BIRD - Baricitinib in patients with relapsing or naive Dermatomyositis

Conditions

Dermatomyositis; Baricitinib in patients with relapsing or naïve dermatomyositis.

Brief summary

Primary endpoint: moderate improvement (defined as a total improvement score superior or equal to 40 following ACR/EULAR definition) without corticosteroids at week 24 (prednisone-free moderate improvement).

Detailed description

-DM improvement at 5, 12 and 24 weeks in terms of: • minimal improvement (≥20 points total improvement ACR/EULAR), • moderate improvement (≥40 points total improvement ACR/EULAR) • major improvement (≥60 points total improvement ACR/EULAR), -Primary endpoint (prednisone-free moderate improvement at W24) in the following subgroups: • DM naive patients at baseline vs others • DM with a severe muscle weakness (MMT8 baseline <125/150) vs others, -Cutaneous disease activity and damage evaluated using the CDASI - Activity and CDASI damages at 5, 12 and 24 weeks, -Cumulative incidence of relapse and the time to first relapse, -Cumulative dose of corticosteroids, -Proportions of participants with an average prednisone dose of 0 mg per day, of more than 0 mg to not more than 4.0 mg per day, of more than 4.0 mg to not more than 7.5 mg per day, and of more than 7.5 mg per day during weeks 20 through 24., -Safety including the incidence, nature, and severity of adverse events and serious adverse events and laboratory abnormalities.

Related papers

No related papers found yet.

Interventions

DRUGOlumiant 4 mg film-coated tablets

DRUGPlacebo of Olumiant 4mg

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Primary endpoint: moderate improvement (defined as a total improvement score superior or equal to 40 following ACR/EULAR definition) without corticosteroids at week 24 (prednisone-free moderate improvement).	—

Secondary

Measure	Time frame
-DM improvement at 5, 12 and 24 weeks in terms of: • minimal improvement (≥20 points total improvement ACR/EULAR), • moderate improvement (≥40 points total improvement ACR/EULAR) • major improvement (≥60 points total improvement ACR/EULAR), -Primary endpoint (prednisone-free moderate improvement at W24) in the following subgroups: • DM naive patients at baseline vs others • DM with a severe muscle weakness (MMT8 baseline <125/150) vs others, -Cutaneous disease activity and damage evaluated using the CDASI - Activity and CDASI damages at 5, 12 and 24 weeks, -Cumulative incidence of relapse and the time to first relapse, -Cumulative dose of corticosteroids, -Proportions of participants with an average prednisone dose of 0 mg per day, of more than 0 mg to not more than 4.0 mg per day, of more than 4.0 mg to not more than 7.5 mg per day, and of more than 7.5 mg per day during weeks 20 through 24., -Safety including the incidence, nature, and severity of adverse events and serious adverse	—

Measure

Time frame

-DM improvement at 5, 12 and 24 weeks in terms of: • minimal improvement (≥20 points total improvement ACR/EULAR), • moderate improvement (≥40 points total improvement ACR/EULAR) • major improvement (≥60 points total improvement ACR/EULAR), -Primary endpoint (prednisone-free moderate improvement at W24) in the following subgroups: • DM naive patients at baseline vs others • DM with a severe muscle weakness (MMT8 baseline <125/150) vs others, -Cutaneous disease activity and damage evaluated using the CDASI - Activity and CDASI damages at 5, 12 and 24 weeks, -Cumulative incidence of relapse and the time to first relapse, -Cumulative dose of corticosteroids, -Proportions of participants with an average prednisone dose of 0 mg per day, of more than 0 mg to not more than 4.0 mg per day, of more than 4.0 mg to not more than 7.5 mg per day, and of more than 7.5 mg per day during weeks 20 through 24., -Safety including the incidence, nature, and severity of adverse events and serious adverse

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Countries

France

Outcome results

None listed