BARICITINIB IN CALCIUM PYROPHOSPHATE DIHYDRATE DEPOSITION DISEASE – A PROOF OF CONCEPT PHASE II CLINICAL TRIAL

Conditions

calcium pyrophosphate deposition disease

Brief summary

Change from baseline in CD68 at 12 weeks.

Detailed description

Change from baseline in Krenn synovitis score at 12 weeks, Change from baseline in CD3, CD8, CD20 at synovial level at 12 weeks, Change from baseline in DAS, HAQ score and WOMAC at 4, 12 and 24 weeks., Change from baseline in MSUS EULAR-OMERACT synovitis score at 4, 12 and 24 weeks, CPP deposition extent according to the OMERACT CPPD scoring system at 4, 12 and 24 weeks and degenerative changes at 4, 12 and 24 weeks., Change from baseline in serum cytokines levels (IL-1, IL-6, IL-8, anti-TNFα, Interferon α and γ, TGF-β) at 12 and 24 weeks, Change from baseline in visual analogic scale (VAS) pain at 4, 12 and 24 weeks

Related papers

No related papers found yet.

Interventions

DRUGMETHOTREXATE

DRUGCOLCHICINE

DRUGOlumiant 4 mg film-coated tablets

DRUGFOLIC ACID

DRUGHYDROXYCHLOROQUINE

DRUGMETHYLPREDNISOLONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in CD68 at 12 weeks.	—

Secondary

Measure	Time frame
Change from baseline in Krenn synovitis score at 12 weeks, Change from baseline in CD3, CD8, CD20 at synovial level at 12 weeks, Change from baseline in DAS, HAQ score and WOMAC at 4, 12 and 24 weeks., Change from baseline in MSUS EULAR-OMERACT synovitis score at 4, 12 and 24 weeks, CPP deposition extent according to the OMERACT CPPD scoring system at 4, 12 and 24 weeks and degenerative changes at 4, 12 and 24 weeks., Change from baseline in serum cytokines levels (IL-1, IL-6, IL-8, anti-TNFα, Interferon α and γ, TGF-β) at 12 and 24 weeks, Change from baseline in visual analogic scale (VAS) pain at 4, 12 and 24 weeks	—

Measure

Time frame

Change from baseline in Krenn synovitis score at 12 weeks, Change from baseline in CD3, CD8, CD20 at synovial level at 12 weeks, Change from baseline in DAS, HAQ score and WOMAC at 4, 12 and 24 weeks., Change from baseline in MSUS EULAR-OMERACT synovitis score at 4, 12 and 24 weeks, CPP deposition extent according to the OMERACT CPPD scoring system at 4, 12 and 24 weeks and degenerative changes at 4, 12 and 24 weeks., Change from baseline in serum cytokines levels (IL-1, IL-6, IL-8, anti-TNFα, Interferon α and γ, TGF-β) at 12 and 24 weeks, Change from baseline in visual analogic scale (VAS) pain at 4, 12 and 24 weeks

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Countries

Italy

Outcome results

None listed