DP, Loftus EV Jr, Choi JM, Cho JH, Abraham B, Gutierrez A, Lichtenstein G, Lee SD, Randall CW, Schwartz DA, Regueiro M, Siegel CA, Spearman M, Kosutic G, Pierre-Louis B, Coarse J, Schreiber S. Clinical and demographic characteristics predictive of treatment outcomes for certolizumab pegol in moderate to severe Crohn's disease: analyses from the 7-year PRECiSE 3 study. Aliment Pharmacol Ther. 2015 Aug;42(3):330-42. doi: 10.1111/apt.13251. Epub 2015 Jun 1.
PubMed 26031921Sandborn WJ, Lee SD, Randall C, Gutierrez A, Schwartz DA, Ambarkhane S, Kayhan C, Pierre-Louis B, Schreiber S, Lichtenstein GR. Long-term safety and efficacy of certolizumab pegol in the treatment of Crohn's disease: 7-year results from the PRECiSE 3 study. Aliment Pharmacol Ther. 2014 Oct;40(8):903-16. doi: 10.1111/apt.12930. Epub 2014 Aug 22.
PubMed 25146586
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00552058
- Acronym / sponsor ID
- C87085
- Conditions
- Crohn Disease
- Keywords
- CDP 870, Certolizumab Pegol, CIMZIA ®, Crohn's disease, Induction, Clinical remission, Clinical response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 1 Nov 2007 (estimated)
- Results
- Posted 30 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Certolizumab pegol | Experimental | Biological: certolizumab pegol (CDP870, CZP)Certolizumab pegol 400 mg for subcutaneous (sc) injection |
| Placebo | Placebo comparator | Other: PlaceboPlacebo, saline solution for sc injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- previous participation in a certolizumab pegol study
- general exclusion criteria as common for studies in this indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| certolizumab pegol (CDP870, CZP)Also: CIMZIA ®, CDP870, CZPCertolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4 | Biological | Certolizumab pegol |
| PlaceboSaline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4 | Other | Placebo |
Primary outcome
Percentage of Subjects in Clinical Remission at Week 6
Time frame: Week 6
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.
16 secondary outcomes
Percentage of Subjects Achieving a Clinical Response at Week 6
Time frame: Week 0, Week 6
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6
Time frame: Week 6
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6
Time frame: Week 0 to Week 6
Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6
Time frame: Week 0 to Week 6
Percentage of Subjects in Clinical Remission at Week 2
Time frame: Week 2
Percentage of Subjects in Clinical Remission at Week 4
Time frame: Week 4
Percentage of Subjects Achieving a Clinical Response at Week 2
Time frame: Week 0, Week 2
Percentage of Subjects Achieving a Clinical Response at Week 4
Time frame: Week 0, Week 4
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2
Time frame: Week 0 to Week 2
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4
Time frame: Week 0, Week 4
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2
Time frame: Week 2
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4
Time frame: Week 4
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
Time frame: Week 6
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
Time frame: Week 6
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Time frame: Week 0, Week 6
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Time frame: Week 0, Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21642014Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, Younes ZH, Bloomfield R, Coteur G, Guzman JP, D'Haens GR. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug;9(8):670-678.e3. doi: 10.1016/j.cgh.2011.04.031. Epub 2011 May 13.
- Derived from this study: PubMed 26031921Sandborn WJ, Melmed GY, McGovern DP, Loftus EV Jr, Choi JM, Cho JH, Abraham B, Gutierrez A, Lichtenstein G, Lee SD, Randall CW, Schwartz DA, Regueiro M, Siegel CA, Spearman M, Kosutic G, Pierre-Louis B, Coarse J, Schreiber S. Clinical and demographic characteristics predictive of treatment outcomes for certolizumab pegol in moderate to severe Crohn's disease: analyses from the 7-year PRECiSE 3 study. Aliment Pharmacol Ther. 2015 Aug;42(3):330-42. doi: 10.1111/apt.13251. Epub 2015 Jun 1.
- Derived from this study: PubMed 25146586Sandborn WJ, Lee SD, Randall C, Gutierrez A, Schwartz DA, Ambarkhane S, Kayhan C, Pierre-Louis B, Schreiber S, Lichtenstein GR. Long-term safety and efficacy of certolizumab pegol in the treatment of Crohn's disease: 7-year results from the PRECiSE 3 study. Aliment Pharmacol Ther. 2014 Oct;40(8):903-16. doi: 10.1111/apt.12930. Epub 2014 Aug 22.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
116 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing certolizumab pegol (CDP870, CZP) in people with Crohn Disease, run by UCB Pharma at 116 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 116 sites in United States, Australia, Germany, Israel, Brazil and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects in Clinical Remission at Week 6 (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552058, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.