Trial Outcomes & Findings for Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator (NCT NCT02413047)
NCT ID: NCT02413047
Last Updated: 2019-11-04
Results Overview
The Harvey-Bradshaw index (HBI) is a simplified version of the CDAI to foster a systematic collection of clinical data related to Crohn's disease. The index considers five parameters, exclusively clinical; patient well-being, abdominal pain, number of liquid or soft stools, abdominal mass, and complications.
TERMINATED
NA
3 participants
4 months
2019-11-04
Participant Flow
Participant milestones
| Measure |
Immunomodulator
Azathioprine, 6 mercaptopurine or methotrexate.
Azathioprine: Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past.
6 mercaptopurine: Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past as an alternative to imuran
Methotrexate: Medication will be given in subcutaneous injection form once a week if the patient cannot take imuran or 6 mercaptopurine.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
Participants on Infliximab
|
2
|
|
Overall Study
Participants on Adalimumab
|
1
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"Normal" c-reactive protein levels are resulted from the laboratory as '\<0.5mg/dL'. Therefore, only levels higher than 0.5mg/dL will be reported.
Baseline characteristics by cohort
| Measure |
Immunomodulator
n=3 Participants
Azathioprine, 6 mercaptopurine or methotrexate.
Azathioprine: Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past.
6 mercaptopurine: Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past as an alternative to imuran
Methotrexate: Medication will be given in subcutaneous injection form once a week if the patient cannot take imuran or 6 mercaptopurine.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 14 • n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=3 Participants
|
|
Duration of Disease
|
16.66666667 years
n=3 Participants
|
|
White Blood Cell Count (WBC)
|
6.566666667 x 10^3 cells/mm^3
n=3 Participants
|
|
Hemoglobin
|
13.63 gm/dL
n=3 Participants
|
|
Platelet Count
|
256.00 x 10^3 cells/mm^3
n=3 Participants
|
|
Aspartate Aminotransferase
|
21.00 units/L
n=3 Participants
|
|
ALT
|
23.67 units/L
n=3 Participants
|
|
Bilirubin
|
0.67 mg/dL
n=3 Participants
|
|
Albumin
|
4.37 gm/dL
n=3 Participants
|
|
Alkaline Phosphatase
|
93.33 units/L
n=3 Participants
|
|
Above-Normal C-Reactive Protein
|
2.0 mg/dL
n=1 Participants • "Normal" c-reactive protein levels are resulted from the laboratory as '\<0.5mg/dL'. Therefore, only levels higher than 0.5mg/dL will be reported.
|
|
Erythrocyte Sedimentation Rate
|
23.67 mm/hr
n=3 Participants
|
|
Calprotectin
|
331.50 mCg/gm
n=3 Participants
|
|
Simple Endoscopic Score for Crohn's Disease
|
6.67 points
n=3 Participants
|
|
Harvey Bradshaw Index (HBI) Score
|
4.67 points
n=3 Participants
|
|
Short Inflammatory Bowel Disease Questionnaire
|
46.00 points
n=3 Participants
|
|
Serum Infliximab concentration
|
6.3 ug/mL
n=1 Participants • Only 2 subjects of 3 subjects were on infliximab for the study. 1 of the 2 subjects had a undetectable trough level (\<1) and the other subject level was 6.3.
|
|
Antibodies to Infliximab concentration
|
20.70 units/mL
n=2 Participants • 2 of the 3 subjects were on infliximab
|
|
Serum Adalimumab concentration
|
2 ug/mL
n=1 Participants • 1 of the 3 subjects were on adalimumab
|
|
Antibodies to Adalimumab concentration
|
2.8 units/mL
n=1 Participants • 1 of 3 subjects on Adalimumab
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Not enough subjects for analysis
The Harvey-Bradshaw index (HBI) is a simplified version of the CDAI to foster a systematic collection of clinical data related to Crohn's disease. The index considers five parameters, exclusively clinical; patient well-being, abdominal pain, number of liquid or soft stools, abdominal mass, and complications.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 monthsPopulation: Not enough subjects for analysis
Trough level is the lowest level of drug detected in a subject prior to next dose of medication
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 monthsPopulation: Not enough subjects for analysis
UCCS is the ulcerative colitis clinical score which is based on disease activity. The score is based on bowel movements, blood in stool, overall well being, and global assessment.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 monthsPopulation: Not enough subjects for analysis
SIBDQ is the short inflammatory bowel disease questionnaire which is a health-related quality of life tool measuring physical, social, and emotional status.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 monthsPopulation: Not enough subjects for analysis
unwanted immunogenicity is an immune response by an organism against a therapeutic antigen. This reaction leads to production of anti-drug antibodies inactivating the therapeutic effects of the treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsPopulation: Not enough subjects for analysis
Mayo endoscopy score is scoring completed during the endoscopy to evaluate disease activity. Scoring is based on stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician rating of disease activity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsPopulation: Not enough subjects for analysis
c-reactive protein, sedimentation rate, and fecal calprotectin were collected to monitor the level of inflammation in the subject. Improvement was determined if inflammation level was reduced.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsPopulation: Not enough subjects for analysis
SESCD is the simple endoscopic score for crohn's disease patients scored during endoscopy. The scoring is based on appearance of ulcers/sizing, % of ulcerative surface, % of affected surface, and if there were any narrowings or strictures found.
Outcome measures
Outcome data not reported
Adverse Events
Immunomodulator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Matthew Bohm, DO (Principal Investigator)
Indiana University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place