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Table 1 Schedule of enrolment, interventions and assessments from SPIRIT checklist

From: The HAVEN study—hydroxychloroquine in ANCA vasculitis evaluation—a multicentre, randomised, double-blind, placebo-controlled trial: study protocol and statistical analysis plan

Study Visitsi

Screen

Baseline

WK4

WK10 Telephone

WK16

WK 22 Telephone

WK28

WK 34 Telephone

WK40

WK44

WK48

WK52 End of study treatment

Follow up WK56

Withdrawalii

Visit Number

1

2

3

-

4

-

5

-

6

7

8

9

10

-

Day (Visit window)

Up to 28 days

0

28 (± 7)

70 (± 7)

112 (± 7)

154 (± 7)

196 (± 7)

238 (± 7)

280 (± 7)

308 (± 7)

336 (± 7)

364 (± 7)

392 (± 7)

 

Patient information and informed consent

X

             

Interventions:

IMP dispensing

 

X

X

 

X

 

X

 

X

     

IMP dose recording / review of patient diary

  

X

 

X

 

X

 

X

X

X

X

 

X

Prednisolone dose recording

X

X

X

 

X

 

X

 

X

X

X

X

X

X

Assessments:

COVID symptom assessment

X

X

X

 

X

 

X

 

X

X

X

X

X

X

Eye screen

           

Xiii

  

Eligibility

X

Xiv

            

Randomisation

 

X

            

Medical history, Demographics

X

             

Physical exam, Weight, Vital signsv, Urine dipstick

X

X

X

 

X

 

X

 

X

X

X

X

X

X

ECG

X

   

X

         

Medications

X

X

X

X

X

X

X

X

X

X

X

X

X

X

BVASvi

X

X

X

 

X

 

X

 

X

X

X

X

X

X

VDI

 

X

  

X

 

X

  

X

 

X

  

GTI

 

X

    

X

    

X

  

Physician’s Global Assessment

X

X

X

 

X

 

X

 

X

X

X

X

X

X

Urine drug screen

X

             

SF-36, EQ5D, HAQ, AAV Pro

 

X

 

Xvii

X

Xvii

X

Xvii

 

X

 

X

X

X

FACIT score

 

X

  

X

 

X

  

X

 

X

X

X

Adverse event reporting

 

X

X

X

X

X

X

X

X

X

X

X

X

X

Clinical Labs:

ANCA

X

   

X

 

X

 

X

  

X

X

X

ESRviii, CRP

 

X

  

X

 

X

 

X

  

X

X

X

Glucose

 

X

  

X

 

X

 

X

  

X

X

X

HbA1C

X

     

X

    

X

  

Lipids

X

     

X

    

X

  

Renal profile including creatinine and eGFRix

X

X

X

 

X

 

X

 

X

  

X

X

X

Full blood count

X

Xx

X

 

X

 

X

 

X

  

X

X

X

Liver function tests

X

Xx

X

 

X

 

X

 

X

  

X

X

X

Protein: creatinine ratioxi

X

X

X

 

X

 

X

 

X

X

X

X

X

X

Viral screenxii

X

             

Pregnancy testxiii

X

X

            

Research Blood Specimens:

              

Hydroxychloroquine levels

 

X

  

X

 

X

    

X

  

Plasma, Serum and Cellsxiv

 

X

  

X

 

X

 

X

  

X

 

Xxv

  1. i Patients will be followed up by telephone at weeks 10, 22 and 34 rather than visiting the study centre. The phone call will be structured using the AAV pro questionnaire. See section 6.13 for more details
  2. ii To be arranged if a patient withdraws from the trial but is willing to have a final study visit. This is only necessary in instances where the patient’s last visit was more than 4 weeks ago
  3. iii The eye screen is only required for patients whose eGFR drops below 60ml/min at any point during the trial. The eye screen should take place between week 52 and week 56 visits by a local optometrist
  4. iv The eligibility criteria require BVAS to be scored and for female patients to have a pregnancy test at baseline as well as screening. Other screening procedures do not need to be repeated
  5. v Vital signs to include BP, pulse, respiration rate and temperature
  6. vi BVAS and VDI to be scored locally following training. BVAS scores will be quality checked by a central adjudication panel to ensure consistency
  7. vii Telephone follow up interviews will only use the AAV Pro questionnaire to structure the conversation. The SF-36, EQ5D and HAQ questionnaires will not be included
  8. viii Where ESR is not available, plasma viscosity may be used instead
  9. ix If the patient’s eGFR drops below 60ml/min at any point of the trial they should be invited for an eye screen between week 52 and 56
  10. x If the baseline visit is less than two weeks after screening, these tests do not need to be performed again
  11. xi Protein:creatinine ratio only needs to be performed if urine dipstick for protein shows 1+ or more, but results can be collected if routinely performed when the urine dipstick is negative
  12. xii Patients who test positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody or HIV-1 will be excluded
  13. xiii Urine pregnancy test
  14. xiv Plasma and serum collected at all sites. Cells at Guy’s Hospital only
  15. xv Samples only collected if the patient is identified as having a flare
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ISSN: 1745-6215