The ANCA Vasculitis Questionnaire (AAV-PRO©)

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

The ANCA Vasculitis Questionnaire (AAV-PRO©)

Official Title

The ANCA Vasculitis Questionnaire (AAV-PRO©)

Brief Summary

      The aim of this project is to develop a disease specific patient reported outcome measure
      (PROM) for patients with AAV (the AAV-PRO). Investigators are developing and validating a
      questionnaire to assess quality of life in patients with ANCA-associated vasculitis (AAV).
      Patients with AAV have inflammation in the small blood vessels leading to involvement of a
      range of organs and can suffer from ongoing disease activity or treatment side effects.
      Quality of life can be measured by patient reported outcome measures (PROMs).

Detailed Description

      Patients with ANCA-associated vasculitis have inflammation in the small vessels that impact a
      range of organs and Investigators understand that patients may suffer ongoing disease
      activity, as well as side effects from the treatments. Assessing patients quality of life can
      be an important tool for conducting clinical trials for new treatments and medications.

      Quality of life can be measured by questionnaires called "patient reported outcome measures"
      (PROM). What is a patient-reported outcome? Patient-reported outcomes, or PROs, are patients'
      feedback on what they are feeling or what they are able to do as participants are dealing
      with a chronic disease . Patient-reported outcomes are important because they provide doctors
      and researchers information about patients' quality of life. Questionnaires can be designed
      to measure specific PROs that are of specific importance to a disease and can provide much
      needed information on evaluating the effectiveness of health care. The aim of this survey is
      to develop a disease specific patient reported outcome measure, or PROM, for patients with
      AAV.

      A small group of Investigators and Patient-Partners developed this survey for people with
      ANCA-associated vasculitis (the AAV-PRO). Investigators will invite patients with AAV to
      complete the questionnaire they have designed, called the AAV-PRO. By analysing how people
      fill in the questionnaire, Investigators will be able to find out how well the questions
      work, and whether they need to ask all of them.

Study Type

Observational [Patient Registry]

Primary Outcome

Completion of AAV-PRO questionnaire.

Condition

Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA)

Intervention

Online questionnaire

Study Arms / Comparison Groups

 Intervention
Description:  The online questionnaire includes questions about how ANCA-associated vasculitis effects patients quality of life.

Publications

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

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

280

Start Date

July 2015

Completion Date

December 2016

Primary Completion Date

December 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Registered in the Vasculitis Patient-Powered Research Network (V-PPRN)

          -  Patients greater than 18 years of age

          -  Diagnosis of ANCA-associated vasculitis including: Eosinophilic Granulomatosis with
             Polyangiitis (also called Churg-Strauss Syndrome), Granulomatosis with Polyangiitis
             (also called Wegener's granulomatosis or GPA), Microscopic Polyangiitis (MPA)

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Joanna Robson, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02507024

Organization ID

VCRC 5537

Responsible Party

Sponsor

Study Sponsor

University of Pennsylvania

Collaborators

 University of Oxford

Study Sponsor

Joanna Robson, MD, Principal Investigator, University of Oxford

Verification Date

May 2017