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Table 4 Summary of study assessments and procedures

From: Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial

 

V1 d0

V2 + 8w

V3 + 16w

V4 + 24w

V5 + 32w

V6 + 40w

V7 + 48w

V8 + 56w

V9 + 64w

V10 + 72w

V11 + 80w

V12 + 88w

V13 + 96w

V14 + 104w

V15# last

Informed consent

X

              

Anamnesis

X

              

Eligibility

X

              

Randomization

X

              

Treatment regimen

X

      

X

     

X

X

Treatment compliance

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Patient global assessment

X

      

X

     

X

X

Physician global assessment

X

      

X

     

X

X

Axial night pain

X

      

X

     

X

X

Use of NSAIDs

X

      

X

     

X

X

BASDAI*

X

      

X

     

X

X

ASAS

X

      

X

     

X

X

Lab testing: CRP, ESR*

X*

      

X*

     

X*

X*

ASDAS-C*

X*

      

X*

     

X*

X*

BASFI

X

      

X

     

X

X

ASQoL

X

      

X

     

X

X

Adverse events

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Ideal therapeutic goal *

 

X

     

X

     

X

X

Acceptable therapeutic goal *

 

X

     

X

     

X

X

Plasma and serum samples

X+

      

X+

      

X#

Imaging (X ray)@

X

      

X

      

X#

  1. See Table 1 for abbreviation and references. *As clinically indicated. For BASDAI and therapeutic goals, they will be always required at visits 8, 14 and 15, regardless of whether these are measured at other time points as clinically indicated. Unplanned assessments will be registered in a specific section of the eCRF. @As clinically available according to routine clinical practice. # Last study visit or patient withdrawal. +To be collected at the time of clinically indicated routine laboratory testing, and at study completion or withdrawal due to treatment failure