Rheumatology Research

Gout, Dr. Brian Mandell
Randomized, multicenter, double-blind, placebo-controlled efficacy and safety study of 8 mg PEG-uricase in two dose regimens in hyperuricemic subjects with symptomatic gout

Osteoarthritis, Dr. Elaine Husni
A Long-Term Study of the Safety of Rituximab in Patients with Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy

Osteoarthritis/Rheumatoid Arthritis, Dr. Elaine Husni
PRECISION: A Randomized, Double Blind, Parallel-Group Study of Cardiovascular Safety In Osteoarthritis or Rheumatoid Arthritis Patients With or at High Risk for Cardiovascular Disease Comparing Celecoxib With Naproxen and Ibuprofen

Rheumatoid Arthritis, Dr. William Wilke
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Retreatment with Rituximab in Subjects with Rheumatoid Arthritis Receiving Background Methotrexate

Airon – National Data Bank for Rheumatic Disease , Dr. Leonard Calabrese

HIV, Rheumatic Manifestations, Dr. Leonard Calabrese
Rheumatic Disorders Before and After HAART

The National Osteoporosis Foundation recommends a bone density test in all women over the age of 65. Postmenopausal women to age 65 with risk factors may also require testing. In 1999 only one-third of women in our clinics over age 65 had received a DXA (dual energy x-ray absorptiometry). In 2003 over two-thirds of women had a DXA. This improvement resulted from an organized effort to educate physicians and practitioners in the Cleveland Clinic system as well as the placement of DXA centers in the Cleveland Clinic satellite offices. In 2003 more than 11,000 DXA's were performed. A project to develop a DXA database that will combine bone density results with relevant clinical data is underway and will enable clinical research and drug trials to proceed at a faster pace. In addition to osteoporosis, the Center sees patients with many metabolic bone diseases, including renal osteodystrophy, transplant bone disease, steroid osteoporosis, hyperparathyroidism, osteogenesis imperfecta and others.

Bone Deficiency: Bone Summit 2004

The Center, along with the Orthopaedic Research Center, organized and hosted an international conference attended by 187 participants from 12 countries and 17 states. The Summit brought together investigators, clinicians and industry professionals to meet around issues of osteoporosis, skeletal repair, cell-based therapies for bone growth and skeletal imaging.

Osteoporosis: Clinical Trials

Numerous clinical drugs are currently underway or completed at the Center for Osteoporosis and Metabolic Bone Disease. They include evaluation of the anabolic agent parathyroid hormone, rhPTH 1-84 and rhPTH 1-34, PTH in combination with raloxifene, and PTH as a treatment in patients with low bone mass who are on TPN. Use of novel dosing of an oral bisphosphonate, ibandronate, as well as evaluation of the intravenous bisphosphonate zolendronate in men and as an agent to prevent hip fractures are also ongoing.

Osteoporosis: Basic Research

The Center for Osteoporosis and Metabolic Bone Disease is a multidisciplinary clinic with the participation of rheumatologists. In addition, the Center has strong ties to the Department of Biomedical Engineering, Department of Orthopaedic Surgery and the Orthopaedic Research Center where molecular mechanisms of bone formation, skeletal repair and bone growth using cell based therapies are active areas of basic and clinical research.

Current Research

• Forteo Observational Study
• Open Label Proof of Concept Study of IV Zoledronic Acid (ZA) 5 mg after Forteo in Postmenopausal Women
• A Randomized, Double-Blind Study to Compare the Efficacy of Treatment with Denosumab versus Alendronate Sodium in Postmenopausal Women with low Bone Mineral Density
• Registry: Hip Fracture Initiative Database
• A Dose Range Finding Study of SB-751689 in Post-Menopausal Women with Osteoporosis

Osteoporosis, Dr. Chad Deal
Forteo Observational Study

Open Label Proof of Concept Study of IV Zoledronic Acid (ZA) 5 mg after Forteo in Postmenopausal Women

A Randomized, Double-Blind Study to Compare the Efficacy of Treatment with Denosumab versus Alendronate Sodium in Postmenopausal Women with low Bone Mineral Density

Registry: Hip Fracture Initiative Database

Mortality Outcomes in Pediatric Rheumatology, Dr. Philip Hashkes

Fibromyalgia, Dr. Philip Hashkes
Randomized Clinical Trial in Juvenile Fibromyalgia

Juvenile Idiopathic (Rheumatoid) Arthritis, Dr. Philip Hashkes
A Pilot Multi-center, Randomized, Double Blind, Placebo Controlled, Ascending Dose, Safety, Tolerability and Preliminary Efficacy Study of Two Dose Levels of IL-1 Trap Administered Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA)

Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT)

Dermatomyositis, Dr. Philip Hashkes
Phase III Clinical Trials in New Onset Juvenile Dermatomyositis: Steroids treatment versus Steroids plus Cyclosporine Treatment versus Steroids plus Methotrexate Treatment

Vasculitis, Dr. Philip Hashkes
ARCHIVE (A Registry of Children with Vasculitis: e-entry)

Scleroderma, Dr. Soumya Chatterjee
Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative

Vasculitis Outcome Measures, Dr. Gary Hoffman

Giant Cell Arteritis, Dr. Rula Hajj-Ali
Gene Expression Profile of Temporal Arteries of Giant Cell Arteritis

PACNS, Dr. Leonard Calabrese
Development of a Web Based Data Management System for the Study of Primary Angiitis of the Central Nervous System (PACNS)

Wegener's Granulomatosis, Dr. Gary Hoffman
Short-term Cyclophosphamide Therapy in a Cohort of Over 200 Patients

