In open-label phase: treatment with tofacitinib for Juvenile Idiopathic Arthritis (JIA)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
UPECLIN Unidade de Pesquisa Clinica da Faculdade de Medicina da UNESP, Botucatu, Brazil
Juvenile Idiopathic Arthritis (JIA)+1 More
In open-label phase: treatment with tofacitinib - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug which is used to treat rheumatoid arthritis may help treat juvenile idiopathic arthritis.

See full description

Eligible Conditions

  • Juvenile Idiopathic Arthritis (JIA)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Juvenile Idiopathic Arthritis (JIA)

Study Objectives

This trial is evaluating whether In open-label phase: treatment with tofacitinib will improve 1 primary outcome and 14 secondary outcomes in patients with Juvenile Idiopathic Arthritis (JIA). Measurement will happen over the course of Up to 82 weeks after randomization.

12 to 40 weeks
Achievement of a corticosteroid dose of 0.2 mg/kg/day or 10 mg/day (whichever is lower) at the end of the open label treatment period
Achievement of corticosteroid tapering at the end of the open-label phase
CRP ≤ 10 mg/L at every visit of the open label phase.
Time to first Adapted JIA ACR 30 response in Part 1 of the open label phase.
Day 14
Fever (Temp >38 Degrees Celsius) attributed to sJIA at Day 3, Day 7 and Day 14 of the open label phase.
Week 82
Adapted sJIA ACR 30/50/70/90/100 response at every visit from Day 7 onward in the open label and double blind phase.
Occurrence of disease flare in double-blind phase
Time to flare
Week 82
"Absence of fever", defined as absence of fever due to sJIA in the week preceding the assessment at every visit from Day 7 onward in the open label and double blind phase.
Change from baseline in Child Health Assessment Questionnaire (CHAQ) at every visit from Day 7 onward in the open label and double blind phase.
Change from baseline in Child Health Questionnaire (CHQ) responses at the end of Part 1 and Part 2 of the open label phase, at randomization and every 3 months thereafter.
Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS 27) at every visit from Day 7 onward in the open label and double blind phase.
Change from baseline in each JIA ACR core variable at every visit from Day 7 onward in the open label and double blind phase.
Occurrence of inactive disease status and clinical remission at every visit from Day 7 onward (JIA ACR) in the open label and double blind phase.
Occurrence of inactive disease status and minimal disease activity clinical remission at every visit from Day 7 onward (JADAS 27) in the open label and double blind phase.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Juvenile Idiopathic Arthritis (JIA)

Trial Design

2 Treatment Groups

Tofacitinib 5 mg BID
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. In Open-label Phase: Treatment With Tofacitinib is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Tofacitinib 5 mg BIDoral, twice daily, tablet or solution.
Placebo
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 3, day 7, day 14
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 3, day 7, day 14 for reporting.

Closest Location

Rady Children's Hospital Rheumatology Clinic - San Diego, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
active sJIA disease according to ILAR criteria before screening and at baseline (Day 1);
Treatment with stable doses of methotrexate (MTX) ≤25 mg/week or ≤20 mg/m2/week, whichever is lower, is permitted;
Treatment with a stable dose of oral prednisone ≤1 mg/kg/day up to a maximum of 30 mg/day, or equivalent, for at least 1 week before the first study drug dose is permitted.

Patient Q&A Section

How many people get arthritis a year in the United States?

"Around 60 million Americans have arthritis at some time in their lives. This prevalence in the US is higher than prevalence reported in other affluent countries." - Anonymous Online Contributor

Unverified Answer

Can arthritis be cured?

"In a recent study, findings of this study suggest that arthritis cannot be cured at the present time, but with treatment, remission and control can be achieved. A longer term randomized study is needed to confirm these results and determine the potential usefulness of therapies such as HA." - Anonymous Online Contributor

Unverified Answer

What is arthritis?

"Arthritis can be summarized as a condition that causes swelling, tenderness, pain, and stiffness in one or more joints. It typically sets in between the ages of 40 and 60. There are multiple subtypes, the most common being [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis) and rheumatoid arthritis." - Anonymous Online Contributor

Unverified Answer

What are the signs of arthritis?

