Tofacitinib for Juvenile Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the long-term safety and tolerability of tofacitinib, a treatment for juvenile arthritis, which causes joint pain and swelling in children. All participants will receive tofacitinib to evaluate its effects over time. Suitable candidates include children and teens who previously participated in a tofacitinib study for juvenile arthritis and still experience active symptoms requiring treatment. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before starting the study drug, but it doesn't specify which ones. You can continue taking medications that are allowed by the study protocol.
Is there any evidence suggesting that tofacitinib is likely to be safe for humans?
A previous study showed that tofacitinib helps people with juvenile idiopathic arthritis (JIA). This treatment is approved for children aged 2 and older with a type of arthritis called pcJIA, indicating it is safe enough for some patients who do not respond well to other treatments.
However, serious risks must be considered. Tofacitinib carries warnings for serious infections, increased risk of death, cancer, and blood clots. These risks are important to consider when thinking about joining a trial.
Long-term studies have demonstrated that tofacitinib can be effective and generally well-tolerated. Discuss these risks with a doctor to decide if joining a trial is appropriate.12345Why do researchers think this study treatment might be promising for juvenile arthritis?
Tofacitinib is unique because it works by targeting and inhibiting Janus kinases (JAKs), which play a crucial role in the inflammatory process associated with juvenile arthritis. Unlike standard treatments such as methotrexate or biologics like TNF inhibitors, which have broader immune-suppressing effects, tofacitinib offers a more targeted approach. Researchers are excited about this treatment because it has the potential to reduce inflammation more precisely and may offer an oral administration option, making it easier for young patients to take compared to injectable therapies.
What is the effectiveness track record for tofacitinib in treating juvenile arthritis?
Research has shown that tofacitinib can help treat juvenile idiopathic arthritis (JIA). In one study, 76.9% of children who started taking tofacitinib continued to see benefits compared to those who switched to a placebo, a pill with no active medicine. Another study found that 27.3% of children reached "clinically inactive disease," where symptoms were well controlled, compared to 17.6% who took a placebo. These findings suggest that tofacitinib can improve symptom control and physical function in children with JIA. All participants in this trial will receive tofacitinib.26789
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for pediatric patients aged 2 to less than 18 with Juvenile Idiopathic Arthritis (JIA) who've been in previous tofacitinib studies. They should have active JIA needing treatment and use effective contraception if applicable. Excluded are those with recent serious infections, certain viral infections like HIV or hepatitis, recurrent herpes zoster, or chronic infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline assessments are conducted before starting the treatment
Treatment
Participants receive tofacitinib treatment with regular follow-up visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tofacitinib
Trial Overview
The study tests the long-term safety of a medication called Tofacitinib in young patients with JIA. It's for those who've already taken part in earlier Tofacitinib trials and focuses on how well they tolerate the drug over an extended period.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
All patients will be in tofacitinib treatment group.
Tofacitinib is already approved in United States, European Union for the following indications:
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Ulcerative Colitis
- Ankylosing Spondylitis
- Polyarticular Course Juvenile Idiopathic Arthritis
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Ulcerative Colitis
- Ankylosing Spondylitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
Safety and efficacy of tofacitinib for the treatment of patients ...
Results: Of 225 patients with JIA (median (range) duration of treatment, 41.6 (1-103) months), 201 (89.3%) had AEs; 34 (15.1%) had serious AEs.
Safety and efficacy of tofacitinib for the treatment of patients ...
Efficacy outcomes included improvement since tofacitinib initiation per the JIA-American College of Rheumatology (ACR)70/90 criteria, JIA flare rate and disease ...
Clinically Inactive Disease and Remission in Patients With ...
Results Of 225 patients with JIA in part 1, 173 (76.9%) were randomized in part 2 to continue tofacitinib or switch to placebo. Rates of JADAS10 ...
Efficacy Study Of Tofacitinib In Pediatric JIA Population
This is a randomized withdrawal, double blind, placebo controlled study of pediatric subjects (2 to <18 years of age) with JIA.
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rheumatologyadvisor.com
rheumatologyadvisor.com/news/tofacitinib-improves-physical-function-in-jia/Tofacitinib Improves Disease Control, Function in Juvenile ...
The percentage of patients who achieved JADAS10-CID plus normal physical function reached 27.3% with tofacitinib vs 17.6% with placebo.
Home Page | XELJANZ® (tofacitinib) For pcJIA | Safety Info
The first and only JAK inhibitor approved to treat active pcJIA in patients 2 and older when TNF blockers did not work well or could not be tolerated.
Xeljanz | European Medicines Agency (EMA)
Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF ...
Long-Term Safety Study Of Tofacitinib In Patients With ...
This is a Phase 2/3, long term, open-label, follow-up study. Subjects will have previously participated in qualifying/index JIA studies of tofacitinib.
Tofacitinib - accessdata.fda.gov
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY. AND THROMBOSIS. See full prescribing information for complete boxed warning.
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