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
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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.)
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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.)
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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.)
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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.)
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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)
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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.)
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|
International Sites |
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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.)
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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)
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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. |