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Table 1 Schedule of procedures

From: Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy

 

Screening

Study drug pre-treatment phase

Study drug + OIT up-dosing phase

OIT up-dosing without study drug phasea

Early term

Unsched visit

Visits

V1

V2

V3

V4

V5j

V6

V7j

V8

V9

V10

V11

V12

V13

V14

v15 + …

V20

v22 + …

PC36n

EoS

ET

UVm

Visit week

Scr

  

W-8

W-6

W-4

W-2

D1

W2

W4

W6

W8

W10

W12

q2w

W24

q2w

W36

W52+

  

Time window

 

No more than 7 days apart

Max 90 days after V1

±4 days

±4 days

e

±7 days

e

±7days

e

±7 days

±7 days

  

Informed consent/assent

X

                    

Check eligibility criteria

X

  

X

                 

QoL questionnaire*

X

            

X

 

X

  

X

X

 

Treatment-related cost evaluation questionnaire**

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Demographics

X

                    

Medical history

X

                    

Allergy history

X

                    

Weight and heightb

X

X

X

X

   

X

 

Xb

 

Xb

 

X

Xb

X

Xb

 

X

X

 

Vital signs

X

Xh

Xh

    

Xh

             

Complete Physical Examination

X

                 

X

X

 

Brief Physical Examination

 

Xi

Xi

X

X

X

X

Xi

X

X

X

X

X

X

X

X

X

   

X

Skin Prick Test

X

      

X

     

X

 

X

  

X

X

 

Blood sampling

X

      

X

 

Xo

   

X

 

X

  

X

X

 

Optional stool sample collection

 

Xp

     

Xq

     

X

    

X

X

 

Urine pregnancy testc

X

  

X

   

X

          

X

X

 

Spirometry

X

                    

Peak expiratory flow (PEF)

X

X

X

    

X

             

Prior/concomitant medicationd

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Adverse event collection (AE)

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Double-blind placebo-controlled challenge

 

X

X

                  

Randomization

   

X

                 

Study drug administratione

   

X

Xj

X

Xj

X

Xj

Xj

 

Xj

         

Initial food escalation

       

X

             

Epinephrine auto-injector trainingf

       

X

             

Review OIT action planf

       

X

X

X

X

X

X

X

X

X

X

X

X

  

Up-dosingg

        

X

X

X

X

X

X

X

X

X

   

X

Food treatment mix dispensation

       

X

X

X

X

X

X

X

X

X

X

   

X

Review and dispense of study home dosing diary

       

X

X

X

X

X

X

X

 

X

X

X

X

X

X

X

  1. aNumber of OIT up-dosing visits depends on time needed to reach a final dose of 1500 mg of total proteins that can be tolerated for 2 weeks. Visit W12, W24, W36 and W52 are mandatory even if OIT up-dosing phase has been completed
  2. bFollowed by monthly weight and height measurements for pediatric patients
  3. cFemale subject of childbearing potential
  4. dAt screening, prior medications taken within 6 months prior to V1 will be collected
  5. eDuring the randomized treatment period, investigational product (IP) injections must be separated by at least 11 days. To assess any injection reaction, subject will be monitored at the study site for a minimum of 2 h after first IP injection and then for 30 min after subsequent injection visits. Observation time can be extended at the discretion of the investigator
  6. fCan be reviewed any time during the study participation as deemed necessary
  7. gUp-dosing will be performed every 2 weeks until maintenance is achieved. Timing of visits is adjusted on treatment tolerance. The OIT dose on up-dosing visits will be determined by the up-dosing rules
  8. hAssessment to be performed before DBPCFC and IFE
  9. iAssessment to be performed before and after completion of DBPCFC and IFE
  10. jFor subjects on a biweekly study drug regimen, weighting ≥ 37.5 kg at time of randomisation
  11. kHalf dosage study drug taper period, 8 mg/kg vs 4 mg/kg vs placebo
  12. lQuarter dosage study drug taper period, 4 mg/kg vs 2 mg/kg vs placebo
  13. mProcedures during the Unscheduled Visit will be performed as deemed necessary by the Investigator
  14. nIf maintenance is achieved at W36, a phone call can be performed instead of an onsite visit
  15. oOptional
  16. pCan be performed on V2 or V3 or anytime prior to V4
  17. qMust be performed prior to IFE
  18. *QoL questionnaires include FAQLQ, SF-6Dv2, CHU9D. Questionnaires should be distributed according to the subject age at screening
  19. **Treatment-related cost evaluation questionnaire assesses direct and indirect cost questions. The initial questionnaire includes a sociodemographic and cost assessment section. The follow-up questionnaires only include a cost assessment section. Subjects will be asked to prospectively record the costs associated with the treatment in their diary
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Allergy, Asthma & Clinical Immunology

ISSN: 1710-1492

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