Completed

RAPAMIÉtude de l'Effet de la Rapamycine Sur la Force Musculaire et la réponse Immunitaire au Cours de la Myosite à Inclusions: étude RAPAMI"

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What is being tested

Rapamycin

+ Placebo

Drug
Who is being recruted

Muscular Diseases+3

+ Musculoskeletal Diseases

+ Myositis

From 45 to 85 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3
Interventional
Study Start: July 2015
See protocol details

Summary

Principal SponsorInstitut National de la Santé Et de la Recherche Médicale, France
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 15, 2015

Actual date on which the first participant was enrolled.

Sporadic Inclusion Body Myositis (IBM) is the most frequent inflammatory myopathy in patients over 50. It is a slowly progressive, but today untreatable (notably by classical immunosuppressants) disease. 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.

Official TitleÉtude de l'Effet de la Rapamycine Sur la Force Musculaire et la réponse Immunitaire au Cours de la Myosite à Inclusions: étude RAPAMI"
NCT02481453
Principal SponsorInstitut National de la Santé Et de la Recherche Médicale, France
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

44 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 45 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Muscular DiseasesMusculoskeletal DiseasesMyositisNervous System DiseasesNeuromuscular DiseasesMyositis, Inclusion Body

Criteria

1 inclusion criteria required to participate
IBM defined by the Benveniste & Hilton-Jones ( Neuromuscul Disord. 2010;20: 414-21) or Llyod criteria (Neurology 2014; 83: 426-433)
15 exclusion criteria prevent from participating
Impossiblility to walk 10 meters
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)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
rapamycin 1 mg/ml oral solution, 2 mg/day (2 ml/day), once a day, during one year

Group II

Placebo
Placebo oral solution, 2 ml/day, once a day, during one year

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

CIC Paris Est _Hôpital Pitié Salpêtrière

Paris, FranceOpen CIC Paris Est _Hôpital Pitié Salpêtrière in Google Maps
CompletedOne Study Center