Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases

CompletedPhase 4MS (type not specified)NCT02040116

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Rituximab

    B-lymphocyte antigen CD20 binding agent

Results by group

Incidence of Infusion Related Reactions With Rapid Infusion Will be Reported

14 Days

GroupValueIntervalNumber analysed
Number of Reactions for Standard Infusion0 infusion reactions19
Number of Reactions for Rapid Infusion0 infusion reactions19

Number of Reactions for Standard Infusion

0

Number of Reactions for Rapid Infusion

0

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Rituximab Infusion190 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Incidence of Infusion Related Reactions With Rapid Infusion Will be Reported

    14 Days

    Safety
  • Grade of Infusion Related Reactions With Rapid Infusion Will be Reported

    14 Days

    Safety

Other measures (1)

  • Change in Chair Time With Rapid Infusion Will be Reported

    14 Days

Who could take part

MS (type not specified) · 18 to 80

Show the full criteria

Inclusion criteria

* Autoimmune patient at Wake Forest Baptist Health that is eligible for rituximab therapy * Tolerate the standard infusion rituximab with ≤ grade 2 hypersensitivity reaction * Consent to participate in the rapid infusion study * Age ≥ 18 years ≤ 80 years

Exclusion criteria

* Tolerate the standard infusion rituximab with ≥ grade 3 hypersensitivity reaction * Neurocognitive impairment (i.e. dementia, Alzheimers, et al)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The purpose of this study is to evaluate the impact of rapid infusion rituximab on the incidence of infusion-related reactions in patients with Autoimmune Diseases.

Papers

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    Related trials

    History

      1. Started

        Feb 2013

      2. Main results due

        Aug 2014

      3. Finished

        Aug 2014

      4. Results posted

        Sept 2017

      Assembled by software from public sources.