Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy

Overview

About this study

The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF therapy is more effective than treatment with anti-TNF therapy alone in inducing and maintaining steroid-free remission for children with Crohn's Disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Pediatric Crohn's Disease (PCD) patients, < 21 years of age, ≥20 kg, initiating anti-TNF therapy with infliximab or adalimumab.
  • Diagnosis of Crohn's Disease (CD) established confirmed by the treating clinician, and established by standard clinical criteria (radiography, endoscopy, histology).
  • Ability to provide parental permission and child assent (where applicable), or adult consent for patients ages 18-20.

Exclusion Criteria:

  • Prior use of anti-TNF or other biological therapy for CD.
  • Lack of stable home address that study medications can be mailed to.
  • Anticipated short length of follow up at study center (plans for family to move, transition to adult GI (gastrointestinal) provider, etc.). Patients expected to leave practice < 24 months from enrollment should not be enrolled.
  • Concurrent pelvic or abdominal abscess. A recent history of abdominal or pelvic abscess, which is controlled, does not exclude the subject.
  • Prior intra-abdominal surgery without a clinically significant relapse (i.e. patients starting on anti-TNF for post-op prophylaxis or for endoscopic recurrence only should not be included).
  • Receipt of a live virus vaccine within the last 30 days.
  • Pregnancy, planning to become pregnant, or high risk of pregnancy as determined by the local investigator.
  • Breastfeeding.
  • Refusal to stay abstinent or utilize 2 forms of birth control while on study medication (for female patients).
  • BMI ≥ 98% for gender and age.
  • Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years). A recent history of basal cell or squamous cell carcinoma, which is considered surgically cured, does not exclude the subject.Those with a recent history of colonic adenoma or dysplastic lesions should be excluded.
  • Known high alcohol consumption (more than seven drinks per week).
  • Patients with serum albumin < 2.5 g/dl at baseline.
  • Patients with white blood cell count (WBC) < 3.0 x109th/L at baseline.
  • Patients with platelet count < 100 x109th/L.
  • Patients with initial elevation of liver enzymes (AST or ALT) > 1.5 times above normal limit at baseline.
  • Patients with known active infection with Clostridium difficile (C. difficile) (untreated infection based on clinician assessment does not apply to colonization or infection controlled with current or prior treatment.).
  • Patients with pre-existing hepatic disease.
  • Patients with pre-existing renal dysfunction (creatinine > 0.8 for children age<10, creatinine > 1.2 mg/dl for children age 10-18, and creatinine > 1.5 mg/dl for adults age 18 years and older).
  • Patients with a pre-existing chronic lung disease other than well controlled asthma.
  • Current treatment with one of the following drugs: Probenecid (Probalan), Acitretin (Soriatane), Streptozocin (Zanosar), Azathioprine (Imuran, Azasan), 6-mercaptopurine (Purinethol, Purixan).
  • Other concerns about the patient/family's ability to participate in the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Stephens, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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