UMIN-CTR Clinical Trial

Public title

A randomized multicenter study for isolated skin vasculitis

Acronym

ARAMIS

Scientific Title

A randomized multicenter study for isolated skin vasculitis

Scientific Title:Acronym

ARAMIS

Region

Japan

North America

Condition

skin vasculitis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

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

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The proportion of participants with a response to therapy at month 6 of the pooled study stages 1 and 2.

Key secondary outcomes

Proportion of patient with complete response to therapy at months 3, 6 and 12
Proportion of patient with significant response to therapy at months 3, 6 and 12
Time to achieve complete or significant response

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_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).

Interventions/Control_2

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.

Interventions/Control_3

If the patient fails this stage two agent, patient will be treated according to physicians discretion, outside of the study.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with primary skin vasculitis, not associated with any significant extra-cutaneous involvement that would require specific immunosuppressive therapy.
2. 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).
3. 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).
4. 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).
5. 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).
6. Patients may have received systemic glucocorticoids for their cutaneous vasculitis before enrollment.

Key exclusion criteria

1. Presence of significant extra-cutaneous manifestations suggestive of a systemic vasculitis or more diffuse condition.
2. Known systemic and/or non-skin-isolated vasculitis.
3. Hypocomplementemic urticarial vasculitis, cryoglobulinemic vasculitis, and other known secondary skin vasculitides.
4. 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.
5. 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.

Target sample size

90

Name of lead principal investigator

1st name
Middle name
Last name	Kawakami Tamihiro

Organization

St. Marianna University, School of Medicine

Division name

Dermatology

Zip code

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511

TEL

044-977-8111

Email

tami@marianna-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kawakami Tamihiro

Organization

St. Marianna University, School of Medicine

Division name

Dermatology

Zip code

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511

TEL

044-977-8111

Homepage URL

Email

tami@marianna-u.ac.jp

Institute

St. Marianna University, School of Medicine

Institute

Department

Personal name

Organization

St. Marianna University, School of Medicine
ARAMIS-JP

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

聖マリアンナ医科大学

Date of disclosure of the study information

2017

Year

08

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2016

Year

12

Month

01

Day

Date of IRB

Anticipated trial start date

2018

Year

04

Month

01

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

2022

Year

03

Month

31

Day

Date trial data considered complete

2022

Year

03

Month

31

Day

Date analysis concluded

2022

Year

03

Month

31

Day

Other related information

Registered date

2017

Year

08

Month

12

Day

Last modified on

2017

Year

08

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032788