B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01156909
First received: July 2, 2010
Last updated: August 29, 2014
Last verified: August 2014

July 2, 2010
August 29, 2014
October 2010
February 2014   (final data collection date for primary outcome measure)
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: Major response of at least six weeks duration, independent on when occuring, during the follow-up period. ] [ Designated as safety issue: Yes ]
The primary endpoint is defined as major response of the CFS symptoms, of at least six weeks duration, independent on when during 36 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.
Same as current
Complete list of historical versions of study NCT01156909 on ClinicalTrials.gov Archive Site
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention ] [ Designated as safety issue: Yes ]
The secondary outcome measures are effect on the CFS symptoms, by evaluation at 3, 6, 10, 15, 20, 24, 30, and 36 months after first intervention (i.e. first Rituximab infusion)
Same as current
Not Provided
Not Provided
 
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome
B-lymphocyte Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. An Open Label Phase II Study With Rituximab Induction and Maintenance Treatment

Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that chronic fatigue syndrome patients may benefit from B-cell depletion therapy using Rituximab induction with maintenance treatment.

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis
Drug: Rituximab

Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart, followed by maintenance Rituximab infusions 500 mg/m2 (max 1000 mg) at 3, 6, 10, and 15 months.

Approved amendment: for patients with gradual improvement in CFS/ME symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period.

Experimental: Rituximab
Rituximab induction using two infusions (500mg/m2, max 1000 mg) two weeks apart, followed by maintenance Rituximab infusions (500 mg/m2, max 1000 mg) after 3, 6, 10 and 15 months.
Intervention: Drug: Rituximab
Fluge Ø, Mella O. Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series. BMC Neurol. 2009 Jul 1;9:28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with CFS
  • age 18-66 years
  • informed consent

Exclusion Criteria:

  • patients with fatigue, not fulfilling criteria for CFS
  • pregnancy or lactation
  • previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
  • previous major immunological disease, except autoimmune diseases such as diabetes mellitus or thyroiditis
  • previous long-term use of immunosuppressive drugs, except steroids e.g. in obstructive lunge disease
  • endogenous depression
  • lack of ability to comply by the protocol
  • multi-allergy with risk of serious drug reaction
  • reduced renal function (creatinin > 1.5 x UNL)
  • reduced liver function (bilirubin or transaminases > 1.5 x UNL)
  • HIV positivity
  • evidence of clinically significant infection
Both
18 Years to 66 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01156909
2010/1318
No
Haukeland University Hospital
Haukeland University Hospital
Not Provided
Principal Investigator: Olav Mella, PhD, MD Haukeland University Hospital
Haukeland University Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP