Overview

This trial is active, not recruiting.

Conditions chronic fatigue syndrome, myalgic encephalomyelitis
Treatment rituximab
Phase phase 2
Target CD20
Sponsor Haukeland University Hospital
Start date October 2010
End date December 2013
Trial size 30 participants
Trial identifier NCT01156909, 2010/1318

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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.

Primary Outcomes

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.

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 66 years old.

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

Additional Information

Official title 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
Principal investigator Olav Mella, PhD, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Haukeland University Hospital.