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

July 10, 2018 updated by: UCB BIOSCIENCES GmbH

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
403

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: From study start to the end of the Safety Follow-up Period (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)
Time Frame: From study start to the end of the Safety Follow-up Period (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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB BIOSCIENCES GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PPD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C87088
  • 2007-002716-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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