Start Time Optimization of Biologics in Polyarticular JIA
Conditions: Polyarticular Juvenile Rheumatoid Arthritis, Arthritis, Juvenile Idiopathic
Sponsor: Hackensack Meridian Health

STOP JIA Guide Version 15 DEC 2017 
 
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STOP-JIA GUIDE 
CONSENSUS TREATMENT PLANS (CTP) FOR NEW ONSET POLYARTICULAR JIA (pJIA) 
 
1. Operational Case Definition 
a. Patients should have: 
 
Age less than 19 at disease onset 
 
Age less than 19 at baseline1 (if 18at enrollment, agrees to be followed for at least one 
year) 
 
Arthritis2 (ACR definition)  
o Present in one joint for at least six weeks 
o >5 active joints are present at baseline 
o May have any of the following:  
- 
RF+ polyarticular JIA 
- 
RF- polyarticular JIA 
- 
Extended oligoarticular JIA 
- 
Psoriatic JIA 
- 
Enthesitis related JIA 
- 
Undifferentiated JIA 
 
Contraception if sexually active (male and female) 
 
b. Patients MAY have: 
 
Psoriasis 
 
Sacroiliitis  
 
Uveitis 
 
Enthesitis 
 
Past or current treatment with 
o NSAIDs 
o Intra-articular, topical and intra-ocular steroids  
o Hydroxychloroquine 
o IV/PO steroids if one of the below criteria are met: 
i. if treated < 3 months prior to baseline: treatment cannot exceed 2 weeks 
ii. if treated > 3 months prior to baseline: any treatment course is permitted as 
long as treatment was completed 90 days prior to baseline 
o Methotrexate (started no more than 1 month prior to enrollment) 
o Biologics (allowed if patient has only received 1 dose within 1 week of enrollment) 
 
c. Patients should NOT have: 
 
Systemic JIA 
 
Treatment with any medications for JIA aside from those listed above 
 
Known inflammatory bowel disease 
 
Known celiac disease 
 
Known Trisomy 21 

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STOP JIA Guide Version 15 DEC 2017 
 
 
History of or current malignancy 
 
Concomitant serious active or recurrent chronic bacterial, fungal or viral infection 
 
Significant organ system disorder limiting use of treatments for pJIA  
 
Live vaccine within a month prior to baseline 
 
1Patients may be enrolled up until their 19th birthday 
2Swelling within a joint, or limitation in the range of joint movement with joint pain or 
tenderness, is observed by a physician, and which is not due to primarily mechanical 
disorders or to other identifiable causes.

STOP JIA Guide Version 15 DEC 2017 
 
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2.  CTP Choices 
If the patient meets the operational case definition, and the treating physician feels that one of 
the CTPs is appropriate for the patient, one of the following CTPs should be chosen. 
d. STEP-UP CTP 
Initiation (baseline 
to 3 months) 
Begin DMARD (methotrexate, sulfasalazine, or leflunomide) 
Optional: 
 
Prednisone  
 
Intra-articular corticosteroid injections 
 
Unscheduled clinic visit at 1-2 months if no response or worsened 
to increase therapy. 
Condition 
improved 
If JADAS ≤ 2.5 and off prednisone, then no change in treatment from the 
prior visit is suggested. 
Condition 
worsened or 
insufficient 
improvement 
If JADAS > 2.5 and/or not off prednisone at any of the follow-up 
assessments, consider one of the following: 
 
Change DMARD dose (if not at maximum) 
 
Change DMARD 
 
Add or change biologic 
Optional: 
 Intra-articular corticosteroids may be added at any time 
 Unscheduled visit at 9 months if biologic was added at the 6 month visit.  

STOP JIA Guide Version 15 DEC 2017 
 
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e. EARLY COMBINATION CTP 
Initiation (up to 3 
months) 
Begin DMARD (methotrexate, sulfasalazine, or leflunomide) and biologic 
treatment within one month of each other 
Optional: 
 
Prednisone  
 
Intra-articular corticosteroid injections 
 
Unscheduled clinic visit at 1-2 months if no response or worsened to 
increase therapy. 
Condition improved  
If JADAS ≤ 2.5 and off prednisone, then no change in treatment from the prior 
visit is suggested. 
Condition worsened 
or insufficient 
improvement  
If JADAS > 2.5 and/or not off prednisone at any of the follow-up assessments, 
consider one of the following: 
 
Change DMARD dose (if not at maximum) 
 
Change DMARD 
 
Add or change biologic 
Optional: 
 
Intra-articular corticosteroids may be added at any time 
 
Unscheduled visit at 9 months if biologic was added at the 6 month visit. 
 

