LuCIN FAQ

Frequently Asked Questions About the Lupus Clinical Investigators Network (LuCIN) Clinical Research Program

About LuCIN

1. What is LuCIN?

Lupus Clinical Investigators Network (LuCIN) is a Lupus clinical trials network, made up of 57 of the most prestigious academic research medical centers throughout North America. Founded and sponsored by the Lupus Research Alliance, LuCIN brings together experts to evaluate the safety and effectiveness of potential new treatments for lupus.

2. What is the purpose of LuCIN?

LuCIN’s goal is to facilitate the development of much-needed new lupus treatments.

3. What is the relationship between Lupus Research Alliance and LuCIN?

LuCIN is a non-incorporated entity and is organized as a cooperative group of institutions and investigators. The Lupus Research Alliance is responsible for organizing and financially supporting LuCIN to participate in Network-wide clinical studies and research initiatives.

4. Why is the Lupus Research Alliance supporting LuCIN?

The Lupus Research Alliance leads the drive to new treatments, prevention and cure for lupus. LuCIN was formed to accelerate development of new therapies. By connecting and engaging the investigator community and lupus patients in a meaningful way, we aim to make it easier and more comfortable for patients to get involved and make a real difference.

5. Why were the LuCIN centers selected?

The investigators and other specialized personnel within LuCIN are experts at planning and conducting lupus clinical research. The academic institutions participating are among the top centers for medical research in the world. Each institution has its own Institutional Review Board (IRB) of highly trained physicians who review and regularly monitor all research studies conducted at that site to assure that appropriate steps are taken to protect the rights and welfare of all people participating in the clinical research. Click here for the list of LuCIN centers across the country.

6. How were the LuCIN centers selected?

LuCIN centers were selected through a highly rigorous site feasibility process, similar to the process that the pharmaceutical and biotech companies utilize when selecting centers to participate in clinical trials. Centers were identified that have well-trained lupus investigators with a large lupus patient base, expressed interest and experience in conducting multi-center clinical trials.

ABOUT LuCIN CLINICAL STUDIES

What studies are being conducted through the LuCIN network?

Six studies are currently being conducted through the LuCIN network. Following is a brief description of each.

The Lupus Research Alliance is collaborating with Celgene Corporation to study an oral drug CC-220 being developed to treat systemic lupus erythematosus. Based on results of earlier studies, Celgene will further evaluate this drug candidate with LuCIN in a global multicenter, placebo-controlled Phase II clinical study.

a. Has CC-220 been tested before and is it safe?

CC-220 has been tested in a Phase 1 study involving small groups of patients, and based on those results, was considered safe by the FDA, which allowed the company to pursue a Phase 2 trial in a larger group of patients to evaluate whether the drug improves patient outcomes.

As required by the FDA for all clinical trials, this study was reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community. Its role is to evaluate if the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits.

b. How do I know if I am eligible for this trial?

Your treating physician and healthcare team will meet with you to determine if you meet the specific inclusion and exclusion criteria for people to participate in the trial. This process is known as “screening.”

c. How do I find out more about this trial and whether it’s offered in my area?

In addition to speaking with your treating physician, more information regarding the trial can be found within the Lupus Research Alliance website at http://lupustrials.org or by calling 646-884-6074.

d. Can I participate if there is no site in my area?

No, but you can ask your physician about what lupus trials are being conducted in your area, which may be right for you to consider.

e. Can I talk to someone who has been or is in this trial?

Your physician may be able to coordinate having you speak with someone who has been in this trial or has participated in other clinical trials to address additional questions you may have.

f. Does the Lupus Research Alliance recommend this trial?

The Lupus Research Alliance does not recommend or endorse any specific trial. We do encourage people to talk to their healthcare professionals about clinical research and to explore if a clinical trial is right for them.

In partnership with Pfizer Inc., a non-interventional clinical study entitled VAlidation in LUpus of an Electronic Patient Reported Outcomes Tool (VALUE) has been initiated within LuCIN to test a custom smartphone app enabling lupus patients to report on their health-related quality of life and fatigue and other symptoms in real time rather than completing surveys during visits to physicians’ offices. The app was designed with input from people with lupus. Pfizer Inc., the Lupus Research Alliance, AMPEL BioSolutions and Tata Consultancy Services Ltd. jointly developed the new mobile app, using the Apple ResearchKit platform and building on existing research tools that have been validated in lupus.

a. Do I have to use my own phone?

