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Table 3 Schedule of enrolment, interventions, and assessments

From: PolyMyalgia Rheumatica treatment with Methotrexate in Optimal Dose in an Early disease phase (PMR MODE): study protocol for a multicenter double-blind placebo controlled trial

Timepoint

Enrolment

Post-allocation (weeks)

Close-out

-t1

Baseline

4

8

12

16

24

32

42

52

Enrolment

 Eligibility screen

X

         

 Informed consent

X

         

 Allocation

 

X

        

Intervention

 Methotrexate

          

 Placebo

          

Assessments

          

 Demographics, medical history, medication overview, RF, ACPA, AP

 

X

        

 Disease characteristics, physical examination, PMR-AS, AE monitoring, PROsa

 

X

X

 

X

 

X

X

 

X

 CRP, ESR, total blood count, creatinine, ALAT, serum for storage

 

X

X

X

X

X

X

X

X

X

 GTI, including serum glucose, HbA1c, LDL

 

X

  

X

 

X

  

X

  1. Abbreviations: RF, rheumatoid factor; ACPA, anti-cyclic citrullinated peptide; AP, alkaline phosphatase; PMR-AS, polymyalgia rheumatica disease activity score; AE, adverse events; PROs, patient-reported outcomes; GTI, Glucocorticoid Toxicity Index; HbA1c, glycated hemoglobin; LDL, low-density lipoprotein; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; ALAT, alanine aminotransferase
  2. aTransition, patient acceptable symptom state, EQ-5D-5L, HAQ, and PROMIS-PF