STOP JIA Guide Version 15 DEC 2017 
 
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f. BIOLOGIC FIRST CTP 
Initiation (up to 3 
months) 
Begin Biologic treatment  
Optional: 
 
Prednisone  
 
Intra-articular corticosteroid injections 
 
Unscheduled clinic visit at 1-2 months if no response or 
worsened to increase therapy.. 
Condition improved  
If JADAS ≤ 2.5 and off prednisone, then no change in treatment 
from the prior visit is suggested. 
Condition worsened 
or insufficient 
improvement  
If JADAS > 2.5 and/or not off prednisone at any of the follow-
up assessments, consider one of the following: 
 
Intra-articular corticosteroids at any time.  
 
Unscheduled visit at 9 months if medication change 
was made at 9 months 
 
 
 
 

STOP JIA Guide Version 15 DEC 2017 
 
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MD Global & Juvenile Arthritis Disease Activity Score (JADAS) Guidelines 
 
• 
The MD global should consider only children with PJIA as defined in the enrollment 
criteria (e.g. think about disease severity relative only to other children with PJIA, not 
across all categories of JIA). 
 
• 
MD Global of 0 should be used to indicate that the child has no evidence of arthritis, 
uveitis, enthesitis or tenosynovitis based on information from the current clinic visit that is 
available during the visit; this may include clinical exam, imaging studies and labs. 
 
• 
MD Global of 10 should be used to indicate severe, diffuse active arthritis, as well as 
severity of uveitis and enthesitis or tenosynovitis based on clinical exam and/or imaging 
studies associated with the current clinic visit, if available during the clinic visit. 
 
Calculating the cJADAS10: 
The cJADAS10 should be calculated at the point of care. It is a simple sum of:  
 
MD Global + Total Active Joint Count (10 maximum) + Parent Global = ________ 
 
Disease activity cut-offs:  
• Low disease activity ≤ 2.5 
• Moderate disease activity 2.51-8.5 
• High disease activity > 8.5 
Caveats:  
• Patients may achieve moderate disease activity if MD Global = 0, 
AJC=0, and Parent Global >2.5.  
• Clinical judgment still required for interpretation of values. 
 
 
 

STOP JIA Guide Version 15 DEC 2017 
 
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Suggested Glucocorticoid dosing and tapering tables 
All doses at each time point are suggested targets.  It is anticipated that tapering of dose to reach the 
next target will occur between time points. Each suggested option below illustrates discontinuation of 
steroids before or at 3 months. 
 
Option 1 
LOW DOSE:  
Starting dose 0.25 mg/kg with 2 week taper  
 
Weight in 
kilograms 
 
10-<20 
 
20-<30 
 
30-<40 
 
40-<50 
 
50-<60 
 
≥60  
 
Weight-based target dose 
0 weeks 
2.5 
5 
7.5 
10 
12.5 
20 
0.25 mg/kg (max 20 mg) 
1 week 
1.5 
2.5 
5 
7.5 
10 
15 
0.125 mg/kg 
11/2 week 
0.5 
1 
1.5 
2 
2.5 
3 
0.05 mg/kg 
2 weeks 
0 
0 
0 
0 
0 
0 
off 
 
Option 2 
MEDIUM DOSE:  
Starting dose 0.5 mg/kg with one month taper  
 
Weight in 
kilograms 
 
10-<20 
 
20-<30 
 
30-<40 
 
40-<50 
 
50-<60 
 
≥60  
 
Weight-based target dose 
0 weeks 
5 
10 
15 
20 
25 
30 
0.5 mg/kg (max 30 mg) 
1 weeks 
4 
7.5 
12.5 
15 
20 
25 
0.4 mg/kg 
2 weeks 
2.5 
5 
7.5 
10 
12.5 
15 
0.25 mg/kg 
3 weeks 
1 
2 
3 
4 
5 
6 
0.1 mg/kg 
4 weeks 
0 
0 
0 
0 
0 
0 
off 

STOP JIA Guide Version 15 DEC 2017 
 
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Option 3 
HIGH DOSE FAST TAPER:  
Starting dose 1 mg/kg with 1 month taper  
 
Weight in 
kilograms 
 
10-<20 
 
20-<30 
 
30-<40 
 
40-<50 
 
50-<60 
 
≥60  
 
Weight-based target dose 
0 weeks 
10 
20 
30 
40 
50 
60 
1 mg/kg (max 60 mg) 
1 weeks 
7.5 
15 
22.5 
30 
37.5 
45 
0.75 mg/kg 
2 weeks 
5 
10 
15 
20 
25 
30 
0.5 mg/kg 
3 weeks 
2.5 
5 
7.5 
10 
12.5 
15 
0.25 mg/kg 
4 weeks 
0 
0 
0 
0 
0 
0 
off 
 