No. Each person in the study will be provided an iPhone (study phone) for the duration of the trial to use. The study phone will have limited functionality and will only allow you to access the study app, make/receive calls and texts, and surf the internet. The study phone and data plan will cost you nothing, but the phone must be returned after the trial ends.

b. How do I know if I am eligible for this trial?

c. How do I find out more about this trial and whether it’s offered in my area?

d. Can I participate if there is no site in my area?

No, but you can ask your physician about what lupus trials are being conducted in your area, which may be right for you to consider.

e. Can I talk to someone who has been or is in this trial?

Your physician may be able to coordinate having you speak with someone who has been in this trial or has participated in other clinical trials to address additional questions you may have.

f. Does the Lupus Research Alliance recommend this trial?

In conjunction with Horizon Pharma, the clinical study entitled Rayos Inhibits Fatigue in Lupus Erythematosus (RIFLE) will test the effect of RAYOS® on severe fatigue and morning stiffness often experienced by people with lupus. RAYOS is the first low-dose, delayed-release form of the steroid prednisone, a widely prescribed anti-inflammatory drug. RIFLE also tests a customized mobile app to measure fatigue, health-related quality of life, disease activity and morning stiffness throughout the trial. RIFLE is a collaboration between the Lupus Research Alliance, AMPEL BioSolutions, Carematix, Verizon and Samsung.

a. Has Rayos been tested before and is it safe?

Rayos has been tested and is approved by the FDA for several rheumatology indications and is considered safe.

b. How do I know if I am eligible for this trial?

c. How do I find out more about this trial and whether it’s offered in my area?

d. Can I participate if there is no site in my area?

No, but you can ask your physician about what lupus trials are being conducted in your area, which may be right for you to consider.

e. Can I talk to someone who has been or is in this trial?

Your physician may be able to coordinate having you speak with someone who has been in this trial or has participated in other clinical trials to address additional questions you may have.

f. Does the Lupus Research Alliance recommend this trial?

The Dynamic Imaging to Assess Variation in Lupus Nephritis (DIVINE) study tests the potential for sophisticated MRI technology to assess lupus nephritis and better tailor treatment decisions based on disease activity. This study is a collaboration between the Lupus Research Alliance, AMPEL BioSolutions and ImageAnalysis.

a. Is the MRI technology safe? Has it been used before?

MRI technology is a commonly used imaging procedure in medicine. Although this particular imaging procedure has never been studied in lupus, it is commonly used in patients with cancer who have kidney involvement to evaluate treatment response. Therefore, there is good reason to believe that it may be a useful tool in assessing the extent of kidney disease and treatment response in patients with Lupus Nephritis as an alternative to receiving a kidney biopsy.

b. How do I know if I am eligible for this trial?

c. How do I find out more about this trial and whether it’s offered in my area?

d. Can I participate if there is no site in my area?

No, but you can ask your physician about what lupus trials are being conducted in your area, which may be right for you to consider.

e. Can I talk to someone who has been or is in this trial?

Your physician may be able to coordinate having you speak with someone who has been in this trial or has participated in other clinical trials to address additional questions you may have.

f. Does the Lupus Research Alliance recommend this trial?

The Lupus Research Alliance, in partnership with Merck/EMD Serono is collaborating on a phase II clinical study to evaluate M2951, a novel inhibitor of Bruton’s Tyrosine Kinase (BTK) in Lupus, within the Lupus Research Alliance Lupus Clinical Investigators Network (LuCIN). Although BTK inhibitors are used as a therapy to treat individuals with blood cancer disorders, the mechanism of action of BTK suggests a use for the potential treatment of autoimmune diseases, including Lupus. Up to 20 LuCIN centers geographically disbursed throughout North America will be participating in the clinical study.

a. Has M2951 been tested before and is it safe?

M2951 has been tested and is approved by the FDA for several blood cancers and is considered safe.

b. How do I know if I am eligible for this trial?

c. How do I find out more about this trial and whether it’s offered in my area?

d. Can I participate if there is no site in my area?

No, but you can ask your physician about what lupus trials are being conducted in your area, which may be right for you to consider.

e. Can I talk to someone who has been or is in this trial?

Your physician may be able to coordinate having you speak with someone who has been in this trial or has participated in other clinical trials to address additional questions you may have.

f. Does the Lupus Research Alliance recommend this trial?

