← Back to Search

T-cell Co-stimulation Modulator

Abatacept for Juvenile Idiopathic 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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose up to 6 months following treatment discontinuation (up to approximately 2 years)

Awards & highlights

Study Summary

This trial estimates the blood concentration of a drug, Abatacept, in children and adolescents with a form of arthritis called pJIA.

Eligible Conditions

Juvenile Idiopathic Arthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose up to 6 months following treatment discontinuation (up to approximately 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose up to 6 months following treatment discontinuation (up to approximately 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose up to 6 months following treatment discontinuation (up to approximately 2 years) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17

Secondary outcome measures

Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose

Number of Participants With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short-Term Period for the 6-17 Year Age-Group Cohort

Number of Participants With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period

+3 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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Short and Long Terms: OrenciaExperimental Treatment1 Intervention

Short Term: Orencia 50 mg/mL, 87.5 mg/mL, 125 mg/mL pre-filled syringes subcutaneously (0.4 mL/0.7 mL/1.0 mL) weekly for 4 months Long term: Orencia 50 mg/mL, 87.5 mg/mL, 125 mg/mL pre-filled syringes subcutaneously (0.4 mL/0.7 mL/1.0 mL) weekly for 20 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abatacept

2005

Completed Phase 4

~112150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,639 Previous Clinical Trials

4,128,813 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent does Abatacept put individuals at risk?

"Abatacept received a score of 3 on our Power scale due to it being a Phase 3 trial. This means that while there is some data supporting efficacy, multiple rounds of data support safety."

Answered by AI

In how many different geographical areas is this study being conducted?

"Currently, this clinical trial is running at 23 sites. If you are considering enrolling, please choose the location closest to you from the following list of cities: Hartford, Birmingham and Portland as well as other locations."

Answered by AI

If I wanted to participate in this experiment, would I be able to?

"Eligible patients for this clinical trial must be 2-17 years old and currently suffering from active polyarticular juvenile idiopathic arthritis. A total of 219 participants are needed."

Answered by AI

Abatacept is a medication used to treat what kind of condition?

"Abatacept is a medication that is often used to treat rheumatoid arthritis. It can also be helpful for patients suffering from psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and severe juvenile idiopathic arthritis."

Answered by AI

Are new participants still being welcomed into this clinical trial?

"The clinical trial in question, which was first posted on 8/30/2013 and edited most recently on 9/8/2022 is not enrolling patients at this time. However, there are 421 other trials currently recruiting participants."

Answered by AI

Are patients over the age of 30 able to participate in this research?

"67 other clinical trials are recruiting patients that are aged 2 to 17 and this study requires 361 people over the age of 65."

Answered by AI

Does Abatacept have a long history of being studied in clinical trials?

"At the moment, there are 8 Abatacept trials in Phase 3 with a total of 36 active studies. While some of these research programs are based out of Toronto, Ontario, 772 other locations across the world are also investigating this medication."

Answered by AI

What is the enrollment for this experiment?

"This research is no longer looking for volunteers. The trial was originally announced on 8/30/2013, with the last update being 9/8/2022. However, there are presently 385 studies actively recruiting patients with active polyarticular juvenile idiopathic arthritis and 36 studies for Abatacept searching for participants."

Answered by AI

Recent research and studies

Arthritis & RheumatologyJournal

Subcutaneous Abatacept in Patients with Polyarticular-course Juvenile Idiopathic Arthritis

Brunner, Hermine I., Nikolay Tzaribachev, Gabriel Vega-Cornejo, Ingrid Louw, Alberto Berman, Inmaculada Calvo Penadés, Jordi Antón, et al.. 2018. “Subcutaneous Abatacept in Patients with Polyarticular-course Juvenile Idiopathic Arthritis”. Arthritis & Rheumatology. Wiley. doi:10.1002/art.40466.

Pediatric RheumatologyJournal

Maintenance of Antibody Response to Diphtheria/tetanus Vaccine in Patients Aged 2–5 Years with Polyarticular-course Juvenile Idiopathic Arthritis Receiving Subcutaneous Abatacept

Brunner, Hermine I., for the Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation, Nikolay Tzaribachev, Gabriel Vega Cornejo, Rik Joos, Elisabeth Gervais, Rolando Cimaz, et al.. 2020. “Maintenance of Antibody Response to Diphtheria/tetanus Vaccine in Patients Aged 2–5 Years with Polyarticular-course Juvenile Idiopathic Arthritis Receiving Subcutaneous Abatacept”. Pediatric Rheumatology. Springer Science and Business Media LLC. doi:10.1186/s12969-020-0410-x.

The Journal of RheumatologyJournal

Absence of Association Between Abatacept Exposure and Initial Infection in Patients with Juvenile Idiopathic Arthritis

Ruperto, Nicolino, Hermine I. Brunner, Nikolay Tzaribachev, Gabriel Vega-Cornejo, Ingrid Louw, Rolando Cimaz, Jason Dare, et al.. 2021. “Absence of Association Between Abatacept Exposure and Initial Infection in Patients with Juvenile Idiopathic Arthritis”. The Journal of Rheumatology. The Journal of Rheumatology. doi:10.3899/jrheum.200154.

clinicaltrials.govStudy