Study 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
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 6 months following COVID-19 vaccine booster
Month 6
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
Week 6
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
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
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
9 Treatment Groups
Treatment Continuation
1 of 9
Treatment Interruption - BAR
1 of 9
Treatment Interruption - IXE
1 of 9
Treatment Interruption - TNFi SQ
1 of 9
Treatment Interruption - UPA
1 of 9
Treatment Interruption - TOF
1 of 9
Treatment Interruption - ABA
1 of 9
Treatment Interruption - SEC
1 of 9
Treatment Interruption - CAN
1 of 9
Active Control
Experimental Treatment
1000 Total Participants · 9 Treatment Groups
Primary Treatment: Upadacitinib · No Placebo Group · Phase 4
Treatment Interruption - BAR
Drug
Experimental Group · 1 Intervention: Baricitinib · Intervention Types: DrugTreatment Interruption - IXE
Drug
Experimental Group · 1 Intervention: Ixekizumab · Intervention Types: DrugTreatment Interruption - TNFi SQ
Drug
Experimental Group · 1 Intervention: TNF Inhibitor · Intervention Types: DrugTreatment Interruption - UPA
Drug
Experimental Group · 1 Intervention: Upadacitinib · Intervention Types: DrugTreatment Interruption - TOF
Drug
Experimental Group · 1 Intervention: Tofacitinib · Intervention Types: DrugTreatment Interruption - ABA
Drug
Experimental Group · 1 Intervention: Abatacept · Intervention Types: DrugTreatment Interruption - SEC
Drug
Experimental Group · 1 Intervention: Secukinumab · Intervention Types: DrugTreatment Interruption - CAN
Drug
Experimental Group · 1 Intervention: Canakinumab Injection · Intervention Types: DrugTreatment ContinuationNoIntervention Group · 1 Intervention: Treatment Continuation · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
FDA approved
Ixekizumab
2020
Completed Phase 4
~6560
Baricitinib
2020
Completed Phase 3
~10920
Tofacitinib
FDA approved
Certolizumab pegol
FDA approved
Secukinumab
FDA approved
Abatacept
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months following covid-19 vaccine booster
Who is running the clinical trial?
NovartisIndustry Sponsor
1,585 Previous Clinical Trials
2,701,760 Total Patients Enrolled
7 Trials studying Rheumatoid Arthritis
746 Patients Enrolled for Rheumatoid Arthritis
Eli Lilly and CompanyIndustry Sponsor
2,466 Previous Clinical Trials
3,134,399 Total Patients Enrolled
27 Trials studying Rheumatoid Arthritis
15,727 Patients Enrolled for Rheumatoid Arthritis
PfizerIndustry Sponsor
4,308 Previous Clinical Trials
7,109,837 Total Patients Enrolled
100 Trials studying Rheumatoid Arthritis
469,639 Patients Enrolled for Rheumatoid Arthritis
Jeffrey CurtisLead Sponsor
University of Alabama at BirminghamOTHER
1,435 Previous Clinical Trials
2,228,234 Total Patients Enrolled
15 Trials studying Rheumatoid Arthritis
114,812 Patients Enrolled for Rheumatoid Arthritis
University of NebraskaOTHER
487 Previous Clinical Trials
1,148,350 Total Patients Enrolled
9 Trials studying Rheumatoid Arthritis
4,077 Patients Enrolled for Rheumatoid Arthritis
University of PennsylvaniaOTHER
1,841 Previous Clinical Trials
41,125,416 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
20 Patients Enrolled for Rheumatoid Arthritis
AbbVieIndustry Sponsor
835 Previous Clinical Trials
470,420 Total Patients Enrolled
46 Trials studying Rheumatoid Arthritis
112,160 Patients Enrolled for Rheumatoid Arthritis
Bristol-Myers SquibbIndustry Sponsor
2,500 Previous Clinical Trials
3,926,522 Total Patients Enrolled
107 Trials studying Rheumatoid Arthritis
370,418 Patients Enrolled for Rheumatoid Arthritis
Jeffrey R Curtis, MD MS MPHPrincipal InvestigatorFoundation for Advancing Science Technology Education and Research
Eligibility Criteria
Age 18 - 85 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must meet all of the inclusion criteria at the time of screening.
You have been diagnosed with rheumatoid arthritis or juvenile idiopathic arthritis.
You have psoriatic arthritis, ankylosing spondylitis, or other spondyloarthritis.
You must have a cell phone capable of receiving text messages, and/or a personal email address.
If you are under 18 years of age, you must have been diagnosed with the disease before the age of 18.
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Cancer Related
Treatments