ClinicalTrials.gov record NCT06941376
Pragmatic, Open-Label Study to Pilot Evaluation for Clinical Trials in Relapsing Polychondritis
Pragmatic, Open-Label, Two-Stage, Pilot Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is an open‑label, pragmatic two‑stage, non-randomized pilot trial comparing several standard immunomodulatory treatments for relapsing polychondritis. About twenty adults with mild to moderately active RP will be enrolled; most start in Stage 1 (methotrexate or azathioprine), but some who cannot tolerate or have already had enough of those drugs and still have active disease may enroll directly into Stage 2 and patients who do not meet the study's effectiveness endpoint, relapse, or cannot tolerate those drugs move to Stage 2 (adalimumab, infliximab, or tocilizumab). All participants receive glucocorticoids that are tapered to 5 mg daily by week 21; outcomes are assessed at weeks 12 and 26.
What it is studying. The study compares five standard-of-care immunomodulatory medicines (methotrexate, azathioprine, adalimumab, infliximab, tocilizumab) to see how they perform for adults with mild to moderately active relapsing polychondritis. The main measurement is the proportion of participants in remission at week 26; the study also records response rates at weeks 12 and 26, physician and patient global assessments, quality-of-life (SF-36), time to flare, and reported adverse events.
What the researchers hope to learn. To evaluate which of the included standard immunomodulatory medications lead to remission at 26 weeks, compare response rates at weeks 12 and 26, measure physician and patient global assessments and quality of life, determine time to disease flare, and collect safety data (adverse events) in people with relapsing polychondritis.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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).
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Methotrexate (MTX)
- Azathioprine (AZA)
- Biological
- Adalimumab
- Infliximab
- Tocilizumab
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- A. ≥18 years of age
- B. 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
- 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
- C. 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.
- D. Willing and able to comply with treatment and follow-up procedures.
- E. 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.
- F. Willing and able to provide written informed consent.
Exclusion criteria
- A. Severe disease manifestations within the past 14 days requiring hospitalization, and/or intravenous pulsed dose glucocorticoid treatment for disease control.
- B. Prior exposure of 4 weeks or longer to adalimumab, infliximab, and/or tocilizumab.
- C. Prior exposure to >2 biologics and/or JAKi.
- D. Evidence of active infection.
- E. Known infection with human immunodeficiency virus (HIV), untreated hepatitis C infection, or a positive hepatitis B virus surface antigen.
- F. Patients at risk for tuberculosis (TB) defined as follows:
- 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.
- G. Inability to comply with study guidelines.
- H. Cytopenia: platelet count <80,000/mm3, absolute neutrophil count <1500/mm3, hematocrit < 20%.
- I. Other uncontrolled disease (co-morbidity) that could prevent a subject from fulfilling the study requirements or that would increase the risk of study procedures.
- J. 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.
- K. Receipt of an investigational agent or device within 30 days prior to enrollment
- L. A live vaccination < 4 weeks before enrollment
- M. 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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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
- History of intolerance or side effects to MTX or AZA with active disease
- 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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants start on or continue non‑biologic drugs (weekly methotrexate 20 mg oral/subcutaneous or daily azathioprine 2–3 mg/kg). Those who do not meet effectiveness goals, relapse, or cannot tolerate MTX/AZA may move to Stage 2 to receive a biologic (adalimumab injections, infliximab infusions, or tocilizumab by injection or infusion). All participants receive glucocorticoids tapered to 5 mg daily by week 21 per a set schedule. The study includes medical visits with physician assessments, safety monitoring (which may include blood tests per protocol), and patient questionnaires at baseline, week 12 and week 26; adverse events and treatment response are recorded.
How the study is structured. Interventional (treatment) study that is open-label (doctors and participants know the drug), non-randomized, and organized in two stages. Stage 1 uses methotrexate or azathioprine for those who are eligible; people who do not meet the primary endpoint, relapse, or cannot tolerate those drugs move to Stage 2 and receive a tumor necrosis factor inhibitor (adalimumab or infliximab) or the interleukin‑6 inhibitor tocilizumab. Outcomes and safety are assessed during the 26‑week study period with key check points at weeks 12 and 26. A standardized prednisone taper to 5 mg daily by week 21 is used for all participants.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on relapsing polychondritis
Important dates
- Study start
- Nov 11, 2025
- Primary completion
- July 2027 (estimated)
- Study completion
- December 2027 (estimated)
- Target enrollment
- 20 participants (estimated)
- Last updated on registry
- Sep 2, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University of Pennsylvania
- Principal investigator
- Shubhasree Banerjee, Assistant Professor of Clinical Medicine
University of Pennsylvania
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Carol McAlear 📞 781-321-4567 ✉ cmcalear@upenn.edu
Participating sites (1)
- University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, 19104 · United States
- Jessica Nguyen · Jessica.Nguyen2@PennMedicine.upenn.edu
Terms used on this page · explanations by MedicalUpdates.ai
- Open label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- standard of care
- Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
- glucocorticoids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- prior to screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- CT
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- women of childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- prior treatment
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- absolute neutrophil count
- The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
- investigational agent
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- relapse
- A condition that improved with treatment and has since returned or worsened.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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