MTX Hold During Covid-19 Booster

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-29

Study Completion Date

2022-12-30

Brief Summary

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To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MTX continue

Group will continue MTX after vaccination

Group Type ACTIVE_COMPARATOR

MTX

Intervention Type DRUG

MTX continuation

MTX 1 week hold

Group will continue MTX for 1 week after vaccination

Group Type EXPERIMENTAL

MTX

Intervention Type DRUG

MTX continuation

Interventions

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MTX

MTX continuation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females ≥ 19 years of age at time of consent
* Have a diagnosis of RA per ACR criteria
* Require methotrexate for RA treatment
* Subject to a Covid-19 booster vaccination
* Must understand and voluntarily sign an informed consent form including writing consent for data protection

Exclusion Criteria

* Pregnant or lactating females
* Previous anaphylactic response to the vaccine components
* Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease
* Any condition including laboratory abnormality which places the subject at unacceptable risk
* Subjects who decline to participate

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No