Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00195715 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 777
- Enrollment target
- 20
- Study locations
NCT00195715: Completed Phase 3 study of Crohn's Disease, sponsored by Abbott.
NCT00195715 is a Phase 3 study of Crohn's Disease that has completed, run by Abbott. The registered enrollment target is 777 participants, below the 2,387-participant average among 105 other Crohn's Disease trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00195715, a Phase 3 study of Crohn's Disease, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 777 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
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 |
What the finished NCT00195715 record still lists
NCT00195715 is an interventional study that assigns participants to a tested intervention. The registered 777 participants enrollment target is mid-sized for trials with a published cap, below the 2,387-participant average among 105 other Crohn's Disease trials with a reported enrollment target (67% lower).
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.
NCT00195715 names 20 study sites across 8 states, led by Florida, California, Colorado.
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.
What interventions are being tested in trial NCT00195715?
The interventions under investigation include: Adalimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00195715?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00195715's enrollment target sits among peer trials
777 14th of 105 higher than 92 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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
-
Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease
RECRUITING · Phase 3
-
Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients
RECRUITING · Phase 3
-
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
RECRUITING · Phase 3
-
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
RECRUITING · Phase 3
-
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
RECRUITING · Phase 3
-
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05642611 · 777 participants · Phase 3
Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy
- NCT06841679 · 778 participants · Phase 2
Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
- NCT06145763 · 776 participants · NA
A Digital Smoking Cessation Intervention for Helping American Indians and Alaska Natives Quit Smoking, IndigeQuit Trial
- NCT03460769 · 775 participants
Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia