32
Participants
Start Date
January 31, 2025
Primary Completion Date
June 30, 2026
Study Completion Date
January 31, 2027
Baricitinib 4 MG Oral Tablet
Baricitinib is a JAK1/JAK2 inhibitor approved for use in Rheumatoid Arthritis. It is under investigation for use in several inflammatory diseases, including Psoriasis and Psoriatic Arthritis, Atopic Dermatitis, Inflammatory Bowel Disease and Systemic Lupus Erythematosus, with encouraging results. As IL-6 plays a central role in CPPD inflammatory process, a broad spectrum of interleukins and other proinflammatory proteins (including interferons) could be involved. A drug that acts by blocking more than one proinflammatory cytokine could be a promising treatment for a multifaceted disease such as CPPD.
Methylprednisolone (Corticosteroid)
The initial dosage of methylprednisolone may vary depending on the entity of inflammation and the patient's comorbidities. Usually in CPPD a short-term administration of methylprednisolone starts with 16 mg per day after breakfast decreasing the initial dosage in small decrements at appropriate time intervals until discontinuation, in about 2 weeks. Methylprednisolone will be given in combination with gastroprotective agents such as proton pump inhibitors.
Colchicine 1 MG Oral Tablet
1 or ½ tablet (depending on individual tolerance) daily after breakfast
Hydroxychloroquine 200 mg
1 tablet daily after lunch
Methotrexate + Folic Acid
MTX 2.5 mg tablets, from 2 to 4 tablets (5-10mg), depending on disease severity, to be administered once weekly after dinner, always in the same day of the week. One tablet of folic acid (folina 5 mg) will be administered the day after MTX administration, after breakfast, to reduce and prevent the common side effects of MTX.
IRCCS Galeazzi - Sant Ambrogio Hospital, Milan
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
OTHER