A Randomized Multicenter Study for Isolated Skin Vasculitis

  • STATUS
    Recruiting
  • End date
    Dec 26, 2022
  • participants needed
    90
  • sponsor
    University of Pennsylvania
Updated on 26 April 2021

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.

Description

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).

If the patient has to discontinue the study drug within the 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) for 6 months. Endpoint in this second stage will again be the response to treatment at 6 months.

Details
Condition Allergic Purpura, IgA Vasculitis, Primary Cutaneous Vasculitis, Cutaneous Polyarteritis Nodosa
Treatment Dapsone, colchicine, Azathioprine
Clinical Study IdentifierNCT02939573
SponsorUniversity of Pennsylvania
Last Modified on26 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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-Schnlein 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

Exclusion Criteria

Presence of significant extra-cutaneous manifestations suggestive of a systemic vasculitis or more diffuse condition. The presence of 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] are not exclusion criteria. Mild and stable microscopic hematuria without RBC casts and/or mild and stable proteinuria (<1g/24 hours) are not exclusion criteria. These latter patients must not require systemic immunosuppressive therapy because of possible renal involvement and their GFR must be >60 ml/min
Known systemic and/or non-skin-isolated vasculitis, such as granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis, cryoglobulinemic vasculitis, systemic polyarteritis nodosa, central nervous system vasculitis and patients with detectable antineutrophil cytoplasmic antibody (ANCA) by immunofluorescence or ELISA
Hypocomplementemic urticarial vasculitis, cryoglobulinemic vasculitis, and other known secondary skin vasculitides such as those secondary to systemic lupus erythematosus, Sjgren syndrome, another auto-immune condition, a cancer, a hematological disorder, an ongoing active infection, or an ongoing medication. Investigators should consider such underlying diagnoses and perform and interpret appropriate laboratory work-up where indicated based on clinical presentation
History of significant intolerance, allergy or serious adverse events to any of the study medications: 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 patients enrolled directly in stage 2 of the study will be capped at 10 (10%)
Patients who have contra-indications to two or three of the study drugs (azathioprine, colchicine, or dapsone), or have been treated prior to enrollment with two or three of the study drugs but failed to respond to them, or had to stop two or three of them because of adverse events
Deficit in glucose-6-phosphate dehydrogenase (G6PD) or history of hemolytic anemia (all patients must be tested for G6PD at the screening visit to assess for their eligibility): 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 (azathioprine or colchicine). The number of patients enrolled directly in stage 2 of the study will be capped at 10 (10%)
Low or absent thiopurine methyltransferase (TPMT) activity (if known, not a requirement for study entry): Patients known to have low or absent TPMT can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs (dapsone or colchicine)
Evidence of significant hepatic insufficiency or liver function tests > 2 times the upper limit of normal
Evidence of significant renal insufficiency or creatinine clearance < 60 mL/min
Evidence of significant or symptomatic anemia or Hb < 10 g/dL
Comorbid condition that has moderate or high likelihood of requiring intermittent courses of prednisone within the study period, according to the investigator (e.g. chronic obstructive pulmonary disease (COPD), unstable or severe asthma)
Active cancer or history of malignancy within the previous 5 years (patient in remission of a cancer >5 years, or with non-metastatic prostate cancer or treated basal or squamous cell carcinoma of the skin can be enrolled)
Active uncontrolled or serious infection that may compromise or contra-indicate the use of the study medications
Patient unable to consent
Pregnant or lactating women
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note