Is NCT06941376 recruiting in Philadelphia, PA?

Yes, NCT06941376 is currently recruiting participants at its Philadelphia, PA location. This relapsing polychondritis clinical trial is actively enrolling qualified participants.

How do I join the relapsing polychondritis clinical trial in Philadelphia?

To join this clinical trial in Philadelphia, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Philadelphia clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Relapsing Polychondritis Clinical Trial in Philadelphia, PA

Who Can Participate

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 20-60 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 28 days, including:

Severe airway inflammation with supplemental oxygen requirement, tracheostomy, airway stenting, ventilation. Patients with prior history of severe airway disease, who currently have damage will be eligible if they have mild- moderate active disease within the past 60 days at the time of enrollment.

Central nervous system (CNS) disease (meningitis, encephalitis, optic neuritis) requiring hospitalization/ treatment with intravenous methylprednisolone/ cyclophosphamide.

Cardiac disease (symptomatic valve dysfunction, heart failure) requiring active treatment for heart failure/ hospitalization/ consideration for surgery.

Severe ophthalmologic manifestations: severe scleritis, uveitis, retinal vasculitis, optic neuritis which is imminently vision threatening.

Any disease manifestation considered organ/ life-threatening felt to require treatment with prednisone\>60 mg/ day or IV methylprednisolone or cyclophosphamide. B. Patients with current/ prior use of methotrexate or azathioprine will be eligible for stage 1 or stage 2 of the study depending on the duration of treatment with the non- biologic DMARD treatment. C. Patients with exposure to biologic DMARDS will be excluded. D. Evidence of active infection. E. Known infection with human immunodeficiency virus (HIV), hepatitis C, or a positive hepatitis B 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

Sarcoidosis

Kawasaki disease

Tuberculosis or atypical mycobacterial infections

Deep fungal infections

Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics vasculitis

Cryoglobulinemic vasculitis

Systemic lupus erythematosus

Rheumatoid arthritis

Overlap with other autoimmune diseases

Diagnosis of VEXAS syndrome

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT06941376) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Relapsing Polychondritis Treatment Options in Philadelphia, PA

If you're searching for relapsing polychondritis treatment options in Philadelphia, PA, this clinical trial (NCT06941376) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced relapsing polychondritis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all relapsing polychondritis clinical trials near you to find additional studies recruiting in your area.

Relapsing Polychondritis Clinical Trial in Philadelphia, PA

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About This Relapsing Polychondritis Study in Philadelphia