"There are a range of symptoms and signs with arthritis of both acute and chronic origin. answer: For example, the use of NSAIDs affects pain and swelling and can cause fever and loss of appetite. The diagnosis can be complicated by the presence of fever, weight loss, malaise, muscle weakness and shortness of breath. The general practitioner can be encouraged to play a key role in initiating investigations and ensuring the early recognition of the signs." - Anonymous Online Contributor

Unverified Answer

What are common treatments for arthritis?

"Treatment for arthritis is most commonly pain-relieving medication in combination with physical therapy. Common treatments include medications like analgesics and NSAIDs as well as corticosteroids. More than 85% of arthritis patients in Denmark are able to speak clearly and speak for themselves, meaning they can understand what treatment they feel is right for them. However, if it is difficult for those who cannot speak to decide about treatment, then an interprofessional or integrated team approach can be helpful in deciding treatment.\nA survey published in 2017 found that the prevalence of treatment for arthritis is low among children aged 14–16 in Sweden, with an estimate of 5% for pain and 5% for stiffness." - Anonymous Online Contributor

Unverified Answer

What causes arthritis?

"The exact cause of arthritis is unknown, but it is likely similar to other conditions with unknown etiology. Possible causes include genetic, physical, traumatic and emotional factors. There are many types of arthritis that can be diagnosed, but it is crucial to have a basic understanding of how this disease manifests in both the different types, and that it can affect all joints. Treatment for arthritis depends on the type of arthritis and the specific affected joints. For example, people with spondylitis and psoriatic arthritis can respond to various medications and procedures. The different types of arthritis can have different treatments and symptoms, but in all it is important to understand that the disease can be caused by many different factors." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in in open-label phase: treatment with tofacitinib for therapeutic use?

"Results from a recent clinical trial of this study indicate improvements at 16 weeks on tofacitinib versus placebo in a post hoc analysis of both efficacy and tolerability. Patients on tofacitinib were less likely to achieve remission compared with those taking placebo. As efficacy was similar between the two groups regarding HAQ-DI score and disease activity at week 8, results at week 16 suggest that longer treatment with tofacitinib is associated with improved long-term outcomes. Overall, data are promising and tofacitinib appears to be feasible and well tolerated for this indication." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets arthritis?

"There is a clear age-related progression in the incidence of synovitis with little change in incidence of polyarticular arthritis. The incidence of inflammatory arthritis is greatest in the oldest age group." - Anonymous Online Contributor

Unverified Answer

How serious can arthritis be?

"Many patients have trouble walking (to make the rounds at least it's not as serious as they think). Other patients are unable to put away laundry for days or weeks because of their arthritis. One patient tells me that it takes him 20 minutes to put on or off socks and shoes after he sheds in the morning, and he is in tremendous pain all day long." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving in open-label phase: treatment with tofacitinib?

"The present study is the first to report an open-label prospective pilot study on tofacitinib. The findings of the present study suggested that tofacitinib has a beneficial effect on certain disease severity and quality of life indicators. Findings from a recent study suggest that one of the possible mechanisms of this beneficial effect might be the reduction of inflammatory-related markers and the improved quality of life." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for arthritis?

"One of the important factors limiting clinical trials of treatments for rheumatic disorders is the unmet need for treatment. As there are no randomized clinical trials for individual medications, pharmacogenomic testing could provide valuable insight into personalized therapeutics for a wide range of rheumatic conditions." - Anonymous Online Contributor

Unverified Answer

Does arthritis run in families?

"Results from a recent clinical trial reveal no clear association between joint symptoms in family members. We did find weak evidence for a paternal risk locus on chromosome 1p that could be associated with offspring. It is feasible that genetic architecture is variable in the expression of arthritis in family members. Genetic and environmental factors combined influence the development of familial arthritis. Alternatively, we could be seeing only a phenotypic manifestation of familial, or polygenic, arthritis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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