Chronic Fatigue SyndromePhase 2/3KTS-1-2008NCT00848692
Drug Intervention in Chronic Fatigue Syndrome
A Phase 2/3 study testing Rituximab in people with Chronic Fatigue Syndrome, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2008to Jun 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- verified chronic fatigue syndrome (CDC-criteria)
- age >18 and <60 years
- informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Oncology and Medical Physics, Haukeland University Hospital
Bergen, N-5021
About this study
Official title: B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.
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.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- Rituximab, Saline (NaCl 0,9 %) (placebo)
- Keywords
- Chronic Fatigue Syndrome, CFS, Myalgic Encephalomyelitis, Rituximab, B-lymphocyte depletion, B-cell depletion
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
Saline (NaCl 0,9 %) (placebo)Drug
Two infusions of saline (NaCl 0,9 %) given two weeks apart
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rituximab Receives: Drug: Rituximab |
| 2 | Placebo comparator | Placebo (saline) Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Measured: 3 months after intervention
Secondary outcomes (1)
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes
Measured: 2, 4, 6, 8, 10, 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olav Mella, MD, PhD, Principal investigator, Department of Oncology and Medical Physics, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848692
- Sponsor's protocol ID
- 18257
- Other IDs
- EudraCT: 2007-007973-22
- Acronym
- KTS-1-2008
- Status last verified
- Jun 2011
- First submitted
- 19 Feb 2009
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22039471
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT00848692
- Acronym / sponsor ID
- KTS-1-2008 / 18257
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic Fatigue Syndrome, CFS, Myalgic Encephalomyelitis, Rituximab, B-lymphocyte depletion, B-cell depletion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RituximabRituximab |
| 2 | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo)Placebo (saline) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- verified chronic fatigue syndrome (CDC-criteria)
- age >18 and <60 years
- informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabTwo infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart | Drug | 1 |
| Saline (NaCl 0,9 %) (placebo)Two infusions of saline (NaCl 0,9 %) given two weeks apart | Drug | 2 |
Primary outcome
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Time frame: 3 months after intervention
1 secondary outcome
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes
Time frame: 2, 4, 6, 8, 10, 12 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Derived from this study: PubMed 22039471Fluge 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olav Mella, MD, PhD principal investigator
Department of Oncology and Medical Physics, Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rituximab in people with Chronic Fatigue Syndrome, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. (time frame: 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00848692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.