Crohn's Disease
Conditions
Keywords
CDP870, certolizumab pegol, Crohn's Disease
Brief summary
This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).
Interventions
BIOLOGICALCertolizumab pegol
Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg). Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2.
Sponsors
UCB Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients previously enrolled in C87059 (COSPAR I, NCT00349752)
Exclusion criteria
* Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions * Subject who received treatment other than study medication and other than medications permitted in C87059 (COSPAR I, NCT00349752) * Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks) | During this study (maximum 122 weeks) | Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids. | Week 34 in this study | Crohn's disease activity index (CDAI) is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34. |
Countries
Canada, Germany, United States
Participant flow
Recruitment details
The study was started in January 2007 with recruitment occurring in the United States, Germany, and Canada. The study had last patient last visit in February of 2010.
Participants by arm
| Arm | Count |
|---|---|
| Placebo/Completer Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059. | 14 |
| CDP870/Completer CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059. | 16 |
| Placebo/Non-completer Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids). | 40 |
| CDP870/Non-completer CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids). | 33 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Lack of Efficacy | 36 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other: Azathioprine stopped | 1 |
| Overall Study | Other: Failed to meet Inc/Exc criteria | 1 |
| Overall Study | Other: Principal investigator discretion | 3 |
| Overall Study | Other: Sponsor request | 1 |
| Overall Study | Other: Subject chose commerical dosing | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Placebo/Completer | CDP870/Completer | Placebo/Non-completer | CDP870/Non-completer | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 16 Participants | 39 Participants | 32 Participants | 101 Participants |
| Age, Continuous | 44.00 years STANDARD_DEVIATION 12.53 | 39.31 years STANDARD_DEVIATION 12.83 | 38.44 years STANDARD_DEVIATION 13.73 | 41.38 years STANDARD_DEVIATION 13.75 | 40.27 years STANDARD_DEVIATION 13.39 |
| Region of Enrollment Canada | 4 participants | 6 participants | 7 participants | 10 participants | 27 participants |
| Region of Enrollment Germany | 2 participants | 0 participants | 2 participants | 2 participants | 6 participants |
| Region of Enrollment United States | 8 participants | 10 participants | 31 participants | 21 participants | 70 participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 22 Participants | 18 Participants | 55 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 18 Participants | 15 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 14 | 15 / 16 | 31 / 40 | 27 / 33 | 84 / 103 |
| serious Total, serious adverse events | 5 / 14 | 0 / 16 | 6 / 40 | 4 / 33 | 15 / 103 |
Outcome results
Primary
Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)
Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.
Time frame: During this study (maximum 122 weeks)
Population: All subjects in the the Intent to Treat (ITT) population are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo/Completer | Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks) | 12 subjects |
| CDP870/Completer | Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks) | 15 subjects |
| Placebo/Non-completer | Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks) | 32 subjects |
| CDP870/Non-completer | Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks) | 30 subjects |
Secondary
Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.
Crohn's disease activity index (CDAI) is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.
Time frame: Week 34 in this study
Population: All subjects in the the Intent to Treat (ITT) population are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo/Completer | Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids. | 28.6 percentage of subjects |
| CDP870/Completer | Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids. | 37.5 percentage of subjects |
| Placebo/Non-completer | Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids. | 35.0 percentage of subjects |
| CDP870/Non-completer | Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids. | 3.0 percentage of subjects |