TNFi Therapy Strategies for Juvenile Spondyloarthritis
(BACK-OFF JSpA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores different strategies for adjusting TNFi (tumor necrosis factor inhibitor) therapy in young people with juvenile spondyloarthritis, focusing on those with inactive disease. The study tests three approaches: continuing the usual treatment, increasing the time between doses, or stopping the treatment altogether. Researchers aim to determine how these changes affect the risk of flare-ups and the daily experiences of participants. The trial seeks young people aged 8 to 21 who have been diagnosed with juvenile spondyloarthritis, are currently on TNFi therapy, and have had their symptoms under control for at least six months. As an unphased trial, this study offers participants the chance to contribute to valuable research that could improve future treatment strategies.
Will I have to stop taking my current medications?
The trial focuses on de-escalating (reducing) TNFi therapy, so you will not have to stop taking your current TNFi medication completely, but you will need to be willing to reduce it.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that TNFi (tumor necrosis factor inhibitor) treatments are generally safe for children with juvenile spondyloarthritis. Studies have found that up to 60% of children experience no active symptoms while on these treatments, indicating good tolerance.
For those considering less frequent TNFi dosing, research has not shown an increase in side effects. Longer gaps between doses do not appear to cause more problems than the regular schedule.
However, studies on stopping TNFi treatment have shown mixed results. Some patients may experience a return of symptoms, but no major safety issues have been reported when discontinuing the treatment.
In summary, TNFi treatments are generally well-tolerated, whether following the regular schedule, extending the time between doses, or stopping altogether. It is always important to consult a healthcare provider before making any changes to treatment.12345Why are researchers excited about this trial?
Researchers are excited about these TNFi therapy strategies for juvenile spondyloarthritis because they explore innovative dosing methods. Unlike the standard TNFi treatment, which follows a fixed schedule, one approach tests longer intervals between doses. This could mean fewer doctor visits and potentially fewer side effects while maintaining effectiveness. Another strategy investigates the possibility of stopping TNFi treatment altogether to see if patients can remain symptom-free without ongoing medication. These approaches aim to enhance convenience and personalize care for young patients.
What evidence suggests that this trial's treatments could be effective for juvenile spondyloarthritis?
Studies have shown that certain medications, called tumor necrosis factor inhibitors (TNFi), effectively reduce symptoms and inflammation in children with juvenile spondyloarthritis (JSpA). In this trial, participants will follow different treatment strategies. One group will continue with standard TNFi therapy, while another will have increased intervals between doses, which research suggests might control the disease without more flare-ups. A third group will stop TNFi treatment entirely, although stopping can lead to a return of symptoms in about 50% to 80% of patients. While some children manage without the medication, many experience symptoms again. Therefore, TNFi is generally effective for JSpA, but stopping it requires caution.12678
Are You a Good Fit for This Trial?
This trial is for kids and young adults aged 8 to 21 with juvenile spondyloarthritis, who have been symptom-free for at least six months while on standard TNFi therapy. They must meet specific criteria including arthritis or enthesitis, and not have certain conditions like inflammatory bowel disease or psoriasis requiring more than topical treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to one of three treatment arms: continued fixed standard dosing, fixed longer dosing intervals, or stopping TNFi, for 12 months
Follow-up
Participants are monitored for long-term outcomes after the intervention period
What Are the Treatments Tested in This Trial?
Interventions
- Standard TNFi Therapy
- TNFi fixed longer dosing intervals
- TNFi treatment
Standard TNFi Therapy is already approved in United States, European Union for the following indications:
- Moderate to Severe Rheumatoid Arthritis
- Moderate to Severe Polyarticular Juvenile Rheumatoid Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Moderate to Severe Plaque Psoriasis
- Rheumatoid Arthritis
- Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Plaque Psoriasis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Philadelphia
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator