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 - ND
- Conditions
- Crohn?s diseaseMedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease
- Registration Number
- EUCTR2007-002716-26-IT
- Lead Sponsor
- CB Celltech
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1.Subject participated in study C87085 in which the subject completed the study at Week 6
OR
the subject completed the week 2 assessment and whose Crohn?s disease was significantly worse as determined by the investigator and whose CDAI score at entry into the study is either:
at least 70 points higher than week 0 in C87085 OR
higher than week 0 in C87085 with an absolute CDAI score of at least 350 points
Subjects may have received active or placebo treatment in C87085
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 (Appendix 17.4) 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
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 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
- Secondary Outcome Measures
Name Time Method