Wegener's Granulomatosis Etanercept Trial (WGET) Longitudinal Study

A Multi-Center, Open-label, Pilot Study of Abatacept (CTLA4-Ig) in the Treatment of Mild Relapsing Wegener's Granulomatosis (WG) , Dr. Carol Langford

Wegener's Granulomatosis and Microscopic Polyangiitis, Dr. Gary Hoffman, Dr. Carol Langford
Principal Investigators:
Dr. Ulrich Specks, The Mayo Clinic Dr. John Stone, Johns Hopkins University
Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis

Ancillary Studies in Vasculitis
Search for Infectious Causes in Wegener's
National Institutes of Health
(PI: Dr. Herbert Virgin, Washington University)

The establishment of case registries for patients with:

1. Primary angiitis of the central nervous system
2. Wegener’s granulomatosis
3. Giant cell arteritis
4. Takayasu's
5. Scleroderma
6. Bone Densities
7. Fractures

Concurrent Pilot Studies in Giant cell arteritis (GCA) and Takayasu’s arteritis (TAK) to Examine the Safety, Efficacy, and Immunologic Effects of Abatacept (CTLA4-Ig) in Large Vessel Vasculitis
Center for Vasculitis Care and Research
(Pl: Dr. Carol Langford)

Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis
National Institutes of Health / Immune Tolerance Network
(PIs: Dr. John Stone, JHU, Dr. Ulrich Specks, Mayo Clinic)
Center for Vasculitis Care and Research
(Pls: Dr. Carol Langford, Dr. Gary Hoffman)

Longitudinal Studies in Takayasu’s, Giant Cell Arteritis, Churg Straus Syndrome, Polyarteritis Nodosa and Wegener’s Granulomatosis / Microscopic Polyangiitis
Vasculitis Clinical Research Consortium
(PI: Dr. Peter Merkel)
Center for Vasculitis Care and Research
(Pl: Dr. Carol Langford)

Rare Diseases Clinical Research Network A Multi-Center, Open-label, Pilot Study of Abatacept (CTLA4-Ig) in the Treatment of Mild Relapsing Wegener's Granulomatosis (WG)
Center for Vasculitis Care and Research
(Pl: Dr. Carol Langford)
Vasculitis Clinical Research Consortium
(PI: Dr. Peter Merkel)

VCRC, Vasculitis Clinic Research Consortium

Gene Expression Profile of Temporal Arteries of Giant Cell Arteritis
(Pl: Dr. Rula Hajj-Ali)

Short-term Cyclophosphamide Therapy in a Cohort of Over 200 Patients.
Wegener's Granulomatosis Association
The Richard J. Fasenmyer Center for Clinical Immunology

Wegener’s Granulomatosis Etanercept Trial Ancillary Studies

Longitudinal Study
Search for Infectious Causes of Wegener's
National Institutes of Health
(PI: Dr. Herbert Virgin, Washington University)
Center for Vasculitis Care and Research
(Pls: Dr. Gary Hoffman)

Genetic Polymorphisms in Wegener’s Granulomatosis
(Wegener ’s Granulomatosis Genetic Repository – WGGER)
National Institutes of Health
(PIs: Dr. Jeffery Edberg, and Dr. Robert Kimberly, University of Alabama at Birmingham)
Center for Vasculitis Care and Research
(Pls: Dr. Gary Hoffman)

The establishment of case registries for patients with:

1. Primary angiitis of the central nervous system
2. Wegener’s granulomatosis
3. Giant cell arteritis

Summer Research Scholarships in Vasculitis.

1. The Esch Family Research Scholarship for Vasculitis
2. The American College of Rheumatology

Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG)

• BVAS/WG Instructions Manual
• BVAS/WG Glossary of Terms
• 20 Paper Cases Used in the Simulation Exercises

• BVAS for Wegener’s Granulomatosis Evaluation Form

Peking Union Medical College Hospital - Cleveland Clinic Education Consortium

Cleveland Clinic's R.J. Fasenmyer Center for Clinical Immunology had more than 200,000 visits to its CME website and issued more than 22,000 CME certificates in 2011, making it the largest provider of online rheumatology CME in the world. The experience and expertise of the center is now being used to develop rheumatology CME in China.

• Cleveland Clinic staff visited Peking Union Medical College Hospital (PUMCH) in Peking, China, in August 2011. Cleveland Clinic delegates were Len Calabrese, MD; Elaine Husni, MD, MPH; and Qingping Yao, MD, PhD.
• PUMCH is an 1,800-bed hospital with a major leadership role in patient care and medical education in China. PUMCH delegates were Feng-chun Zhang, MD, Chief of the Department of Rheumatology and Clinical Immunology, and President of the Chinese Rheumatology Association; Weng Zhang, MD; and Yong Hou, MD.
• A bilingual website for postgraduate medical education will be implemented.
• The Cleveland Clinic/PUMCH collaboration will offer audio and scientific graphic content in both Mandarin and English.
• Cleveland Clinic's CME series "Rheumatology Highlights Report" will be expanded to encompass content of specific interest to Asian audiences.
• Novel forms of education are needed among the rapidly expanding Chinese rheumatology community (2,200 rheumatologists, with a targeted expansion to 6,000 by 2015, and to 10,000 by 2020.)

Integrated Visual Health Record

The integrated visual health record (iVHR) was developed with the goal of overcoming some of the limitations of the standard electronic medical record. This integrated system:

• Combines patient- and physician-collected data with Epic functionality
• Captures standardized electronic patient data via a touch-screen questionnaire
• Offers automated scoring of patient-validated functional outcomes and quality-of-life measures
• Allows for a visual display of trends of standard clinical measures (obtained from patients and from discrete fields in clinic notes)
• Organizes patient data in a format that allows easy and rapid assessment of the patient's status and disease course