Actively Recruiting
Pragmatic Open-Label Two-Stage Study of Immunomodulatory Medications for Relapsing Polychondritis
Led by University of Pennsylvania · Updated on 2026-02-04
20
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness of five standard treatment options for patients with relapsing polychondritis (RP), a condition characterized by inflammation of cartilage and other tissues. The study is a two-stage, open-label, non-randomized pilot trial involving twenty patients with mild to moderately active RP. It evaluates immunomodulatory medications in a pragmatic clinical setting to better understand their impact on managing RP symptoms. Participants will start in Stage 1 if they have not previously used methotrexate (MTX) or azathioprine (AZA), or have active disease on these drugs for 8 weeks or less. Those new to treatment will begin MTX or AZA depending on suitability. Patients who do not meet the primary effectiveness endpoint or experience relapse or intolerance will move to Stage 2, where they will receive either a tumor necrosis factor inhibitor (adalimumab or infliximab) or an interleukin 6 inhibitor (tocilizumab). All patients receive glucocorticoids tapered to 5 mg daily by week 21 following a standardized schedule. During the 26-week study, participants will undergo assessments including physician and patient global response evaluations at weeks 0, 12, and 26, quality of life measurements, and monitoring of time to disease flare and safety of study drugs. The primary outcome is efficacy of the treatments over 26 weeks. Patients will have regular follow-up visits to monitor disease activity, medication effects, and adherence to therapy. The study provides detailed tracking to understand how these therapies work in controlling RP symptoms.
CONDITIONS
Brief 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...
- 18 years of age or older
- Diagnosed with relapsing polychondritis by McAdam's, Damiani's, or Michet's criteria
- Mild to moderately active disease within 60 days prior to screening requiring prednisone dose increase between 20-60 mg/day
- Willing and able to comply with treatment and follow-up procedures
- If of childbearing potential, willing to use effective birth control during treatment
- Able and willing to provide written informed consent
You will not qualify if you...
- Severe disease manifestations within past 28 days including severe airway inflammation requiring oxygen or ventilation
- Central nervous system disease requiring hospitalization or intravenous treatment
- Symptomatic cardiac disease requiring active treatment or surgery
- Severe eye inflammation that threatens vision
- Any organ- or life-threatening disease requiring high-dose prednisone or intravenous treatment
- Prior use of biologic DMARDs
- Evidence of active infection or positive tests for HIV, hepatitis B or C
- Risk or history of active or latent tuberculosis without appropriate treatment
- Inability to comply with study guidelines
- Blood disorders such as low platelets, neutrophils, or hematocrit
- Other uncontrolled diseases that increase risk
- Current or recent malignancy within 5 years except certain skin or cervical cancers
- Receipt of investigational agent or device within 30 days prior to enrollment
- Live vaccination within 4 weeks before enrollment
- Presence of other specified autoimmune or vasculitis diseases and VEXAS syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive immunomodulatory medications including methotrexate, azathioprine, adalimumab, infliximab, or tocilizumab along with glucocorticoids tapered over time according to a standardized schedule.
Visits at weeks 0, 12, and 26 for assessments
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
C
Carol McAlear
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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