A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease

A Phase IIIb, Multinational, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-TNF-alpha Monoclonal Antibody, Administered at Weeks 0, 2 and 4, and Then Every 4 Weeks Thereafter, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085

The primary objective of the study is to assess the safety of long term therapy with Certolizumab Pegol in those subjects participating in study C87085 [NCT00552058].

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Biological: Cimzia

Detailed Description

This study consisted of:

• Induction Period (dosing at Weeks 0, 2, and 4)
• Maintenance Dosing (dosing every 4 weeks up to Week 260)
• End of Treatment Visit that occurred at Week 262/Withdrawal Visit and a Safety Follow-up Visit (SFU; 12 weeks after final dose)

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • Bankstown, Australia
    • 14
  • Fitzroy, Australia
    • 11
  • Fremantle, Australia
    • 13
  • Garran, Australia
    • 18
  • New South Wales
    • Concord, New South Wales, Australia
      • 15
  • Victoria
    • Box Hill, Victoria, Australia
      • 20
    • Footscray, Victoria, Australia
      • 12
    • Parkville, Victoria, Australia
      • 16
• Austria
  • Wien, Austria
    • 270
• Belgium
  • Bonheiden, Belgium
    • 32
  • Gent, Belgium
    • 31
  • Leuven, Belgium
    • 35
  • Liege, Belgium
    • 34
  • Roeselare, Belgium
    • 30
• Brazil
  • Belo-Horizonte, Brazil
    • 45
  • Curitiba, Brazil
    • 41
  • Rio de Janeiro, Brazil
    • 51
  • Santos, Brazil
    • 53
  • Sao Paulo, Brazil
    • 55
  • RS
    • Porto Alegre, RS, Brazil
      • 52
• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • 64
  • Manitoba
    • Winnepeg, Manitoba, Canada
      • 60
  • Ontario
    • Hamilton, Ontario, Canada
      • 67
    • Kingston, Ontario, Canada
      • 62
    • London, Ontario, Canada
      • 63
    • London, Ontario, Canada
      • 70
    • Toronto, Ontario, Canada
      • 66
    • Toronto, Ontario, Canada
      • 68
• Czechia
  • Hradec Kralove, Czechia
    • 95
  • Hradek Kralove, Czechia
    • 97
  • Praha 7, Czechia
    • 98
• Estonia
  • Tallin, Estonia
    • 100
  • Tartu, Estonia
    • 101
• Germany
  • Homburg, Germany
    • 140
  • Kiel, Germany
    • 137
  • Ulm, Germany
    • 144
  • Wilhelmshaven, Germany
    • 130
• Hungary
  • Budapest, Hungary
    • 151
  • Budapest, Hungary
    • 155
  • Budapest, Hungary
    • 156
  • Gyor, Hungary
    • 154
  • Nagykanizsa, Hungary
    • 150
  • Szeged, Hungary
    • 153
  • Szombathely, Hungary
    • 152
• Israel
  • Beer Sheva, Israel
    • 161
  • Haifa, Israel
    • 164
  • Holon, Israel
    • 167
  • Kfar Saba, Israel
    • 163
  • Petha Tikva, Israel
    • 166
  • Tel Aviv, Israel
    • 160
  • Zerifin, Israel
    • 169
• Italy
  • Padova, Italy
    • 176
  • Roma, Italy
    • 171
  • Roma, Italy
    • 174
• Latvia
  • Riga, Latvia
    • 191
  • Riga, Latvia
    • 192
  • Riga, Latvia
    • 193
• New Zealand
  • Auckland, New Zealand
    • 201
  • Christchurch, New Zealand
    • 200
  • Hamilton, New Zealand
    • 203
  • Auckland
    • Milford, Auckland, New Zealand
      • 202
  • Wellington
    • Newton, Wellington, New Zealand
      • 204
• Poland
  • Czestochowa, Poland
    • 217
  • Czestochowa, Poland
    • 218
  • Lodz, Poland
    • 210
  • Warszawa, Poland
    • 211
  • Warszawa, Poland
    • 212
  • Wroclaw, Poland
    • 213
• Romania
  • Cluj Napoca, Romania
    • 221
  • Constanta, Romania
    • 225
• Russian Federation
  • Kazan, Russian Federation
    • 232
  • Moscow, Russian Federation
    • 230
  • Moscow, Russian Federation
    • 234
  • St Petersburg, Russian Federation
    • 233
• Ukraine
  • Dniepropetrovsk, Ukraine
    • 258
  • Donetsk, Ukraine
    • 251
  • Kiev, Ukraine
    • 256
  • Kiev, Ukraine
    • 259
  • Lviv, Ukraine
    • 257
  • Simferopol, Ukraine
    • 254
• United States
  • Colorado
    • Lakewood, Colorado, United States
      • 284
    • Littleton, Colorado, United States
      • 285
  • Florida
    • New Port Richey, Florida, United States
      • 278
    • Winter Park, Florida, United States
      • 300
  • Illinois
    • Chicago, Illinois, United States
      • 276
  • Kentucky
    • Louisville, Kentucky, United States
      • 279
  • Louisiana
    • Metairie, Louisiana, United States
      • 275
    • Monroe, Louisiana, United States
      • 307
  • Maryland
    • Annapolis, Maryland, United States
      • 281
    • Towson, Maryland, United States
      • 295
  • Michigan
    • Chesterfield, Michigan, United States
      • 310
  • Minnesota
    • Rochester, Minnesota, United States
      • 298
  • North Carolina
    • Raleigh, North Carolina, United States
      • 272
  • Ohio
    • Cincinnati, Ohio, United States
      • 296
    • Cleveland, Ohio, United States
      • 289
  • Pennsylvania
    • Lancaster, Pennsylvania, United States
      • 280
  • Tennessee
    • Germantown, Tennessee, United States
      • 305
    • Germantown, Tennessee, United States
      • 306
  • Virginia
    • Norfolk, Virginia, United States
      • 308
  • Washington
    • Seattle, Washington, United States
      • 290

