NCT01218360
Completed
Not Applicable
Observational Study on Disease Severity, Evaluation Tools and the Long Term Impact of Each Treatment Strategy in the Daily Clinical Practice in Patients With Moderate to Severe Active Crohn's Disease (Protocol P06484)
Overview
- Phase
- Not Applicable
- Intervention
- Physician standard-of-care
- Conditions
- Crohn Disease
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 71
- Primary Endpoint
- Record of treatment strategy followed
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This is an observational study to determine the prevalence of moderate to severe Crohn's disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a standard clinical practice.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Participants
All participants enrolled
Intervention: Physician standard-of-care
Outcomes
Primary Outcomes
Record of treatment strategy followed
Time Frame: Week 0 to 2 years
Percentage of Crohn's disease participants among the study population with a Crohn's Disease Activity Index (CDAI) score of 220-450 at the enrollment to the study.
Time Frame: Week 0
Change in the CDAI score during the observational period
Time Frame: Week 0 to 2 years
Secondary Outcomes
- Number of surgeries and hospitalizations during the observational period(Week 0 to 2 years)
Similar Trials
Active, not recruiting
Not Applicable
Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohn's Disease PatientsCrohn DiseaseNCT06324591Meyer Children's Hospital IRCCS30
Recruiting
Phase 2
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's DiseaseCrohn's DiseaseNCT06548542AbbVie540
Withdrawn
Phase 2
Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's DiseaseCrohns DiseaseCrohn's DiseaseNCT04151225GlaxoSmithKline
Recruiting
Phase 3
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseNCT06332534AbbVie110
Active, not recruiting
Phase 1
Study to Evaluate Safety, Tolerability and Efficacy of Oral E-B-FAHF-2 in Mild-to-Moderate Crohn's DiseaseCrohn's DiseaseNCT03992469Icahn School of Medicine at Mount Sinai7