Sequential Medications for Juvenile Rheumatoid Arthritis

(SMART-JIA Trial)

Recruiting at 5 trial locations

Overseen By Laura E Schanberg (Contact PI)

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Duke University

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is an open-label, randomized, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential multiple assignment randomized trial design with 2 randomization stages corresponding with clinical decision points. The first randomization addresses whether each of the 3 non-TNFi medications is superior to treatment with a second TNFi. The second randomization allows identification of optimal sequential use of biologics (treatment strategies).

Are You a Good Fit for This Trial?

Inclusion Criteria

My disease is still active even after 3 months of TNFi treatment.

I am not taking steroids, or my steroid dose is low and stable for at least 2 weeks.

I have given my consent or my guardian has consented for me to participate.

What Are the Treatments Tested in This Trial?

Interventions

• Abatacept
• TNFi (Tumor Necrosis Factor inhibitor) medication
• Tocilizumab
• Tofacitinib

How Is the Trial Designed?

Group I: Second TNFi (Tumor Necrosis Factor inhibitor) medication Active Control 1 Intervention

Adalimumab originator or biosimilar; etanercept originator or biosimilar depending on which TNFi the participant had failed.

Group II: Abatacept Active Control 1 Intervention

The 50 mg, 87.5 mg and 125 mg SQ doses will be available for weight-based dosing. All participants randomized to abatacept in the first or second stage randomization will receive abatacept SQ weekly at a dosage based on the participant's body weight

Group III: Tocilizumab originator or biosimilar Active Control 1 Intervention

Tocilizumab will be provided in prefilled syringes (162 mg tocilizumab/0.9 mL solution). All participants randomized to tocilizumab in the first or second stage randomization will be receiving 1 prefilled syringe (162 mg) with a dosing interval based on the body weight criteria.

Group IV: Tofacitinib Active Control 1 Intervention

Tofacitinib will be provided as oral tablets (tofacitinib citrate 5 mg) and as an oral solution (1 mg/mL). All participants randomized to tofacitinib in the first or second stage randomization will receive tofacitinib oral tablets or oral solution twice daily, approximately 12 hours apart, in the morning and evening, at a dosage based on the participant's body weight .

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+