Baricitinib in CPPD - the BAPTIST Study

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

January 31, 2027

Conditions
Calcium Pyrophosphate Deposition DiseaseChondrocalcinosis
Interventions
DRUG

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.

DRUG

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.

DRUG

Colchicine 1 MG Oral Tablet

1 or ½ tablet (depending on individual tolerance) daily after breakfast

DRUG

Hydroxychloroquine 200 mg

1 tablet daily after lunch

COMBINATION_PRODUCT

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.

Trial Locations (1)

20157

IRCCS Galeazzi - Sant Ambrogio Hospital, Milan

All Listed Sponsors
lead

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER