Clinical Trials Logo
  1. Home
  2. Crohn's Disease
  3. NCT02193048
  4. Details
NCT02193048 Clinical Trial

Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease

Crohn's Disease Clinical Trial

— PROGNOS  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02193048
Other study ID # 000150
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2014
Est. completion date December 31, 2021

Study information
Verified date October 2021
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to prospectively evaluate a scoring system to predict a mild course of disease in patients newly diagnosed with Crohn's disease.

Recruitment information / eligibility
Status Completed
Enrollment 216
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: All patients with Crohn's disease who - have been newly diagnosed (initial diagnosis not more than 6 weeks previously) and - are as yet untreated (permitted medications are a maximum of 10 days of 5-aminosalicylates (5-ASA) or glucocorticosteroids and antibiotics for non-intestinal indications) and - have consented to the documentation of their patient data and - agree to the up to 5-year documentation of the course of disease Exclusion Criteria: - Pre-treatment with 5-ASA > 10 days - Treatment with steroids > 10 days - Treatment with antibiotics, immunosuppressants or biological agents > 10 days

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• This study will evaluate a new clinical scoring system in patients receiving routine treatment
Treatment for Crohn's disease will be performed routinely based on the treating physicians clinical determination and patients' needs.

Locations
Country Name City State
Germany Investigational site (there may be other sites in this country) Altenholz

Sponsors (1)
Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of a Crohn's scoring system Measured as percentage of patients with a low score at initial diagnosis having a mild course of disease during the 5 year follow-up period. Up to 5 years
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 NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
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
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With 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
Completed NCT03010787 - A First Time in Human Study in Healthy Volunteers and Patients Phase 1
Completed NCT02542917 - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Terminated NCT02417974 - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) Phase 2
Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Completed NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
Completed NCT01958827 - A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease Phase 3
Completed NCT01951326 - Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease Phase 3