Trial Outcomes & Findings for Cimzia Versus Mesalamine for Crohn's Recurrence (NCT NCT01696942)
NCT ID: NCT01696942
Last Updated: 2018-01-12
Results Overview
To evaluate the difference in clinical recurrence rates between certolizumab and mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI). CDAI scores of 150 or greater are considered a recurrence.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
4 weeks, 3 months, 6 months, 9 months, and 12 months
Results posted on
2018-01-12
Participant Flow
Participant milestones
| Measure |
Cimzia Treatment Arm
Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.
Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks
|
Mesalamine Treatment Arm
Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.
Mesalamine: mesalamine 800 mg orally three times daily
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Cimzia Treatment Arm
Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.
Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks
|
Mesalamine Treatment Arm
Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.
Mesalamine: mesalamine 800 mg orally three times daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
screen failure
|
0
|
1
|
Baseline Characteristics
Cimzia Versus Mesalamine for Crohn's Recurrence
Baseline characteristics by cohort
| Measure |
Cimzia Treatment Arm
n=3 Participants
Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.
Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks
|
Mesalamine Treatment Arm
n=2 Participants
Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.
Mesalamine: mesalamine 800 mg orally three times daily
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 4 weeks, 3 months, 6 months, 9 months, and 12 monthsPopulation: Subjects who received CDAI questionnaire. Number of participants fluctuates due to withdrawals and missed appointments.
To evaluate the difference in clinical recurrence rates between certolizumab and mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI). CDAI scores of 150 or greater are considered a recurrence.
Outcome measures
| Measure |
Cimzia Treatment Arm
n=5 Participants
Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.
Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks
|
Mesalamine Treatment Arm
n=3 Participants
Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.
Mesalamine: mesalamine 800 mg orally three times daily
|
|---|---|---|
|
Clinical Recurrence Rates of Crohn's Disease
4 week CDAI recurrence
|
3 Participants
|
1 Participants
|
|
Clinical Recurrence Rates of Crohn's Disease
3 month CDAI reccurence
|
2 Participants
|
1 Participants
|
|
Clinical Recurrence Rates of Crohn's Disease
6 month CDAI recurrence
|
1 Participants
|
2 Participants
|
|
Clinical Recurrence Rates of Crohn's Disease
9 month CDAI recurrence
|
2 Participants
|
0 Participants
|
|
Clinical Recurrence Rates of Crohn's Disease
12 month CDAI recurrence
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One year following enrollmentPopulation: Subjects available for colonoscopy at 12 month visit. This visit was sometimes separated from the overall 12-month visit so only 1 (cimzia) and 2 (mesalamine) patients respectively had the colonoscopy performed.
To compare the endoscopic recurrence rates at one year following surgery between patients treated with certolizumab and mesalamine.
Outcome measures
| Measure |
Cimzia Treatment Arm
n=1 Participants
Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.
Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks
|
Mesalamine Treatment Arm
n=2 Participants
Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.
Mesalamine: mesalamine 800 mg orally three times daily
|
|---|---|---|
|
Number of Participants With Endoscopic Recurrence of Crohn's Disease
|
0 Participants
|
0 Participants
|
Adverse Events
Cimzia Treatment Arm
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Mesalamine Treatment Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cimzia Treatment Arm
n=5 participants at risk
Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.
Cimzia: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks
|
Mesalamine Treatment Arm
n=5 participants at risk
Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.
Mesalamine: mesalamine 800 mg orally three times daily
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
40.0%
2/5 • Number of events 2
|
0.00%
0/5
|
|
General disorders
dehydration
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
Episcleritis
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
General disorders
fatigue
|
40.0%
2/5 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Abdominal Pain
|
40.0%
2/5 • Number of events 2
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Perianal rash
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
papular rash
|
40.0%
2/5 • Number of events 2
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal ache
|
40.0%
2/5 • Number of events 2
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
anemia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
ulcer (anastamotic)
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Psychiatric disorders
Attention Deficit
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
melena
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Psychiatric disorders
panic attack
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary nodules
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
General disorders
insomnia
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
seizure
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Urinary Tract infection
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
|
Gastrointestinal disorders
constipation
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
fecal calprotectin elevation
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
General disorders
Headache
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Elevated CRP
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
colon inflammation
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
cramping with BM
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Crohn's flare
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place