Research libraryMOLEKUL / SOURCE RECORD

Early placebo-controlled rituximab trial

Fluge Ø et al. · 2011 · PLOS ONE

Indexed 2026-11-12.

Randomized trialEnglish abstractSource linked

Reported findings and study design

Reported findings

Two IV rituximab infusions of 500 mg/m² or saline two weeks apart. The prespecified primary endpoint was self-reported fatigue at three months.

Dose, route and schedule

Two IV rituximab infusions of 500 mg/m² or saline two weeks apart. The prespecified primary endpoint was self-reported fatigue at three months.

Protocol source ↗ · Original article abstract

Results · Original article abstract
MeasureResultComparison, timing and statistics
Three-month primary endpointNo significant difference in fatigue at three months.
Response over follow-up10/15 with rituximab versus 2/15 with placebo met the reported major or moderate response definition.

The later response signal was secondary and came from a small trial. A larger randomized trial did not reproduce it.

Source for these results ↗ · Reviewed 2026-11-12

For research and education. Consult a qualified clinician for medical advice.

Study limitations and source details

Study limitations

  • The later response signal was secondary and came from a small trial. A larger randomized trial did not reproduce it.

Source access

Two IV rituximab infusions of 500 mg/m² or saline two weeks apart. The prespecified primary endpoint was self-reported fatigue at three months.

Source reviewed 2026-11-12.

Open source ↗

DOI: 10.1371/journal.pone.0026358

Citation and original source

Original source: Fluge Ø et al.. Early placebo-controlled rituximab trial PLOS ONE 2011.

Molekul research summary: https://molekul.io/research/rituximab-early-2011. Cite the original publication for its findings and this page when referring to Molekul’s summary or evidence appraisal.

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