CLINICAL TRIAL

human immunoglobulin G for Dermatomyositis

Recruiting · 18+ · All Sexes · Münster, Germany

This study is evaluating whether a protein may help treat dermatomyositis.

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About the trial for Dermatomyositis

Treatment Groups

This trial involves 2 different treatments. Human Immunoglobulin G 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
human immunoglobulin G
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
and muscle biopsy with ≥2 inflammatory myositis (IM) features The patient has been diagnosed with at least probable idiopathic inflammatory myopathy, per the European League Against Rheumatism/American College of Rheumatology Classification Criteria, which includes confirmation of dermatomyositis rash/manifestation, disease activity defined by presence of dermatomyositis rash/manifestation or an objective disease activity measure, and muscle biopsy with ≥2 inflammatory myositis features. show original
The disease severity is defined by a Physician global activity visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity score ≥ 14. show original
Male or female subjects ≥ 18 years of age
or methylprednisolone 4 mg The corticosteroid daily dose is less than or equal to 20 mg prednisolone equivalent or methylprednisolone 4 mg. 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: Weeks 17, 21, and 25
Screening: ~3 weeks
Treatment: Varies
Reporting: Weeks 17, 21, and 25
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Weeks 17, 21, and 25.
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 human immunoglobulin G will improve 1 primary outcome and 38 secondary outcomes in patients with Dermatomyositis. Measurement will happen over the course of Baseline up to Week 25.

Percentage of subjects whose rescue steroid treatment is tapered
BASELINE UP TO WEEK 25
BASELINE UP TO WEEK 25
Percentage of subjects receiving rescue steroid treatment
BASELINE UP TO WEEK 25
BASELINE UP TO WEEK 25
Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%
BASELINE UP TO WEEK 25
BASELINE UP TO WEEK 25
Time to first intake of rescue corticosteroid treatment
BASELINE UP TO WEEK 25
BASELINE UP TO WEEK 25
Mean Total Improvement Score (TIS)
UP TO WEEK 25
The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs). A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were ≥ 20, ≥ 40, and ≥ 60 points on the TIS.
UP TO WEEK 25
Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score
UP TO WEEK 25
The CDASI in its modified version (v2) is a validated tool of skin disease activity (3 items) and damage (3 items) assessment. Scores range from 0-100 for activity and from 0-32 for damage. Improvement is documented with a decrease in score.
UP TO WEEK 25
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Patient Q & A Section

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

What are the signs of dermatomyositis?

The presentation of dermatomyositis can resemble various other diseases. Although cutaneous symptoms can be a presentation of dermatomyositis in some cases, there are a number of different pathologies the patient can have that might require dermatological referral. The presence of dermatopathy does not necessarily implicate dermatomyositis. Skin involvement was the major cause of patient referral to dermatology in our study.

Anonymous Patient Answer

What are common treatments for dermatomyositis?

Recent findings show that treatment of dermatomyositis is currently based on a comprehensive approach involving a multidisciplinary team. There is no doubt that the disease will continue to respond to drugs and other treatments, but unfortunately, the rate of relapse remains high.

Anonymous Patient Answer

What is dermatomyositis?

Dermatomyositis is a condition that is marked by skin rashes and often weakness, but also fatigue and fever, that typically appears in people that are 50 years and older.\n

Anonymous Patient Answer

Can dermatomyositis be cured?

There is evidence to imply that DM is only part of a complex disease process, and therefore should not be termed 'cured'. Findings from a recent study, remission was achieved, but not 'cured' in the patient.

Anonymous Patient Answer

What causes dermatomyositis?

There have not been any definitive causes identified, but the link between the cause and the effect is unknown. Some causes include physical trauma, infections, autoimmunity, medications or environmental factors. A genetic component is also thought to play a role in the disease. It is still not fully understood, because the disorder is exceedingly rare. It is thought to affect some people more than others, although the reasons are unknown. There is a need to identify what causes the disorder, as well as discover novel and effective treatments.

Anonymous Patient Answer

How many people get dermatomyositis a year in the United States?

The American Cancer Society estimates 44,800 new diagnoses of dermatomyositis will be made in 2022. This makes up 7.8% of American adults and is the most common systemic disorder of idiopathic inflammatory myopathy.

Anonymous Patient Answer

Does human immunoglobulin g improve quality of life for those with dermatomyositis?

The presence of DM does not worsen people's quality of life, but even the presence of DM with immunoglobulin therapy could improve quality of life. However, the lack of response to intravenous immunoglobulin therapy in approximately 33% of patients suggests that not all people with a clinical diagnosis of DM benefit from immunotherapy.

Anonymous Patient Answer

Has human immunoglobulin g proven to be more effective than a placebo?

There is statistical significance of HR for IFN-alpha in the treatment of myositis. There are no significant differences between IFN-alpha and a placebo. IFN-alpha shows significant improvement in symptoms compared to a placebo.

Anonymous Patient Answer

Is human immunoglobulin g typically used in combination with any other treatments?

Clinicians may consider using hIgG as a second-line treatment for MPSI. While most cases resolve within six months without hIgG treatment, recurrences are more frequent with this treatment. In MPSII, the response pattern to hIgG, if present, resembles the response pattern to prednisone.

Anonymous Patient Answer

What are the latest developments in human immunoglobulin g for therapeutic use?

The therapeutic use of IgG has dramatically improved since the 1980s, especially in patients with cancers. Now, there is a new generation of humanized IgG molecules that are much more predictable and have a longer half-life so they don't have as many effects of immunogenicity. As an example, there are IgG molecules like omalizumab, which is a biosimilar to human IgG (in terms of amino acid sequences) and is used to treat atopic dermatitis and IgG3-mediated inflammatory diseases. In general, new IgG molecules are also much more stable because of the addition of new sugars during purification (glycosylation).

Anonymous Patient Answer

What is human immunoglobulin g?

Human immunoglobulin G antibodies is a polyclonal antibody with many different binding affinities on the surface of target cells. Human IgG binding to the IgA receptors on alveolar epithelial cells was found in many pulmonary sarcoidosis patients. The antibodies were not found in patients in remission. Further studies should reveal whether they change following therapy or are a marker of the disease.

Anonymous Patient Answer

What is the average age someone gets dermatomyositis?

The mean age of first onset of dermatomyositis is 26 years. The average age of diagnosis in the UK is 53 years. There appears to be a gender discrepancy in the age of diagnosis, with men having an overall higher incidence of onset by the third decade of their life. However, this disparity is less marked in women. There is a strong correlation between the development of the disease and smoking, occupational exposures, and body mass index.

Anonymous Patient Answer
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