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Monoclonal Antibodies

Risankizumab for Psoriatic Arthritis

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Active Disease in >= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both) are eligible for inclusion in the study.

Have had an inadequate response (lack of efficacy after minimum 2-month duration of therapy at maximally tolerated dose).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Study Summary

This trial is studying the safety and effectiveness of a medication called risankizumab for the treatment of psoriatic arthritis in children. Psoriatic arthritis is a type of arthritis that causes joint

Who is the study for?

This trial is for children with juvenile Psoriatic Arthritis (jPsA) who have had it for at least 6 months, are experiencing active disease in three or more joints, and haven't responded well to treatments like methotrexate. Kids can't join if they meet certain medical conditions that the study outlines.Check my eligibility

What is being tested?

The trial is testing Risankizumab against Adalimumab, both given as injections based on body weight. Participants will be randomly assigned to one of these drugs for an initial period of 24 weeks and may continue up to another 100 weeks depending on their response.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, nausea, and potential allergic reactions. Long-term effects are monitored over several months.

Eligibility Criteria

Inclusion Criteria

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

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I have active disease in 3 or more joints.

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My previous treatment for at least 2 months did not work.

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I cannot tolerate one of the common arthritis medications like methotrexate.

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

Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)

Secondary outcome measures

Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10

Change from Baseline in JADAS-27

Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: RisankizumabExperimental Treatment1 Intervention

Participants will receive risankizumab for 24 weeks, in Period 1. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. There will be a 140 day safety follow up after the treatment period.

Group II: AdalimumabExperimental Treatment1 Intervention

Participants will receive adalimumab for 24 weeks, in Period 1. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. There will be a 70 day safety follow up after the treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adalimumab

2013

Completed Phase 4

~6480

Risankizumab

2021

Completed Phase 3

~3140

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,350 Total Patients Enrolled

23 Trials studying Psoriatic Arthritis

108,905 Patients Enrolled for Psoriatic Arthritis

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

147,069 Total Patients Enrolled

7 Trials studying Psoriatic Arthritis

9,670 Patients Enrolled for Psoriatic Arthritis

Frequently Asked Questions

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

What is the current number of individuals enrolled in this clinical study?

"Indeed, the information provided on clinicaltrials.gov indicates that this study is actively seeking eligible participants. The trial was initially posted on January 16th, 2024 and last updated on January 10th, 2024. The study aims to enroll a total of 40 participants at one designated site."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"Indeed, the information available on clinicaltrials.gov indicates that this ongoing medical trial is actively seeking eligible participants. The initial posting of the trial was on January 16th, 2024, and it was last updated on January 10th, 2024."

Answered by AI

What is the level of safety associated with Adalimumab when administered to individuals?

"Based on the classification of this trial as Phase 3, indicating evidence supporting both efficacy and multiple rounds of safety data, our team at Power rates the safety level of Adalimumab with a score of 3."

Answered by AI