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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

COVER Trial Summary

This trial is designed to see if briefly holding certain medications around the time of getting a booster COVID-19 vaccine dose improves the response to the vaccine, with safety concerns for the effects of the autoimmune disease in mind.

Eligible Conditions
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Ankylosing Spondylitis

COVER Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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

COVER Trial Design

9Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Interruption - UPAExperimental Treatment1 Intervention
Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Group II: Treatment Interruption - TOFExperimental Treatment1 Intervention
Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Group III: Treatment Interruption - TNFi SQExperimental Treatment1 Intervention
Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Group IV: Treatment Interruption - SECExperimental Treatment1 Intervention
Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Group V: Treatment Interruption - IXEExperimental Treatment1 Intervention
Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Group VI: Treatment Interruption - CANExperimental Treatment1 Intervention
Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Group VII: Treatment Interruption - BARExperimental Treatment1 Intervention
Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Group VIII: Treatment Interruption - ABAExperimental Treatment1 Intervention
Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Group IX: Treatment ContinuationActive Control1 Intervention
Treatment Continuation of All Immunomodulatory Therapy at the time of COVID Vaccine Booster
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
FDA approved
Baricitinib
2017
Completed Phase 3
~9510
Ixekizumab
2020
Completed Phase 4
~6560
Tofacitinib
FDA approved
Adalimumab
FDA approved
Secukinumab
FDA approved
Abatacept
FDA approved

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,907,050 Total Patients Enrolled
101 Trials studying Rheumatoid Arthritis
469,250 Patients Enrolled for Rheumatoid Arthritis
Eli Lilly and CompanyIndustry Sponsor
2,612 Previous Clinical Trials
3,199,907 Total Patients Enrolled
28 Trials studying Rheumatoid Arthritis
16,178 Patients Enrolled for Rheumatoid Arthritis
Bristol-Myers SquibbIndustry Sponsor
2,636 Previous Clinical Trials
4,126,564 Total Patients Enrolled
108 Trials studying Rheumatoid Arthritis
370,540 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to participate in this experiment?

"This clinical trial is enrolling 1000 participants with psoriatic arthritis who are aged 18 to 85. To be eligible, they must have already received two doses of an mRNA COVID-19 vaccine at least 28 days prior and plan on getting a booster shot within the next 30 days; take one of the medications listed in Table 1; possess either a cell phone that can receive text messages or use email regularly; stayed on their current immunomodulatory therapy for 8 weeks without any changes or interruptions greater than 2 weeks; live in the US and meet all other inclusion criteria specified."

Answered by AI

How many participants have been included in this research project?

"Affirmative. The information on clinicaltrials.gov indicates that this investigation is actively enrolling participants. Initially posted on the 15th November 2021, it was most recently edited 19th September 2022 and requires 1000 individuals to be recruited across 8 study centres."

Answered by AI

What ailments can Upadacitinib most effectively ameliorate?

"Upadacitinib is a commonly prescribed treatment for dermatitis, atopic and other ailments such as nomid, crohn disease, and rheumatoid arthritis."

Answered by AI

Have prior endeavors studied the effectiveness of Upadacitinib?

"The University of Nebraska Medical Centre first studied upadacitinib in 2007 and since then, 1035 trials have reached completion. Currently, 198 active studies are being conducted with a significant proportion taking place in Philadelphia, Pennsylvania."

Answered by AI

Does this research program accept geriatric participants?

"Patients of age 18 years or older and below 85 are admissible for this clinical trial."

Answered by AI

What is the scope of this trial in terms of hospital participation?

"This trial is recruiting from numerous sites, including the University of Pennsylvania Medical Center in Philadelphia, Attune Health situated in Beverly Hills and Bendcare located in Hoover."

Answered by AI

Are there any vacancies left in this clinical investigation?

"According to the latest update hosted on clinicaltrials.gov, this experimental medical study is still recruiting participants since its initial posting date of November 15th 2021. The trial was last updated on September 19th 2022."

Answered by AI

Is Upadacitinib sanctioned by the Federal Drug Administration?

"After an assessment on a 1-3 scale, Upadacitinib received the highest safety score of 3 due to being in Phase 4 and having regulatory approval."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
University of Pennsylvania Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
COVID-19 VaccinE Response in Rheumatology Patients
Jeffrey Curtis 2021. "COVID-19 VaccinE Response in Rheumatology Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05080218.
All > Xeljanz
~293 spots leftby Apr 2025
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