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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Carol McAlear
cmcalear@upenn.edu
781-321-4567
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 20
Treatments
Experimental: Azathioprine or Methotrexate
Experimental: Adalimumab, Infliximab, or Tocilizumab
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov