A Randomized Multicenter Study for Isolated Skin Vasculitis

Who is this study for? Adult patients with Skin Vasculitis
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Multi-center sequential multiple assignment randomized trial comparing the effectiveness of three different standard of care treatment options for patients with isolated skin vasculitis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with primary skin vasculitis, not associated with any significant extra-cutaneous involvement that would require specific immunosuppressive therapy. Eligible patients will have a diagnosis of either:

‣ Isolated cutaneous small vessel (SV) or medium-sized vessel (MV) vasculitis or cutaneous polyarteritis nodosa (PAN)

⁃ IgA vasculitis (IgA, formerly Henoch-Schönlein purpura), without active and/or progressing renal involvement (stable glomerular filtration rate (GFR) \>60 ml/min; absence of, or mild-and-stable microscopic hematuria without red blood cell casts; absence of, or mild-and-stable proteinuria (\<1g/24 hours); not requiring systemic immunosuppressive therapy).

• These conditions, when skin-limited, are all currently treated in similar manners in practice. Mild arthralgias, myalgias, peripheral limb edema, fatigue, weight loss ≤6 lbs or 3 kg within past 3 months, low-grade fever, and mild anemia (Hb ≥ 10 g/dL) will be allowed.

• The diagnosis of vasculitis must have been confirmed by skin biopsy prior to enrollment (earlier, at diagnosis, and/or just prior to enrollment) that has included an immunofluorescence study (in the case of small vessel vasculitis).

• Patients must have active cutaneous vasculitis lasting for at least 1 month continuously and/or have had 2 or more flares over the six months preceding enrollment (post-inflammatory lesions such as hyperpigmentation or healing ulceration(s) are not to be considered active vasculitis).

• Patients must have active / ongoing cutaneous vasculitis lesions at the time of enrollment (post-inflammatory lesions such as hyperpigmentation or healing ulceration(s) are not to be considered active vasculitis).

• Patients may have a contra-indication to one of the study drug or have been treated prior to enrollment with one of the study medications but failed to respond to it (according to the study definitions of failure and if they have been on the drug at the target dose or higher for 3 months or longer) or had to stop it because of an adverse event. Such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs. The number of such patients enrolled directly in stage 2 will be capped at 10 (10% of the total recruitment target).

• Patients may have received systemic glucocorticoids for their cutaneous vasculitis before enrollment. For the patients on prednisone at the time of enrollment, prednisone should be stopped within a maximum of 6 weeks after enrollment and initiation of the study drug, following a pre-defined tapering schedule. Patients on long-term, low and stable dose of glucocorticoids (≤5 mg/day prednisone-equivalent) for other conditions (e.g., asthma or adrenal insufficiency) can be enrolled if the likelihood of requiring a dose increase for this other condition is low during the 6 month study period (these patients will remain on that low and stable dose during the study period, with the option to receive one short course of prednisone at higher doses for skin vasculitis flare during the first 3 months of the study period, like any other patients enrolled).

• Participant age 18 years or greater.

Locations
United States
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Boston University School of Medicine
COMPLETED
Boston
Minnesota
Mayo Clinic
COMPLETED
Rochester
New York
Northwell Health
COMPLETED
Lake Success
Hospital for Special Surgery
COMPLETED
New York
Ohio
Cleveland Clinic
COMPLETED
Cleveland
Pennsylvania
Penn State Hershey Medical Center
COMPLETED
Hershey
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Vanderbilt University
RECRUITING
Nashville
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Utah
University of Utah
COMPLETED
Salt Lake City
Virginia
University of Virginia
RECRUITING
Charlottesville
Other Locations
Canada
St. Joseph's Healthcare
RECRUITING
Hamilton
McGill University Health Centre
RECRUITING
Montreal
University of Toronto Mount Sinai Hospital
RECRUITING
Toronto
Japan
Tohoku Medical and Pharmaceutical University Hospital
COMPLETED
Kyoto
Contact Information
Primary
Carol McAlear, MA
cmcalear@upenn.edu
Time Frame
Start Date: 2017-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 90
Treatments
Experimental: Stage 1
Eligible patients will be initially randomized (1:1:1) to receive one of the 3 medications under investigation (colchicine 0.6 mg x 2/day; dapsone 150 mg/day; azathioprine 2 mg/kg/day) for 6 months. Endpoint is response to treatment at month 6 (stage 1).
Experimental: Stage 2
If the patient has to discontinue the study drug within the (stage 1) 6 month study period or during the subsequent follow-up period (up to month 12) because of a lack of response (or failure), flare or side effect, he/she will be randomized again to receive one of the remaining two study drugs (stage 2, with a 1:1 randomization ratio, colchicine 0.6 mg x 2/day; dapsone 150 mg/day; azathioprine 2 mg/kg/day) for 6 months. Endpoint in this second stage will again be the response to treatment at 6 months.
Authors
Kawakami Tamihiro
Sponsors
Leads: University of Pennsylvania
Collaborators: National Center for Advancing Translational Sciences (NCATS), Office of Rare Diseases (ORD), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov