An open-label multi-center single-cohort study to assess the safety and efficacy of certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek patients who have previously responded to infliximab but who no longer have a sustained response or became intolerant to infliximab
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
certolizumab pegol 400 mg (lyophilized product) administered as 2 x 200 mg subcutaneous injections at Weeks 0, 2, 4, 8 and 12. Treatment duration: 12 weeks.
Unnamed facility
Heraklion, Crete, Greece
Unnamed facility
Athens, Greece
Unnamed facility
Ioannina, Greece
Unnamed facility
Piraeus, Greece
Unnamed facility
Thessaloniki, Greece
Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time frame: Baseline, Week 6
Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time frame: Baseline to Weeks 1, and 14 or Withdrawal
Number of Patients With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time frame: Baseline to Weeks 1, 6 and 14
Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time frame: Weeks 1, 6 and 14 or Withdrawal
Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
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The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time frame: Weeks 1, 2, 4, 6, 8, 12 and 14
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time frame: Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14
C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
Time frame: Weeks 1, 2, 4, 6, 8, 12 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14
The IBDQ Total Score is the sum of 32 responses, each ranging from 0 to 7, thus the Total Score ranges from 0 to 224; a higher score indicating a better quality of life.
Time frame: Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14
The IBDQ Bowel Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
Time frame: Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14
The IBDQ Systemic Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
Time frame: Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14
The IBDQ Emotional Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
Time frame: Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14
The IBDQ Social Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
Time frame: Baseline, and Weeks 6 and 14