Clinical Trials Logo

Clinical Trial Summary

The investigators will test the hypothesis that that greater efficacy of anti-tumor necrosis factor (antiTNF) therapy results in reduced need for bowel resection surgery, fewer serious infections, and reduced short term mortality risks, and therefore has a more favorable benefit to harm profile than corticosteroids for inflammatory bowel disease.


Clinical Trial Description

The investigators will conduct a comparative effectiveness study among Medicare Parts A, B, and D beneficiaries with inflammatory bowel disease. The investigators will compare the incidence of severe infection, bowel resection surgery, and death among new users of anti-tumor necrosis factor therapies and corticosteroids. The investigators will compute propensity scores to describe the propensity for treatment with anti-tumor necrosis factor drugs compared to corticosteroids, and will match corticosteroids and anti-tumor necrosis factor drug treated patients on the propensity score. Cox regression will be employed to assess the hazard ratio for each of the outcomes. ;


Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT02316678
Study type Observational
Source University of Pennsylvania
Contact
Status Active, not recruiting
Phase N/A
Start date September 2014
Completion date December 2016

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03815851 - Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery N/A
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Completed NCT02883452 - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis Phase 1
Recruiting NCT04777656 - Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. Phase 3
Terminated NCT03017014 - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Recruiting NCT06053424 - Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease Phase 1
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Terminated NCT02882841 - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients N/A
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A
Completed NCT02542917 - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Completed NCT03010787 - A First Time in Human Study in Healthy Volunteers and Patients Phase 1
Terminated NCT02417974 - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) Phase 2
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT02193048 - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
Completed NCT01951326 - Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease Phase 3
Completed NCT01958827 - A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease Phase 3