B-cell Depletion Using the Monoclonal Anti-CD20 Antibody... | NCT01156909 | Trialant

B-cell Depletion Using the Monoclonal Anti-CD20 Antibody... | NCT01156909 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rituximab	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.	Drug: Rituximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rituximab	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.	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.	Major response of at least six weeks duration, independent on when occuring, during the follow-up period.

Secondary Outcomes

Measure	Description	Time Frame
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.	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)	At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19566965	Background	Fluge O, 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. doi: 10.1186/1471-2377-9-28.
26132314	Derived	Fluge O, Risa K, Lunde S, Alme K, Rekeland IG, Sapkota D, Kristoffersen EK, Sorland K, Bruland O, Dahl O, Mella O. B-Lymphocyte Depletion in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An Open-Label Phase II Study with Rituximab Maintenance Treatment. PLoS One. 2015 Jul 1;10(7):e0129898. doi: 10.1371/journal.pone.0129898. eCollection 2015.

Condition Browse Module

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