This study aims to investigate the clinical efficacy of baricitinib in patients with adult idiopathic inflammatory myositis (IIM). Half of the patients enrolled onto the study will receive 24 weeks of baricitinib from the baseline visit with a 12 week follow-up period. The other half of patients will receive 24 weeks of barcitinib treatment after an initial 12-week delay with a 4 week follow up period for safety.
Potential participants will attend a screening visit to confirm their eligibility to participate in the trial. Once eligibility is confirmed the participant will be randomised to receive 24 weeks of baracitinib from the baseline visit with 12 weeks of follow up or receive 24 weeks of baracitinib after a delayed-start of 12 weeks from the baseline visit. Participants will attend study visits every 4 weeks starting at the baseline visit at week 0. At each visit data will be collected about the following: 1. Muscle function 2. Signs of disease activity 3. Vital signs 4. Physical examination 5. A blood test to check blood count, liver and kidney function and markers of inflammation for safety purposes. 6. Participant reported assessment of how disease disease is progressing. In addition the following data will be collected at week 0, week 12, week 24 and week 36: 1. Signs of disease damage 2. Blood and urine sample collection for biomarker analysis 3. Additional muscle function and disease activity assessments 4. Participant reported assessment of how disease affects their day-to-day life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
4mg daily for 24 weeks from baseline
4mg daily for 24 weeks starting after a 12-week treatment delay from baseline
King's College Hospital NHS Foundation Trust
London, United Kingdom
Assess the clinical response across treatment arms after 24 weeks of active treatment.
Response (yes/no): where 'response' is defined as 'achieving at least minimal clinical response according to the IMACS criteria at 24 weeks post-active treatment (at 24 weeks in the immediate-start arm and at 36 weeks in the delayed-start arm)'.
Time frame: Immediate-start arm: 24 weeks after baseline visit; Delayed-start arm: 36 weeks after baseline visit
To assess the extent of clinical response across treatment arms after 24 weeks of active treatment
Response (yes/no): where 'response' is defined as 'achieving: i) at least moderate and ii) major clinical response according to the IMACS criteria at 24 weeks post-active treatment (at 24 weeks in the immediate-start arm and at 36 weeks in the delayed-start arm)'.
Time frame: Immediate-start arm: 24 weeks after baseline visit; Delayed-start arm: 36 weeks after baseline visit
To compare the clinical response between treatment arms: (i) at 12 weeks and (ii) at 24 weeks
Response (yes/no): where 'response' is defined as 'achieving at least minimal clinical response according to the IMACS criteria: (i) at 12 weeks and (ii) at 24 weeks'
Time frame: For both arms: 12 weeks and 24 weeks after the baseline visit
To compare the clinical response between treatment arms after 24 weeks of active treatment.
Response (yes/no): where 'response' is defined as 'achieving at least moderate clinical response according to the IMACS criteria at 24 weeks post-active treatment (at 24 weeks in the immediate-start arm and at 36 weeks in the delayed-start arm)'.
Time frame: Immediate-start arm: 24 weeks after baseline visit; Delayed-start arm: 36 weeks after baseline visit
To assess the time taken to achieve clinical response across treatment arms up to 24 weeks of active treatment.
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Time taken to achieve at least minimal clinical response according to the IMACS criteria up to 24 weeks post-active treatment (at 24 weeks in the immediate-start arm and at 36 weeks in the delayed-start arm).
Time frame: Immediate-start arm: 24 weeks after baseline visit; Delayed-start arm: 36 weeks after baseline visit
To compare the change from baseline between treatment arms in the following outcomes: - Individual components of the IMACS CSMs - Physical functioning - Muscle endurance - Pain - Fatigue - Health-related quality of life
Change from baseline: (i) at 12 weeks, (ii) at 24 weeks and (iii) at 24 weeks post-active treatment (at 24 weeks in the immediate-start arm and at 36 weeks in the delayed-start arm), in the following: * Individual components of the IMACS CSMs for disease activity * Physical functioning as measured by the PROMIS PF-20 * Muscle endurance as tested by the myositis functional index (FI-3) * Perceived pain measured by * the two body pain related items of the SF-36v2 * a visual analogue scale (VAS, within HAQ) * Fatigue as measured by * the FACIT-Fatigue questionnaire v4 and * components of SF-36v2 Health status as measured by the mental and physical sub-scales of the SF-36v2 and health utility as measured by the EQ-5D-5L
Time frame: Immediate-start arm: 12 weeks and 24 weeks after baseline visit; Delayed-start arm: 12 weeks, 24 weeks and 36 weeks after baseline visit
To assess harms across treatment arms: (i) after 12 weeks of active treatment and (ii) after 24 weeks of active treatment.
Cumulative (S)AEs and (S)ARs: (i) at 12 weeks post-active treatment (i.e., at 12 weeks in the immediate-start arm and at 24 weeks in the delayed-start arm) and (ii) at 24 weeks post-active treatment (i.e., at 24 weeks in the immediate-start arm and at 36 weeks in the delayed-start arm)
Time frame: Immediate-start arm: 12 weeks and 24 weeks after baseline visit; Delayed-start arm: 24 weeks and 36 weeks after baseline visit
To assess the steroid-sparing effect of baricitinib across treatment arms: (i) after 12 weeks of active treatment and (ii) after 24 weeks of active treatment.
Prescribed daily dose of glucocorticoids: (i) at 12 weeks post-active treatment (i.e., at 12 weeks in the immediate-start arm and at 24 weeks in the delayed-start arm) and (ii) at 24 weeks post-active treatment (i.e., at 24 weeks in the immediate-start arm and at 36 weeks in the delayed-start arm)
Time frame: Immediate-start arm: 12 weeks and 24 weeks after baseline visit; Delayed-start arm: 24 weeks and 36 weeks after baseline visit