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T-cell Co-stimulation Modulator

Upadacitinib for Rheumatoid Arthritis

Phase 3

Waitlist Available

Research Sponsored by AbbVie

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 at week 12

Awards & highlights

Study Summary

This trial is comparing the safety and efficacy of upadacitinib to abatacept for the treatment of RA in people who have an inadequate response or are intolerant to bDMARDs. The long-term safety, tolerability, and efficacy of upadacitinib will also be evaluated.

Eligible Conditions

Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 12 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Non-inferiority)

Secondary outcome measures

Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)

Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343

URINARY TRACT INFECTION

UPPER RESPIRATORY TRACT INFECTION

NASOPHARYNGITIS

HYPERTENSION

100%

80%

60%

40%

20%

Study treatment Arm

Abatacept

Upadacitinib 15 mg

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Upadacitinib 15 mgExperimental Treatment2 Interventions

One 15 mg tablet taken once per day by mouth for 24 weeks

Group II: AbataceptActive Control2 Interventions

500 mg (for body weight <60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight >100 kg) intravenous (IV) infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

2014

Completed Phase 3

~9670

Placebo for upadacitinib

2018

Completed Phase 3

~1470

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

500,431 Total Patients Enrolled

48 Trials studying Rheumatoid Arthritis

113,007 Patients Enrolled for Rheumatoid Arthritis

AbbVie Inc.Study DirectorAbbVie

264 Previous Clinical Trials

100,944 Total Patients Enrolled

24 Trials studying Rheumatoid Arthritis

17,588 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.

Could you tell me if there is any prior research on Upadacitinib?

"Upadacitinib has 55 clinical trials associated with it, 21 of which are Phase 3 trials. The majority of these studies are being conducted in Miami, Florida, but there are over 4000 other locations running these trials."

Answered by AI

Are there many facilities in North America where this clinical trial is taking place?

"There are a total of 48 trial sites that are recruiting patients. These include The Center for Rheumatology & Bone Research /ID# 158723 in Wheaton, Adriana Pop-Moody MD Clinic PA /ID# 154607 in Corpus Christi, and Groupe de Recherche en Maladies Osseuses /ID# 154601 in Sainte-foy."

Answered by AI

What illnesses does Upadacitinib commonly treat?

"Upadacitinib is often used when patients don't respond well to traditional treatments. It can also help patients manage dermatitis, atopic, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis."

Answered by AI

Is this study looking for more volunteers at this time?

"Unfortunately, this clinical trial is no longer recruiting patients, as is indicated on clinicaltrials.gov. The study was first posted on 5/9/2017, and was last edited on 7/15/2022. Although this particular trial is not an option, there are 451 other studies that are still recruiting patients."

Answered by AI

Are there long-term repercussions to prescription Upadacitinib?

"Upadacitinib has been evaluated for safety in multiple Phase 3 trials, meaning that there is both efficacy and safety data available. Therefore, it receives a score of 3."

Answered by AI