Rapamycine vs Placebo for the Treatment of Inclusion Body Myositis
NCT ID: NCT02481453
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
44 participants
INTERVENTIONAL
2015-07-15
2018-01-22
Brief Summary
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Rapamycin used in organ transplantation blocks the activity of T effector cells, preserves T regulatory cells and induces autophagy (protein degradation), all parameters impaired during IBM.
RAPAMI is a prospective, randomised, controlled, double blind, monocentric, phase IIb trial evaluating rapamycine against placebo.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Rapamycin
rapamycin 1 mg/ml oral solution, 2 mg/day (2 ml/day), once a day, during one year
Rapamycin
Experimental: rapamycin oral solution, 2 mg/day during one year Comparator: placebo
Placebo
Placebo oral solution, 2 ml/day, once a day, during one year
Placebo
Comparator: placebo
Interventions
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Rapamycin
Experimental: rapamycin oral solution, 2 mg/day during one year Comparator: placebo
Placebo
Comparator: placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hypersensitivity to rapamycin or one compound of the oral solution
* Severe respiratory insufficiency (FVC \< 50% and/or FEV1 \< 50%)
* Severe chronic kidney disease (Estimated Glomerular Filtration Rate \< 15 ml/min and/or proteinuria \> 0.3 g/24h)
* Chronic liver disease (cirrhosis and/or ALT/AST \> 2.5 normal values)
* Cancer non in remission (necessitating specific treatment) during the past 12 months
* Connective Tissue Disease non in remission (necessitating specific treatment) during the past 12 months
* Pregnancy
* Seropositivity for HIV, HCV or HBV
* Total cholesterolemia \> 8 mmol/l
* Triglyceridemia \> 5 mmol/l
* Hemoglobinemia \< 11 g/dL
* Thrombopenia \< 100 000/mm3
* Neutropenia \< 1500/ mm3
* Lymphopenia \< 1000/ mm3
45 Years
85 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Locations
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CIC Paris Est _Hôpital Pitié Salpêtrière
Paris, , France
Countries
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References
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Benveniste O, Hogrel JY, Belin L, Annoussamy M, Bachasson D, Rigolet A, Laforet P, Dzangue-Tchoupou G, Salem JE, Nguyen LS, Stojkovic T, Zahr N, Hervier B, Landon-Cardinal O, Behin A, Guilloux E, Reyngoudt H, Amelin D, Uruha A, Mariampillai K, Marty B, Eymard B, Hulot JS, Greenberg SA, Carlier PG, Allenbach Y. Sirolimus for treatment of patients with inclusion body myositis: a randomised, double-blind, placebo-controlled, proof-of-concept, phase 2b trial. Lancet Rheumatol. 2021 Jan;3(1):e40-e48. doi: 10.1016/S2665-9913(20)30280-0. Epub 2020 Oct 12.
Benveniste O, Hilton-Jones D. International Workshop on Inclusion Body Myositis held at the Institute of Myology, Paris, on 29 May 2009. Neuromuscul Disord. 2010 Jun;20(6):414-21. doi: 10.1016/j.nmd.2010.03.014. Epub 2010 Apr 21. No abstract available.
Lloyd TE, Mammen AL, Amato AA, Weiss MD, Needham M, Greenberg SA. Evaluation and construction of diagnostic criteria for inclusion body myositis. Neurology. 2014 Jul 29;83(5):426-33. doi: 10.1212/WNL.0000000000000642. Epub 2014 Jun 27.
Other Identifiers
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2013-003485-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C12-66
Identifier Type: -
Identifier Source: org_study_id
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