Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-27 @ 10:35 PM
Study NCT ID:
NCT01730495
Status:
TERMINATED
Last Update Posted:
2015-12-02
First Post:
2012-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
Sponsor:
Haukeland University Hospital
Organization:
Study Overview
Official Title:
Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Moderate and Serious Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (CFS/ME), Including in Patients With no Clinical Response After B-lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab.
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After inclusion of four patients, two experienced moderate worsening of symptoms
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis factor-alpha inhibition using Etanercept as weekly subcutaneous injections.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-006069-16 | EUDRACT_NUMBER | None | View |