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Relapsing PolychondritisPhase 2PROSECT RPNCT06941376

Pragmatic, Open-Label Study to Pilot Evaluation for Clinical Trials in Relapsing Polychondritis

A Phase 2 study testing Methotrexate (MTX), Azathioprine (AZA) and Adalimumab in people with Relapsing Polychondritis, run by University of Pennsylvania at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsing Polychondritis
What is being tested?
Methotrexate (MTX), Azathioprine (AZA) and Adalimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
11 Nov 2025to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age
  • Must fulfill McAdam's or Damiani's or Michet's Criteria Diagnostic Criteria for Relapsing Polychondritis McAdam's Criteria (1976)
  • ≥ 3 criteria out of 6 of the following:
  • Bilateral auricular chondritis
  • Non-erosive seronegative polyarthritis
  • Nasal chondritis
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  • Ocular inflammation
  • Respiratory tract chondritis
  • Cochlear and/or vestibular dysfunction
  • Damiani's Criteria (1979)
  • ≥3 of McAdam's Criteria as above
  • ≥1 of McAdam's Criteria with histological confirmation of chondritis
  • ≥2 of McAdam's Criteria with positive response to glucocorticoids or dapsone
  • Michet's Criteria (1986)
  • Presence of ≥2 of the following criteria:
  • Auricular chondritis
  • Nasal chondritis
  • Laryngotracheal chondritis
  • Or presence of ≥1 of the above criteria and ≥2 of the following criteria
  • Seronegative inflammatory arthritis
  • Ocular inflammation
  • Hearing loss
  • Vestibular dysfunction
  • Mild to moderately active disease within 60 days prior to screening where the symptoms cannot be attributed to any cause other than RP and which, in the investigator's opinion, requires addition/ increase in prednisone dose between 15-60 mg/ day.
  • At the time of enrollment and during the trial, the following symptoms of active disease which will be evaluated:
  • Auricular inflammation: defined as increase/ new onset pain/ swelling/redness of external ear(s), ear canal
  • Nasal inflammation: defined as increase/ new onset pain/ swelling/redness of external nose
  • Ocular inflammation: defined as new onset/ worsening unilateral/ bilateral episcleritis/scleritis/ uveitis.
  • Inflammatory arthritis: defined as new onset/ worsening morning stiffness≥30 minutes, physician diagnosed tenderness/swelling in ≥1 joint; new onset/ worsening costochondritis.
  • Mild to moderate airway inflammation: defined as new onset/ worsening mild to moderate inflammation of upper airway diagnosed by direct laryngoscopy and attributed to RP; abnormal CT airway/ bronchoscopy showing wall thickening of airway (larynx, trachea, bronchi) and absence of severe manifestations such as new onset SGS/tracheomalacia/ bronchomalacia.
  • Sinonasal disease: defined as new onset/ increase in nasal crusting, discharge bleeding
  • Constitutional symptoms: defined as new onset/ worsening fever, unintentional weight loss of ≥ 5% of body weight, night sweats Patients must have at least 1 of the first 5 criteria within the past 60 days prior to the enrollment.
  • Willing and able to comply with treatment and follow-up procedures.
  • Both men and women of childbearing potential must be willing to use an effective means of birth control while receiving treatment throughout the study. Effective contraception methods include abstinence, oral contraceptives (birth control pills), intra-uterine-device, diaphragm, approved hormone injections, condoms, or medical sterilization.
  • Willing and able to provide written informed consent.

