Status and phase
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About
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).
Full 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
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.
Enrollment
Sex
Ages
Volunteers
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:
Damiani's Criteria (1979)
Michet's Criteria (1986)
Presence of ≥2 of the following criteria:
Or presence of ≥1 of the above criteria and ≥2 of the following criteria
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:
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:
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:
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:
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups
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Central trial contact
Carol McAlear
Data sourced from clinicaltrials.gov
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