BIGTIM: Blocking Interferon-γ by ruxolitinib for Treating Inclusion body Myositis: a phase IIb trial.

Conditions

Inclusion body Myositis

Brief summary

Improvement of 60 meters for the distance walked during 6-minute (6WMD) from baseline to M12 (6MWD).

Detailed description

1. Safety and tolerance of ruxolitinib in IBM patients: Adverse events according to the MedDRA classification., Therapeutic muscular efficacy of ruxolitinib through change from baseline to M12 of the parameters depending on skeletal muscle involvement: (i) Muscle strengt (ii) Overall muscle status, (iii) Respiratory ability, (iv) Swallowing, (v) Lower limb Quantification of fat replacement of muscle tissue, residual muscle tissue and markers of disease activity using MRI, 3. Improvement or stability between baseline and M12 in quality of life assessed by the scoring through Health Assessment Questionnaire without Disability Index (HAQ-DI), Duke health profile., 4. Quality of the blinding assessed by the New Blinding Index (Bang, 2004).

Related papers

No related papers found yet.

Interventions

DRUGJakavi 15 mg tablets

DRUGPlacebo of Jakavi 15mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Improvement of 60 meters for the distance walked during 6-minute (6WMD) from baseline to M12 (6MWD).	—

Secondary

Measure	Time frame
1. Safety and tolerance of ruxolitinib in IBM patients: Adverse events according to the MedDRA classification., Therapeutic muscular efficacy of ruxolitinib through change from baseline to M12 of the parameters depending on skeletal muscle involvement: (i) Muscle strengt (ii) Overall muscle status, (iii) Respiratory ability, (iv) Swallowing, (v) Lower limb Quantification of fat replacement of muscle tissue, residual muscle tissue and markers of disease activity using MRI, 3. Improvement or stability between baseline and M12 in quality of life assessed by the scoring through Health Assessment Questionnaire without Disability Index (HAQ-DI), Duke health profile., 4. Quality of the blinding assessed by the New Blinding Index (Bang, 2004).	—

Measure

Time frame

1. Safety and tolerance of ruxolitinib in IBM patients: Adverse events according to the MedDRA classification., Therapeutic muscular efficacy of ruxolitinib through change from baseline to M12 of the parameters depending on skeletal muscle involvement: (i) Muscle strengt (ii) Overall muscle status, (iii) Respiratory ability, (iv) Swallowing, (v) Lower limb Quantification of fat replacement of muscle tissue, residual muscle tissue and markers of disease activity using MRI, 3. Improvement or stability between baseline and M12 in quality of life assessed by the scoring through Health Assessment Questionnaire without Disability Index (HAQ-DI), Duke health profile., 4. Quality of the blinding assessed by the New Blinding Index (Bang, 2004).

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Countries

France

Outcome results

None listed