Baricitinib in CPPD - the BAPTIST Study
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55+
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
About this trial
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.
Eligibility criteria
Qualifiers
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.);
Disqualifiers
Patients positive at anticitrullinated positive antibodies (ACPA), any titre;
Patients affected by seronegative arthritis or other conditions that may be responsible of arthritis (i.e. gout, rheumatic polymyalgia, etc);
Patients that refuse synovial biopsy or present contraindications, according to investigator's judgement, including (but not limited to) increased risk for bleeding (platelet count <100000 or use of anticoagulants), allergy to local anesthetics, suspicion of septic arthritis;
Patients with history of malignancy or lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for < 5 years;
Trial design
Treatments tested in this trial
- Baricitinib 4 MG Oral Tablet
- Methylprednisolone (Corticosteroid)
- Colchicine 1 MG Oral Tablet
- Hydroxychloroquine 200 mg
- Methotrexate + Folic Acid
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov