Kick in to Stop Sarcoidosis
 

 
 
 

Clinical studies (sometimes called trials or protocols) are medical research studies in which people participate as volunteers and are one way of developing new treatments and medications for diseases like sarcoidosis.  Clinical studies can also provide researchers information that may be an important first step toward developing a treatment.  For example, research may show how the disease progresses or how it affects other systems in the body.  Before deciding to participate in a study, you should carefully weigh any risks against possible benefits.  Find a Trial.

Potential Benefits:

  • Free medical care & laboratory studies.
  • Receive treatments before they are offered to others.
  • You may or may not receive direct benefit for yourself and your condition as a result of participating in research, however, you will know that the knowledge learned by researchers may help others. 

Know the Risks:

  • Some risks are involved in clinical research, just as in routine medical care and activities of daily living.  These may include unpleasant, serious or even life-threatening side effects to experimental treatment or the experimental treatment may not be effective.
  • Risks associated with any research study should be described in detail in a written consent document and by a member of the research team.
  • Carefully weigh these risks against possible benefits.

Before Participating in a Study:
You should know as much as possible about the study and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial and the cost of the trial.

  • The purpose of the study.
  • Who is conducting the study.
  • How long the study will last and how participation might affect your daily life.
  • The kinds of tests and experimental treatments involved.
  • How the possible risks, side effects and benefits compare with your current treatment.
  • Who will pay for the experimental treatment and other related expenses.
  • What type of long-term follow up care is part of this study.

Understanding Clinical Trial Keywords:

  • placebo:  an inactive pill, liquid or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the effectiveness.
  • double-blind study:  a clinical trial design in which neither the participants nor the study staff knows who receives the experimental drug or the placebo, to produce objective results.
  • randomized trial:  participants are randomly (by chance) assigned to one of two or more treatment arms of a clinical trial, some may receive a placebo.
  • controlled trial:  a control is a standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimental drug, while another group (the control group) is given either a standard treatment or a placebo.
  • observational study:  participants are observed or certain outcomes are measured but no treatment is given.

FIND A TRIAL

The National Institutes of Health has developed an on-line searchable database that contains current information on clinical research studies. Research studies typically provide free care to those who participate.   A summary of these trials is listed below.  CLICK HERE or visit www.clinicaltrials.gov and search 'sarcoidosis' to find additional information on current clinical trials.

Studies at the National Institutes of Health (NIH) in Bethesda, Maryland are free of charge to those who are eligible to participate and willing to receive treatment at the center.  In some cases, travel expenses are reimbursed.

US Locations

Click for International
 

Trial Descriptions as of Summer 2010
 
United States
54 Sites		 A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study Evaluating the Safety and Efficacy of Treatment With Ustekinumab or Golimumab in Subjects With Chronic Sarcoidosis.  See site locations.
 
University of Chicago,
Chicago, IL		 A Study of the Natural Progression of Interstitial Lung Disease (ILD)
The purpose of this observational study is to obtain information on all patients being cared for by the ILD program in an effort to better understand the natural course of these diseases. (Contact: Spring Maleckar 773-834-5864).
 
Northwestern University,
Chicago, IL		 Hematopoietic Stem Cell Support in Patients With Refractory Sarcoidosis
This non-randomized, open label study is designed to examine whether treating patients with high dose cyclophosphamide and ATG, followed by return of the previously collected blood stem cells will stop the progression of sarcoidosis.  (Contact: Dzemila Spahovic, MD, 312-908-0059)
 
Ohio State University
Columbus, OH
 		 Stromal Gene Expression During Pulmonary Sarcoidosis
This observational study will identify gene expression patterns that specifically correlate with active pulmonary sarcoidosis.  (Contact: Janice E Drake, CRTT 800-678-6495.)
 
Ohio State University
Columbus, OH		 Study of Nicotine Patches in Patients With Sarcoidosis
The goal of this randomized interventional study is to see if the nicotine patch is an anti-inflammatory treatment for sarcoidosis.  (Contact: Janice E. Drake, CRT 614-366-2287.)
 
Ohio State University
Columbus, OH		 Immunological Characterization of Bronchoalveolar Cells in Normals
Investigators hope to obtain monocytes (white blood cells) from normal volunteers for the purpose of studying how proteins, fats, carbohydrates, as well as RNA and DNA for gene expression, relate to immunity. This information will be compared to other studies in patients with lung diseases like sarcoidosis. (Contact: Pulmonary Clinical Trials Office 800-678-6495.)
 
University of Cincinnati,
Cincinnati, OH		 Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension (BOSAPAH)
 The purpose of this Double Blind, Randomized Trial is to determine if bosentan (Tracleer) will help sarcoidosis associated pulmonary hypertension.  (Contact: Robert P Baughman, MD 513-584-5225.)
 
University of Cincinnati,
Cincinnati, OH		 Rituximab as a Novel Therapy in Refractory Sarcoidosis
This interventional study will evaluate the efficacy of rituximab in improving the symptoms and functional capacity in patients with chronic sarcoidosis with pulmonary involvement who are symptomatic despite current treatment. (Contact:  Robert P Baughman, MD 513-584-5225)
 
NHLBI
Bethesda, MD
 		 Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
This observational study will examine bacteria and toxins in the mouth, lung and digestive system that may be the cause of various diseases or symptoms.
(Contact: NIH Patient Recruitment and Public Liaison Office, 800-411-1222.)
 
NHLBI
Bethesda, MD		 Role of Genetic Factors in the Development of Lung Disease
This observational study is designed to evaluate the genetics involved in the development of lung disease by surveying genes involved in the process of breathing and examining the genes in lung cells of patients with lung disease. 
(Contact: NIH Patient Recruitment and Public Liaison Office, 800-411-1222.)
 

NHLBI
Bethesda, MD

Atorvastatin to Treat Pulmonary Sarcoidosis
This is a double-blind, placebo-controlled, randomized trial which aims to determine if atorvastatin administration results in less steroid use and longer steroid-free intervals in patients with pulmonary sarcoidosis who require prednisone treatment. (Contact: NIH Patient Recruitment and Public Liaison Office, 800-411-1222.)
 
MUSC, Northwestern, UNC
Charleston, SC
Chicago, IL
Chapel Hill, NC
 		 Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
This open label trial will assess whether Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis.  (Contact: Marc A Judson, MD 843-697-7272.)
 
Wake Forest University,
Winston-Salem, NC		 Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis
 This is a Phase II, Multi-Center, Open Label Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis.  (Contact: Susie Dowd 336-716-3775.)
 
Oregon Health and Science University,
Portland, OR		 Uveitis Gene-Expression Profiling
In this observational study, investigators propose to create a data base on peripheral blood gene expression for patients with 3 of the most important diseases associated with uveitis: ankylosing spondylitis, sarcoidosis, and Behcet's disease. (Contact: James Rosenbaum, MD.)
 
Vanderbilt University,
Nashville, TN		 Trial of Antimycobacterial Therapy in Sarcoidosis (CLEAR)
The purpose of this randomized, placebo controlled study is to assess if administration of anti-mycobacterial drug therapy will aid in resolution of cutaneous sarcoidosis lesions. (Contact: Wonder P Drake, MD 615-322-2035)
 
Virginia Clinical Research, Inc.,
Norfolk, VA		 A Study of Adalimumab to Treat Sarcoidosis of the Skin
 The purpose of this double-blind, randomized, placebo-controlled study is to determine if adalimumab is an effective for the skin manifestations of sarcoidosis.  (Contact: Robert J Pariser, MD, 757-622-6315.)
 
International Sites  
Medical University of Vienna,
Austria		 Safety and Efficacy Study of Bosentan in Progressive Pulmonary Sarcoidosis (BOPSAC)
Preliminary data have shown the therapeutic potential of the endothelin receptor antagonist (ERA) bosentan in sarcoidosis associated pulmonary hypertension.  This prospective randomized, double blind, placebo-controlled, safety and efficacy study will assess bosentan as add-on therapy in progressive pulmonary sarcoidosis.  (Contact: Michael Wolzt, MD +43 1 40400 ext 2981.)
 
Leiden University,
Belgium, Denmark, Germany, Netherlands, Poland, UK		 Trial for the Diagnosis of Sarcoidosis (GRANULOMA)
This randomized study investigates two different diagnostic strategies for patients with suspected pulmonary sarcoidosis stage I/II. (Contact: J T Annema, M.D. PhD 0715262950 ext 0031)
 
Kurume Hospital,
Japan		 Sarcoidosis With Cardiac Involvement and FDG-PET
This observational study will assess the usefulness of fasting FDG-PET for diagnosis and management of cardiac sarcoidosis. (Contact: Nobuhiro Tahara, MD, PhD +81-942-31-7580)
Assistance Publique - Hôpitaux de Paris,
France		 Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis (UVEXATE)
The purpose of this randomized, placebo-controlled study is to determine whether methotrexate is a effective corticosteroid sparing agent in the treatment of sarcoid-associated uveitis.  (Contact: Sébastien ABAD, MD 01-48-95-53-52.)
 
The Netherlands
Maastricht University		 Role of Proteomics in Diagnosing Sarcoidosis
This observational study has been designed to evaluate the use of a new technique, called SELDI-TOF mass spectrophotometry, for the diagnosis of sarcoidosis. This technique enables the analysis of all enzymes present in the blood of sarcoidosis patients which may hopefully lead to creating a disease-specific protein-profile that may facilitate the recognition of sarcoidosis.  Contact: Marjolein Drent, 0031-43-3874347.)
 
University College London Hospital,
United Kingdom		 A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY)
Endobronchial ultrasound (EBUS) is a new procedure that may be able to diagnose these glands without the need for mediastinoscopy. The REMEDY trial aims to examine whether EBUS can reduce the number of mediastinoscopies and healthcare costs in patients with enlarged glands in the chest. (Contact: Neal Navani, MD +447951602494)
 

Web Sites:
In addition to the trials listed above, CLICK HERE or visit www.clinicaltrials.govand search 'sarcoidosis' to find additional information on current clinical trials.  If you conduct a ‘Focused Search’, you can learn about those studies on sarcoidosis within your geographical area.

Sarcoidosis clinical trials at the clinical center of the National Institutes of Health (NIH) in Bethesda, Maryland are free of charge to those who are eligible to participate and willing to receive treatment at the center.  For more information on these studies, see the NIH clinical center Web site at: www.cc.nih.gov.

The National Heart, Lung, and Blood Institute (NHLBI) also maintains a database of current trials. Visit their Patient Recruitment Site for more information.