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

Conditions: Crohn`s disease
MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease

Registration Number: EUCTR2007-002716-26-CZ

Lead Sponsor: CB Celltech

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>To obtain data on the plasma concentrations of certolizumab pegol and antibodies to certolizumab pegol<br>To obtain data on the plasma concentrations of anti-double-stranded (ds)-DNA and anti-nuclear (ANA) autoantibodies<br>;Primary end point(s): Harvey Bradshaw Index (HBI) scores <br>Crohn’s disease Activity Index (CDAI) scores <br>Inflammatory Bowel Disease Questionnaire (IBDQ) scores <br>

Secondary Outcome Measures

Name	Time	Method

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