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T-cell Co-stimulation Modulator

Abatacept vs Adalimumab for Rheumatoid Arthritis

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA
Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limit of normal and positive for rheumatoid factor (RF) according to central lab testing during screening
Must not have
History of or current inflammatory joint disease other than RA (e.g., psoriatic arthritis, gout, reactive arthritis, Lyme disease)
At risk for tuberculosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29, 57, 85, 113, 141, 169
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will compare the effectiveness of two different drugs for people with early rheumatoid arthritis who haven't responded well to methotrexate.

Who is the study for?
Adults with early rheumatoid arthritis (RA) that began within the last year, who have not responded well to methotrexate alone. Participants must not have used other RA drugs or treatments and should test positive for specific RA markers. They need at least 3 tender and swollen joints and a certain level of disease activity.
What is being tested?
The trial is testing if abatacept is more effective than adalimumab when both are taken with methotrexate in adults with early, seropositive RA who haven't had a good response to methotrexate alone. Patients will be randomly assigned to receive either abatacept or adalimumab.
What are the potential side effects?
Possible side effects include injection site reactions, increased risk of infections, headaches, nausea, and potentially serious allergic reactions. Both medications can affect the immune system's ability to fight off infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't taken any RA drugs except for methotrexate.
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My tests show high levels of Anti-CCP-2 and positive for rheumatoid factor.
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My rheumatoid arthritis symptoms started less than a year ago.
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I have at least 3 tender and 3 swollen joints now and when first checked.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had an inflammatory joint disease that is not rheumatoid arthritis.
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I am at risk for tuberculosis.
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I cannot have 5 or more of my joints checked for pain or swelling.
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I have an autoimmune disease other than rheumatoid arthritis or active fibromyalgia.
Select...
I have a history of ongoing or repeated bacterial infections.
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I have or had a condition that affects the protective covering of my nerves.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29, 57, 85, 113, 141, 169
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29, 57, 85, 113, 141, 169 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 SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24
Secondary study objectives
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for All Participants
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for SE+ Participants
+31 more

Side effects data

From 2023 Phase 3 trial • 657 Patients • NCT03086343
24%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
ACUTE RESPIRATORY FAILURE
12%
RASH
12%
INFLUENZA
12%
ARTHRALGIA
12%
URINARY TRACT INFECTION
12%
WEIGHT INCREASED
12%
FALL
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
LIVER FUNCTION TEST INCREASED
12%
OROPHARYNGEAL PAIN
6%
SEBORRHOEIC KERATOSIS
6%
HEADACHE
6%
NAUSEA
6%
HIP FRACTURE
6%
PHARYNGITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
HYPOKALAEMIA
6%
SJOGREN'S SYNDROME
6%
RHINORRHOEA
6%
PNEUMONIA BACTERIAL
6%
ASTHMA
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
CONSTIPATION
6%
HYPONATRAEMIA
6%
HEPATIC STEATOSIS
6%
DEHYDRATION
6%
PHOTODERMATOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
VOMITING
6%
PERIPHERAL SWELLING
6%
STAPHYLOCOCCAL INFECTION
6%
ORAL CANDIDIASIS
6%
HAEMOGLOBIN DECREASED
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
FEELING HOT
6%
COSTOCHONDRITIS
6%
LEUKOCYTOSIS
6%
TACHYCARDIA
6%
STOMATITIS
6%
PATELLA FRACTURE
6%
ACTINIC KERATOSIS
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CHEST PAIN
6%
FATIGUE
6%
CANDIDA INFECTION
6%
SKIN LACERATION
6%
COVID-19
6%
CATARACT
6%
INFECTIOUS PLEURAL EFFUSION
6%
DYSPHAGIA
6%
SWELLING
6%
ACUTE KIDNEY INJURY
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
OSTEOARTHRITIS
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
FEMUR FRACTURE
6%
LIGAMENT RUPTURE
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
INSOMNIA
6%
ERYTHEMA
6%
PRURITUS
6%
DERMATITIS ALLERGIC
6%
BACK PAIN
6%
DIZZINESS
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
OSTEOPENIA
100%
80%
60%
40%
20%
0%
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
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)Experimental Treatment3 Interventions
Group II: Arm 1: Abatacept + MethotrexateExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
2005
Completed Phase 4
~112250
Adalimumab
2013
Completed Phase 4
~7950
Methotrexate
2019
Completed Phase 4
~4400

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,733 Total Patients Enrolled
108 Trials studying Rheumatoid Arthritis
371,213 Patients Enrolled for Rheumatoid Arthritis

Media Library

Abatacept (T-cell Co-stimulation Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04909801 — Phase 3
Rheumatoid Arthritis Research Study Groups: Arm 1: Abatacept + Methotrexate, Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)
Rheumatoid Arthritis Clinical Trial 2023: Abatacept Highlights & Side Effects. Trial Name: NCT04909801 — Phase 3
Abatacept (T-cell Co-stimulation Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04909801 — Phase 3
~80 spots leftby Dec 2025
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