Immunomodulatory Medications for Polychondritis

(PROSECT RP Trial)

Overseen By Carol McAlear

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Pennsylvania

Must not be taking: Biologic DMARDs

Disqualifiers: Severe disease, CNS disease, Cardiac disease, Active infection, Malignancy, others

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

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

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, patients with current or prior use of certain medications like methotrexate or azathioprine are eligible, while those with exposure to biologic DMARDs are excluded. It's best to discuss your specific medications with the trial team.

What evidence supports the effectiveness of the drugs Adalimumab and Tocilizumab for treating polychondritis?

Adalimumab has shown rapid improvement in symptoms for a patient with relapsing polychondritis, reducing inflammation markers. Tocilizumab has been effective in resolving symptoms and normalizing inflammation markers in patients with refractory relapsing polychondritis, even when other treatments failed. ^{1 2 3 4 5}

Is it safe to use immunomodulatory medications like Adalimumab, Azathioprine, Infliximab, Methotrexate, and Tocilizumab for treating conditions like polychondritis?

Studies and case reports suggest that medications like Adalimumab, Infliximab, Methotrexate, and Tocilizumab have been used in patients with polychondritis and other conditions, showing improvement in symptoms. However, these treatments can have side effects, and their safety can vary depending on the individual, so it's important to discuss with a healthcare provider. ^{1 2 3 4 5}

How does this drug differ from other treatments for relapsing polychondritis?

This treatment is unique because it includes biologics like adalimumab and tocilizumab, which target specific inflammatory pathways, offering an alternative for patients who do not respond to traditional high-dose steroids and immunosuppressive drugs. These biologics have shown promise in reducing inflammation and symptoms in cases where other treatments have failed. ^{2 4 5 6 7}

Research Team

Shubhasree Banerjee, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for patients with relapsing polychondritis, a condition where cartilage becomes inflamed. Participants should have this diagnosis and be in need of treatment.

Inclusion Criteria

Willing and able to provide written informed consent

Must fulfill McAdam's or Damiani's or Michet's Criteria Diagnostic Criteria for Relapsing Polychondritis

Willing and able to comply with treatment and follow-up procedures

Exclusion Criteria

Patients at risk for tuberculosis (TB)

Inability to comply with study guidelines

Receipt of an investigational agent or device within 30 days prior to enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants receive methotrexate (MTX) or azathioprine (AZA) for up to 8 weeks if naïve or with active disease on these medications

8 weeks

Stage 2 Treatment

Participants who do not meet primary effectiveness end point in Stage 1 or develop relapse/intolerance to MTX/AZA will receive TNFi or IL6i

18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Adalimumab
• Azathioprine
• Infliximab
• Methotrexate
• Tocilizumab

Trial Overview The study tests five medications: Methotrexate (MTX), Azathioprine (AZA), Adalimumab, Tocilizumab, and Infliximab to see which is most effective for treating relapsing polychondritis. It's an open-label, non-randomized pilot study.

Participant Groups

Group I: Azathioprine or Methotrexate Experimental Treatment 2 Interventions

Group II: Adalimumab, Infliximab, or Tocilizumab Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

References

1. Norway pubmed.ncbi.nlm.nih.gov

[Polychondritis--a rare and difficult diagnosis]. [2013]

2. Italy pubmed.ncbi.nlm.nih.gov

Biologics in relapsing polychondritis: a case series. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of biologics in relapsing polychondritis: a French national multicentre study. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of adalimumab for a refractory case of relapsing polychondritis with reduction of pro-inflammatory cytokines. [2016]

5. Germany pubmed.ncbi.nlm.nih.gov

Sustained response to tocilizumab in a patient with relapsing polychondritis with aortic involvement: a case based review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Relapsing polychondritis in a Latin American man. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Sustained Remission with Tocilizumab in Refractory Relapsing Polychondritis with Ocular Involvement: A Case Series. [2021]