Baricitinib in CPPD - the BAPTIST Study

Summary

The aim of this clinical trial is to determine if baricitinib is effective in treating calcium pyrophosphate deposition disease (CPPD) in adults. The primary objective is to assess its impact on joint inflammation. The key questions the study seeks to answer are:

* Can baricitinib reduce inflammation in affected joints?
* Will baricitinib lead to changes in ultrasound findings, such as calcium crystal deposition and synovitis?

Researchers will compare baricitinib to other treatments, including methylprednisolone, colchicine, hydroxychloroquine, and methotrexate with folic acid, for managing CPPD.

Conditions

• Calcium Pyrophosphate Deposition Disease
• Chondrocalcinosis

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.

Sponsors & Collaborators

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

  lead OTHER

Principal Investigators

• Georgios Filippou, Assistant Professor · IRCCS Galeazzi - Sant'Ambrogio Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-31

Primary Completion

2026-06-30

Completion

2027-01-31

Countries

• Italy

Study Locations