Crohn's Disease
Conditions
Keywords
Certolizumab pegol, Cimzia, Crohn's disease, Greek patients
Brief summary
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
Interventions
BIOLOGICALCertolizumab pegol
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.
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adult men and women with Crohn's disease previously responsive to infliximab who became non-responsive or intolerant
Exclusion criteria
* Symptomatic obstructive intestinal strictures * Bowel resection within 4 weeks * Current total parenteral nutrition * Short bowel syndrome * Concomitant disease or pathological condition that could interfere with Crohn's disease or to be harmful for the well being of the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6 | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline to 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. |
| Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal | 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. |
| Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14 | 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. |
| Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14 | Baseline to 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. |
| C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14 | Weeks 1, 2, 4, 6, 8, 12 and 14 | — |
| 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 | Baseline to 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. |
| Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14 | 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. |
| Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14 | 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. |
| Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14 | 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. |
| Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14 | 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. |
| Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14 | 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. |
Countries
Greece
Participant flow
Recruitment details
This study screened 17 subjects in 7 sites in Greece. The first subject was screened in March 2007 and the last subject was screened in February 2008. Of the 17 subjects screened, 16 were included in the Intention-to-treat population, i.e., were enrolled in the study and received at least one dose of study medication.
Participants by arm
| Arm | Count |
|---|---|
| Certolizumab Pegol 400 mg Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12 | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Certolizumab Pegol 400 mg |
|---|---|
| Age Continuous | 42.45 years STANDARD_DEVIATION 15.4 |
| Body Height | 168.7 cm STANDARD_DEVIATION 9.2 |
| Body Mass Index | 22.20 kg/m^2 STANDARD_DEVIATION 4.98 |
| Body Weight | 64.0 kg STANDARD_DEVIATION 19.5 |
| Region of Enrollment Greece | 16 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 16 |
| serious Total, serious adverse events | 3 / 16 |
Outcome results
Primary
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
Population: This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 400 mg | Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6 | 7 participants |
Secondary
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
Population: Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Secondary
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
Population: Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Secondary
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: Weeks 1, 2, 4, 6, 8, 12 and 14
Population: Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Secondary
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
Population: Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Secondary
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
Population: Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Secondary
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
Population: Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Secondary
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
Population: Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Secondary
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
Population: Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Secondary
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
Population: This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Certolizumab Pegol 400 mg | Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal | Week 1 | 3 participants |
| Certolizumab Pegol 400 mg | Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal | Week 6 | 5 participants |
| Certolizumab Pegol 400 mg | Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal | Week 14 or Withdrawal | 3 participants |
Secondary
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
Population: This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Certolizumab Pegol 400 mg | 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 | Week 1 | 6 participants |
| Certolizumab Pegol 400 mg | 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 | Week 14 or Withdrawal | 6 participants |
Secondary
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
Population: Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.