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Table 1 Timeline of the study according to the SPIRIT guidelines

From: Optimizing adalimumab treatment in psoriasis with concomitant methotrexate (OPTIMAP): study protocol for a pragmatic, single-blinded, investigator-initiated randomized controlled trial

Time

Screening

Week −2

Week −1

Week 0

Week 3

Week 5

Every 12 weeks from week 13 up to week 145

Early termination

Enrollment

Informed consent

X

       

Demography, medical history

X

       

Vital signs and full physical examination

X

  

X

 

X

X

X

Psoriasis Area and Severity Index (PASI)

X

  

X

 

X

X

X

Eligibility criteria

X

       

Laboratory assessments

X

 

X

X

X

X

X

X

Chest X-ray, Mantoux test, and interferon-gamma release assay (IGRA)

X

       

Randomization

X

       

Intervention

Adalimumab (Humira) + MTX

 

X (MTX)

X (MTX)

X (Humira + MTX)

Humira monotherapy

   

X (Humira)

Assessments

Laboratory assessments

X

 

X

X

X

X

X

X

PASI

X

  

X

 

X

X

X

Physician global assessment

X

  

X

 

X

X

X

Patient global assessment

X

  

X

 

X

X

X

Impact on quality of life (Skindex 29 and Dermatology Life Quality Index (DLQI))

X

  

X

 

X

X

X

Prior or concomitant therapy

X

  

X

 

X

X

X

Adverse events

X

  

X

 

X

X

X

Drug adherence

   

X

 

X

X

X