KTS-1-2008: Drug Intervention in Chronic Fatigue Syndrome

Sponsor
Haukeland University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00848692
Collaborator
(none)
30
1
2
24
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Rituximab

Drug: Rituximab
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart

Placebo Comparator: 2

Placebo (saline)

Drug: Saline (NaCl 0,9 %) (placebo)
Two infusions of saline (NaCl 0,9 %) given two weeks apart

Outcome Measures

Primary Outcome Measures

  1. Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [3 months after intervention]

Secondary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Oncology and Medical Physics, Haukeland University Hospital Bergen Norway N-5021

Sponsors and Collaborators

  • Haukeland University Hospital

Investigators

  • Principal Investigator: Olav Mella, MD, PhD, Department of Oncology and Medical Physics, Haukeland University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00848692
Other Study ID Numbers:
  • 18257
  • EudraCT: 2007-007973-22
First Posted:
Feb 20, 2009
Last Update Posted:
May 11, 2021
Last Verified:
Jun 1, 2011

Study Results

No Results Posted as of May 11, 2021