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NCT01070303 · ClinicalTrials.gov registry record · Phase 3
Remission in Subjects With Crohn's Disease, Open Label Extension
A Phase 3 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 177
- Enrollment target
NCT01070303: Completed Phase 3 study, sponsored by Abbott.
NCT01070303 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 177 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01070303, a Phase 3 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 177 participants
- Enrollment target
Study Summary
The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease.
Primary Outcome
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.
Interventions
- BIOLOGICAL Adalimumab 40 mg eow or ew
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2002-08 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
What the finished NCT01070303 record still lists
NCT01070303 is an interventional study that assigns participants to a tested intervention. The registered 177 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 (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Adalimumab 40 mg eow or ew is the first listed.
NCT01070303 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01070303 about?
NCT01070303 is a clinical study titled "Remission in Subjects With Crohn's Disease, Open Label Extension". The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease.
What is the current status of trial NCT01070303?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 177 participants. The study started on 2002-08. Estimated completion is 2008-12.
What interventions are being tested in trial NCT01070303?
The interventions under investigation include: Adalimumab 40 mg eow or ew (BIOLOGICAL).
Who is sponsoring clinical trial NCT01070303?
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 NCT01070303's enrollment target sits among peer trials
177 1438th of 2000 higher than 563 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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