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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-002716-26-FI
Enrollment
200
Registered
2007-10-16
Start date
2007-12-12
Completion date
Unknown
Last updated
2012-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn`s disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease

Interventions

Product Name: certolizumab pegol Product Code: CDP870 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: certolizumab pegol CAS Number: 428863-50-7 Current Sponsor code: CDP87

Sponsors

UCB Celltech
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subject participated in study C87085 in which the subject completed the study at Week 6 2. Subject is capable of providing informed consent, which must be obtained prior to any study related procedures 3. 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 TB or old inactive TB 4. Subject has taken a TB survey and is committed to comply with TB prophylaxis if applicable Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. 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 2. Subject has an intercurrent illness that requires termination of treatment, such as a serious infection (e.g. TB, pneumonia, sepsis, pyelonephritis, fistula abscess) 3. Subject is non-compliant with TB prophylactic treatment (if applicable) 4. Subject has had a chest X-ray at visit 1 that shows an abnormality suggestive of a malignancy or active infection, including TB 5. Female who is pregnant or breast feeding 6. Female of child bearing age or post puberty males not practicing effective birth control 7. 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

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the safety of long term therapy with certolizumab pegol in those subjects participating in study C87085;Secondary Objective: To obtain long term efficacy data on certolizumab pegol To obtain data on the plasma concentrations of certolizumab pegol and antibodies to certolizumab pegol To obtain data on the plasma concentrations of anti-double-stranded (ds)-DNA and anti-nuclear autoantibodies (ANA) ;Primary end point(s): Harvey Bradshaw Index (HBI) scores Crohn’s disease Activity Index (CDAI) scores Inflammatory Bowel Disease Questionnaire (IBDQ) scores—

Countries

Austria, Belgium, Czech Republic, Estonia, Finland, Hungary, Italy, Latvia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026