Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
NCT00195715 · View on ClinicalTrials.gov ↗
Study Summary
To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.
Conditions Studied
Interventions
- BIOLOGICAL Adalimumab
Study Locations (20)
Florida
- Site Ref # / Investigator 1827 — Clearwater
- Site Ref # / Investigator 1883 — Gainesville
- Site Ref # / Investigator 1909 — Hollywood
- Site Ref # / Investigator 1884 — Ormond Beach
- Site Ref # / Investigator 1786 — Winter Park
California
- Site Ref # / Investigator 1787 — La Jolla
- Site Ref # / Investigator 1902 — Roseville
- Site Ref # / Investigator 1824 — San Diego
- Site Ref # / Investigator 1891 — San Diego
Colorado
- Site Ref # / Investigator 1860 — Englewood
- Site Ref # / Investigator 6178 — Lone Tree
- Site Ref # / Investigator 1904 — Wheat Ridge
Illinois
- Site Ref # / Investigator 1878 — Arlington Heights
- Site Ref # / Investigator 2534 — Chicago
- Site Ref # / Investigator 1823 — Peoria
Alabama
- Site Ref # / Investigator 1894 — Huntsville
- Site Ref # / Investigator 1895 — Jacksonville
Connecticut
- Site Ref # / Investigator 1858 — Bridgeport
Georgia
- Site Ref # / Investigator 1912 — Atlanta
Indiana
- Site Ref # / Investigator 1885 — Anderson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 777 participants |
| Start Date | 2004-09 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00195715
The ClinicalTrials.gov registry entry for NCT00195715 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 777 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention — of which Adalimumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00195715 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00195715 about?
NCT00195715 is a clinical study titled "Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease". To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.
What is the current status of trial NCT00195715?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 777 participants. The study started on 2004-09. Estimated completion is 2008-12.
What conditions does trial NCT00195715 study?
This clinical trial studies the following conditions: Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00195715?
The interventions under investigation include: Adalimumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00195715?
This trial is sponsored by Abbott, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00195715 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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