What side effects are associated with this type of intervention?

TNF-alpha inhibitors, such as etanercept, adalimumab, and infliximab, are commonly used to treat Juvenile Idiopathic Arthritis (JIA). Known side effects of these treatments include increased risk of infections, injection site reactions, and potential development of antibodies against the medication, which can reduce its effectiveness. Other possible side effects are gastrointestinal issues, liver enzyme abnormalities, and rare cases of demyelinating disorders or lupus-like syndrome. Regular monitoring and consultation with a healthcare provider are essential to manage these risks.

What prior FDA approvals exist?

Several TNF-alpha inhibitors have been approved by the FDA for the treatment of Juvenile Idiopathic Arthritis (JIA). These include Etanercept, which was one of the first biologics approved for JIA, and Infliximab, which has shown efficacy in treating severe cases. Adalimumab is another TNF-alpha inhibitor that has been approved for use in children with JIA. These drugs work by targeting and neutralizing tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation in autoimmune diseases like JIA.

What other types of research exist?

Promising alternatives to Certolizumab Pegol for JIA patients include other TNF-alpha inhibitors such as Etanercept and Adalimumab, which have demonstrated efficacy and safety in pediatric populations. Additionally, newer biologic agents like Ustekinumab and Tofacitinib are emerging as potential options due to their effectiveness in treating refractory cases of inflammatory diseases. These alternatives provide a range of options for personalized treatment plans in 2024.

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Monoclonal Antibodies

Certolizumab Pegol for Juvenile Idiopathic Arthritis (PASCAL Trial)

Phase 3

Waitlist Available

Research Sponsored by UCB BIOSCIENCES GmbH

Eligibility Criteria Checklist

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

Must have

Study participants must have had onset of signs and symptoms consistent with a diagnosis of Juvenile Idiopathic Arthritis (JIA) (according to the International League of Associations for Rheumatology Classification of Juvenile Idiopathic Arthritis, 2001) and initiation of JIA treatment for at least 6 months prior to Baseline (Visit 2). Eligible JIA categories include: polyarthritis rheumatoid factor-positive, polyarthritis rheumatoid factor-negative, extended oligoarthritis, juvenile psoriatic arthritis, and enthesitis-related arthritis (ERA)

Study participants must have active polyarticular-course disease, defined as ≥5 joints with active arthritis at Screening and at Baseline

Must not have

Study participant had previous treatment with a biological therapy for juvenile idiopathic arthritis (JIA) that resulted in a severe hypersensitivity reaction or an anaphylactic reaction

Study participant has a history of systemic JIA, with or without systemic features

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) up to the final visit (70 days after final dose of czp) (maximum up to 12 years)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing Certolizumab Pegol, a drug that reduces inflammation, in children and teens with severe arthritis affecting many joints. The medication works by blocking a protein that causes swelling and pain. Certolizumab Pegol is a new treatment effective in reducing symptoms of rheumatoid arthritis. The study will take place over an extended period, with ongoing monitoring to ensure safety and effectiveness.

Who is the study for?

Children and teens aged 2-17 with moderately to severely active polyarticular-course Juvenile Idiopathic Arthritis (JIA) who weigh at least 22 pounds. They must have had JIA symptoms for over 6 months, be poorly responsive or intolerant to a DMARD like methotrexate, and not currently have severe infections or a history of serious reactions to biological therapies.

What is being tested?

The trial is testing Certolizumab Pegol (CZP) in young patients with JIA. It's an open-label study, meaning everyone knows they're getting the drug, focusing on how well it works, its safety profile, and how the body processes it.

What are the potential side effects?

While not specified here, common side effects of drugs like CZP may include injection site reactions, upper respiratory infections, headache, and possibly increased risk of developing serious infections.

Eligibility Criteria

Inclusion Criteria

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

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I have been treated for Juvenile Idiopathic Arthritis for at least 6 months.

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I have active arthritis in 5 or more joints.

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I am between 2 and 17 years old.

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I weigh at least 22 pounds.

Exclusion Criteria

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

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I had a severe allergic reaction to a previous JIA treatment.

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I have been diagnosed with systemic juvenile idiopathic arthritis.

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I have been treated with more than 2 biologic agents.

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I have an inflammatory condition like lupus or IBD.

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I have been part of this study or treated with CZP before.

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I currently have, or often get, serious infections.

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I have not responded to more than one TNFα blocker treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) up to the final visit (70 days after final dose of czp) (maximum up to 12 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) up to the final visit (70 days after final dose of czp) (maximum up to 12 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) up to the final visit (70 days after final dose of czp) (maximum up to 12 years) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16

Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48

Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16

+3 more

Secondary study objectives

Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16

Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16

Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16

+1 more

Side effects data

From 2012 Phase 4 trial • 736 Patients • NCT01255761

10%

Upper respiratory tract infection

10%

Urinary tract infection

Bronchitis

Sinusitis

Arthralgia

Small intestinal obstruction

Chest pain

Atrial fibrillation

Lupus-like syndrome

Pneumonia

Rheumatoid arthritis

Anaemia

100%

80%

60%

40%

20%

Study treatment Arm

CDAI to Assess Response to Cimzia

RAPID3 to Assess Response to Cimzia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Certolizumab PegolExperimental Treatment1 Intervention

Active treatment with Certolizumab Pegol; dose adjustment is based on weight.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Certolizumab Pegol (CZP)

2010

Completed Phase 4

~1860

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

TNF-alpha inhibitors, such as Certolizumab Pegol, work by blocking the activity of tumor necrosis factor-alpha (TNF-alpha), a cytokine that is central to the inflammatory process in Juvenile Idiopathic Arthritis (JIA). By inhibiting TNF-alpha, these treatments reduce inflammation, decrease joint damage, and improve overall function. This mechanism is vital for JIA patients as it helps manage symptoms, prevent long-term joint damage, and improve their quality of life.