Giant Cell Arteritis Clinical Trial
Official title:
VCRC Validation of Patient-Reported Diagnostic Data
NCT number | NCT02190942 |
Other study ID # | 5535 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | June 18, 2019 |
Verified date | October 2019 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The purpose of this study is to provide validation of patient-reported data in the VCRC Patient Contact Registry by comparing patient-reported data with data provided by the physician who is the primary provider caring for the patient's vasculitis. Patients enrolled in the Patient Contact Registry with Behcet's disease, eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA), giant cell arteritis (GCA), granulomatosis with polyangiitis (Wegener's) (GPA), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN), and Takayasu's arteritis (TAK) were invited via email to participate in this study.
Status | Completed |
Enrollment | 198 |
Est. completion date | June 18, 2019 |
Est. primary completion date | December 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - At least 20 patients with each of the following self-identified diagnoses in the VCRC Patient Contact Registry: Behçet's disease, EGPA, GCA, GPA, MPA, PAN, and TAK who have completed the online questionnaires. Exclusion Criteria: - Inability to provide informed consent and complete survey - Patients whose diagnosis of vasculitis was not confirmed by a physician - Patients who did not complete the initial questionnaire in its entirety |
Country | Name | City | State |
---|---|---|---|
United States | University of South Florida Data Management Coordinating Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | Boston University, University of Pennsylvania, University of Pittsburgh, Wayne State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Validation of the currently utilized VCRC Patient Contact Registry Questionnaire | The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures. | Up to 24 months from the date of the last patient assessment | |
Secondary | Evaluate diagnostic accuracy of specific questions | The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures. | Up to 24 months form the last patient assessment received |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03812302 -
Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)
|
Phase 2 | |
Recruiting |
NCT02257866 -
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
|
||
Recruiting |
NCT04888221 -
Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement
|
Phase 3 | |
Recruiting |
NCT05380453 -
Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission
|
Phase 3 | |
Recruiting |
NCT02333708 -
Study of Circulating Microparticles in Giant Cell Arteritis
|
||
Completed |
NCT01450137 -
Tocilizumab for Patients With Giant Cell Arteritis
|
Phase 2 | |
Completed |
NCT03827018 -
KPL-301 for Subjects With Giant Cell Arteritis
|
Phase 2 | |
Active, not recruiting |
NCT04519580 -
Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
|
||
Recruiting |
NCT04239196 -
Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA
|
Phase 2 | |
Recruiting |
NCT06460142 -
Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
|
||
Completed |
NCT03202368 -
An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)
|
Phase 3 | |
Not yet recruiting |
NCT02523625 -
Giant Cell Arteritis: Improving Use of Ultrasound Evaluation
|
N/A | |
Completed |
NCT03285945 -
FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment
|
N/A | |
Completed |
NCT02190916 -
Vasculitis Illness Perception (VIP) Study
|
N/A | |
Recruiting |
NCT01241305 -
One-Time DNA Study for Vasculitis
|
||
Terminated |
NCT02531633 -
Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
|
Phase 3 | |
Completed |
NCT03765424 -
Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis
|
||
Completed |
NCT03409913 -
Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA
|
N/A | |
Completed |
NCT01910038 -
Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.
|
Phase 2 | |
Not yet recruiting |
NCT04012905 -
Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering
|
Phase 3 |