Drug Intervention in Chronic Fatigue Syndrome | NCT00848692

Studies
Drug Intervention in Chronic Fatigue Syndrome

NCT00848692

Sponsor

Haukeland University Hospital

Status

Completed

Last Update Posted

May 11, 2021Actual

Enrollment

30Actual

Phase

Phase 2Phase 3

Conditions

Chronic Fatigue Syndrome

Interventions

Rituximab
Saline (NaCl 0,9 %) (placebo)

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT: 2007-007973-22

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Feb 19, 2009

First Submission Date that Met QC Criteria

Feb 19, 2009

First Posted Date

Feb 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2021

Last Update Posted Date

May 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (CFS) patients may benefit from B-cell depletion therapy.

The hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Rituximab	Drug: Rituximab
2	Placebo Comparator	Placebo (saline)	Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rituximab	Drug	Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.		3 months after intervention

Secondary Outcomes

Measure	Description	Time Frame
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes		2, 4, 6, 8, 10, 12 months after intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

verified chronic fatigue syndrome (CDC-criteria)
age >18 and <60 years
informed consent

Exclusion Criteria:

pregnancy or lactation
previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
previous long-term use of immunosuppressive drugs
previous exposure to rituximab
endogenous depression
multi-allergy with risk of serious drug reaction
reduced renal function (creatinin > 1.2 x UNL)
reduced liver function (bilirubin or transaminases > 1.5 x UNL)
known HIV infection
signs of active viral infection by pretreatment investigations

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olav Mella, MD, PhD	Department of Oncology and Medical Physics, Haukeland University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Oncology and Medical Physics, Haukeland University Hospital		Bergen		N-5021	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22039471	Derived	Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Naess H, Dahl O, Nyland H, Mella O. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study. PLoS One. 2011;6(10):e26358. doi: 10.1371/journal.pone.0026358. Epub 2011 Oct 19.

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D004679	Encephalomyelitis
D000090862	Neuroinflammatory Diseases

ID	Term
D000069283	Rituximab
D012965	Sodium Chloride

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins