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Upadacitinib for Rheumatoid Arthritis (COVER Trial)

Phase 4

Recruiting

Led By Jeffrey R Curtis, MD MS MPH

Research Sponsored by Jeffrey Curtis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months following covid-19 vaccine booster

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests an extra dose of the COVID-19 vaccine in patients with autoimmune diseases. It aims to see if pausing their medications temporarily can make the vaccine more effective. The goal is to improve their immune response to COVID-19.

Eligible Conditions

Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months following covid-19 vaccine booster

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months following covid-19 vaccine booster

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months following covid-19 vaccine booster for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Number of patients with individual symptoms consistent with vaccine reactogenicity, as measured by the CDC Vsafe program, stratified by treatment arm

Number of patients with score change beyond the minimal clinically important difference in the Rheumatoid Arthritis Flare Questionnaire (for patients with RA/PsA) and the BASDAI (Axial Spondyloarthritis), stratified by treatment arm

Other study objectives

Number of patients with clinical COVID-19 infection, as initially self-reported by the patient, and confirmed by medical records, by treatment arm

Number of patients with clinical manifestations of new onset autoimmune disease and other pre-specified adverse events, as classified by CTCAE 4.0, by treatment arm

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

9Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Interruption - UPAExperimental Treatment1 Intervention