Tofacitinib for Juvenile Arthritis

Recruiting at 176 trial locations

Overseen By Pfizer CT.gov Call Center

Age: < 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Pfizer

Must be taking: Tofacitinib

Disqualifiers: Chronic infections, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Variable, up to 1 year or until marketing approval

302 Participants Needed

Trial Summary

What is the purpose of this trial?

Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

I am under 18, have JIA, and need tofacitinib as per my doctor's advice.

I have stopped taking certain medications as required and only take approved ones.

Fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be using a highly effective method of contraception as outlined in this protocol throughout the study and for at least 28 days after the last dose of study medication.

Exclusion Criteria

I have a long-term infection.

I am infected with HIV, hepatitis B, or hepatitis C.

You have had an infected joint replacement in the past and still have the replacement in place.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 28 days

1 visit (in-person)

Baseline

Baseline assessments are conducted before starting the treatment

1 day

1 visit (in-person)

Treatment

Participants receive tofacitinib treatment with regular follow-up visits

Variable, up to 1 year or until marketing approval

Visits at 1 month, 3 months, then every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: Tofacitinib Experimental Treatment 1 Intervention

All patients will be in tofacitinib treatment group.

Tofacitinib is already approved in United States, European Union for the following indications:

Approved in United States as Xeljanz for:

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Ulcerative Colitis
• Ankylosing Spondylitis
• Polyarticular Course Juvenile Idiopathic Arthritis

Approved in European Union as Xeljanz for:

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Ulcerative Colitis
• Ankylosing Spondylitis

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

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