Evaluate the Effect of Low-Dose Oral Methotrexate in Pediatric Crohn's Disease With an Anti-TNF

Clinical Trial

Offered by: Nemours Children's
Location: Delaware Valley, Jacksonville, Fla. and Orlando, Fla. 

Trial Name

Evaluate the Effect of Low-Dose Oral Methotrexate in Pediatric Crohn's Disease With an Anti-TNF.

What is the trial about?

To determine whether, in children with Crohn’s disease initiating biological therapy with Remicade or Humira®, combined with low-dose oral methotrexate is more effective than placebo in the induction and subsequent maintenance of steroid-free remission for a treatment period of up to two years.

Who can participate?

Less than 21 years of age. Patient should weigh greater to or equal to 20 kg. Initiating Remicade or Humira®, consenting within 4 weeks of starting.

What is involved?

Crohn's disease patient <21 years. Patients greater the 20 kg. Patient who just started on a biologic. Duration of administration is 24 months with a two year follow up period. Two arms in the study; 1) methotrexate, folic acid and zofran, 2) placebo methotrexate, placebo zofran and folic acid. The patient will be randomized to a group. No extra visits will be need, just your regular GI appointment. All medication or placebos will be mailed to your home address.

All blood, CT, MRI and X-rays will be standard of care. There will not be any extra procedures. There is an optional two blood draws through the study. Patient will be compensated for extra blood draws if consented.