CLINICAL TRIAL

Treatment for Myositis, Inclusion Body

Waitlist Available · 18+ · All Sexes · Baltimore, MD

This study is evaluating whether sirolimus is effective in slowing the progression of IBM.

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About the trial for Myositis, Inclusion Body

Eligible Conditions
Myositis, Inclusion Body · Myositis · Inclusion Body Myositis (IBM)

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Control Group 1
Placebo
DRUG
Control Group 2
Sirolimus
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person can walk a distance of 200 meters within six minutes using a walking aid. show original
The text is about how a neuromuscular specialist determines how a patient's disease is progressing over the previous 12 months. show original
People aged 45 years or older, both male and female. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, Week 84
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, Week 84.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 3 secondary outcomes in patients with Myositis, Inclusion Body. Measurement will happen over the course of Baseline, Week 84.

Change in Modified Timed Up and Go (mTUG) from Baseline to Week 84
BASELINE, WEEK 84
The Timed Up and Go (mTUG) was initially developed as a tool to determine falls risk, mobility, balance and walking ability in an elderly population. It has since been adopted as an outcome measure in a broader clinical setting including myositis.
Change in IBM Functional Rating Scale (IBM-FRS) from Baseline to Week 84
BASELINE, WEEK 84
The IBM-FRS is a concise and quick (~10 minute), clinician-administered ordinal rating scale used to determine participants' assessment of their capability and independence. It includes 10 measures (swallowing, handwriting, cutting food and handling utensils, fine motor tasks, dressing, hygiene, turning in bed and adjusting covers, changing position from sitting to standing, walking, and climbing stairs), graded on a Likert scale from 0 (being unable to perform) to 4 (normal). The sum of the 10 items gives a value between 0 and 40, with a higher score representing less functional limitation.
Change in Manual Muscle Testing (MMT) from Baseline to Week 84
BASELINE, WEEK 84
Manual Muscle Testing (MMT) is a relatively simple method of assessing a patient's strength in a muscle or group of muscles. There is however a degree of subjectivity when assigning a score. MMT will be used to assess change in strength throughout the study period. This method is routinely performed in a clinical setting and has been shown to be reliable. This tool assesses muscle strength using a 0 - 10 point scale.
Change in 6 Minute Walk Test (6MWT) from Baseline to Week 84
BASELINE, WEEK 84
The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance in patients with cardiopulmonary disease. It is now a commonly used and validated test to estimate the functional walking capacity in patients with a range of chronic diseases including IBM.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get myositis, inclusion body a year in the United States?

The estimates from the U.S. cross-sectional study are about 45 new cases per 100,000 person year or approximately 7 per 1000 new cases of myositis, inclusion body per year and per 100,000 person year in U.S adults.

Anonymous Patient Answer

What are common treatments for myositis, inclusion body?

No single medication has been identified as a standard treatment. Anti-mitogen or immunosuppressant medications may be considered when myositis-related complications develop. Immunosuppression with methotrexate, tacrolimus or leflunomide may be useful for the treatment of myositis with weakness. In some patients, the use of tacrolimus may result in a clinical improvement while awaiting a biologic response. In patients with pulmonary disease, treatment with corticosteroid alone is usually not efficacious, and corticosteroid therapy combined with anti-myositis medication is effective. If corticosteroid is ineffective, statins may delay progression of pulmonary disease and myositis.

Anonymous Patient Answer

What are the signs of myositis, inclusion body?

The signs of myositis/inclusion body are very different. Patients with myositis tend to be more likely to experience weakness in the face, neck and shoulder, while patients with inclusion bodys tend to experience more intense muscle tenderness and greater swelling.

Anonymous Patient Answer

What causes myositis, inclusion body?

Myositis is the most common manifestation of inclusion body myositis. Although it manifests as a myopathy in many different ways, myositis is almost always a manifestation of inclusion body myositis, with an incidence of up to 91% in these cases. Even with this high incidence of myositis, the disease is still one of few that can rarely be diagnosed as a presentation of inclusion body myositis without the finding and/or confirmation of inclusion bodies in the skeletal muscle biopsy. Inclusion body myositis is diagnosed solely on the basis of histologic features. On skeletal muscle biopsy, there are few if any other diseases that are commonly misdiagnosed with inclusion bodies.

Anonymous Patient Answer

What is myositis, inclusion body?

myositis-inclusion body, inclusion body, is a myopathy that occurs with marked muscle weakness, wasting or atrophy with a wide spectrum of clinical features. An important feature of inclusion body is weakness of the eye-lids, which appears as a fluttering ptosis or lid retraction or both in about half of all cases.

Anonymous Patient Answer

Can myositis, inclusion body be cured?

There was no evidence found of a significant change in clinical data for patients treated for one year with glucocorticoids. Nevertheless, clinical improvement or cure could not be proven, either in the short or in the long term.

Anonymous Patient Answer

What is the primary cause of myositis, inclusion body?

This report provides preliminary evidence that antibodies against Ro/RS-SSA (or one of its autoantigens) and Scl can cause a primary form of myositis, as well as a secondary form.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

There have been few other clinical trials in the UK that have investigated the use of methotrexate in the treatment of scleroderma. There is an ongoing study at [University of Southampton|University of Southampton]] for which participants have been recruited on a volunteer basis. Data from a recent study from this trial should be informative about which drugs might be effective in the future. If you want to find clinical trials in general, you can use []Power(http://www.withpower.com/clinical-trials).

Anonymous Patient Answer

Have there been any new discoveries for treating myositis, inclusion body?

Many new methods are used and researched to treat myositis, inclusion body, but the effects are still unknown. New research in myositis will continue to develop new effective methods.

Anonymous Patient Answer

What does treatment usually treat?

There are currently no treatments to prevent the inclusion body myositis phenotype. Treatments focus on treating symptoms. For example, [pain management](https://www.withpower.com/clinical-trials/pain-management) is paramount in the management of myositis. Most treatments that are prescribed are for pain, fatigue, or muscle weakness/tenderness. Exercise is an effective method to treat fatigue and muscle pain. Although myositis will occur and become progressively worse at the same intensity of exercise, some patients may experience reduced exercise intensity or fatigue associated with the exercise. This is related to the reduced sympathetic nervous system activity of the myositis, resulting in reduced metabolism and decreased energy needs. Exercise should be avoided during recovery and if tolerated, exercise should be increased progressively.

Anonymous Patient Answer

Does myositis, inclusion body run in families?

There is a significant family history of myositis, inclusion body in North Indian families. We concluded that it is not myositis, inclusion body run in families, but a single gene mutation which probably affects mitochondria.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

There does not currently have a proven way to prevent either a case of rheumatoid myositis or muscle damage. However, there are currently a lot of different treatments prescribed to help with these conditions, and [information on non-curative treatments is available here(http://www.curesearch.ca/info/curative_treatments.html). The best way to determine whether the treatment is more effective and safer than a placebo is try out the treatment first and make a decision based on the benefits reported.

Anonymous Patient Answer
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