A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
|ClinicalTrials.gov Identifier: NCT00552344|
Recruitment Status : Completed
First Posted : November 1, 2007
Results First Posted : January 21, 2016
Last Update Posted : February 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Biological: Cimzia||Phase 3|
This study consisted of:
- Induction Period (dosing at Weeks 0, 2, and 4)
- Maintenance Dosing (dosing every 4 weeks up to Week 260)
- End of Treatment Visit that occurred at Week 262/Withdrawal Visit and a Safety Follow-up Visit (SFU; 12 weeks after final dose)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||403 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2008|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
Experimental: Certolizumab Pegol
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
- Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks) [ Time Frame: From study start to the end of the Safety Follow-up Period (up to 272 weeks) ]An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
- Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks) [ Time Frame: From study start to the end of the Safety Follow-up Period (up to 272 weeks) ]An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.
- Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262) [ Time Frame: Week 262 ]HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
- Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262) [ Time Frame: Week 262 ]IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.
- Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52) [ Time Frame: Week 52 ]Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
- 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 [ Time Frame: From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks) ]Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 [NCT00552058] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552344
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|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|