IMACS FORM 11: ASSESSMENT OF STUDY OUTCOME

Subject's IMACS number
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

# Assessor \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Date of assessment (mm/dd/yy)
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Assessment number
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

PHYSICIAN ASSESSMENT OF OUTCOME IN THE TRIAL/STUDY

**[Change in Disease Activity]{.underline}**

#### Based upon all the information available to me at this time, I believe that compared to the condition of the subject on \_\_\_\_\_\_\_\_\_\_\_\_ (mm/dd/yy), the subject's disease activity is now (please check only one):

> Markedly improved

##### Moderately improved

> Slightly improved
>
> Unchanged
>
> Slightly worse
>
> Moderately worse
>
> Markedly worse

According to the criteria for improvement used in your trial/study
(primary endpoint), does this patient now meet the improvement criteria?

> Yes, this patient meets this trial's/study's improvement criteria at
> this time
>
> No, this patient does not meet this trial's/study's improvement
> criteria at this time
>
> This trial/study does not have improvement criteria

The improvement criteria for this trial/study are (primary endpoint
criteria):

> IMACS Definition of Improvement (improvement in at least 3 of 6 core
> set measures by ≥ 20%, with no more than 2 worse by ≥ 25%, which
> cannot be MMT)
>
> Other:
> (specify)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

IMACS has currently defined a complete clinical response as a 6-month
continuous period of no disease activity while still receiving myositis
therapy and clinical remission as a 6-month continuous period of no
disease activity while not receiving any therapy for myositis. Based on
this information please check all of the following that apply:

My patient currently has:

> Complete Clinical Response by IMACS criteria
>
> Complete Clinical Response by other criteria:
> Specify:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Clinical Remission by IMACS criteria
>
> Clinical Remission by other criteria:
> Specify:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> None of the above (my patient's myositis remains active)
>
> Don't know

**[Change in Disease Damage]{.underline}**

#### Based upon all the information available to me at this time, I believe that compared to the condition of the subject on \_\_\_\_\_\_\_\_\_\_\_\_ (mm/dd/yy), the subject's disease damage is now (please check only one):

> Markedly improved

##### Moderately improved

> Slightly improved
>
> Unchanged
>
> Slightly worse
>
> Moderately worse
>
> Markedly worse

SUBJECT ASSESSMENT OF OUTCOME IN THE TRIAL/STUDY

Subject's IMACS number
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

# Assessor \_\_\_\_\_\_\_**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**\_\_\_\_\_\_\_\_\_

Date of assessment (mm/dd/yy)
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Assessment number
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

#### Based upon everything that I know about me and how I feel at this time, I believe that compared to my condition on \_\_\_\_\_\_\_\_\_\_\_\_ (mm/dd/yy), I am now (please check only one):

> A great deal better

##### Moderately better

> Slightly better
>
> No change
>
> Slightly worse
>
> Moderately worse
>
> A great deal worse

I believe that I have achieved:

> No evidence of myositis activity, but still taking myositis therapy
>
> No evidence of myositis activity and off all myositis therapy
>
> Neither: my myositis remains active
>
> Don't know

PARENT ASSESSMENT OF SUBJECT OUTCOME IN THE TRIAL/STUDY

Subject's IMACS number
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

# Assessor \_\_\_\_\_\_\_**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**\_\_\_\_\_\_\_\_\_

Assessor's relationship to subject: Mother:\_\_; Father\_\_; Other
(specify):\_\_\_\_\_\_\_\_\_\_\_\_\_

Date of assessment (mm/dd/yy)
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Assessment number
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

#### Based upon everything that I know about my child and how he/she feels at this time, I believe that compared to his/her condition on \_\_\_\_\_\_\_\_\_\_\_\_ (mm/dd/yy), they are now (please check only one):

> A great deal better

##### Moderately better

> Slightly better
>
> No change
>
> Slightly worse
>
> Moderately worse
>
> A great deal worse

I believe that my child has achieved:

> No evidence of myositis activity, but still taking myositis therapy
>
> No evidence of myositis activity and off all myositis therapy
>
> Neither: my child's myositis remains active
>
> Don't know