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.

Location

Trial Descriptions as of December 2007
 

Bethesda, MD
NHLBI

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.)
 
Bethesda, MD
National Eye Institute (NEI)		 Eye and Immunogenetic Features of Sarcoidosis
This observational study will examine the clinical, immunological and genetic features of ocular sarcoidosis.  (Contact: NIH Patient Recruitment and Public Liaison Office, 800-411-1222.)
 

Chicago, IL
University of Chicago
 

Trial of Adalimumab in Progressive Sarcoidosis
The purpose of this non-randomized study is to evaluate the safety and effectiveness of adalimumab in the treatment of patients with sarcoidosis with pulmonary (lung) involvement who show symptoms of the disease even though they are currently being treated with medication.   (Contact: Amy Hires, 773-702-2645.)
 

Vlaams-Brabant, Belgium
University Hospital Leuven

EXercise TRAining in Sarcoidosis (EXTRAS Study)
This study is a prospective, randomized, controlled, 24-week crossover clinical trial in which the participants are randomly assigned to receive 12 weeks of dynamic resistance and whole-body endurance exercises followed by 12 weeks without intervention or vice versa. Consenting participants will be assessed at baseline (before randomization, week 0) and at weeks 12 and 24.  (Contact: Martijn A. Spruit, PhD, +32 16 34 71 08.)
 
Cincinnati, Ohio,
University of Cincinnati		 Use of Armodafinil for Fatigue in Sarcoidosis
This randomized, double blind study is designed to determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.  Patients will have complete detailed questionnaires regarding their fatigue, sleepiness, and overall quality of life. They will have sleep studies done at the start and after each half of the study to determine the effect of therapy on sleepiness(Contact: Carrie Thacker - 513-584-6252 or Stacy Harman, 513-584-2196.)
 
Copenhagen, Denmark
Statens Serum Institut
Bispebjerg Hospital
 		 Rickettsial Genesis to Sarcoidosis in Denmark
The purpose of this study is to find serological and molecular evidence of an infection with Rickettsia species in Danish patients with sarcoidosis.  (Contact:  Claus B Svendsen, MD +45 (32) 68 38 98.)
 
Chicago, IL
University of Chicago		 A Prospective Open-Label Trial of Rituximab in Progressive Sarcoidosis
This is an open label study of Rituximab in patients with progressive sarcoidosis to assess the safety and tolerability of Rituximab in this patient population. The length of the study will be 52 weeks. (Contact: Misel Ramirez, 773-702-2645.)
 
The Netherlands
Maastricht University
University of Tilburg		 The Influence of Personality on Pulmonary Fibrosis and Sarcoidosis
The aim of this study is to examine the role of personality factors as predictors of fatigue, quality of life, prognosis and health care consumption in sarcoidosis and pulmonary fibrosis.  A number of possible moderators, such as social support, will also be examined aiming to get a full picture of the relationship between the various factors. (Contact: Marjolein Drent, MD, PhD, 0031-433877047 )
 
Norfolk, VA
Virginia Clinical Research, Inc.		 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.)
 
Cincinnati, Ohio
University of Cincinnati		 Inhaled Iloprost for Sarcoidosis Associated Pulmonary Hypertension.
 This open label trial, with patients receiving 16 weeks of therapy, will study the effectiveness of inhaled iloprost for sarcoidosis associated pulmonary hypertension (SAPAH).  (Contact:  Robert P Baughman, MD, 513-584-5225.)
 
Chicago, IL
University of Chicago		 A Study of the Natural Progression of Interstitial Lung Disease (ILD)
The purpose of this 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)
 

Chicago, IL
Northwestern University

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)
 

Newark, NJ
University of Medicine and Dentistry of New Jersey

Pathogen Specific Immunity in Patients With Sarcoidosis
The purpose of this observational study is to assess the lung cells of healthy volunteers and patients with stage II and III pulmonary sarcoidosis for pathogen specific memory immunity and gene expression patterns.  (Contact: Matthew Marin, MD, 973-972-6111.)
 

Bethesda, MD
National Institute of Dental And Craniofacial Research (NIDCR)

Salivary Proteins in Disease and Health
This observational study will examine saliva samples from healthy volunteers and patients with various diseases to learn more about how disease affects the mouth and salivary glands. (Contact: NIH Patient Recruitment and Public Liaison Office, 800-411-1222.)
 

Bethesda, MD
NHLBI

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.)
 

Bethesda, MD
NHLBI

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.)
 

Bethesda, MD
National Eye Institute (NEI)

Evaluation & Treatment of Patients with Inflammatory Eye Diseases
The purpose of this observational study is to allow NEI physicians to increase their knowledge of inflammatory eye conditions, identify new avenues of possible research in this area and establish a pool of patients who may be eligible for new studies as they are developed. 
(Contact: NIH Patient Recruitment and Public Liaison Office, 800-411-1222.)
 

Multiple Sites
The Netherlands

Database of Interstitial Lung Diseases
This observational study will develop a database with relevant clinical data and DNA/serum samples from patients patients with interstitial lung diseases to facilitate future research on the cause of these diseases.  (Contact: J.M.M. van den Bosch, MD, +31306092424.)
 

Web Sites:
In addition to the trials listed above, CLICK HERE or visit www.clinicaltrials.gov and 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.