Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
Status: | Recruiting |
---|---|
Conditions: | Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | Any - 20 |
Updated: | 11/1/2018 |
Start Date: | October 2016 |
End Date: | December 2020 |
Contact: | Michael D Kappelman, MD |
Email: | michael_kappelman@med.unc.edu |
Phone: | (919) 843-5908 |
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF Therapy
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.
therapy is more effective than treatment with anti-TNF therapy alone in inducing and
maintaining steroid-free remission for children with Crohn's Disease.
Overall study duration: 4 years Multi-center study: up to 42 centers
Number of subjects: 425 Duration of treatment for each subject: up to 104 weeks (2 years)
The primary endpoint is time to treatment failure.
Number of subjects: 425 Duration of treatment for each subject: up to 104 weeks (2 years)
The primary endpoint is time to treatment failure.
Inclusion Criteria:
- Pediatric Crohn's Disease (PCD) patients, < 21 years of age, ≥20 kg, initiating
anti-TNF therapy with infliximab or adalimumab (including biosimilars).
- 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
- Patients with white blood cell count (WBC) < 3.0 x109th/L
- Patients with platelet count < 100 x109th/L
- Patients with initial elevation of liver enzymes (AST or ALT) > 1.5 times above normal
limit
- 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
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