Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigator-Initiated, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.
Zsuzsanna H McMahanCathie SpinoSindhu JohnsonLorinda ChungMichael L WhitfieldChristopher P DentonVeronica BerrocalJennifer M FranksBhavan MehtaJerry MolitorVirginia D SteenRobert LafyatisRobert W SimmsAnna GillSuzanne KafajaTracy M FrechVivien HsuRobyn T DomsicJanet E PopeJessica K GordonMaureen D MayesElena SchiopuAmber YoungNora SandorfiJane ParkFaye N HantElana J BernsteinSoumya ChatterjeeFlavia V CastelinoAli AjamYue WangTammara WoodYannick AllanoreMarco Matucci-CerinicOliver DistlerOra SingerErica BushDavid A FoxDaniel E FurstPublished in: Arthritis & rheumatology (Hoboken, N.J.) (2019)
In this phase II trial, abatacept was well-tolerated, but change in the MRSS was not statistically significant. Secondary outcome measures, including gene expression subsets, showed evidence in support of abatacept. These data should be confirmed in a phase III trial.
Keyphrases
- double blind
- phase iii
- phase ii
- placebo controlled
- systemic sclerosis
- rheumatoid arthritis
- interstitial lung disease
- clinical trial
- gene expression
- open label
- rheumatoid arthritis patients
- study protocol
- disease activity
- dna methylation
- electronic health record
- peripheral blood
- big data
- low grade
- artificial intelligence
- machine learning
- high grade
- data analysis