NCT06941376

An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis

Pragmatic, Open-Label, Two-Stage, Pilot Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open label pragmatic two-stage non-randomized trial comparing the effectiveness of five different standard of care treatment options for patients with relapsing polychondritis (RP).

Detailed description

Twenty eligible patients with mild to moderately active RP within 60 days prior to screening will be enrolled to the study. Subjects will be eligible to enroll into stage 1 if they are naïve to methotrexate (MTX) or azathioprine (AZA), or having active disease on MTX or AZA for 8 weeks or less. Patients naïve to MTX and AZA will be started on MTX. AZA will be started if there is a contraindication to MTX. Patients on MTX/AZA for 8 weeks or less with active disease will be continued with the respective medication. Patients who do not meet primary effectiveness end point in Stage 1 or develop relapse of RP or intolerance to MTX/AZA will move to Stage 2. Patients eligible to be enrolled to Stage 2 directly 1. History of intolerance or side effects to MTX or AZA with active disease 2. Currently on MTX or AZA for at least 8 weeks or has received it within the past 60 days for at least 8 weeks and still has mild/ moderate active disease All patients in Stage 2 will be started on Tumor necrosis factor inhibitor (TNFi) or Interleukin 6 inhibitor (IL6i). The two TNFis that will be used in the trial are adalimumab or infliximab. The choice between the 2 TNFis will be based on patients' preference/ feasibility. The IL6i in the study will be tocilizumab. All patients will receive glucocorticoids (GC) which will be tapered to 5 mg daily by week 21 according to a standardized schedule in both stages of the trial.

Conditions

• Relapsing Polychondritis

Interventions

Type	Name	Description
DRUG	Methotrexate (MTX)	Weekly methotrexate dose of 20 mg (oral or subcutaneous).
DRUG	Azathioprine (AZA)	Azathioprine dose will be 2-3 mg/kg body weight per day.
BIOLOGICAL	Adalimumab	Adalimumab dose will be 40 mg subcutaneously every 1-2 weeks
BIOLOGICAL	Infliximab	Infliximab dose will be 5mg/kg at week 0 and week 2, and then every 4-8 weeks.
BIOLOGICAL	Tocilizumab	Tocilizumab dose will be 162 mg subcutaneous injection every week or 4-8 mg/kg every 4 weeks

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2025-04-23
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study