Current Clinical Trials
Genentech / NIH/ University of Pittsburgh
“Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM), RIM Study.” Enrollment has closed but study is continuing.
“Fracture Incidence Reduction and Safety of TSE – 424 (Bazedoxifene Acetate) Compared to Placebo and Raloxifene in Osteoporotic Postmenopausal Women.” Enrollment ended but study is ongoing.
Human Genome Sciences and PPD Development
“A Multi-Center, Open Label Continuation Trial of Lympho Stat B Antibody (Monoclonal Anti-BLyS Antibody) in Subjects with Systemic Lupus Erythematosus (SLE) who completes the Phase 2 Protocol LBSL02, Protocol LBSL99.” Enrollment ended but study is ongoing.
“DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo-controlled, multicenter study, Protocol TDE-DU-201.” A study for digital ulcers (ulcers on your finger tips) caused by a condition called systemic sclerosis. The purpose of this study is to determine if the drug treprostinil diethanolamine (UT-15C SR) is effective at healing digital ulcers.
Enrollment is beginning and inclusion criteria included: Adult patients with SSc as defined by ACR criteria; > one digital ulcer at baseline that occurred < 3 months and > 1 week prior to randomization and qualified as the cardinal ulcer.
Must not: have digital ulcers due to a condition other than SSc; have pulmonary arterial hypertension for which current approved or investigational therapies are being administered; if female, be pregnant or failing to practice acceptable birth control; have been treated recently with gemfibrozil (Lopid), glitazones (to treat type 2 diabetes), rifampin or botulinum toxin (Botox (in an affected finger) or systemic antibiotics to treat digital ulcers; have blood pressure < 85 mmHg, low hemoglobin concentration, high AST and/or ALT levels, moderate to severe hepatic impairment, intractable diarrhea, severe malabsorption, body weight < 40 kg, any severe organ failure, or any life-threatening condition.
TDE-DU-202 DISTOL-EXT: Digital Ischemic Lesions in Scleroderma Treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study. This is an extension study that follows the blinded study TDE-DU-201. Only those enrolled in TDE-DU-201 may participate.
“A Study of a Topical Formulation of Nitroglycerin, Vascana® (MQX-503), and Matching Vehicle in the Treatment and Prevention of Symptoms Associated with Raynaud’s Phenomenon, Protocol Number 09-001.”
The purpose of this clinical study is to determine, in a controlled fashion, the ability of a topical formulation of nitroglycerin, Vascana®(formerly MQX-503), to treat and prevent the symptoms experienced by patient’s with Raynaud’s: decrease the frequency of Raynaud’s events, decrease the duration of Raynaud’s events, and decrease the pain, tingling, and numbness in the fingers of Raynaud’s patients.
The study will include patients with moderate to severe primary and secondary Raynaud’s phenomenon. Some of the inclusion criteria includes: Outpatients, 18 years to 70 years. Patients with a clinical diagnosis of Raynaud’s phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers or by such an event observed by the study physician AND with a history of at least two Raynaud’s events during a typical winter day.
Patients who agree to apply the test creams to their fingers as specified in the protocol. Patients who agree to the controlled cold exposures as described in the protocol. Patients who are willing to discontinue current vasodilator therapies, starting with Visit 1. Patients who agree not to use any other investigational medications or approved therapies to treat Raynaud’s phenomenon and its symptoms while participating in this study. Such medications include but are not limited to: other dosages forms of nitroglycerin, isosorbide dinitrate(Isordil), fenoldopam mesylate (Corlopam), milrinone lactate (Primacor), nifedipine (Procardia), diltiazem (Cardizem), felodipine (Plendil), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Isoptin, Veramil). Negative pregnancy test in fertile women prior to the first study treatment and who agree to use effective contraception throughout the study. Patients who are able to give written informed consent and comply with all study requirements.
CORRONA (Consortium of Rheumatology Researchers of North America, Inc.)
This study is a data registry of patients with inflammatory arthritis. Only patients that are seen in the Rheumatology clinic by Dr. M.E. Csuka are currently enrolling and must have the diagnosis of rheumatoid arthritis or psoriatic arthritis.
The purpose of the registry is to understand the natural history of these conditions and to improve the understanding of treatment in clinical practice as opposed to pharmaceutical-sponsored clinical trials. All subjects complete paperwork at their regularly scheduled rheumatology appointments.
The registry, called the Consortium of Rheumatology Researchers of North America (CORRONA), collects data on 14,000 patients at 92 sites around the country, making it the largest registry in rheumatology that collects data from both rheumatologists and patients. Particular aspects of the rheumatology specialty, such as the need to treat patients with complex conditions and use a variety of treatment options, make a national database such as CORRONA particularly important.
If you would like more information about any of our ongoing clinical trials, please call Marit Johnson, RN at 414-955-7022.