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject participated in study C87085 [NCT00552058] in which the subject completed the study at Week 6
• Subject is capable of providing informed consent, which must be obtained prior to any study related procedures
• Have a chest X-ray taken at Visit 1 that is read by a qualified radiologist or pulmonary physician, with no evidence of current active Tuberculosis (TB) or old inactive TB
• Subject has taken a TB survey and is committed to comply with TB prophylaxis if applicable

Exclusion Criteria:

• Subject is experiencing an ongoing serious adverse event assessed as being related to study medication or is experiencing a serious adverse event that is still not assessable
• Subject has an intercurrent illness that requires termination of treatment, such as a serious infection (e.g. TB, pneumonia, sepsis, pyelonephritis, fistula abscess)
• Subject is non-compliant with TB prophylactic treatment (if applicable)
• Subject has had a chest X-ray at Visit 1 that shows an abnormality suggestive of a malignancy or active infection, including TB
• Female who is pregnant or breast feeding
• Female of child bearing age or post puberty males not practicing effective birth control
• Subject is expecting to receive any live virus or bacterial vaccination within 3 months of first Study Medication administration, during the trial or 3 months after last dose of study drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Certolizumab Pegol; Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.	Biological: Cimzia; Active substance: Certolizumab Pegol; Pharmaceutical form:first reconstituted, lyophilized powder formulation of CZP and after implementation of Amendment 2 (after 401 subjects were enrolled) prefilled syringe; Concentration: 200 mg/ml; Route of Administration: Subcutaneous use; Other Names: CZP; CDP870; Certolizumab Pegol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)	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.	From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)	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.	From study start to the end of the Safety Follow-up Period (up to 272 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)	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.	Week 262
Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)	IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.	Week 262
Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)	Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.	Week 52
Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088	Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 [NCT00552058] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.	From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)

Collaborators and Investigators

• Sponsor: UCB BIOSCIENCES GmbH
• Collaborators: PPD

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 31, 2007
• First Submitted That Met QC Criteria: October 31, 2007
• First Posted (Estimate): November 1, 2007

Study Record Updates

• Last Update Posted (Actual): August 9, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Clinical remission; Certolizumab Pegol; Crohn's Disease; Crohn Disease; Clinical response; Induction; CIMZIA; CDP 870; CD Induction
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Certolizumab Pegol
• Other Study ID Numbers: C87088; 2007-002716-26 (EudraCT Number)