Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

NCT00552058 | Completed Phase 3 Results

• 2 other identifiers: C870852007-001913-41
• Study Type: interventional
• Target: 439
• Locations: 19 countries
• Sites: 115

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.

Conditions

Crohn Disease

Keywords

CDP 870; Certolizumab Pegol; CIMZIA ®; Crohn's disease; Induction; Clinical remission; Clinical response

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 6

Secondary Outcomes (16)

• Percentage of Subjects Achieving a Clinical Response at Week 6

  Week 0, Week 6

• Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6

  Week 6

• Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6

  Week 0 to Week 6

• Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6

  Week 0 to Week 6

• Percentage of Subjects in Clinical Remission at Week 2

  Week 2

Study Arms (2)

Certolizumab pegol

EXPERIMENTAL

Certolizumab pegol 400 mg for subcutaneous (sc) injection

Biological: certolizumab pegol (CDP870, CZP)

Placebo

PLACEBO COMPARATOR

Placebo, saline solution for sc injection

Other: Placebo

Interventions

certolizumab pegol (CDP870, CZP) BIOLOGICAL

Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4

Also known as: CIMZIA ®, CDP870, CZP

Certolizumab pegol

Placebo OTHER

Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male/female
• 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

You may not qualify if:

• previous participation in a certolizumab pegol study

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (116)

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Pell City, Alabama, United States

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Colorado Springs, Colorado, United States

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Lakewood, Colorado, United States

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Littleton, Colorado, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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New Port Richey, Florida, United States

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Winter Park, Florida, United States

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Chicago, Illinois, United States

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Louisville, Kentucky, United States

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Metairie, Louisiana, United States

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Monroe, Louisiana, United States

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Annapolis, Maryland, United States

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Towson, Maryland, United States

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Chesterfield, Michigan, United States

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West Bloomfield, Michigan, United States

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Rochester, Minnesota, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Lancaster, Pennsylvania, United States

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Germantown, Tennessee, United States

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Norfolk, Virginia, United States

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Seattle, Washington, United States

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Concord, New South Wales, Australia

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Box Hill, Victoria, Australia

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Footscray, Victoria, Australia

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Parkville, Victoria, Australia

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Adelaide, Australia

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Bankstown, Australia

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Clayton, Australia

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Fitzroy, Australia

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Fremantle, Australia

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Garran, Australia

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Vienna, Austria

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Bonheiden, Belgium

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Brussels, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

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Roeselare, Belgium

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Belo Horizonte, Minas Gerais, Brazil

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Curitiba, Brazil

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Goiânia, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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Santo André, Brazil

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Santos, Brazil

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São Paulo, Brazil

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Calgary, Canada

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Santiago, Chile

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Viña del Mar, Chile

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Hradec Králové, Czechia

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Hradek Kralove, Czechia

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Prague, Czechia

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Ústí nad Orlicí, Czechia

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Zlín, Czechia

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Tallinn, Estonia

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Tartu, Estonia

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Mikkeli, Finland

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Berlin, Germany

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Frankfurt, Germany

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Freiburg im Breisgau, Germany

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Homburg, Germany

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Jena, Germany

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Kiel, Germany

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München, Germany

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Ulm, Germany

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Wilhelmshaven, Germany

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Budapest, Hungary

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Győr, Hungary

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Nagykanizsa, Hungary

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Szeged, Hungary

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Szombathely, Hungary

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Beersheba, Israel

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Haifa, Israel

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Holon, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Petha Tikva, Israel

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Rehovot, Israel

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Tel Aviv, Israel

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Ẕerifin, Israel

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Bologna, Italy

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Padua, Italy

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Roma, Italy

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Riga, Latvia

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Valmiera, Latvia

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Milford, Auckland, New Zealand

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Newton, Wellington Region, New Zealand

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Auckland, New Zealand

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Christchurch, New Zealand

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Hamilton, New Zealand

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Częstochowa, Poland

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Lodz, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Bucharest, Romania

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Cluj-Napoca, Romania

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Constanța, Romania

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Kazan', Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Dniepropetrovsk, Ukraine

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Donetsk, Ukraine

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Kiev, Ukraine

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Kyiv, Ukraine

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Lviv, Ukraine

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Simferopol, Ukraine

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Related Publications (3)

• 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.

  PMID: 21642014 RESULT

• Sandborn 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.

  PMID: 26031921 DERIVED

• Sandborn 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.

  PMID: 25146586 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Crohn Disease

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: UCB

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: November 1, 2007
• Study Start: March 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 9, 2018
• Results First Posted: December 30, 2010

Record last verified: 2011-10

Locations

BR (8); PL (4); RO (3); CA (8); AU (10); IT (3); FI (1); HU (5); IL (9); LA (2); DE (9); RU (3); UA (6); CL (2); BE (6); US (24); ES (2); CZ (5); NZ (5)