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Janus Kinase (JAK) Inhibitor

Upadacitinib for Rheumatoid Arthritis (SELECT-EARLY Trial)

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 week 24

Awards & highlights

SELECT-EARLY Trial Summary

This trial is testing a new drug for arthritis called upadacitinib. The objectives are to compare its safety and efficacy to the current standard treatment of methotrexate monotherapy, and to evaluate its long-term safety and efficacy.

Eligible Conditions

Rheumatoid Arthritis

SELECT-EARLY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 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 Modified Total Sharp Score (mTSS) at Week 24 - Global Analysis

Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Global Analysis

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 - Global Analysis

+1 more

Secondary outcome measures

Change From Baseline in DAS28 (CRP) at Week 12 - Global Analysis

Change From Baseline in DAS28 (CRP) at Week 12 - Japan Sub-study

Change From Baseline in DAS28 (CRP) at Week 24 - Global Analysis

+20 more

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

SELECT-EARLY Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Upadacitinib 7.5 mg (Japan-only)Experimental Treatment2 Interventions

Period 1: Participants will receive upadacitinib 7.5 mg once daily and placebo to methotrexate once weekly for 48 weeks. Period 2: Participants will continue on upadacitinib 7.5 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 7.5 mg up to Week 260.

Group II: Upadacitinib 30 mgExperimental Treatment2 Interventions

Period 1: Participants will receive upadacitinib 30 mg once daily and placebo to methotrexate once weekly for 48 weeks. Period 2: Participants will continue on upadacitinib 30 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 30 mg once daily. After implementation of Protocol Amendment 6 participants will receive upadacitinib 15 mg once daily up to Week 260.

Group III: Upadacitinib 15 mgExperimental Treatment2 Interventions

Period 1: Participants will receive upadacitinib 15 mg once daily and placebo to methotrexate once weekly for 48 weeks. Period 2: Participants will continue on upadacitinib 15 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 15 mg up to Week 260.

Group IV: MethotrexateActive Control2 Interventions

Period 1: Participants will receive placebo to upadacitinib once daily and methotrexate once weekly for 48 weeks. Period 2: Participants will continue on placebo to upadacitinib once daily and methotrexate once weekly until the study is unblinded, after which participants will receive open-label methotrexate up to Week 260.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo to Methotrexate

2016

Completed Phase 3

~1970

Upadacitinib

2014

Completed Phase 3

~9670