A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease

NCT00160706 | Completed Phase 3 Results

• 2 other identifiers: C870342005-002623-13
• Study Type: interventional
• Target: 310
• Locations: 21 countries
• Sites: 136

Brief Summary

A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] due to an exacerbation of Crohn's Disease.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months)

  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.

  Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)

• Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months)

  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.

  Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)

Secondary Outcomes (7)

• Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit

  Study Completion Visit (Week 362) / (Early) Withdrawal Visit

• Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032

  From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months)

• Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034

  From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)

• Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit

  Study Completion Visit (Week 362) / (Early) Withdrawal Visit

• Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034

  From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)

Study Arms (1)

Certolizumab Pegol

EXPERIMENTAL

3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.

Biological: Certolizumab Pegol (CDP870)

Interventions

Certolizumab Pegol (CDP870) BIOLOGICAL

Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.

Also known as: Cimzia, CDP870, CZP

Certolizumab Pegol

Eligibility Criteria

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

You may qualify if:

• Participation in either of the CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] clinical studies in which the subject completed the Week 2 assessment in CDP870-031 \[NCT00152490\] or the Week 6 randomization in CDP870-032 \[NCT00152425\] but whose Crohn's Disease was significantly worse as determined by the investigator and whose Clinical Disease Activity Index (CDAI) score at entry to this study is either (subjects may have received active or placebo treatment):
• At least 70 points higher then Baseline (Week 0 CDP870-031 \[NCT00152490\]; Week 6 CDP870 032 \[NCT00152425\] responders) OR
• Higher than Baseline (Week 0 CDP870-031 \[NCT00152490\]; Week 6 CDP870-032 \[NCT00152425\] responders) with an absolute score of at least 350 points
• Subjects must be able to understand the information provided to them and give written informed consent

Sponsors & Collaborators

• UCB Pharma SA: lead

Study Sites (141)

