Baricitinib in CPPD - the BAPTIST Study

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study ID
NCT06768294
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Calcium Pyrophosphate Deposition Disease
  • Chondrocalcinosis

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib 4 MG Oral Tablet — DRUG
    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) — DRUG
    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 — DRUG
    1 or ½ tablet (depending on individual tolerance) daily after breakfast
  • Hydroxychloroquine 200 mg — DRUG
    1 tablet daily after lunch
  • Methotrexate + Folic Acid — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2025
Status verified
Jan 2025
Primary completion
Jun 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: One group will receive baricitinib at the dose of 4mg/daily
  • Sham Comparator: standard of care (to be decided according to the guidelines)
    Methylprednisolone tablets, Colchicine 1 mg tablets, Hydroxychloroquine 200 mg tablets, MTX + folic acid (to be decided according to the guidelines)

Primary Outcome Measure

The evaluation the effect of baricitinib on inflammation of the synovial membrane in CPPD [ Time Frame: The outcome for the primary objective is the changes in the synovial tissue CD68 scoring at 12 weeks, an objective outcome measure. ]

Central Contacts