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Blocage de l'interféron-ɣ par le ruxolitinib pour le traitement de la myosite à inclusion : un essai de phase IIb
EU CTIS ID: 2023-507666-32-00
What this study is testing
to evaluate whether ruxolitinib may improve the overall locomotor performance of IBM patients after a 1 year duration treatment period
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Age ≥ 45 years
- - Effective contraception for the duration of the clinical trial for fertile women of childbearing age. The participant agrees to follow the contraceptive requirements detailed in the protocol.
- - Defined diagnosis of IBM according to data-derived criteria (Llyod et al, 2014): Patient must fulfill the three following criteria for being diagnosed as IBM: (1) finger flexor or quadriceps weakness; and (2) muscle biopsy showing endomysial inflammation; and (3) muscle biopsy showing invasion of nonnecrotic muscle fibers or rimmed vacuoles
- - To be able to walk 6 min without assistance from another person (external assist devices permitted [e.g., canes, walkers, or rollators])
- - Patient informed and having signed the consent for participation, possibly assisted by a trusted person
You likely can't join if
- - Pregnancy or breastfeeding
- - Any medical condition which limits the ability of participant to participate in study
- - Necessity to use a drug incompatible with ruxolitinib (see 7.4)
- - Hypersensitivity to the IMP’s active substance (ruxolitinib) or to any of the excipients (Cellulose microcrystalline, magnesium stearate, silica colloidal anhydrous, sodium carboxymethyl starch (Type A), povidone K30, hydroxypropylcellulose 300 to 600 cps, lactose monohydrate)
- - Non-affiliation to a social security scheme or to another social protection scheme, patient on AME (state medical aid)
- - Foreseeable inability, according to the investigator, to participate in all the visits, treatments and measures provided for in the protocol
See the full eligibility criteria
Who can join
- - Age ≥ 45 years
- - Effective contraception for the duration of the clinical trial for fertile women of childbearing age. The participant agrees to follow the contraceptive requirements detailed in the protocol.
- - Defined diagnosis of IBM according to data-derived criteria (Llyod et al, 2014): Patient must fulfill the three following criteria for being diagnosed as IBM: (1) finger flexor or quadriceps weakness; and (2) muscle biopsy showing endomysial inflammation; and (3) muscle biopsy showing invasion of nonnecrotic muscle fibers or rimmed vacuoles
- - To be able to walk 6 min without assistance from another person (external assist devices permitted [e.g., canes, walkers, or rollators])
- - Patient informed and having signed the consent for participation, possibly assisted by a trusted person
What rules you out
- - Pregnancy or breastfeeding
- - Any medical condition which limits the ability of participant to participate in study
- - Necessity to use a drug incompatible with ruxolitinib (see 7.4)
- - Hypersensitivity to the IMP’s active substance (ruxolitinib) or to any of the excipients (Cellulose microcrystalline, magnesium stearate, silica colloidal anhydrous, sodium carboxymethyl starch (Type A), povidone K30, hydroxypropylcellulose 300 to 600 cps, lactose monohydrate)
- - Non-affiliation to a social security scheme or to another social protection scheme, patient on AME (state medical aid)
- - Foreseeable inability, according to the investigator, to participate in all the visits, treatments and measures provided for in the protocol
- - Concomitant participation in another clinical trial on medical product for human use, to a clinical investigation on a medical device, to interventional study involving human participants or in the exclusion period at the end of a previous clinical trial on medical product for human use, a clinical investigation on a medical device, or study involving human participants. Participation in non-interventional research is permitted.
- - Patient under guardianship, curatorship, safeguard of justice or deprived of liberty
- - Patient with cognitive disorders or unable, according to the investigator, to understand the study and/or to give informed consent According to the appreciation of the investigator, non-French speaking patients may be included if a close one is able to translate the information provided. The patient must be able to benefit from the accompaniment of a relative for all of their visits (in teleconsultation and in hospital).
- - Quadriceps weakness (manual muscle testing, MRC) below or equal 1
- - Forced vital capacity (FVC) or forced expiratory volume (FEV) < 50% of predicted value
- - Concomitant use of immunomodulatory drugs including previous treatment with JAK inhibitor, or medications acting on muscle anabolism or catabolism
- - Live vaccine within the 4 weeks before starting ruxolitinib therapy
- - Comorbidity or active chronic disease which contraindicate ruxolitinib: • If the results of the biological assessment including blood count, blood formula and biochemistry and dating back less than three months are available, see the non-inclusion criteria below. For patients whose results of the biological assessment carried out on the day of the inclusion and randomization visit are not yet available, these criteria constitute secondary exclusion criteria to be checked upon receipt of the results and before the randomization. Lipid parameters abnormalities/elevations (in lack of cardiovascular risk factors, normal values with or without lipid-lowering treatment are: CTtotal cholesterol < 2 g/L; LDL-C < 1.6 g/L; HDL-C > 0.4 g/L; TGtriglycerides < 1.5 g/L) Severe renal impairment (stage 4) and end-stage renal disease (stage 5): GFR < 30mL/min/1.73m2 Hepatic impairment: AST/ALT > 3 ULN and bilirubin > 1.5 ULN Cytopenia (polymorphonuclear neutrophilsPNN ≤ 1.5 Giga/L or platelets ≤ 75 Giga/L or hemoglobin ≤ 10 g/dL)
- - Active SARS-CoV-2 infection (patient can be included once infection resolved)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.