Option 4 
HIGH DOSE SLOW TAPER:  
Starting dose 1mg/kg with 3 Month taper  
 
Weight in 
kilograms 
 
10-<20 
 
20-<30 
 
30-<40 
 
40-<50 
 
50-<60 
 
≥60  
 
Weight-based target dose 
0 weeks 
10 
20 
30 
40 
50 
60 
1 mg/kg (max 60mg) 
2 weeks 
7.5 
15 
22.5 
30 
37.5 
45 
0.75 mg/kg 
1 month 
5 
10 
15 
20 
25 
30 
0.5 mg/kg 
2 months 
2.5 
7.5 
7.5 
10 
12.5 
15 
0.25 mg/kg 
3 months 
0 
0 
0 
0 
0 
0 
off 
 
 

STOP JIA Guide Version 15 DEC 2017 
 
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2. SCHEDULE OF ASSESSMENTS 
 
Baseline 
3 +/-1 
mos 
6 +/-1 
mos 
9 +/-1 
mos 
12 +/-1 
mos 
Unscheduled 
Physician Assessments 
 
 
 
 
 
 
Pre-existing conditions 
x 
 
 
 
 
 
Comorbid conditions 
 
x 
x 
x 
x 
x 
Medication history 
x 
 
 
 
 
 
Concomitant Meds  
x 
x 
x 
x 
x 
x 
Physician Assigned ILAR JIA category 
x 
x 
x 
x 
x 
x 
JIA Disease Manifestations 
x 
x 
x 
x 
x 
x 
Height & weight 
x 
x 
x 
x 
x 
x 
Active Joint Count 
x 
x 
x 
x 
x 
x 
# of Joints with LROM 
x 
x 
x 
x 
x 
x 
# of Joints with Swelling 
x 
x 
x 
x 
x 
x 
Physician Global Assessment of Disease activity 
x 
x 
x 
x 
x 
x 
Morning Stiffness 
x 
x 
x 
x 
x 
x 
Uveitis assessment 
x 
x 
x 
x 
x 
x 
Adverse events 
 
x 
x 
x 
x 
x 
Intended CTP 
x 
 
 
 
 
 
Actual CTP followed 
 
x 
x 
x 
x 
x 
JADAS 
x 
x 
x 
x 
x 
x 
Imaging results (if obtained) 
x 
x 
x 
x 
x 
x 
Parent/Subject  
 
 
 
 
 
 
Demographics 
x 
x 
x 
x 
x 
x 
Global Health 
x 
x 
x 
x 
x 
x 
Functional Ability 
x 
x 
x 
x 
x 
x 
Pain 
x 
x 
x 
x 
x 
x 
Fatigue 
x 
 
x 
 
x 
 
Depression 
x 
 
 
 
x 
 
Anxiety 
x 
 
 
 
x 
 
 
 
 
 
 
 
 
Other medication side effects 
x 
x 
x 
x 
x 
x 
Family Impact 
x 
 
 
 
x 
 
Standard of Care Labs 
 
 
 
 
 
 
Serologies 
x 
x 
x 
x 
x 
x 
HLA-B27 
x 
x 
x 
x 
x 
x 
ESR and/or CRP 
x 
x 
x 
x 
x 
x 
Labs for medication safety depends on 
medications (see section 5: pp 10-14) 
x 
x 
x 
x 
x 
x 
 

STOP JIA Guide Version 15 DEC 2017 
 
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3. PATIENT REPORTED OUTCOME MEASURES 
To be completed by parent/proxy for children < 8 and by children ≥ 8 years. 
Outcome 
Measure 
Timing 
Source 
Global Health 
PROMIS® pediatric global 
health measure (PGH-7) 
Every study visit 
 Parent-proxy report if 
child < 8 years 
 Child self-report (children 
≥ 8 years) 
Functional Ability 
PROMIS® physical function – 
mobility and upper 
extremity short forms 
 
