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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: Clinical Trial Phase 4 study, sponsored by Milton S. Hershey Medical Center.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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). CDAI scores of 150 or greater are considered a recurrence.
Interventions
- DRUG Mesalamine
- DRUG Cimzia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
Why NCT01696942 stopped before completion
NCT01696942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Mesalamine is the first listed.
NCT01696942 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01696942's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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