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NCT01696942 · ClinicalTrials.gov registry record · Phase 4
Cimzia Versus Mesalamine for Crohn's Recurrence
A Phase 4 study, sponsored by Milton S. Hershey Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT01696942 is a Phase 4 study that was terminated before completion, run by Milton S. Hershey Medical Center. The registered enrollment target is 10 participants.
The verdict
NCT01696942, a Phase 4 study, was terminated before completion, sponsored by Milton S. Hershey Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
Hypothesis: Cimzia provides superior reduction in endoscopic and clinical recurrence rates compared to mesalamine in the treatment of Crohn's disease one-year following ileocolectomy for Crohn's disease. 1. To evaluate the difference in clinical recurrence rates between certolizumab and mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI). 2. To compare the endoscopic recurrence rates at one year following surgery between patients treated with certolizumab and mesalamine. 3. To compare medication side-effects and tolerance of therapy, including the need to interrupt therapy due to side-effects, the incidence of opportunistic infections, and a general assessment of each patient's health and well-being using the short-form 36 (SF-36).
Interventions
- DRUG Mesalamine
- DRUG Cimzia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01696942
The ClinicalTrials.gov registry entry for NCT01696942 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mesalamine is the first listed.
NCT01696942 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01696942 about?
NCT01696942 is a clinical study titled "Cimzia Versus Mesalamine for Crohn's Recurrence". Hypothesis: Cimzia provides superior reduction in endoscopic and clinical recurrence rates compared to mesalamine in the treatment of Crohn's disease one-year following ileocolectomy for Crohn's disease. 1. To evaluate the difference in clinical recurrence rates between certolizumab and mesalamine ...
What is the current status of trial NCT01696942?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2013-02. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01696942?
The interventions under investigation include: Mesalamine (DRUG), Cimzia (DRUG).
Who is sponsoring clinical trial NCT01696942?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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