Cyclophosphamide bolus therapy in refractory Crohn’s disease – patient registry

• Conditions: Refractory Crohn's disease; K50; Crohn disease [regional enteritis]

• Registration Number: DRKS00009494
• Lead Sponsor: CED Service GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-02-01
• Study Start: 2015-10-12
• Results First Posted: 2017-11-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Crohn's disease patients with cyclophosphamid bolus therapy
- over 18 years old

Exclusion Criteria

pregnancy and breastfeeding

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of cyclophosphamid bolus therapy by refractory Crohn’s disease – remission induction (CDAI = 150) at week 12 after therapy start

Secondary Outcome Measures

Name	Time	Method
- Optimierung der Therapiestrategie<br>-Effectiveness of cyclophosphamid bolus therapy by refractory Crohn’s disease – remission duration after the cyclophosphami therapy<br>-Safety of the cyclophosphamid bolus therapy by patients with refractory Crohn’s disease (if required SAE/-AE-reporting)<br>-Identification of a patient cohort, which can benefit from the cyclophosphamid bolus therapy<br>- Optimisation of therapy strategy<br>