Study Conducted by Great Lakes Clinical Trials Shows Positive Results in Rheumatoid Arthritis

Great Lakes Clinical Trials is proud to share the results of a Rheumatoid Arthritis clinical trial conducted at our research clinic under the direction of our board-certified Rheumatologist, Dr. Manish Jain.

Manish Jain, MD Board-Certified Rheumatologist

Manish Jain, MD
Board-Certified Rheumatologist

“We are excited to have such a quality Rheumatology research team on staff led by Dr. Jain,” commented Steve Satek, President of Great Lakes Clinical Trials. “We are grateful for the commitment of volunteers who joined this clinical trial. Without their participation, we would not be able to bring new effective medications to market to treat this painful and debilitating disease.”

Great Lakes Clinical Trials is currently conducting multiple clinical trials in Rheumatoid Arthritis. For more information on these programs or to sign up, click HERE to be directed to our webpage dedicated to our Rheumatoid Arthritis program.

The following are key highlights of the press release announcing the results of this study. To view a full copy of the press release, click the button at the bottom of the page.


AbbVie's Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints

  • SELECT-MONOTHERAPY, the third study in the robust SELECT program, showed positive results, with both doses (15 mg and 30 mg once-daily) meeting the primary endpoints in patients with an inadequate response to methotrexate

  • Upadacitinib monotherapy resulted in low disease activity by week 14 in 45 percent of patients in the 15 mg group and 53 percent in the 30 mg group

  • A response of ACR20/50/70 was achieved by 68/42/23 percent of patients receiving 15 mg upadacitinib and 71/52/33 percent of patients receiving 30 mg of upadacitinib

  • The safety profile of upadacitinib was consistent with previously reported Phase 3 studies, with no new safety signals detected

  • Upadacitinib, an oral agent engineered by AbbVie to selectively inhibit JAK1, is being studied as a once-daily therapy in rheumatoid arthritis in the SELECT program and across multiple immune-mediated diseases

NORTH CHICAGO, Ill., Dec. 20, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial. This ongoing study evaluated upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond to treatment with methotrexate. Results showed that after 14 weeks of treatment, both once-daily doses of upadacitinib (15 mg and 30 mg) met the study's primary endpoints of ACR20 and low disease activity (LDA) versus continuing prior stable methotrexate therapy.1 Both doses also achieved all ranked and all key secondary endpoints. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.

"The positive results from the SELECT-MONOTHERAPY study are encouraging, as they are the first evidence to support the potential of upadacitinib as a therapy without the need for background methotrexate," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These findings add to the growing body of data showing the potential for upadacitinib as a meaningful treatment option for patients suffering from rheumatoid arthritis. We look forward to sharing additional data from the upadacitinib Phase 3 rheumatoid arthritis program with the scientific community in 2018."


Great Lakes Clinical Trials Welcomes Gilleon Health to Andersonville

Great Lakes Clinical Trials is pleased to announce that Gileon Health has opened their Andersonville clinic within our medical office suite.

Cherie Gilleon, DO

Cherie Gilleon, DO

Motivated by the belief everyone has a right to excellent healthcare, Dr. Gilleon launched Gilleon Health in August of 2018. Gilleon Health is the culmination of Dr. Cherie Gilleon’s activist spirit and years of experience as a healthcare executive. At Gilleon Health, she has set out to build a judgement-free medical home in which dignity, compassion and respect for everyone is just the start. Whether you are LGBTQ, homeless, undocumented, uninsured, non-binary, cis..... also collectively known as human ..... you deserve access to care.

Dr. Gilleon is a board certified Family Medicine Physician. She completed her training at Amita Saint Joseph Hospital.

“At Gilleon Health, we’re passionate about Primary Care, commented Dr. Gilleon. “For us, Primary Care isn’t an afterthought or part of a corporate strategy to gain market share. We believe exemplary Primary Care can only be achieved when it’s rooted in a trusting relationship built over time. We’re here to help with chronic illness, woman’s health, acute medical conditions, mental health, and gender identity issues. Our office is judgement-free and we welcome all humans…and some canines.”

While Gilleon Health subleases office space from Great Lakes Clinical Trials, there is no common ownership or overlapping financial interest between the two organizations. The close proximity of our offices offers convenient opportunities for Dr. Gilleon patients to participate in clinical trials, and for our research patients to obtain primary care from Dr. Gilleon, but that is the extent of our relationship. Simply put, Gilleon Health and Great Lakes Clinical Trials are kindred spirits and fortunate to be neighbors!

In addition to this Andersonville location, Gilleon Health has also opened a clinic in Chicago’s Logan Square neighborhood. For more information on Gilleon Health, you can visit their website by clicking the button below.

Great Lakes Clinical Trials Contributes to FDA Approval of Vyleesi™ for Female Sexual Dysfunction

Great Lakes Clinical Trials and our Medical Director, Jeffrey Ross MD, are pleased to announce that our research team contributed to the clinical data reviewed by the Food and Drug Administration (FDA) or the approval of Vyleesi™ (bremelanotide injection) for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).

Per their June 21, 2019 press release, “Palatin Technologies, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval of AMAG Pharmaceuticals, Inc.'s New Drug Application (NDA) for Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist developed by Palatin indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).”

“We are proud to have participated in this important research program,” commented Steve Satek, President of Great Lakes Clinical Trials. “It is important to acknowledge the significant contribution that our Great Lakes Clinical Trials study participants provided, in order to move this novel medication to market and offer a treatment for this under-recognized medical condition.”

