Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric… (NCT01802593) | Clinical Trial Compass
TerminatedPhase 4
Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure
Stopped: lack of budget and failure to reach milestones
Israel20 participantsStarted 2013-02
Plain-language summary
The goal of the present study is to evaluate the best regimen for infliximab monotherapy, and to evaluate if limited combination therapy with IFX and an Immunomodulator for the first 6 months of therapy, in prior Immunomodulator failures, is superior to monotherapy with Immunomodulator cessation from the second infusion, in preventing loss of remission to IFX.
Who can participate
Age range6 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Crohns disease
✓. Age: 6 - 18 years ( inclusive)
✓. Active disease PCDAI \>10, or any steroid dependence despite thiopurine use for \>10 weeks.
✓. Naïve to biologics
✓. Informed consent
✓. CRP ≥0.6 mg/dl
✓. Neg. TB-Test, negative HBV- S Ag
✓. Use of IMM at present or in past for at least 10 weeks ( for Withdraw only).
Exclusion criteria
✕. Intolerance to thiopurines/methotrexate
✕. Pregnancy
✕. Contraindication for any of the drugs.
✕. Leukopenia \<4000 or absolute neutrophil count below 1200 on two consecutive tests during screening.