45102

Birmingham, Alabama, United States

Location

45028

Huntsville, Alabama, United States

Location

45044

Little Rock, Arkansas, United States

Location

45095

Orange, California, United States

Location

45101

San Francisco, California, United States

Location

45130

Colorado Springs, Colorado, United States

Location

45094

Gainesville, Florida, United States

Location

45005

Hialeah, Florida, United States

Location

45087

Miami, Florida, United States

Location

45004

North Miami Beach, Florida, United States

Location

45016

Chicago, Illinois, United States

Location

45037

Indianapolis, Indiana, United States

Location

45019

Lexington, Kentucky, United States

Location

45033

Chevy Chase, Maryland, United States

Location

45013

Laurel, Maryland, United States

Location

45083

Rochester, Minnesota, United States

Location

45108

Jefferson City, Missouri, United States

Location

45035

Berlin, New Jersey, United States

Location

45009

Great Neck, New York, United States

Location

45070

New York, New York, United States

Location

45145

Greenville, North Carolina, United States

Location

45067

High Point, North Carolina, United States

Location

45003

Raleigh, North Carolina, United States

Location

45040

Winston-Salem, North Carolina, United States

Location

45081

Cincinnati, Ohio, United States

Location

45091

Cincinnati, Ohio, United States

Location

45054

Dayton, Ohio, United States

Location

45025

Mayfield Heights, Ohio, United States

Location

45039

Oklahoma City, Oklahoma, United States

Location

45041

Tulsa, Oklahoma, United States

Location

45093

Hershey, Pennsylvania, United States

Location

45113

Germantown, Tennessee, United States

Location

45119

Nashville, Tennessee, United States

Location

45022

Houston, Texas, United States

Location

45073

San Antonio, Texas, United States

Location

45139

Salt Lake City, Utah, United States

Location

45052

South Ogden, Utah, United States

Location

45134

Charlottesville, Virginia, United States

Location

45078

Christiansburg, Virginia, United States

Location

45109

Norfolk, Virginia, United States

Location

45141

Seattle, Washington, United States

Location

11011

Bankstown, New South Wales, Australia

Location

11005

New Lambton, New South Wales, Australia

Location

11017

Herston, Queensland, Australia

Location

11006

South Brisbane, Queensland, Australia

Location

11014

Lauceston, Tasmania, Australia

Location

11016

Ballarat, Victoria, Australia

Location

11007

Box Hill, Victoria, Australia

Location

11002

Fitzroy, Victoria, Australia

Location

11013

Frankston, Victoria, Australia

Location

11012

Parkville, Victoria, Australia

Location

11009

Adelaide, Australia

Location

11010

Fremantle, Australia

Location

11015

Garran, Australia

Location

11018

Newtown, Australia

Location

46006

Linz, Austria

Location

46003

Salzburg, Austria

Location

46002

Vienna, Austria

Location

12001

Minsk, Belarus

Location

13004

Brussels, Belgium

Location

13001

Ghent, Belgium

Location

13003

Leuven, Belgium

Location

15001

Sofia, Bulgaria

Location

16005

Winnipeg, Manitoba, Canada

Location

16014

Halifax, Nova Scotia, Canada

Location

16013

Toronto, Ontario, Canada

Location

16008

Montreal, Quebec, Canada

Location

18006

Hradek Kralove, Czechia

Location

18001

Ostrava, Czechia

Location

18002

Prague, Czechia

Location

18004

Prague, Czechia

Location

19004

Aalborg, Denmark

Location

19009

Copenhagen, Denmark

Location

19010

Herlev, Denmark

Location

19007

Hvidovre, Denmark

Location

19003

Vejle, Denmark

Location

20001

Tallinn, Estonia

Location

20002

Tartu, Estonia

Location

22002

Berlin, Germany

Location

22009

Berlin, Germany

Location

22004

Celle, Germany

Location

22019

Frankfurt, Germany

Location

22013

Göttingen, Germany

Location

22017

Hanover, Germany

Location

22015

Kiel, Germany

Location

22016

Leipzig, Germany

Location

22001

Minden, Germany

Location

22012

Munich, Germany

Location

22008

Münster, Germany

Location

24002

Budapest, Hungary

Location

24009

Pécs, Hungary

Location

24011

Szekszárd, Hungary

Location

26004

Beersheba, Israel

Location

26007

Haifa, Israel

Location

26005

Petha Tikva, Israel

Location

27001

Milan, Italy

Location

27004

Palermo, Italy

Location

27007

Roma, Italy

Location

31002

Auckland, New Zealand

Location

31001

Christchurch, New Zealand

Location

31005

Hamilton, New Zealand

Location

31004

Milford, New Zealand

Location

31003

Tauranga, New Zealand

Location

32005

Oslo, Norway

Location

32008

Oslo, Norway

Location

32004

Tromsø, Norway

Location

33008

Bydgoszcz, Poland

Location

33003

Gdansk, Poland

Location

33018

Lublin, Poland

Location

33013

Szczecin, Poland

Location

33007

Warsaw, Poland

Location

33009

Warsaw, Poland

Location

34017

Lipetsk, Russia

Location

34006

Moscow, Russia

Location

34016

Nizhny Novgorod, Russia

Location

34001

Saint Petersburg, Russia

Location

34005

Saint Petersburg, Russia

Location

34007

Saint Petersburg, Russia

Location

34013

Saint Petersburg, Russia

Location

35001

Belgrade, Serbia

Location

35002

Belgrade, Serbia

Location

35004

Belgrade, Serbia

Location

36002

Singapore, Singapore

Location

38001

Celje, Slovenia

Location

38003

Ljubljana, Slovenia

Location

39013

Johannesburg, Gauteng, South Africa

Location

39003

Cape Town, Somerset West, South Africa

Location

39016

Cape Town, South Africa

Location

39018

Cape Town, South Africa

Location

39012

Goodwood, South Africa

Location

39010

Johannesburg, South Africa

Location

39008

Midrand, South Africa

Location

39004

Port Elizabeth, South Africa

Location

39006

Pretoria, South Africa

Location

39009

Pretoria, South Africa

Location

39014

Pretoria, South Africa

Location

39019

Pretoria, South Africa

Location

40009

Barcelona, Spain

Location

43008

Dniepropetrovsk, Ukraine

Location

43003

Lviv, Ukraine

Location

43006

Odesa, Ukraine

Location

Related Publications (1)

• Sandborn WJ, Schreiber S, Hanauer SB, Colombel JF, Bloomfield R, Lichtenstein GR; PRECiSE 4 Study Investigators. Reinduction with certolizumab pegol in patients with relapsed Crohn's disease: results from the PRECiSE 4 Study. Clin Gastroenterol Hepatol. 2010 Aug;8(8):696-702.e1. doi: 10.1016/j.cgh.2010.03.024. Epub 2010 Apr 2.

  PMID: 20363366 RESULT

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: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493 (UCB)

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: February 1, 2004
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 7, 2018
• Results First Posted: July 4, 2013

Record last verified: 2013-05

Locations

IL (3); NO (3); SE (3); ZA (12); BU (1); PL (6); SL (2); US (41); CZ (4); BE (3); UA (3); CA (4); DK (5); AU (14); HU (3); IT (3); ES (2); RU (7); SG (1); NZ (5); DE (11)