None listed
Conditions
Brief summary
Glucocorticoids have been the treatment of choice for polymyalgia rheumatica but are commonly associated with serious adverse events even when given in lower doses. A reliable alternative to glucocorticoids or an acceptable steroid-sparing drug has not been identified. A recent pilot study suggested that infliximab may have a steroid-sparing effect in the treatment of polymyalgia rheumatica. The primary purpose of this double blind,randomized, placebo controlled study is to evaluate the efficacy and safety of infliximab in maintaining glucocorticosteroid-induced remission and in sparing corticosteroids in newly diagnosed polymyalgia rheumatica patients. Patients, investigators, and study personnel will be blinded to treatment assignments during the study, with the exception of the site pharmacists who prepare study medication.
Interventions
Patients will be randomly assigned to receive infusions of infliximab 3 mg/Kg, respectively, at weeks 0, 2, 6, 14, 22. All patients will be treated with oral prednisone according to a fixed tapering protocol with a starting daily dosage of 15 mg tapered to 0 in 16 weeks. Prednisone dosage will be increased/restarted if flare-ups occurred. Patients will be evaluated every 4 weeks during
Patients will be randomly assigned to receive infusions of infliximab 3 mg/Kg, respectively, at weeks 0, 2, 6, 14, 22. All patients will be treated with oral prednisone according to a fixed tapering protocol with a starting daily dosage of 15 mg tapered to 0 in 16 weeks. Prednisone dosage will be increased/restarted if flare-ups occurred. Patients will be evaluated every 4 weeks during the 52 week follow-up period.
Sponsors
Hospital S. Maria Nuova, Reggio Emilia Italy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Consecutive adult patients who satisfy Healey’s criteria for the diagnosis of PMR will be included in the study.
Exclusion criteria
1) Patients previously treated with corticosteroids; 2) Patients with clinical and/or histological evidence of giant cell arteritis; 3) Uncontrolled diabetes and hypertension, infection and neoplasm;4) Active or inactive (latent) Tuberculosis (TB), evaluated by detailed medical history (including personal history of TB, possible previous contacts with TB, and family history of TB), chest X-rays (performed in the 2 months prior entering the study), and PPD test. If any of those are positive or suggestive of TB the patient can not be enrolled.
Outcome results
None listed