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Table 1 Schedule of enrolment, interventions and assessments (SPIRIT)

From: The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protocol of a randomized, double blind, placebo-controlled, multicenter trial

TIMEPOINT

STUDY PERIOD

Screening

Baseline/ treatment

Treatment period

End of study

Safety registration

Within 6 weeks before baseline

Day 0

Day 14

Day 42

Day 98

Day 154

Day 278

ENROLMENT:

 Eligibility screen

X

      

 Informed consent

X

      

 Medical history

X

      

 MRI-scana

X

    

X

 

 Chest X-ray

X

      

 Urine pregnancy testb

X

X

 

X

X

X

 

 Blood samples (hematology, clinical chemistry, CRP)c

X

X

X

X

X

X

 

 TB, Hep C, Hep B-screening

X

      

 Allocation

 

X

     

INTERVENTION:

 Infliximab

 

X

X

X

X

  

Placebo

 

X

X

X

X

  

ASSESSMENTS:

 Background datad

X

X

     

Clinical safety evaluatione

X

X

X

X

X

X

 

Clinical pain/neuro evaluationf

X

      

Blood samples for drug concentrations and antibodiesg

 

X

X

X

X

X

 

Blood samples for biobank

 

X

  

X

X

 

Adverse events

  

X

X

X

X

X

Primary outcomeh

 

X

X

X

X

 

X

Pain monitoringi

 

X

X

X

X

X

X

Concomitant medication

X

X

X

X

X

X

X

Co-interventions (non-pharm)

X

X

X

X

X

X

X

Sick listing

 

X

  

X

X

X

Questionnairesj

 

X

  

X

X

 

Compliancek

 

X

X

X

X

  
  1. aBaseline MRI according to the study protocol can be maximum 4 weeks old when treatment starts. A follow-up MRI is taken between 6 and 7 months after treatment start (i.e. 7 to 8 months after baseline MRI).
  2. bUrine pregnancy test will be performed at screening and monthly from treatment initiation until 9 months. Results will be enquired with telephone follow up.
  3. cHaematological parameters (hemoglobin, haematocrit (hct), erythrocytes, white blood cells with differentials, platelet counts), Clinical chemistry (AST and/or ALT, ALP, albumine, creatinine, random glucose, potassium, sodium) and CRP (SLV-imposed). Random glucose is for further safety monitoring (self-imposed)
  4. dBaseline data
  5. eWeight, blood pressure, pulse, auscultation of hearth and lunges, GI and neurological examination
  6. fPain provocation tests, neurological tests
  7. gAntibodies to infliximab
  8. hODI
  9. iPain-monitoring (LBP intensity) weekly during follow-up period
  10. jEQ 5D-5L,RMDQ, Patients’satisfaction, global perceived effect, symptom specific well-being, leg pain intensity, hours with LBP last 4 weeks
  11. kNumber of completed intravenous infusions with the IMP