A Phase IIa Trial of the Oral JAK 1/2 Inhibitor, Baricitinib, in the Treatment of Adult IIM (MYOJAK)
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|ClinicalTrials.gov Identifier: NCT04208464|
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Inflammatory Myopathies||Drug: Baricitinib||Phase 2|
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:
- Muscle function
- Signs of disease activity
- Vital signs
- Physical examination
- A blood test to check blood count, liver and kidney function and markers of inflammation for safety purposes.
- Participant reported assessment of how disease disease is progressing and how it affects their day-to-day life.
In addition the following data will be collected at week 0, week 12, week 24 and week 36:
- Signs of disease damage
- Blood and urine sample collection for biomarker analysis
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a randomised, treatment-delayed trial design. Participants will be randomised into two arms: participants in one arm will receive 24 weeks of baracitinib treatment from baseline with 12 weeks of follow up; participants in the other arm will have a delayed treatment start for 12 weeks, then will receive 24 weeks of baracitinib treatment with 4 weeks of follow up for safety.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The participant and investigators will not be blinded because it will be clear whether IMP is being administered from baseline or after a 12 week delayed start. However every attempt will be made to keep the muscle function and disease activity and damage outcome assessor blinded to the treatment arm.|
|Official Title:||A Randomised, Phase IIa Treatment Delayed-start Trial of the Oral JAK 1/2 Inhibitor, Baricitinib, in the Treatment of Adult Idiopathic Inflammatory Myopathy|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||February 28, 2022|
Experimental: Arm A
Participants will receive 4mg baracitinib daily for 24 weeks from the baseline visit in week 0. After treatment participants will be followed up for 12 weeks.
4mg daily for 24 weeks from baseline
Experimental: Arm B
After the baseline visit in week 0, participants will wait for a 12 week treatment delay and will then receive 4mg baracitinib daily from week 12-week 36 (i.e. for 24 weeks). After treatment participants will be followed up for 4 weeks for safety.
4mg daily for 24 weeks starting after a 12-week treatment delay from baseline
- Assess the clinical response at 24 weeks post-active treatment [ Time Frame: Arm A: 24 weeks post randomisation; Arm B: 36 weeks post randomisation ]Minimal, moderate or major clinical response according to the IMACS criteria at 24-weeks post active treatment
- Compare the clinical response between arm A and arm B at 12 and 24 weeks post randomisation [ Time Frame: 12 weeks and 24 weeks post randomisarion ]Minimal, moderate or major clinical response according to the IMACS criteria
- Compare the clinical response between arm A and arm B at 24-weeks post active treatment [ Time Frame: Arm A: 24 weeks post randomisation; Arm B: 36 weeks post randomisation ](b) Moderate or major clinical response according to the IMACS criteria at 24 weeks post active treatment
- Assess the time taken to achieve clinical improvement following treatment with baricitinib up to 24 weeks after active treatment [ Time Frame: Arm A: 24 weeks post randomisation; Arm B: 36 weeks post randomisation ]Time taken to achieve minimal, moderate or major clinical response in myositis up to 24 weeks after active treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208464
|Contact: Holly Woodwark||+44 (0) 161 306 email@example.com|
|Principal Investigator:||Hector Chinoy||University of Manchester|