Trial Outcomes & Findings for Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab (NCT NCT00307931)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

16 participants

Primary outcome timeframe

Baseline, Week 6

Results posted on

2011-08-31

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Certolizumab Pegol 400 mg Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Certolizumab Pegol 400 mg Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Study Adverse Event	1

Baseline Characteristics

Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Certolizumab Pegol 400 mg n=16 Participants Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Age Continuous	42.45 years STANDARD_DEVIATION 15.40 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Greece	16 participants n=5 Participants
Body Height	168.7 cm STANDARD_DEVIATION 9.2 • n=5 Participants
Body Mass Index	22.20 kg/m^2 STANDARD_DEVIATION 4.98 • n=5 Participants
Body Weight	64.0 kg STANDARD_DEVIATION 19.5 • n=5 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=16 Participants Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
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 outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=16 Participants Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=16 Participants Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
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
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Certolizumab Pegol 400 mg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Certolizumab Pegol 400 mg n=16 participants at risk Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Gastrointestinal disorders Diarrhoea	12.5% 2/16 • Number of events 2 • Adverse event data were collected during the treatment period and safety follow-up period, namely until 12 weeks following the last dose of study medication for each subject (which could be a time frame up to 24 weeks).
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • Number of events 1 • Adverse event data were collected during the treatment period and safety follow-up period, namely until 12 weeks following the last dose of study medication for each subject (which could be a time frame up to 24 weeks).
Infections and infestations Streptococcal sepsis	6.2% 1/16 • Number of events 1 • Adverse event data were collected during the treatment period and safety follow-up period, namely until 12 weeks following the last dose of study medication for each subject (which could be a time frame up to 24 weeks).
General disorders Pyrexia	12.5% 2/16 • Number of events 2 • Adverse event data were collected during the treatment period and safety follow-up period, namely until 12 weeks following the last dose of study medication for each subject (which could be a time frame up to 24 weeks).

Other adverse events

Other adverse events
Measure	Certolizumab Pegol 400 mg n=16 participants at risk Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Gastrointestinal disorders Crohn's disease	12.5% 2/16 • Number of events 2 • Adverse event data were collected during the treatment period and safety follow-up period, namely until 12 weeks following the last dose of study medication for each subject (which could be a time frame up to 24 weeks).
Infections and infestations Perianal abscess	6.2% 1/16 • Number of events 1 • Adverse event data were collected during the treatment period and safety follow-up period, namely until 12 weeks following the last dose of study medication for each subject (which could be a time frame up to 24 weeks).
Investigations C-reactive protein increased	12.5% 2/16 • Number of events 2 • Adverse event data were collected during the treatment period and safety follow-up period, namely until 12 weeks following the last dose of study medication for each subject (which could be a time frame up to 24 weeks).

Additional Information

UCB Clinical Trial Call Center

UCB Pharma

Phone: +1 877 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Publication restrictions are in place

Restriction type: OTHER