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

• 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
• 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: Azathioprine

Drug: 6 mercaptopurine

Drug: Methotrexate

Primary Outcome(s)

Eliminate Antibodies: Threshold Levels for ATI is < 3.1and is < 1.7 for ADA. [Time Frame: 4 months]

Change Inflammatory Bowel Disease Questionnaire SIBDQ [Time Frame: 4 months]

Ulcerative Colitis Clinical Score UCCS Decrease >3 Points or Remission Score <3 [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]

Secondary Outcome(s)

Improvement or Normalization of C-reactive Protein, Sedimentation Rate and Fecal Calprotectin [Time Frame: 4 months]

Improvement or Normalization of the Simple Endoscopic Score-Crohn's Disease (SES-CD) [Time Frame: 4 months]

Improvement or Normalization of Mayo Endoscopy Score for UC Patients [Time Frame: 4 months]

Secondary ID(s)

1502834262

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02413047