Phase 3
Completed N=402
A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
Source: ClinicalTrials.gov NCT00552344 ↗Enrolled (actual)
402
Serious AEs
37.1%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks) — 89.6 percentage of subjects
Summary
The primary objective of the study is to assess the safety of long term therapy with Certolizumab Pegol in those subjects participating in study C87085 [NCT00552058].
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks) |
89.6 | — |
| PRIMARY Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks) |
37.1 | — |
| SECONDARY Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262) |
11.6 | — |
| SECONDARY Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262) |
7.8 | — |
| SECONDARY Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52) |
6.317 | — |
| SECONDARY Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088 |
10.2 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- Female who is pregnant or breast feeding
- Female of child bearing age or post puberty males not practicing effective birth control
- 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
Data sourced from ClinicalTrials.gov (NCT00552344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.