COVID-19 VaccinE Response in Rheumatology Patients

Conditions

• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Upadacitinib — DRUG
  Hold UPA x 2 weeks at time of COVID booster
• Abatacept — DRUG
  Hold SQ ABA x 2 weeks at time of COVID booster
• Secukinumab — DRUG
  Hold SEC x 2 weeks at time of COVID booster
• Tofacitinib — DRUG
  Hold TOF x 2 weeks at time of COVID booster
• TNF Inhibitor — DRUG
  Hold SQ TNFi x 2 weeks at time of COVID booster
• Canakinumab Injection — DRUG
  Hold CAN TNFi x 2 weeks at time of COVID booster
• Baricitinib — DRUG
  Hold BAR x 2 weeks at time of COVID booster
• Ixekizumab — DRUG
  Hold IXE x 2 weeks at time of COVID booster

Study Details

The COVID-19 VaccinE Response in Rheumatology patients (COVER) study is a multicenter randomized controlled trial designed to evaluate the efficacy and safety of a mRNA COVID-19 vaccine supplemental dose (booster) in patients with autoimmune conditions and to evaluate the impact of different immunomodulatory therapies on vaccine response. The investigators propose to recruit up to 1000- patients with autoimmune conditions who have a completed 2-dose regime of mRNA COVID-19 vaccine (\>28 days prior) and who are planning to receive an additional dose of mRNA COVID-19 vaccine (i.e., booster). Participants in this study will be men and women 18 years and older with confirmed rheumatic disease, including psoriatic arthritis (PsA), axial spondyloarthritis (SpA) and rheumatoid arthritis (RA) who express a decision to receive the mRNA vaccination booster within 30 days post enrollment. A primary objective of this study is to test the hypothesis that holding certain medications for a brief period of time around the time of COVID-19 vaccination might improve the response to the vaccine while not unduly having safety concerns with respect to the effects of their disease. During the study, participants using the immunomodulatory therapies described outlined in protocol will be randomized to temporarily hold (for 2 weeks) versus continue after they receive the COVID-19 vaccine supplemental dose. Patients who temporarily stop one of their medications for their autoimmune inflammatory disease may be at increased risk of flares of their autoimmune condition. If these occur, they are expected to occur within 2 - 4 weeks of treatment interruption. Detailed protocol outlines the hold schedules for the therapies to be randomized in this study.

Key Dates

Start date

Nov 15, 2021

Status verified

Jun 2024

Primary completion

Apr 4, 2024

Completion

May 28, 2024

Study Design

Enrollment

841 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Treatment Interruption - UPA
  Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
• No Intervention: Treatment Continuation
  Treatment Continuation of All Immunomodulatory Therapy at the time of COVID Vaccine Booster
• Experimental: Treatment Interruption - ABA
  Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
• Experimental: Treatment Interruption - TOF
  Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
• Experimental: Treatment Interruption - SEC
  Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
• Experimental: Treatment Interruption - TNFi SQ
  Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
• Experimental: Treatment Interruption - CAN
  Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
• Experimental: Treatment Interruption - BAR
  Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
• Experimental: Treatment Interruption - IXE
  Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster

Primary Outcome Measure

Quantitative ratio post booster vs. pre-booster of IgG against SARS-CoV-2 using electrochemiluminescent (ECL) technology against the receptor binding domain (RBD) of spike protein, stratified by treatment arm [ Time Frame: 6 weeks following COVID-19 vaccine booster ]

Locations (8)

Find similar trials in Birmingham, AL

Related Studies

• Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
  Recruiting · University of California, San Diego · La Jolla, California
• Physica System Total Knee Replacement Registry Study
  Recruiting · Limacorporate S.p.a · Rancho Mirage, California
• Early Rheumatoid Arthritis Lung Disease Study
  Recruiting · University of Nebraska · Omaha, Nebraska
• Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
  PHASE3 · Recruiting · University of Nebraska · Omaha, Nebraska