Phase 3
Completed N=306
Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
Pediatric Crohn's Disease
Source: ClinicalTrials.gov NCT02772965 ↗
Enrolled (actual)
306
Serious AEs
17.2%
Results posted
Apr 2023
Primary outcomePrimary: Percent of Participants Experiencing Treatment Failure — 25.64; 34.04 percentage of participants — p=0.08
◆ Published Evidence
Established
40citations · ~13 / year
Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn's Disease: A Pragmatic Randomized Trial.
Summary
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.
Linked Publications
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Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn's Disease: A Pragmatic Randomized Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Experiencing Treatment Failure |
25.64; 34.04 | 0.08 |
| SECONDARY Mean Patient Reported Outcome Measurement and Information System (PROMIS ) Pain Interference T-score-52 Weeks |
37.5; 39.5 | 0.32 |
| SECONDARY Mean Patient Reported Outcome Measurement and Information System (PROMIS ) Pain Interference T-score-week 104 |
38.1; 39.9 | 0.69 |
| SECONDARY Mean PROMIS (Patient Reported Outcome Measurement and Information System) Fatigue T Score-week 52 |
41.8; 41.8 | 0.72 |
| SECONDARY Mean PROMIS (Patient Reported Outcome Measurement and Information System) Fatigue T Score-week 104 |
41.1; 41.5 | 0.64 |
| SECONDARY Percent of Patients With Positive Anti-TNF Antibody |
28.5; 40 | 0.08 |
Eligibility Criteria
Inclusion Criteria
- Pediatric Crohn's Disease (PCD) patients, 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 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 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
Data sourced from ClinicalTrials.gov (NCT02772965) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.