Every study visit 
 Parent-proxy report if 
child < 8 years 
 Child self-report (children 
≥ 8 years) 
Pain 
Visual analog scales and 
FACES scale; PROMIS®  
pediatric pain interference  
Every study visit 
 Parent-proxy report if 
child < 8 years 
 Child self-report (children 
≥ 8 years) 
Fatigue 
PROMIS® pediatric fatigue; 
short form 
Baseline, 6 
months, end of 
study 
 Parent-proxy report if 
child < 8 years 
 Child self-report (children 
≥ 8 years) 
Depression 
PROMIS® pediatric 
emotional distress – 
depression; short form 
Baseline, end of 
study 
 Parent-proxy report if 
child < 8 years 
 Child self-report (children 
≥ 8 years) 
Anxiety 
PROMIS® pediatric 
emotional distress – anxiety; 
short form 
Baseline, end of 
study 
 Parent-proxy report if 
child < 8 years 
 Child self-report (children 
≥ 8 years) 
Other medication 
side effects 
Juvenile Arthritis 
Multidimensional Arthritis 
Report (question #11)(57)  
 
 
 
  
All visits 
(All patients) 
 Parent-proxy report if 
child < 8 years 
 Child self-report (children 
≥ 8 years) 
Family Impact 
PedsQLTM Family Impact 
Module(92) 
Baseline, end of 
study 
 Parent-proxy report (for 
all children) 
 
 

STOP JIA Guide Version 15 DEC 2017 
 
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5. Medication Dosing and Monitoring for pJIA CTPs 
Glucocorticoids 
A. Steroid exposure prior to starting on CTP  
  
i. Intraarticular corticosteroid injections (IAS) 
 
IAS will be allowed at any time prior to starting on CTP, and number of joints injected 
and date(s) will be documented (dose, which joints, etc. will not be)  
 
ii. Systemic steroids (PO) 
 
May be allowed prior to starting CTP, if subject has taken steroids for < 2 weeks prior to 
baseline 
 
B. Steroid use during CTP 
     i. Systemic steroids  
 
Starting dose per provider’s discretion, but encourage lowest possible dose for the 
shortest period of time  
 
STOP-JIA CTP glucocorticoid regimen rapid taper (1 month) (recommend but not 
required) 
 
Encourage rapid taper (should be off or on very low dose steroid by 3 months) 
 
ii. Intraarticular corticosteroid injections 
 
IAS will be allowed during CTPs at provider’s discretion (document number and date 
only) 
 
 
_________________________________________________________ 
 
 

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STOP JIA Guide Version 15 DEC 2017 
 
Non-Biologic DMARDs 
Methotrexate  
A. Route 
 
Oral or subcutaneous dosing allowed (reminder that subcutaneous route may have 
fewer side effects, better absorption and improved efficacy at doses greater than 10 
mg/m2) 
 
B. Dose 
 
Initial target dose should be reached by 6 weeks: 10-15 mg/m2/week or 0.5 mg/kg/week  
 
Maximum recommended dose at any time: 25 mg 
 
Dose adjustments allowed based on response and tolerability after 4-8 weeks on 
therapy (study visit not required).  
 
C. Toxicity monitoring 
 
Check CBC, LFTs (AST, ALT), Creatinine prior to initiation, approximately 1 month after 
initiation, approximately 1-2 months after an increase in dose, repeat every 3-4 months 
if prior results are normal and dose is stable. 
 
Consider hepatitis B screening at baseline 
 
PPD prior to starting? 
 
D. Will capture additional tolerability variables such as: 
 
Nausea* 
 
Vomiting* 
 
Abdominal pain* 
*** 
Leflunomide  
A. Loading dose 
No loading dose recommended. 
B. Maintenance dose 
 
<20kg-10 mg every other day 
 
20-30kg-10 mg/d  
 
30-40kg-10mg/d alternating 20mg/d 
 
>40kg-20 mg/d 
Target dose may be reached with incremental dosing over 4-6 weeks 
C. Toxicity monitoring 
Same as methotrexate: 
Check CBC, LFTs (AST, ALT), Creatinine prior to initiation, approximately 1 month after initiation, 
approximately 1-2 months after an increase in dose, repeat every 3-4 months if prior results are 
normal and dose is stable. 
 
Consider hepatitis B screening at baseline 
 

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STOP JIA Guide Version 15 DEC 2017 
 
D. Other issues 
 
Side effect to capture: diarrhea, hair loss 
*** 
Sulfasalazine  
A. Dosing 
 
30-50 mg/kg/day up to recommended dose of 2 grams/day (maximum 3 grams/day) 
B. Toxicity monitoring:  
Same as methotrexate:  
 
Check CBC, LFTs (AST, ALT), Creatinine prior to initiation, approximately 1 month after 
initiation, approximately 1-2 months after an increase in dose, repeat every 3-4 months 
if prior results are normal and dose is stable. 
 
