Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00001901 · ClinicalTrials.gov registry record · Phase 2
Etanercept to Treat Wegener's Granulomatosis
A Phase 2 study of Vasculitis and Wegener's Granulomatosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00001901: Completed Phase 2 study of Vasculitis and Wegener's Granulomatosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001901 is a Phase 2 study of Vasculitis and Wegener's Granulomatosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 60 participants, below the 27,313-participant average among 11 other Vasculitis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001901, a Phase 2 study of Vasculitis and Wegener's Granulomatosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the use of etanercept (also called Enbrel or TNFR:Fc) in patients with Wegener's granulomatosis, a type of vasculitis (blood vessel inflammation). Wegener's granulomatosis may affect many parts of the body, including the brain, nerves, eyes, sinuses, lungs, kidneys, intestinal tract, skin, joints, heart, and other sites. Generally, the greater the disease involvement, the more life-threatening it is. Standard treatment is a combination of prednisone and a cytotoxic agent-usually cyclophosphamide or methotrexate. However, many patients treated with this regimen have a disease relapse, and others cannot take these drugs because of severe side effects. This study will evaluate etanercept's safety and effectiveness, and particularly its value in reducing the need for prednisone and preventing disease relapse. The Food and Drug Administration has approved etanercept for treating rheumatoid arthritis, another inflammatory disease. The drug works by blocking the activity of TNF-a protein made by white blood cells that is involved in the inflammatory process. Since prednisone also affects inflammatory proteins and lowers TNF production, the use of etanercept may reduce the need for prednisone in patients with Wegener's granulomatosis, and thus the risk of its side effects. Patients between 10 and 70 years of age with Wegener's granulomatosis who have never taken prednisone, methotrexate or cyclophosphamide, or have taken these drugs for less than 3 weeks may be eligible for this study. Participants will have a medical history review and physical examination, including laboratory studies. If medically indicated, X-rays, consultations and biopsies (surgical removal of a small tissue sample) of affected organs will also be done. All patients will begin treatment with prednisone, methotrexate and etanercept. Those who improve on this regimen will stop prednisone gradually over 3 months. Those who achieve disease remission at the end of another 3 month
Conditions Studied
Interventions
- DRUG Etanercept
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 1999-02 |
| Est. Completion | 2005-03 |
| Phase | Phase 2 |
What the finished NCT00001901 record still lists
NCT00001901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 27,313-participant average among 11 other Vasculitis trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Vasculitis appearing as the primary indexed condition, and to 1 intervention - of which Etanercept is the first listed.
NCT00001901 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001901 about?
NCT00001901 is a clinical study titled "Etanercept to Treat Wegener's Granulomatosis". This study will examine the use of etanercept (also called Enbrel or TNFR:Fc) in patients with Wegener's granulomatosis, a type of vasculitis (blood vessel inflammation). Wegener's granulomatosis may affect many parts of the body, including the brain, nerves, eyes, sinuses, lungs, kidneys, intestina...
What is the current status of trial NCT00001901?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 1999-02. Estimated completion is 2005-03.
What conditions does trial NCT00001901 study?
This clinical trial studies the following conditions: Vasculitis, Wegener's Granulomatosis.
What interventions are being tested in trial NCT00001901?
The interventions under investigation include: Etanercept (DRUG).
Who is sponsoring clinical trial NCT00001901?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001901 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Vasculitis
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 NCT00001901's enrollment target sits among peer trials
60 5th of 11 higher than 7 of 11 other Vasculitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vasculitis 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
-
Effects of Angiotensin-Converting Enzyme Inhibitor (Ramipril) Therapy on Blood Vessel Inflammation
COMPLETED · Phase 2
-
Comparison of Treatments to Maintain Disease Remission in Patients With Wegener's Granulomatosis and Related Vasculitis Syndromes
COMPLETED · Phase 2
-
Longitudinal Study for Relapsing Polychondritis
RECRUITING
-
Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms
RECRUITING · Phase 1
-
A Real-World Registry of Chronic Wounds and Ulcers
RECRUITING
-
Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
RECRUITING
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
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
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