Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

checkorphan
Learn more about:
Wegener’s Granulomatosis
Related Clinical Trial
Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis Hydroxychloroquine in ANCA Vasculitis Evaluation Vasculitis Illness Perception (VIP) Study Reproductive Health in Men and Women With Vasculitis Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis Impact of Vasculitis on Employment and Income Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases VCRC Tissue Repository Yellow Fever Vaccine in Patients With Rheumatic Diseases Journey of Patients With Vasculitis From First Symptom to Diagnosis One-Time DNA Study for Vasculitis Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. Clinical Transcriptomics in Systemic Vasculitis (CUTIS) The ANCA Vasculitis Questionnaire (AAV-PRO©) Vasculitis Pregnancy Registry VCRC Patient Contact Registry Patient-Reported Data Validation Study Educational Needs of Patients With Systemic Vasculitis Diagnostic Effectiveness of Virtual Bronchoscopy Alemtuzumab for ANCA Associated Refractory Vasculitis Interventional Cryotherapy for the Eradication of Benign Airway Disease (“ICE the BAD”) PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides Plasma Exchange for Renal Vasculitis PRO Development for ANCA Associated Vasculitis BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides Pulse Versus Continuous Cyclophosphamide for Induction of Remission in ANCA-Associated Vasculitides Rituximab Vasculitis Maintenance Study Anti-Cytokine Therapy for Vasculitis Rituximab and Belimumab Combination Therapy in PR3 COMBIVAS American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis Low-dose Glucocorticoid Vasculitis Induction Study Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis. The Assessment of Prednisone In Remission Trial (TAPIR) – Patient Centric Approach Steroids and Methotrexate to Treat Systemic Vasculitis Efficacy Study of Two Treatments in the Remission of Vasculitis Assessment of Lung Inflammation in Patients With Atopic Asthma Using Positron Emission Tomography The Assessment of Prednisone In Remission Trial – Centers of Excellence Approach Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener’s) Rituximab for the Treatment of Wegener’s Granulomatosis and Microscopic Polyangiitis Cyclophosphamide and Prednisone Followed by Methotrexate To Treat Vasculitides Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener’s) or Microscopic Polyangiitis Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener’s) and Microscopic Polyangiitis Mycophenolate Mofetil for Treatment of Relapses of Wegener’s Disease or Microscopic Polyangiitis (MPA) Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) Daclizumab to Treat Wegener’s Granulomatosis An Open Label Pilot Study Examining the Use of Rituximab in Patients With Wegener’s Granulomatosis Who Have Experienced Disease Relapse on Standard Therapies Etanercept to Treat Wegener’s Granulomatosis Treatment of Wegener’s Granulomatosis With Cyclophosphamide Mycophenolate Mofetil to Treat Wegener’s Granulomatosis and Related Vascular Inflammatory Conditions Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener’s Granulomatosis Comparison of Treatments to Maintain Disease Remission in Patients With Wegener’s Granulomatosis and Related Vasculitis Syndromes Neutrophils as Prognostic Factors in Granulomatosis With Polyangiitis (Formerly Named Wegener’s Granulomatosis) Natural History of Granulomatosis With Polyangiitis: Clinical and Genetic Biomarkers of Airway Disease NoAAC PR-03 Study Analysis of Bronchial Tissue and Fluid in Patients With Wegener’s Granulomatosis TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener’s) or Microscopic Polyangiitis Study of One Protein Implicated in Wegener Disease Abatacept in Treating Adults With Mild Relapsing Wegener’s Granulomatosis Phase II Study on Gusperimus in Patients With Refractory Wegener’s Granulomatosis Etanercept for Wegener’s Granulomatosis Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener’s Granulomatosis

Brief Title

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Official Title

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Brief Summary

      Multi-center observational study to evaluate the histopathology and transcriptome of
      cutaneous lesions in patients with several different types of vasculitis.

Detailed Description

      This study employs a multi-center approach to evaluate cutaneous vasculitis across several
      forms of idiopathic vasculitis. Patients with cutaneous manifestations of vasculitis will be
      evaluated by teams of primary vasculitis care providers and Dermatologists in order to
      facilitate optimal selection of patients and sampling of lesions.

      A punch skin biopsy at a site of active vasculitis will be the source of material for
      histopathologic and transcriptomic evaluation. The histopathology of cutaneous vasculitis
      will be characterized using a standardized approach.

Study Type

Observational

Primary Outcome

Evaluation of clinical data and linked biopsy specimens

Condition

Cryoglobulinemic Vasculitis (CV)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

50

Start Date

January 2017

Completion Date

August 2021

Primary Completion Date

August 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Have a cutaneous lesion (purpuric macules, palpable purpura, retiform purpura,
             nodules, ulcers, or urticarial) believed to be related to active vasculitis

          -  Have a suspected or confirmed diagnosis of:

               -  Cryoglobulinemic vasculitis (CV)

               -  Drug-induced vasculitis

               -  Eosinophilic granulomatosis with polyangiitis (EGPA)

               -  IgA vasculitis

               -  Isolated cutaneous vasculitis

               -  Granulomatosis with polyangiitis (GPA)

               -  Microscopic polyangiitis (MPA)

               -  Polyarteritis nodosa (PAN)

               -  Urticarial vasculitis

          -  Be willing and able to provide written informed consent (or assent for those under

        Exclusion Criteria:

          -  You are less than five years old

          -  Considered not to be a candidate for a biopsy or have a higher risk of developing an
             infection, bleeding, etc., from the biopsy, or a doctor believes that the risks for
             you participating in this study do not outweigh the potential benefit of learning
             information from your biopsy

          -  You have a neutrophil count (type of white blood cell) less than 1500/mm3, platelet
             count less than 50,000/mm3, or a hemoglobin less than 7 g/dL

          -  You have an uncontrolled disease that could prevent you from completing the study
             procedures

          -  You have an active infection at or near the potential biopsy site, have poor
             circulation, or have bony prominence or other structure that would increase your risk
             of complications if you participated in this study

          -  You are pregnant or nursing

          -  You are not able to provide informed consent

Gender

All

Ages

5 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Robert Micheletti, MD, , [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT03004326

Organization ID

VCRC5563

Secondary IDs

U54AR057319

Responsible Party

Sponsor-Investigator

Study Sponsor

Peter Merkel

Collaborators

 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study Sponsor

Robert Micheletti, MD, Principal Investigator, University of Pennsylvania

Verification Date

May 2021