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Janus Kinase (JAK) Inhibitor

Upadacitinib for Rheumatoid Arthritis (SELECT-COMPARE 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

Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits

Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs)

Must not have

Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 26

Awards & highlights

Pivotal Trial

Summary

This trial found that upadacitinib was more effective than placebo and adalimumab in adults with RA who had an inadequate response to MTX.

Who is the study for?

Adults with moderately to severely active rheumatoid arthritis who have been on a stable dose of methotrexate but haven't responded well to it. Participants must have at least 6 swollen and tender joints, evidence of bone erosion or positive RA markers, and may have had limited exposure to one other RA drug (not adalimumab). Those with other joint diseases or previous JAK inhibitor use are excluded.

What is being tested?

The trial is testing the effectiveness and safety of Upadacitinib compared to a placebo and Adalimumab in adults with rheumatoid arthritis. All participants are already taking Methotrexate. The goal is to see if Upadacitinib can better reduce joint inflammation and prevent further damage.

What are the potential side effects?

Upadacitinib might cause infections, headaches, nausea, high blood pressure, liver issues or blood clots. Adalimumab could lead to injection site reactions, upper respiratory infections like sinusitis or sore throat, headache, rash or gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have 6 or more swollen and tender joints.

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I have stopped taking all rheumatic disease drugs except for methotrexate.

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I have been diagnosed with rheumatoid arthritis for at least 3 months.

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I have bone erosions and either a positive rheumatoid factor or anti-CCP antibodies.

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I have been on methotrexate for over 3 months and take folic or folinic acid.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously taken JAK inhibitor medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 26 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12

Rheumatoid Factor

Secondary study objectives

Change From Baseline in DAS28 (CRP) at Week 12

Change From Baseline in Duration of Morning Stiffness at Week 12

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

+9 more

Side effects data

From 2023 Phase 3 trial • 657 Patients • NCT03086343

24%

UPPER RESPIRATORY TRACT INFECTION

24%

HYPERTENSION

18%

BRONCHITIS

12%

RASH

12%

ACUTE RESPIRATORY FAILURE

12%

WEIGHT INCREASED

12%

URINARY TRACT INFECTION

12%

INFLUENZA

12%

FALL

12%

ARTHRALGIA

12%

SINUSITIS

12%

MUSCLE SPASMS

12%

CHOLELITHIASIS

12%

NASOPHARYNGITIS

12%

OROPHARYNGEAL PAIN

12%

LIVER FUNCTION TEST INCREASED

VULVOVAGINAL MYCOTIC INFECTION

LIGAMENT RUPTURE

DEHYDRATION

NASAL CONGESTION

PULMONARY EMBOLISM

HYPONATRAEMIA

CONSTIPATION

RHINORRHOEA

LEUKOCYTOSIS

BLOOD PRESSURE INCREASED

COUGH

BONE CONTUSION

HIP FRACTURE

VOMITING

PERIPHERAL SWELLING

STAPHYLOCOCCAL INFECTION

ORAL CANDIDIASIS

PNEUMONIA

FEELING HOT

HEADACHE

HAEMOGLOBIN DECREASED

PHOTODERMATOSIS

RHEUMATOID ARTHRITIS

PARAESTHESIA

PNEUMONIA BACTERIAL

STOMATITIS

SKIN LACERATION

HYPOKALAEMIA

GLAUCOMA

FEMUR FRACTURE

BACTERIAL SEPSIS

CHEST PAIN

FATIGUE

ATRIOVENTRICULAR BLOCK FIRST DEGREE

CANDIDA INFECTION

TACHYCARDIA

COVID-19

CATARACT

INFECTIOUS PLEURAL EFFUSION

SJOGREN'S SYNDROME

DIZZINESS

DYSPHAGIA

SWELLING

SEBORRHOEIC KERATOSIS

ACUTE KIDNEY INJURY

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

HERPES ZOSTER

OSTEOARTHRITIS

NAUSEA

NON-CARDIAC CHEST PAIN

RHINITIS

BLOOD CREATINE PHOSPHOKINASE INCREASED

OSTEOPENIA

INSOMNIA

PRURITUS

SUPRAVENTRICULAR TACHYCARDIA

SCRATCH

EYE HAEMATOMA

ERYTHEMA

COSTOCHONDRITIS

ACTINIC KERATOSIS

DERMATITIS ALLERGIC

ASTHMA

PATELLA FRACTURE

FLANK PAIN

SCIATICA

ANAEMIA

BILIARY COLIC

DERMATITIS CONTACT

HEPATIC STEATOSIS

DRUG HYPERSENSITIVITY

HERPES SIMPLEX

LOCALISED INFECTION

PHARYNGITIS

DIABETES MELLITUS

VITAMIN D DEFICIENCY

BACK PAIN

100%

80%

60%

40%

20%

Study treatment Arm

Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD

Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD

Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD

Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD

Period 1, 30 mg Cohort: Upadacitinib 30 mg QD

Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD

Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD

Period 1, Primary and 30 mg Cohorts: Abatacept

Period 1, Primary Cohort: Upadacitinib 15 mg QD

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: UpadacitinibExperimental Treatment3 Interventions

Participants were to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 40 mg adalimumab eow. At Week 26 remaining participants who did not achieve low disease activity (defined as CDAI ≤ 10) were to be switched to 40 mg adalimumab eow until Week 48. Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.

Group II: AdalimumabActive Control3 Interventions

Participants were to receive placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26 remaining participants who did not achieve low disease activity (defined as Clinical Disease Activity Index \[CDAI\] ≤ 10) were to be switched to 15 mg upadacitinib orally QD until Week 48. Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.

Group III: Placebo followed by ABT-494Placebo Group3 Interventions

Participants were to receive placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26, all remaining participants were to be switched to 15 mg upadacitinib QD until Week 48 (end of Period 1). Participants who complete Period 1 will continue to receive 15 mg upadacitinib orally QD for up to 5 years in Period 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

2014

Completed Phase 3

~11250

Placebo for Adalimumab

2018

Completed Phase 3

~390