Completed
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
What is being tested
Cimzia
Biological
Who is being recruted
Crohn Disease+3
+ Digestive System Diseases
+ Gastroenteritis
From 18 to 75 Years
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: May 2008
Summary
Principal SponsorUCB BIOSCIENCES GmbH
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2008
Actual date on which the first participant was enrolled.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)
Official TitleA 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
Principal SponsorUCB BIOSCIENCES GmbH
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
403 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Crohn DiseaseDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases
Criteria
4 inclusion criteria required to participate
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
7 exclusion criteria prevent from participating
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalCertolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 100 locations
Suspended
Suspended
257
Lviv, UkraineSuspended
254
Simferopol, UkraineSuspended
284
Lakewood, United StatesCompleted100 Study Centers