[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588436":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":44,"centralContacts":48,"locations":54,"responsibleParty":72,"collaborators":11,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":11,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":56,"whyStopped":11,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Azathioprine or Methotrexate","EXPERIMENTAL",null,[13,14],"Drug: Methotrexate (MTX)","Drug: Azathioprine (AZA)",{"label":16,"type":10,"description":11,"interventionNames":17},"Adalimumab, Infliximab, or Tocilizumab",[18,19,20],"Biological: Adalimumab","Biological: Infliximab","Biological: Tocilizumab",[22,27,31,36,40],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"DRUG","Methotrexate (MTX)","Weekly methotrexate dose of 20 mg (oral or subcutaneous).",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Azathioprine (AZA)","Azathioprine dose will be 2-3 mg\u002Fkg body weight per day.",[9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"BIOLOGICAL","Adalimumab","Adalimumab dose will be 40 mg subcutaneously every 1-2 weeks",[16],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"Infliximab","Infliximab dose will be 5mg\u002Fkg at week 0 and week 2, and then every 4-8 weeks.",[16],{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"Tocilizumab","Tocilizumab dose will be 162 mg subcutaneous injection every week or 4-8 mg\u002Fkg every 4 weeks",[16],[45],{"name":46,"affiliation":5,"role":47},"Shubhasree Banerjee, MD","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":11,"email":53},"Carol McAlear","CONTACT","781-321-4567","cmcalear@upenn.edu",[55],{"facility":5,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-75.16362,39.95238,{"lat":66,"lon":65},[69],{"name":70,"role":51,"phone":11,"phoneExt":11,"email":71},"Jessica Nguyen","Jessica.Nguyen2@PennMedicine.upenn.edu",{"type":47,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Shubhasree Banerjee","Assistant Professor of Clinical Medicine","100588436","phase-2-an-open-label-study-of-effectiveness-of-immunomodulatory-medications-for-patients-with-relapsing-polychondritis-100588436",false,"NCT06941376","An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis","Pragmatic, Open-Label, Two-Stage, Pilot Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis","PROSECT RP","Inclusion Criteria:\n\nA. ≥18 years of age\n\nB. Must fulfill McAdam's or Damiani's or Michet's Criteria Diagnostic Criteria for Relapsing Polychondritis McAdam's Criteria (1976)\n\n≥ 3 criteria out of 6 of the following:\n\n1. Bilateral auricular chondritis\n2. Non-erosive seronegative polyarthritis\n3. Nasal chondritis\n4. Ocular inflammation\n5. Respiratory tract chondritis\n6. Cochlear and\u002For vestibular dysfunction\n\nDamiani's Criteria (1979)\n\n1. ≥3 of McAdam's Criteria as above\n2. ≥1 of McAdam's Criteria with histological confirmation of chondritis\n3. ≥2 of McAdam's Criteria with positive response to glucocorticoids or dapsone\n\nMichet's Criteria (1986)\n\nPresence of ≥2 of the following criteria:\n\n1. Auricular chondritis\n2. Nasal chondritis\n3. Laryngotracheal chondritis\n\nOr presence of ≥1 of the above criteria and ≥2 of the following criteria\n\n1. Seronegative inflammatory arthritis\n2. Ocular inflammation\n3. Hearing loss\n4. Vestibular dysfunction\n\nC. 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\u002F increase in prednisone dose between 20-60 mg\u002F day.\n\nAt the time of enrollment and during the trial, the following symptoms of active disease which will be evaluated:\n\n1. Auricular inflammation: defined as increase\u002F new onset pain\u002F swelling\u002Fredness of external ear(s), ear canal\n2. Nasal inflammation: defined as increase\u002F new onset pain\u002F swelling\u002Fredness of external nose\n3. Ocular inflammation: defined as new onset\u002F worsening unilateral\u002F bilateral episcleritis\u002Fscleritis\u002F uveitis.\n4. Inflammatory arthritis: defined as new onset\u002F worsening morning stiffness≥30 minutes, physician diagnosed tenderness\u002Fswelling in ≥1 joint; new onset\u002F worsening costochondritis.\n5. Mild to moderate airway inflammation: defined as new onset\u002F worsening mild to moderate inflammation of upper airway diagnosed by direct laryngoscopy and attributed to RP; abnormal CT airway\u002F bronchoscopy showing wall thickening of airway (larynx, trachea, bronchi) and absence of severe manifestations such as new onset SGS\u002Ftracheomalacia\u002F bronchomalacia.\n6. Sinonasal disease: defined as new onset\u002F increase in nasal crusting, discharge bleeding\n7. Constitutional symptoms: defined as new onset\u002F 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.\n\nD. Willing and able to comply with treatment and follow-up procedures.\n\nE. 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.\n\nF. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\nA. Severe disease manifestations within the past 28 days, including:\n\n1. 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.\n2. Central nervous system (CNS) disease (meningitis, encephalitis, optic neuritis) requiring hospitalization\u002F treatment with intravenous methylprednisolone\u002F cyclophosphamide.\n3. Cardiac disease (symptomatic valve dysfunction, heart failure) requiring active treatment for heart failure\u002F hospitalization\u002F consideration for surgery.\n4. Severe ophthalmologic manifestations: severe scleritis, uveitis, retinal vasculitis, optic neuritis which is imminently vision threatening.\n5. Any disease manifestation considered organ\u002F life-threatening felt to require treatment with prednisone\\>60 mg\u002F day or IV methylprednisolone or cyclophosphamide.\n\nB. Patients with current\u002F 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.\n\nC. Patients with exposure to biologic DMARDS will be excluded.\n\nD. Evidence of active infection.\n\nE. Known infection with human immunodeficiency virus (HIV), hepatitis C, or a positive hepatitis B surface antigen.\n\nF. Patients at risk for tuberculosis (TB) defined as follows:\n\n1. Current clinical, radiographic or laboratory evidence of active TB, even if currently being treated. Chest x-rays (posterior\u002Fanterior 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.\n2. 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.\n3. 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.\n\nG. Inability to comply with study guidelines.\n\nH. Cytopenia: platelet count \\\u003C80,000\u002Fmm3, absolute neutrophil count \\\u003C1500\u002Fmm3, hematocrit \\\u003C 20%.\n\nI. Other uncontrolled disease (co-morbidity) that could prevent a subject from fulfilling the study requirements or that would increase the risk of study procedures.\n\nJ. 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.\n\nK. Receipt of an investigational agent or device within 30 days prior to enrollment\n\nL. A live vaccination \\\u003C 4 weeks before enrollment\n\nM. Presence of any of the following diseases:\n\n1. ANCA-associated vasculitis\n2. Polyarteritis nodosa\n3. Giant cell arteritis\n4. Takayasu's arteritis\n5. Cogan's syndrome\n6. Sarcoidosis\n7. Kawasaki disease\n8. Tuberculosis or atypical mycobacterial infections\n9. Deep fungal infections\n10. Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics vasculitis\n11. Cryoglobulinemic vasculitis\n12. Systemic lupus erythematosus\n13. Rheumatoid arthritis\n14. Overlap with other autoimmune diseases\n15. Diagnosis of VEXAS syndrome","ALL","18 Years",{"count":86,"type":87},20,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","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).",[93],"Relapsing Polychondritis",[93,95,96,97],"RP","Vasculitis","Polychondritis, relapsing","2026-02-03",{"date":100,"type":101},"2026-02-04","ACTUAL",{"date":103,"type":101},"2025-08-01",{"date":105,"type":87},"2027-12",{"name":5,"class":6},1]