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NCT00348283 · ClinicalTrials.gov registry record · Phase 3
Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
A Phase 3 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 135
- Enrollment target
NCT00348283: Completed Phase 3 study, sponsored by Abbott.
NCT00348283 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 135 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00348283, a Phase 3 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 135 participants
- Enrollment target
Study Summary
The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.
Primary Outcome
Subjects were to have undergone up to 4 endoscopies to evaluate the presence or absence of mucosal ulceration: at Screening, at Week 12 (subjects who moved to open label (OL) drug between Week 8 and Week 12 because of disease flare or non-response were evaluated by endoscopy prior to receiving OL dosing), at the time of switch from blinded study drug to OL adalimumab at any time after Week 12, and at Week 52 or Early Termination. Subjects who remained blinded for the entire 52-week trial or swit
Interventions
- BIOLOGICAL placebo
- BIOLOGICAL adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2006-08 |
| Phase | Phase 3 |
What the finished NCT00348283 record still lists
NCT00348283 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00348283 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00348283 about?
NCT00348283 is a clinical study titled "Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon". The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.
What is the current status of trial NCT00348283?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2006-08.
What interventions are being tested in trial NCT00348283?
The interventions under investigation include: placebo (BIOLOGICAL), adalimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00348283?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00348283's enrollment target sits among peer trials
135 1582nd of 2000 higher than 416 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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