Acthar gel for Sarcoidosis

3
Effectiveness
3
Safety
University of California, San Francisco, San Francisco, CA
Sarcoidosis
Acthar gel - Drug
Eligibility
18+
All Sexes
Eligible conditions
Sarcoidosis

Study Summary

This study is evaluating whether a drug called Acthar may help improve lung function and symptoms for individuals with sarcoidosis.

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Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Acthar gel will improve 1 primary outcome and 2 secondary outcomes in patients with Sarcoidosis. Measurement will happen over the course of within 6 months.

within 6 months
Decrease in blood CXCL9 levels by 50%
Improvement in FVC by 5% of predicted
Improvement in dyspnea score

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
Acthar gel

This trial requires 14 total participants across 2 different treatment groups

This trial involves 2 different treatments. Acthar Gel is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Acthar gel
Drug
After a 4-week period of baseline monitoring, Acthar gel will be administered by intramuscular or subcutaneous injection. Initial dosing will be 40 U every 72 hours (or twice per week) for 4 weeks. Dosage will then be increased to 80 U with similar frequency for 8 weeks and up to 16 weeks.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within 6 months for reporting.

Closest Location

University of California, San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient was diagnosed with sarcoidosis after a biopsy showed lesions in the lungs. show original
is the hallmark of lupus nephritis Lupus nephritis is characterized by a refusal or intolerance to immunosuppressive agents like prednisone or methotrexate. show original

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 sarcoidosis?

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Data from a recent study suggest that signs of sarcoidosis, such as cough, pulmonary hypertension, pulmonary wedge thickness, or pulmonary hilar adenopathy, are very unusual. On the other hand, signs of lupus, such as oral ulcers, erythema nodosum, and arthralgias, are common. Some rare signs of sarcoidosis, such as erythema on the face or ears, are common while some uncommon signs of sarcoidosis, such as hepatosplenomegaly are extreme signs.

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

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Rates of disease incidence are not a good indicator of disease prevalence. The number of cases diagnosed yearly in the United States varies substantially by age, ethnicity, geographic region, and other factors. Only about one-third of the cases are diagnosed by physicians other than those who specialize in sarcoidosis. Further research is needed to determine the size of this population in order to provide accurate rates of disease diagnosis and improved care for patients with sarcoidosis.

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What causes sarcoidosis?

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There is growing evidence that the development of sarcoidosis may occur by an immunological reaction to a microorganism. Sarcoidosis is usually a disease of Caucasians and Native Americans, and is rare or nonexistent in black and Asian people. Nevertheless, there is a growing belief among the general population that the disease is more common than previously believed and that Asians and Africans are at a greater risk during adolescence for developing this disease. Even though the exact organism triggering sarcoidosis is still unknown, epidemiological studies have suggested that this is a bacterial disease. There is also growing evidence to support a link between tuberculosis and sarcoidosis, but this need not be an effect of bacilli.

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What is sarcoidosis?

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Sarcoidosis is a disease that affects the small and large airway and presents with nonspecific respiratory symptoms. It is generally considered a systemic autoimmune disease since the symptoms differ from those of other lung diseases. There is little evidence of sarcoidosis occurring with malignant disease.\n

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What are common treatments for sarcoidosis?

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Surgical removal of nodules and/or lesions is the only cure for sarcoidosis. But some patients may not get better even with a surgical solution and may require long-term glucocorticoid treatment.

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Can sarcoidosis be cured?

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Lung involvement, which is associated with sarcoidosis, is associated with significant morbidity and mortality. Despite aggressive treatment of sarcoidosis with a corticosteroid regimen, long-term control is poor, and treatment with steroids is associated with a high rate of relapse. Lung disease in sarcoidosis is not amenable to cure. Even though sarcoidosis is not curable, some clinicians and patients may have satisfaction with their response to treatment.

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What does acthar gel usually treat?

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What does acthar gel usually treat? No one should use acthar as a substitute for other treatments and/or medication, nor on the basis of any clinical presentation whatsoever that is not related to acthar. Use of acthar alone can lead to harm. Therefore, acthar has no place on the treatment path unless and until it is needed for the treatment of severe disease manifestations, and in these instances, should be used only with other treatments. Physicians and patients alike must recognize the risks associated with acthar therapy and must only use acthar when absolutely necessary (for example, as a second-line therapy to control the progression of a debilitating and disabling disease, and in a life and limb-threatening situation).

Unverified Answer

Is acthar gel safe for people?

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Acthar gel cannot be considered a treatment option in adults for the treatment of scalp enlargement because it did not significantly improve the symptoms of scalp enlargement nor was it able to ameliorate itchiness. As such, the use of Acthar gel for the treatment of scalp enlargement in adults is inadvisable and should not be considered as a treatment option by the clinicians conducting the present study. In adults who have scalp enlargement that has not improved with previous therapy, Acthar gel is an optional option to consider as a therapy. In adults who have unresponsive symptoms to Acthar gel, it should be considered as a treatment option.

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What is the primary cause of sarcoidosis?

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A primary cause, defined as the first agent the patient had ingested, is not present in 96% of cases. For those in whom a probable cause exists, the primary agent is most frequently a bacterial pathogen. In children with sarcoidosis, the most common bacterial agent is Mycobacterium xenopi. However, in many cases of sarcoidosis associated with a bacterial causative agent, the patient was not consuming the suspected agent, implying that the bacteria was neither the first nor main cause of the disease. For most cases, no trigger could be identified.

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Does acthar gel improve quality of life for those with sarcoidosis?

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Acthar gel (0.1% and 1% dosage) was well tolerated by patients and improves QoL to a similar degree compared with placebo. Acthar gel appears effective in the treatment of sarcoidosis with regard to skin symptoms as well as symptoms of overall disease activity.

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Have there been any new discoveries for treating sarcoidosis?

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I am not sure I remember any new treatments that are proving effective, but I am sure I can't recommend those treatments to somebody for their current symptoms or I would have trouble with my doctor if we put us down for one, and this is a serious drawback with medication. The only reason I know of a drug that is showing effectiveness is a drug called mitomycin\n

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What is the latest research for sarcoidosis?

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There is not a lot of research on sarcoidosis because the disease is not very common and because of lack of knowledge on the disease. Sarcoidosis seems to affect most men, and is not as common in women as some report, while the prevalence of sarcoidosis in the country of Kuwait is lower than what is reported in countries like Denmark or Japan. Sarcoidosis is not a curable disease, although some people get better on their own. There are few ways to evaluate sarcoidosis. There are different forms of sarcoidosis, which should be considered differently according to the person's age and symptoms displayed on the body.

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