Consider hepatitis B screening at baseline 
Reminder that hemolytic anemia (associated with glucose-6-phosphate dehydrogenase 
deficiency), Stevens Johnson Syndrome, and DRESS syndrome* have been reported in patients 
taking SSZ. 
 
*DRESS syndrome – Rash, eosinophilia at least one of the following: enlarged LN, 
hepatitis (>2X), interstitial nephropathy, lung disease or myocardial involvement 
 
_________________________________________________________ 
 
 

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STOP JIA Guide Version 15 DEC 2017 
 
Biologic DMARDs 
A. General Dosing 
Minimum starting doses provided. Adjustments at provider’s discretion. 
 
B. General Toxicity Monitoring  
 
Complete blood count, liver enzymes, serum creatinine prior to initiation  
o Repeat approximately every 4- 6 months if prior results normal and dose stable 
 
TB screen prior to initiation (PPD or TB quantiferon gold) 
o Repeat approximately once yearly 
o If positive, need chest Xray and treatment per infectious diseases prior to initiating 
treatment (usually at least 4-6 weeks of treatment) 
 
Consider screening for hepatitis B prior to initiation 
 
C. Other general recommendations  
 
Avoid live vaccinations while on biologic agents 
 
Avoid combinations of biologic agents 
_________________________________________________________ 
Anti-TNF   
A. Dosing  
 
Etanercept - 0.4 mg/ kg sc twice weekly (max 25 mg)/ or 0.8 mg/ kg sc weekly (max 50 mg) 
 
Infliximab - 5-10 mg/kg iv 0,2,6 q 4-8 weekly  
 
Adalimumab 
 
15-30 kg -- 20 mg sc every other week  
 
≥ 30 kg -- 40 mg sc q every other week 
 
Certolizumab ** - Dose in adult RA may be used for those 18yr or older  
 
400 mg/dose at 0,2 and 4 week then 200 mg sc every 2 week 
Or 
 
400mg/dose at 0, 2, 4 week then 400 mg sc every 4 weeks 
 
Golimumab** - Dose in adult RA may be used for those 18yr or older  
 
50 mg monthly subcutaneous injection 
**will update when pediatric trial results available 
 
B. Special monitoring recommendations for TNF antagonists 
 
Consider screening for histoplasmosis, blastomycosis, coccidiomycosis in endemic areas  
 
C. Special other considerations for TNF antagonist 
 
Recommend discussion of the FDA malignancy risk warning as part of routine counseling prior to 
initiation of therapy  
 
DMARD use is recommended but not required with infliximab to avoid HACA 
*** 

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STOP JIA Guide Version 15 DEC 2017 
 
Tocilizumab 
A. Dosing  
 
<25 kg -- 4-8 mg/kg q 4 weeks diluted in sterile saline to total volume 50 ml as IV infusion over 1 
hour every 4 weeks  
 
>25 kg -- 4-8 mg/kg q 4 weeks diluted in sterile saline to total volume 100 ml as IV infusion over 
1 hour every 4 weeks ( 
 
Will adopt pediatric doses of 8-10mg/kg once data is available 
B. Special Toxicity Monitoring  
 
Total neutrophil count, platelets, ALT and AST at the time of the 2nd infusion and then monthly  
 
Lipid level (Total cholesterol, HDL, LDL, triglycerides) monitoring 1-2 months following initiation 
of therapy, then at 6 month intervals. 
*** 
Rituximab 
A. Dosing 
 
750 mg/m2/dose iv infusion every 2 weeks X 2 doses (max 1 gm), repeat every 4-8 months 
 
B. Special toxicity monitoring 
 
Consider monitoring serum IgG and IgM levels, circulating B cell numbers 
 
Consider IVIG replacement therapy if hypogammaglobulinemia develops  
 
C. Special other considerations 
 
Consider vaccination of children prior to initiation of therapy due to poor ability to mount 
immune response once therapy started, avoid live vaccines on therapy 
 
Consider re-dosing based on response in 4-8 months 
 
*** 
Abatacept  
A. Dosing 
 
IV 
 
10mg/kg up to 1000mg Q2 weeks for 3 doses, then Q4 weeks  
 
Children above 75kg -- follow adult dosing schedule below. 
 
Adult dosing— 
o <60kg 500mg 
o 60-100kg-750mg 
o >100kg-100mg 
 
SQ 
 
Dose recommendations from pediatric trial: 
o Body Weight of Patient Dose (once weekly) 
o 10 to less than 25 kg 50 mg 
o 25 to less than 50 kg 87.5 mg 
o 50 kg or more 125 mg