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Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and Remission

NCT ID: NCT05116228

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2021-11-01

Brief Summary

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To investigate whether a reduced-dose dosing regimen (1x500mg semiannually) of rituximab (RTX) (Mabthera®) is non-inferior in patients with rheumatoid arthritis (RA) whose disease is in persistent low disease activity (LDA) or clinical remission (REM) (pLDA/pREM) as compared to the standard dosing regimen of 1x1000mg semi-annual infusions.

Detailed Description

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Randomized, controlled, single-centre study with 1x500mg or 1x1000 semi-annual infusions of RTX (Mabthera) as intervention and a follow-up period of 2 years. Patients as well as assessors will be blinded to the type of treatment. Patients in the 1x500mg group who experience a flare as defined by the disease activity score 28-ESR (DAS28) will receive 1x1000mg RTX (Mabthera) at their upcoming scheduled infusion appointment. Patients in the 1x1000mg group whose disease activity reaches DAS28 \>3.2 during the duration of the study will be re-evaluated for a change in biological therapy and will discontinue the study.

Conditions

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Rheumatoid Arthritis Remission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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500mg RTX Group

Patients in this group will receive 1x500mg (500mg RTX group) RTX (Mabthera) at baseline (time-point of their upcoming semi-annual infusion) and at months 6, 12, 18 and 24

Group Type ACTIVE_COMPARATOR

500mg RTX Group

Intervention Type DRUG

Patients will receive 1x500mg RTX (Mabthera) at baseline (time-point of their upcoming semi-annual infusion) and at months 6, 12, 18 and 24

1000mg RTX group

Patients in this group will receive 1x1000mg RTX (Mabthera) at baseline (time-point of their upcoming semi-annual infusion) and at months 6, 12, 18 and 24

Group Type ACTIVE_COMPARATOR

1000mg RTX Group

Intervention Type DRUG

Patients will receive 1x1000mg RTX (Mabthera) at baseline (time-point of their upcoming semi-annual infusion) and at months 6, 12, 18 and 24

Interventions

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500mg RTX Group

Patients will receive 1x500mg RTX (Mabthera) at baseline (time-point of their upcoming semi-annual infusion) and at months 6, 12, 18 and 24

Intervention Type DRUG

1000mg RTX Group

Patients will receive 1x1000mg RTX (Mabthera) at baseline (time-point of their upcoming semi-annual infusion) and at months 6, 12, 18 and 24

Intervention Type DRUG

Other Intervention Names

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Mabthera 500mg Mabthera 1000mg

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of RA according to the 2010 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria
* Current treatment with RTX (at time of inclusion have already received at least 2 cycles of 1000mg RTX) at the Day-Clinic of the Division of Rheumatology of the Medical University of Vienna
* Persistent low disease activity or clinical remission as defined below
* Persistent clinical remission (pREM) will be defined as a simplified disease activity index (CDAI) (12) ≤2.8 measured at two time-points 6 months apart. The CDAI is calculated as follows: tender joint count (TJC) + swollen joint count (SJC) + patient's assessment of general health on a 100 mm visual analogue scale (GH) + evaluator's assessment of general health on a 100 mm visual analogue scale (EGH)
* Persistent low disease activity (pLDA) will be defined as a CDAI ≤10 measured at two timepoints 6 months apart Patients who achieve REM at only either one of the two successive time-points will be considered as having pLDA with regard to the current trial

Exclusion Criteria

* Patients ≤ 18 yrs
* Patients receiving RTX for a disease other than RA
* Patients who fail to meet criteria for REM or LDA at either one of the two successive timepoints (i.e. having a disease activity \>10 as measured by the clinical disease activity index, (CDAI))
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Dr. Peter Mandl

Co-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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2015-002156-27

Identifier Type: -

Identifier Source: org_study_id