6. The Lupus Research Alliance’s affiliate, Lupus Therapeutics, is collaborating with the pharmaceutical company, Bristol-Myers Squibb (BMS), to test a novel investigational drug, BMS-986165, as a potential new therapy for lupus. The first of its kind to be tested in lupus, BMS-986165 is a potent and highly selective inhibitor of Tyrosine kinase 2 (Tyk2), which suppresses pathways that have been implicated in lupus. The Phase 2 global, multi-center study, sponsored by Bristol-Myers Squibb, will evaluate the efficacy and safety of BMS-986165 among 360 people with lupus worldwide.

a. Has BMS-986165 been tested before and is it safe?

BMS-986165 is an investigational compound. It is being developed to suppress pathways implicated in lupus.

b. How do I know if I am eligible for this trial?

c. How do I find out more about this trial and whether it’s offered in my area?

d. Can I participate if there is no site in my area?

No, but you can ask your physician about what lupus trials are being conducted in your area, which may be right for you to consider.

e. Can I talk to someone who has been or is in this trial?

Your physician may be able to coordinate having you speak with someone who has been in this trial or has participated in other clinical trials to address additional questions you may have.

f. Does the Lupus Research Alliance recommend this trial?

I’m interested in finding out about all the LuCIN studies. How do I learn more?

Click here to see if there is a site in your area that is a member of LuCIN. If you find a participating LuCIN study site in your area and already receive treatment at that center, make an appointment to meet with your physician so he/she can advise whether any of these or any other clinical studies may be right for you.

If you are not being treated at any of these sites, you can print out the list of trials and study sites and ask your own physician to advise if any of these trials or other clinical studies being conducted in your area might be right for you.

1. What if there are no LuCIN sites in my area?

Many lupus studies are being conducted at institutions throughout the country that may not be participating at this time in LuCIN. You can ask your physician what trials are being conducted in your area and which may be right for you to consider.

2. Why are some trials right for some patients and not others?

Depending on the goal of the specific study, many factors determine if a patient is eligible to participate; some common criteria can include whether you are an adult or a child, a female or male, the severity of your lupus, or if you’re in a flare. Talk to your physician about which studies may be appropriate for you to consider.

3. What if my rheumatologist is not aware of a particular trial that I want to consider?

It is always good to initiate a conversation with your doctor about the possibility of participating in clinical trials. To prepare for a conversation during your next doctor’s visit, visit LupusTrials.org to learn about what lupus trials are going on in your area. Print out the information to bring to your appointment and ask him and her to look into and see if any of the trials might be right for you.

You can also use the list of trials in your search to contact specific institutions directly to see which studies you might be eligible for that you can consider.

4. My lupus is pretty well controlled right now. What would be the benefit for me to participate in a trial?

Only you and your healthcare professionals can determine if participating in a clinical study would be beneficial to you given your medical situation. But not all clinical trials involve a new treatment. Some might test a new technology that monitors how you’re doing, while others may examine tissue and blood samples so doctors can learn more about the disease and how treatment is affecting your body. These types of studies can help researchers advance knowledge that can help people with lupus in the future as well as current patients.

5. Are pharmaceutical companies paying for these studies?

Many of the trials conducted through LuCIN are in collaboration with pharmaceutical companies while others are fully funded by the Lupus Research Alliance.

Clinical trials can be funded by pharmaceutical and biotechnology companies as well as a variety of organizations, medical institutions, or federal agencies, such as the National Institutes of Health NIH and the U.S. Department of Defense.

GENERAL CLINICAL TRIAL QUESTIONS

1. What is a clinical trial?

The U.S. Food and Drug Administration (FDA) defines a clinical trial as: voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.

2. What is the FDA?

“The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”

3. Why are clinical trials necessary?

Clinical trials provide the FDA with the scientific information needed to weigh the benefits and risks of a therapy and decide whether it would offer a valuable treatment option for patients. All drugs must be tested in human beings with the disease or condition the drug is intended to help before it can be approved by the FDA to be widely prescribed by doctors.

4. Why would I want to participate in a clinical study?

For some people, the benefits to enrolling in a clinical trial may be the chance to get state-of-the-are treatment and specialized medical attention—usually at no extra cost. Some trials even pay for time spent, travel costs, or other trial-related expenses.

