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

NCT06941376 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-04

No results posted yet for this study

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).

Conditions

  • Relapsing Polychondritis

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Shubhasree Banerjee, MD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-07-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06941376 on ClinicalTrials.gov