Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02413047
Recruitment Status : Terminated (physician decision to stop study early due to low enrollment)
First Posted : April 9, 2015
Results First Posted : November 4, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Bohm, Indiana University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Inflammatory Bowel Disease
Ulcerative Colitis
Crohn's Disease
Interventions Drug: Azathioprine
Drug: 6 mercaptopurine
Drug: Methotrexate
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Immunomodulator
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 3
Participants on Infliximab 2
Participants on Adalimumab 1
Completed 3
Not Completed 0
Arm/Group Title Immunomodulator
Hide Arm/Group Description

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 Number of Baseline Participants 3
Hide Baseline Analysis Population Description
Not enough study participants enrolled for data analysis
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
48  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
3
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
 100.0%
Duration of Disease  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants
16.66666667
(4 to 40)
White Blood Cell Count (WBC)  
Mean (Full Range)
Unit of measure:  X 10^3 cells/mm^3
Number Analyzed 3 participants
6.566666667
(6.2 to 7.0)
Hemoglobin  
Mean (Full Range)
Unit of measure:  gm/dL
Number Analyzed 3 participants
13.63
(12.6 to 14.5)
Platelet Count  
Mean (Full Range)
Unit of measure:  X 10^3 cells/mm^3
Number Analyzed 3 participants
256.00
(237 to 292)
Aspartate Aminotransferase  
Mean (Full Range)
Unit of measure:  units/L
Number Analyzed 3 participants
21.00
(16 to 30)
ALT  
Mean (Full Range)
Unit of measure:  units/L
Number Analyzed 3 participants
23.67
(13 to 42)
Bilirubin  
Mean (Full Range)
Unit of measure:  mg/dL
Number Analyzed 3 participants
0.67
(0.60 to 0.70)
Albumin  
Mean (Full Range)
Unit of measure:  gm/dL
Number Analyzed 3 participants
4.37
(4.10 to 4.60)
Alkaline Phosphatase  
Mean (Full Range)
Unit of measure:  units/L
Number Analyzed 3 participants
93.33
(66 to 126)
Above-Normal C-Reactive Protein   [1] [2] 
Measure Type: Number
Unit of measure:  mg/dL
Number Analyzed 1 participants
2.0
[1]
Measure Description: 'Normal" c-reactive protein levels are resulted as <0.5mg/dL
[2]
Measure Analysis Population Description: "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  
Mean (Full Range)
Unit of measure:  Mm/hr
Number Analyzed 3 participants
23.67
(15 to 34)
Calprotectin  
Mean (Full Range)
Unit of measure:  mCg/gm
Number Analyzed 3 participants
331.50
(232 to 431)
Simple Endoscopic Score for Crohn's Disease   [1] 
Mean (Full Range)
Unit of measure:  Points
Number Analyzed 3 participants
6.67
(6.00 to 8.00)
[1]
Measure Description: 0-2 = remission 3-6 = mild endoscopic activity 7-15 = moderate endoscopic activity >15 = severe endoscopic activity
Harvey Bradshaw Index (HBI) Score   [1] 
Mean (Full Range)
Unit of measure:  Points
Number Analyzed 3 participants
4.67
(3 to 6)
[1]
Measure Description: <5 = Remission 5-7 = mild activity 8-16 = moderate activity >16 = severe activity
Short Inflammatory Bowel Disease Questionnaire   [1] 
Mean (Full Range)
Unit of measure:  Points
Number Analyzed 3 participants
46.00
(28 to 56)
[1]
Measure Description: SIBDQ measure the quality of life in patients with IBD. Each question is graded from 1-7. outcomes vary with '32' (very poor quality of life) to 224 (perfect quality of life. Patients in systematic remission typically have a score of 170 or greater. An increase of 16-32 points constitutes clinically meaningful improvement.
Serum Infliximab concentration   [1] [2] 
Measure Type: Number
Unit of measure:  ug/mL
Number Analyzed 1 participants
6.3
[1]
Measure Description: Trough Level: lowest level of drug detected in subjected prior to next dose.
[2]
Measure Analysis Population Description: 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   [1] 
Mean (Full Range)
Unit of measure:  units/mL
Number Analyzed 2 participants
20.70
(18.5 to 22.9)
[1]
Measure Analysis Population Description: 2 of the 3 subjects were on infliximab
Serum Adalimumab concentration   [1] [2] 
Measure Type: Number
Unit of measure:  ug/mL
Number Analyzed 1 participants
2
[1]
Measure Description: Trough level: lowest level of drug detected in subject prior to next dose
[2]
Measure Analysis Population Description: 1 of the 3 subjects were on adalimumab
Antibodies to Adalimumab concentration   [1] 
Measure Type: Number
Unit of measure:  units/mL
Number Analyzed 1 participants
2.8
[1]
Measure Analysis Population Description: 1 of 3 subjects on Adalimumab
1.Primary Outcome
Title Harvey Bradshaw Index HBI: Decrease >3 Points or Remission Score<5
Hide Description

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.

Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough subjects for analysis
Arm/Group Title Immunomodulator
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Therapeutic Trough Level for Infliximab is Defined as >3 and as > 5 for Adalimumab.
Hide Description Trough level is the lowest level of drug detected in a subject prior to next dose of medication
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough subjects for analysis
Arm/Group Title Immunomodulator
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Ulcerative Colitis Clinical Score UCCS Decrease >3 Points or Remission Score <3
Hide Description 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.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough subjects for analysis
Arm/Group Title Immunomodulator
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Change Inflammatory Bowel Disease Questionnaire SIBDQ
Hide Description SIBDQ is the short inflammatory bowel disease questionnaire which is a health-related quality of life tool measuring physical, social, and emotional status.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough subjects for analysis
Arm/Group Title Immunomodulator
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Eliminate Antibodies: Threshold Levels for ATI is < 3.1and is < 1.7 for ADA.
Hide Description 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.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough subjects for analysis
Arm/Group Title Immunomodulator
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Improvement or Normalization of Mayo Endoscopy Score for UC Patients
Hide Description 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
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough subjects for analysis
Arm/Group Title Immunomodulator
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Improvement or Normalization of C-reactive Protein, Sedimentation Rate and Fecal Calprotectin
Hide Description 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.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough subjects for analysis
Arm/Group Title Immunomodulator
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Improvement or Normalization of the Simple Endoscopic Score-Crohn's Disease (SES-CD)
Hide Description 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.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough subjects for analysis
Arm/Group Title Immunomodulator
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Enrollment to 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immunomodulator
Hide Arm/Group Description

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.

All-Cause Mortality
Immunomodulator
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Serious Adverse Events
Immunomodulator
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immunomodulator
Affected / at Risk (%)
Total   0/3 (0.00%) 
The study terminated early due to low subject enrollment. Since only 3 patients were enrolled, study analysis was not possible for measurable outcomes.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Matthew Bohm, DO (Principal Investigator)
Organization: Indiana University
Phone: 3179485136
EMail: mbohm@iu.edu
Layout table for additonal information
Responsible Party: Matthew Bohm, Indiana University
ClinicalTrials.gov Identifier: NCT02413047    
Other Study ID Numbers: 1502834262
First Submitted: March 6, 2015
First Posted: April 9, 2015
Results First Submitted: September 19, 2019
Results First Posted: November 4, 2019
Last Update Posted: November 4, 2019