Clinical Trial: Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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
Brief 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.
Detailed Summary:
Overall study duration: 4 years Multi-center study: up to 50 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.
Sponsor: University of North Carolina, Chapel Hill
Current Primary Outcome: Time to treatment failure [ Time Frame: Continuous from randomization through week 104 ]
Original Primary Outcome: Time to treatment failure [ Time Frame: Continuous from randomization through week 104 ]
Current Secondary Outcome:
- Mean PROMIS (Patient Reported Outcome Measurement and Information System) Pain Interference T score by treatment arm [ Time Frame: Week 52 and 104 from randomization ]T scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores above 50 represent higher than average pain interference and scores below 50 represent lower than average pain interference. We will compare the mean of PROMIS Pain Interference T scores at week 52 and week 104 between the treatment groups. Minimal important differences (MIDs) for many PROMIS domains are in the range of 2 to 6.
- Mean PROMIS (Patient Reported Outcome Measurement and Information System) Fatigue T score by treatment arm [ Time Frame: Week 52 and 104 from randomization ]T scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores above 50 represent higher than average fatigue and scores below 50 represent lower than average fatigue. We will compare the mean of PROMIS Fatigue T scores at week 52 and week 104 between the treatment groups. Minimal important differences (MIDs) for many PROMIS domains are in the range of 2 to 6.
- Proportion of patients with positive anti-TNF antibody status [ Time Frame: Between week 91 and week 104 from randomization ]Proportion of patients with positive anti-TNF antibody status will be compared between the two treatment groups using the chi-squared test. The year two sample will be collected at a single time point between week 91 and week 104 from randomization. if a sample is not collected in the second year, the sample collected in the first year will be used (week 14).
Original Secondary Outcome:
- Mean PROMIS (Patient Reported Outcome Measurement and Information System) Pain Interference T score by treatment arm [ Time Frame: Week 52 and 104 from randomization ]T scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores above 50 represent higher than average pain interference and scores below 50 represent lower than average pain interference. We will compare the mean of PROMIS Pain Interference T scores at week 52 and week 104 between the treatment groups. Minimal important differences (MIDs) for many PROMIS domains are in the range of 2 to 6.
- Mean PROMIS (Patient Reported Outcome Measurement and Information System) Fatigue T score by treatment arm [ Time Frame: Week 52 and 104 from randomization ]T scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores above 50 represent higher than average fatigue and scores below 50 represent lower than average fatigue. We will compare the mean of PROMIS Fatigue T scores at week 52 and week 104 between the treatment groups. Minimal important differences (MIDs) for many PROMIS domains are in the range of 2 to 6.
- Mean anti-TNF trough levels by treatment arm [ Time Frame: Between week 91 and week 104 from randomization ]Mean anti-TNF trough levels will be compared between the two treatment groups using Wilcoxon rank-sum test. The year two sample will be collected at a single time point between week 91 and week 104 from randomization.
- Proportion of patients with positive anti-TNF antibody status [ Time Frame: Between week 91 and week 104 from randomization ]Proportion of patients with positive anti-TNF antibody status will be compared between the two treatment groups using the chi-squared test. The year two sample will be collected at a single time point between week 91 and week 104 from randomization.
Information By: University of North Carolina, Chapel Hill
Dates:
Date Received: April 27, 2016
Date Started: October 2016
Date Completion: December 2020
Last Updated: December 2, 2016
Last Verified: December 2016