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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02413047
Date of registration: 06/03/2015
Prospective Registration: Yes
Primary sponsor: Indiana University
Public title: Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator
Scientific title: A Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an Immunomodulator
Date of first enrolment: May 2015
Target sample size: 3
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02413047
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Matthew Bohm, DO
Address: 
Telephone:
Email:
Affiliation:  IndianaU IRB
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with inflammatory bowel disease who on are stable doses of infliximab or
adalimumab for at least 3 months who experience a secondary loss of response to the
medication based on clinical symptoms.

- Presence of at least one objective marker of active disease: active disease based on
endoscopy, elevated fecal calprotectin or serologic markers of inflammation
(C-reactive protein or sedimentation rate).

- Crohn's patients have a Harvey Bradshaw index >5

- Ulcerative colitis patients have a Ulcerative Colitis Clinical Score > 5

- Have an undetectable or inadequate trough level of infliximab or adalimumab and
detectable ATI or ADA.

- Oral corticosteroid therapy is allowed. (prednisone at a stable dose =30 mg/day,
budesonide at a stable dose =9 mg/day, or equivalent steroid) provided that the dose
has been stable for the 4 weeks immediately prior to enrollment if corticosteroids
have recently been initiated

Exclusion Criteria:

- Previous noncompliant with medications

- < 18 years of age or >80 years of age.

- Congestive heart failure

- Abnormal liver tests alanine aminotransferase (ALT) or aspartate aminotransferase
(AST) 2 × the upper limit of normal (ULN) or leucopenia WBC count <3 × 109/L

- Pregnant or planning on becoming pregnant.

- Active tuberculosis or hepatitis B infection

- Any cancer within the past 5 years. (Exception non-melanomatous skin cancer.)

- Receiving any immunomodulator therapy within the past 3 months

- Evidence of or treatment for C. difficile infection within 60 days or other intestinal
pathogen within 30 days prior to enrollment

- Clinically significant extra-intestinal infection (e.g., pneumonia, pyelonephritis)
within 30 days of the initial screening visit

- Any live vaccinations within 30 days prior to study drug administration except for the
influenza vaccine

- Any identified congenital or acquired immunodeficiency (e.g., common variable
immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation)

- Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal,
endocrine/metabolic, or other medical disorder that, in the opinion of the
investigator, would confound the study results or compromise patient safety

- Unable to give own informed consent



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Inflammatory Bowel Disease
Ulcerative Colitis
Intervention(s)
Drug: 6 mercaptopurine
Drug: Azathioprine
Drug: Methotrexate
Primary Outcome(s)
Change Inflammatory Bowel Disease Questionnaire SIBDQ [Time Frame: 4 months]
Eliminate Antibodies: Threshold Levels for ATI is < 3.1and is < 1.7 for ADA. [Time Frame: 4 months]
Harvey Bradshaw Index HBI: Decrease >3 Points or Remission Score<5 [Time Frame: 4 months]
Therapeutic Trough Level for Infliximab is Defined as >3 and as > 5 for Adalimumab. [Time Frame: 4 months]
Ulcerative Colitis Clinical Score UCCS Decrease >3 Points or Remission Score <3 [Time Frame: 4 months]
Secondary Outcome(s)
Improvement or Normalization of C-reactive Protein, Sedimentation Rate and Fecal Calprotectin [Time Frame: 4 months]
Improvement or Normalization of Mayo Endoscopy Score for UC Patients [Time Frame: 4 months]
Improvement or Normalization of the Simple Endoscopic Score-Crohn's Disease (SES-CD) [Time Frame: 4 months]
Secondary ID(s)
1502834262
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 04/11/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02413047
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