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Hypoactive Sexual Desire Disorder (HSDD) is the most common type of female sexual dysfunction in the U.S. The condition is characterized by low sexual desire and marked distress which are not attributable to existing medical, pharmacologic, psychiatric, or relationship issues. Approximately 6 million pre-menopausal women meet the diagnosis criteria for acquired, generalized HSDD. Patient awareness and understanding of the condition remains low, and few women currently seek or receive treatment. Recent industry-sponsored market research indicates that up to 95 percent of premenopausal women suffering from HSDD are unaware that it is a treatable medical condition.

To view the Palatin Technologies press release in its entirety, click here.

A New Alzheimer's Blood Test Proved 94% Accurate in Finding Brain Changes Related to the Disease

More than a century after Alzheimer’s disease was first described, there still isn’t a treatment to control the cognitive decline and memory loss that are the hallmarks of the neurodegenerative condition. The drugs that are available can alleviate some of the disease’s symptoms, but don’t work to address the root cause of the brain disease. And recent studies of promising drug therapies have failed to show much benefit for patients.

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One challenge in developing a treatment for Alzheimer’s lies in that by the time symptoms occur, brain neurons have already been damaged, perhaps beyond repair. And once neural connections are compromised, they aren’t likely to reform or rebuild. Drug treatments that start after people report declines in their thinking skills may simply be too little too late.

That’s why there’s strong interest in developing a reliable way to identify Alzheimer’s patients as early as possible, years or even decades before their memories start to fade. Researchers are investigating a number of promising markers that appear in the blood that could be useful in tracking Alzheimer’s. Some of the most encouraging of this work centers on amyloid, the protein that is the hallmark of the disease. Current methods of testing for amyloid, including taking samples of cerebrospinal fluid and PET imaging of the brain, are expensive, time consuming and, in the case of the spinal fluid samples, invasive. That limits the number of people who get tested; having a blood test would potentially allow more people at risk of developing Alzheimer’s to learn of their status.

Researchers at Washington University School of Medicine in St. Louis report in the journal Neurology that they have developed such a blood test that may be up to 94% accurate in finding people with early Alzheimer’s brain changes. They had previously reported the results at the Alzheimer’s Association International conference in July, and it’s among the most advanced efforts to bring a blood-based test to the clinic.

While everyone makes amyloid, in some, the protein is produced in abnormally copious amounts that clump together and form plaques in the brain, which experts believe start to strangle nerves and sever their critical connections to each other. Having amyloid plaques in the brain is a requirement for an Alzheimer’s diagnosis, so the researchers developed a test that could pick up amyloid levels in the blood.

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The team, led by senior author Dr. Randall Bateman, professor of neurology, and first author Dr. Suzanne Schindler, associate professor of neurology, documented the ratio of two fragments of amyloid protein, called a-beta 42 and a-beta 40 to each other; the fragments form when the parent protein is normally chopped by enzymes. In people who develop Alzheimer’s, however, for some reason the resulting fragments start sticking together, and aren’t cleared from the brain. As more amyloid aggregates in the brain to form plaques, less of it, particularly a-beta 42, is available to circulate in the blood, so the ratio of the two forms to each other is a proxy for how much is being pulled into clumps in the brain. The lower the ratio, the more plaques are forming in the brain.

To detect the circulating amyloid, researchers used mass spectrometry, a technique that separates out compounds in a sample by vaporizing them and then shooting them with an electron beam to create specific ionic signatures that identify specific molecules or proteins. The technique can record the amount of a-beta 42 and a-beta 40 from a blood sample.

In this study, the team took samples from 158 people over the age of 50, most of whom were cognitively normal at the start of the study, and followed them for about four years to see which participants developed Alzheimer’s. To verify the amyloid levels found in the blood test, the volunteers also had a PET scan of their brains and provided samples of cerebrospinal fluid, near the start and then again near the end of the study period.

The blood samples were collected within 18 months of the first amyloid PET scan, and 88% of the time, the blood test matched the scan.

That’s not accurate enough to use as a test to identify people at-risk of Alzheimer’s, so the team then combined the blood test with other well-known risk factors, such as the presence of a genetic factor called ApoE4, and age. When these additional factors were considered, the combination matched the PET scan 94% of the time.

Previous efforts, including one by a group of Japanese researchers, to develop a blood test have compared the blood results to PET imaging, but for the first time, the Washington University researchers also tracked the blood test and PET scan results over time. They found that people who had negative amyloid PET scans at the start of the study but positive amyloid blood tests had a 15-fold higher risk of having a positive PET scan by the end of the study.

In other words, the blood test may be picking up very early changes in amyloid, that weren’t detectable on the brain scans. “Typically, with a one-time reading, we would have called those people false positive on the blood test and said it was a failure of the test,” says Schindler. “But the test wasn’t a failure, and those weren’t false positives but rather the blood test was more sensitive than the amyloid PET in picking up early changes of Alzheimer’s.”

Schindler says the test is not perfect yet, and needs more refinement and validation in larger groups of patients. But the research team has already worked with other patients in Australia and Europe and found similarly accurate results.

Using the blood test in a doctor’s office to identify those at the highest risk of developing brain changes linked to Alzheimer’s may still be a few years away. But Maria Carillo, chief science officer at the Alzheimer’s Association, says that in the immediate future, the test could be a huge help in ensuring that the right patients—those with higher levels of amyloid—are taking part in trials of new drug treatments for the disease.

Big questions about a blood test for detecting Alzheimer’s still remain, including how experts will set the threshold for “normal” and “high” levels of amyloid or other proteins in the blood. Making such a determination will be “complicated,” says Schindler, since while the presence of amyloid is necessary for an Alzheimer’s diagnosis, not everyone who harbors amyloid plaques necessarily develops the disease. But having a reliable way to track changes in people’s amyloid levels would be a start.

From Time.com
BY
ALICE PARK
AUGUST 1, 2019
Contac
t: editors@time.com.