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Trial record 2 of 3 for:
kts-1-2008
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome
This study has been completed.
Sponsor:
Haukeland University Hospital
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Chronic Fatigue Syndrome Myalgic Encephalomyelitis | Drug: Rituximab | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Haukeland University Hospital:
Primary Outcome Measures:
- 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. ]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.
Secondary Outcome Measures:
- 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 ]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)
| Enrollment: | 29 |
| Study Start Date: | October 2010 |
| Study Completion Date: | February 2014 |
| Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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. |
Eligibility| Ages Eligible for Study: | 18 Years to 66 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01156909
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156909
Locations
| Norway | |
| Department of Oncology, Haukeland University Hospital | |
| Bergen, Norway, N-5021 | |
Sponsors and Collaborators
Haukeland University Hospital
Investigators
| Principal Investigator: | Olav Mella, PhD, MD | Haukeland University Hospital |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT01156909 History of Changes |
| Other Study ID Numbers: |
2010/1318 |
| Study First Received: | July 2, 2010 |
| Last Updated: | August 29, 2014 |
Keywords provided by Haukeland University Hospital:
|
Chronic fatigue syndrome CFS Myalgic encephalomyelitis Rituximab B-cell depletion |
Additional relevant MeSH terms:
|
Syndrome Fatigue Fatigue Syndrome, Chronic Encephalomyelitis Myalgia Disease Pathologic Processes Signs and Symptoms Virus Diseases Muscular Diseases Musculoskeletal Diseases Central Nervous System Diseases |
Nervous System Diseases Neuromuscular Diseases Central Nervous System Infections Musculoskeletal Pain Pain Neurologic Manifestations Rituximab Antibodies Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on September 19, 2017