Baricitinib in CPPD - the BAPTIST Study (NCT06768294) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Baricitinib in CPPD - the BAPTIST Study
Italy32 participantsStarted 2025-01
Plain-language 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.
Who can participate
Age range55 Years
SexALL
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Inclusion Criteria:
* Signed Informed Consent;
* Male and female patients aged ≥55 years;
* Patients that according to the investigator's judgement will benefit from the proposed treatments (favourable benefit/risk profile)
* Menopause for women;(no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a high follicle stimulating single measurement is insufficient.);
* Male patients must avoid having a child during the trial and must use one of the highly effective methods of contraception or sexual abstinence or have a menopause partner (no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a high follicle stimulating single measurement is insufficient). Contraception methods include:
* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
* Sterilization of the female partner (have had surgical bi…
What they're measuring
1
The evaluation the effect of baricitinib on inflammation of the synovial membrane in CPPD
Timeframe: The outcome for the primary objective is the changes in the synovial tissue CD68 scoring at 12 weeks, an objective outcome measure.