Clinical study to assess the long term safety of certolizumab pegol, administered at weeks 0, 2 and 4 and every 4 weeks thereafter, in patients with Crohn's disease and who participated in a previous study encoded C87085
- Conditions
- Crohn`s diseaseMedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2007-002716-26-AT
- 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
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
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
- Secondary Outcome Measures
Name Time Method