Study of One Protein Implicated in Wegener Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators recently showed an abnormal expansion of NK-like CD4+ T cells in Wegener's granulomatosis (WG), mainly in the diffuse vasculitis presentation. These cells expressed an assortment of activating NK cell receptors and their signaling partners, in particular DAP12. The investigators hypothesize that DAP12, or a downstream signaling target of DAP12, is the missing link between the different cell components involved in WG (neutrophils, macrophages, CD4 T cells).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neutrophils as Prognostic Factors in Granulomatosis With Polyangiitis (Formerly Named Wegener's Granulomatosis)

NCT01862068

Granulomatosis With Polyangiitis

COMPLETED

Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis

NCT00468208

Wegener's Granulomatosis

COMPLETED PHASE1/PHASE2

Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener's) and Microscopic Polyangiitis

NCT00315393

Granulomatosis With Polyangiitis Microscopic Polyangiitis Wegener's

COMPLETED

Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis

NCT00104299

Vasculitis Wegener's Granulomatosis Microscopic Polyangiitis

COMPLETED PHASE2/PHASE3

Intravenous Immunoglobulin After Relapse in Vasculitis

NCT00307658

ANCA + Vasculitides Relapsing Either Under Corticosteroid and Immunosuppressant Therapies or After One Year Post Treatment.

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators will test our hypothesis of "DAP-12 gain-of-function" by quantitative (mRNA and protein) and qualitative (DNA, signaling and cellular activation) analysis of the DAP12 signaling pathway in WG patients with localized (group 1; n=30) or diffuse WG (group 2; n=30) by comparison with patients with micro polyangitis (group 3; n=30), or with sarcoidosis ( group 4; n=30), and healthy blood donors (group 5; n=30). Blood samples will be collected during a routine medical visit. These results may help to design future therapeutic strategies based on modulation of specific intra-cellular pathways involved in the disease.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wegener's Granulomatosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Disease group

Physiopathology

Group Type OTHER

Physiopathology Endpoint Classification

Intervention Type BIOLOGICAL

Blood samples will be collected during a routine medical visit.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physiopathology Endpoint Classification

Blood samples will be collected during a routine medical visit.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Group 1: WG, with granulomatous lesions limited to upper airway or lungs and no evidence of generalized vasculitis ,± biopsy, ± anti-PR3 ANCA
* Group 2: WG with granulomatous lesions plus vasculitis expression (renal, neurological, skin, gut or heart involvement), ± biopsy, ± anti-PR3 ANCA
* Group 3: Necrotizing vasculitis with no granulomatous lesions, ± PAUCI immune glomerulonephritis, ± anti-MPO ANCA
* Group 4: clinical presentation compatible with sarcoidosis, ± biopsy, ± ECA elevated ± tuberculin anergy