Actively Recruiting
An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis
Led by University of Pennsylvania · Updated on 2026-02-04
20
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of relapsing polychondritis meeting McAdam's, Damiani's, or Michet's criteria
- Mild to moderately active disease within 60 days before screening requiring prednisone increase between 20-60 mg/day
- Presence of active symptoms such as auricular inflammation, nasal inflammation, ocular inflammation, inflammatory arthritis, or mild to moderate airway inflammation within 60 days before enrollment
- Willingness and ability to comply with treatment and follow-up
- Use of effective birth control during treatment for women and men of childbearing potential
- Ability to provide written informed consent
You will not qualify if you...
- Severe disease manifestations within 28 days before enrollment including severe airway inflammation needing oxygen or ventilation, CNS disease requiring hospitalization, symptomatic heart failure, or severe eye inflammation threatening vision
- Prior or current use of biologic DMARDs
- Evidence of active infection or known HIV, hepatitis B or C infection
- Risk or history of active or latent tuberculosis without appropriate treatment
- Inability to comply with study guidelines
- Cytopenia: low platelet count, low neutrophil count, or low hematocrit
- Other uncontrolled diseases that increase risk or prevent study participation
- Current or recent malignancy within 5 years except certain skin or cervical cancers
- Receipt of investigational agents or devices within 30 days before enrollment
- Live vaccination within 4 weeks before enrollment
- Presence of specific autoimmune or infectious diseases such as ANCA-associated vasculitis, sarcoidosis, Kawasaki disease, systemic lupus erythematosus, rheumatoid arthritis, or VEXAS syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
C
Carol McAlear
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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