Who cannot join

  • Severe disease manifestations within the past 14 days requiring hospitalization, and/or intravenous pulsed dose glucocorticoid treatment for disease control.
  • Prior exposure of 4 weeks or longer to adalimumab, infliximab, and/or tocilizumab.
  • Prior exposure to >2 biologics and/or JAKi.
  • Evidence of active infection.
  • Known infection with human immunodeficiency virus (HIV), untreated hepatitis C infection, or a positive hepatitis B virus surface antigen.
  • Patients at risk for tuberculosis (TB) defined as follows:
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  • Current clinical, radiographic or laboratory evidence of active TB, even if currently being treated. Chest x-rays (posterior/anterior and lateral) obtained within the 6 months prior to screening and TB testing (IFN gamma release assay or PPD) performed in the past month prior to screening will be accepted; however, a copy of the reports must be placed in the participant binder.
  • A history of active TB unless there is documentation that the patient had received prior anti-TB treatment that was appropriate in duration and type according to local health authority guidelines.
  • Patients with a positive TB screening test indicative of latent TB will not be eligible for the study unless they: i. Have no evidence of current TB based on chest x-ray performed during the screening period and by history and physical exam, and ii. They are currently being treated for latent TB or the site has documentation of successful prior treatment of latent TB. Treatment regimens should be dictated by local guidelines as long as the treatment dose and duration meet or exceed local health authority guidelines. Patients with latent TB may be eligible for the trial prior to completion of treatment as long as they have completed at least 4 weeks of treatment and they have no evidence of current TB on chest x-ray at screening.
  • Inability to comply with study guidelines.
  • Cytopenia: platelet count <80,000/mm3, absolute neutrophil count <1500/mm3, hematocrit < 20%.
  • Other uncontrolled disease (co-morbidity) that could prevent a subject from fulfilling the study requirements or that would increase the risk of study procedures.
  • Patients who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Patients who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.
  • Receipt of an investigational agent or device within 30 days prior to enrollment
  • A live vaccination < 4 weeks before enrollment
  • Presence of any of the following diseases:
  • ANCA-associated vasculitis
  • Polyarteritis nodosa
  • Giant cell arteritis
  • Takayasu's arteritis
  • Cogan's syndrome
  • Tuberculosis or atypical mycobacterial infections
  • Deep fungal infections
  • Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics vasculitis
  • Overlap with other systemic autoimmune diseases which would impair assessment of response
  • Diagnosis of VEXAS syndrome

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carol McAlear contact

781-321-4567

cmcalear@upenn.edu

United States1 site, 1 recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Jessica Nguyen, Jessica.Nguyen2@PennMedicine.upenn.edu

    Recruiting

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Methotrexate (MTX), Azathioprine (AZA), Adalimumab, Infliximab, Tocilizumab
Keywords
Relapsing Polychondritis, RP, Vasculitis, Polychondritis, relapsing
Medical subject headings
Polychondritis, Relapsing, Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methotrexate (MTX)Drug

    Weekly methotrexate dose of 20 mg (oral or subcutaneous).

  • Azathioprine (AZA)Drug

    Azathioprine dose will be 2-3 mg/kg body weight per day.

  • AdalimumabBiological

    Adalimumab dose will be 40 mg subcutaneously every 1-2 weeks

  • InfliximabBiological

    Infliximab dose will be 5mg/kg at week 0 and week 2, and then every 4-8 weeks.

  • TocilizumabBiological

    Tocilizumab dose will be 162 mg subcutaneous injection every week or 4-8 mg/kg every 4 weeks

Study groups in NCT06941376
Study groupRoleWhat they receive
Azathioprine or MethotrexateExperimentalNot described
Receives: Drug: Methotrexate (MTX); Drug: Azathioprine (AZA)
Adalimumab, Infliximab, or TocilizumabExperimentalNot described
Receives: Biological: Adalimumab; Biological: Infliximab; Biological: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of the study drugs for the treatment of relapsing polychondritis.

    The proportion of subjects in remission at week 26

    Measured: 26 weeks

Secondary outcomes (6)

  1. Physician's global assessment of response

    Health-related quality of life as measured using physician's global assessment scale.

    Measured: Assessed at weeks 0, 12, and 26

  2. Response rates for each of the study drugs

    Proportion of patient with complete response and significant response to therapy at weeks 12 and 26

    Measured: Response evaluated weeks 12 and 26

  3. Patient's global assessment of response

    Health-related quality of life as measured using patient's global assessment scale.

    Measured: Assessed at weeks 0, 12, and 26

  4. Health-related quality of life

    Health-related quality of life as measured using SF-36

    Measured: Assessed at weeks 0, 12, and 26

  5. Time to disease flare

    Disease flare defined as increase on a disease activity instrument by at least 1 point

    Measured: 26 weeks

  6. Safety of study drugs in RP

    Safety of study drugs in patients with RP as assessed by reported adverse events.

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2025
  2. Study start11 Nov 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06941376
Sponsor's protocol ID
VCRC5565
Acronym
PROSECT RP
Status last verified
Aug 2026
First submitted
15 Apr 2025
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Methotrexate (MTX), Azathioprine (AZA) and Adalimumab in people with Relapsing Polychondritis, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carol McAlear (781-321-4567, cmcalear@upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of the study drugs for the treatment of relapsing polychondritis. (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06941376.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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