For others, participation in a clinical trial may be a chance to try new medicines, learn more about the disease, and have the personal satisfaction of helping scientists find answers about lupus that can help generations to come.

5. Does the Lupus Research Alliance recommend participating in clinical trials?

The decision to participate in a clinical trial is one that can only be made through discussion with your healthcare professionals. The Lupus Research Alliance encourages people with lupus to learn about clinical trials and start the conversation with your physician. The desperately needed new treatments for lupus will only be possible if people volunteer to be part of clinical research. If a trial is right for you, you might not only help yourself but also help other people with lupus and future generations through what is learned in a clinical study.

6. How have other people felt about being in a lupus clinical trial?

Here are some words of wisdom from people who have shared with us their experience in a clinical trial:

I am taking part in a trial because my doctor and I felt it was the best treatment option for me. I know I am getting excellent treatment with people who really care about how I am doing. And it has made a major difference in how I feel physically. Emotionally, taking part in a trial is very empowering. I feel like I have a sense of responsibility to the lupus community to do everything I can to help everyone dealing with this disease. – Kaamilah

The most positive aspect of my clinical trials experience was the way I was treated by the principal investigator and her staff. They treated me like an intelligent human being and gave me hope for the future by explaining what was happening with new research in lupus, and how it might impact me. Participating in clinical trials made me feel like I was part of a much bigger picture and that I could contribute to society even though I am disabled. – Kathleen

I resolved that if I was to be cured of systemic lupus nephritis, partaking in a clinical trial offered me the chance to take matters into my own hands and attack this dangerous and debilitating autoimmune disease rather than continue to allow it to attack me. I would not hesitate to participate again, if I could, because the only way to find the cure to lupus is to participate in clinical drug trials. – Vera

7. Are there any medical benefits of participating in a clinical study?

Clinical trials offer another option when standard treatments have not worked or you can’t tolerate their side effects. You are monitored more often and have access to the most up-to-date medical technology and care.

8. Do I have to take an experimental drug to participate in a clinical study?

Not necessarily. A clinical trial is a research study with human volunteers designed to answer specific health questions. Some studies, called Interventional trials, aim to determine if a treatment is safe and effective. This type of study might look at a type of technology, a new, experimental therapy or a drug that’s already been shown to be safe in another disease. In others, you can help advance lupus research just by donating blood or tissue samples. Observational trials address health issues in large groups of people or populations in natural settings. Ask your physician about the many clinical studies you can consider.

9. Will I get the drug being studied?

Usually the trial compares the effects of the study drug plus standard of care used to treat lupus versus standard of care alone so researchers can assess the effectiveness of the investigational drug. Those who do not receive the experimental drug still receive the standard treatment so no one goes untreated.

Most clinical trials are “blinded”, meaning that volunteers are not told what treatment they are receiving until the study is over. Not knowing whether you are taking the study drug or not helps participants stay objective in reporting their experience so the drug can be best evaluated.

10. Is participating in a trial safe?

The FDA has carefully written rules about what must be followed to protect the safety and privacy of participants. According to federal regulation, every clinical trial must be approved and monitored by an Institutional Review Board (IRB). This independent committee of doctors, nurses, and others is charged with ensuring that the trial is ethical and that the rights of participants are properly protected.

11. Am I allowed to quit a trial after I start?

You are entitled to withdraw from a study at any point without jeopardizing your future medical care. However, since enormous resources are required to perform studies, a potential participant must put weigh carefully whether he or she can keep the commitment.

12. How will trial researchers protect my confidentiality?

Investigators will never use your name in any published documents nor can they give out information that would identify you to outside sources. Although the FDA and other agencies can access your medical records for inspection, your medical information cannot be used for any other purpose.

Smart Questions to Ask

Before meeting with your healthcare professional to talk about the possibility of participating in a clinical trial, you might print out these questions to help you decide:

What do I tell my family about my decision to participate in a clinical trial?

How long will I be in the study?

Will I be allowed to keep taking my other medicines?

How often will I have checkups, have to give blood or undergo other tests?

How will participation affect my ability to work, run a household, take care of my kids?

Will I need someone to drive me to doctors’ appointments and lab tests?

Will this affect my ability to have children some day?

Will I be allowed to keep seeing my regular rheumatologist and other doctors?

Will I get paid?

Will I get reimbursed for travel and/or childcare costs?

Will I find out the results of the trial I participated in?

Can I continue to take the experimental medicine after I complete the trial?

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