Table 3

Protocol deviations

COBRA (n=81)COBRA-light (n=81)
Protocolised treatment deviations811
 No full dose methotrexate due to elevated liverenzymes or gastrointestinal adverse events55
 Reduction prednisolone due to adverse events1*2†
 Reduction sulfasalazine due to adverse events1
 Switch to leflunomide due to methotrexate intolerance1
 Intra-articular injection3
 Intramuscular injection1
Minor violations134
 No increase to full methotrexate92
 Inappropriate increase methotrexate2
 Inappropriate step in patient with methotrexate intolerance1
 Lower dose sulfasalazine1
 Inadequate prednisolone dose1‡
 No DMARD temporarily1
Major violations62
 No medication for weeks2
 Mesalazine instead of sulfasalazine1
 Permanent stop of DMARD1
 Prednisolone not tapered to 7.5 mg
 Anti-TNF started at week 131
 Inappropriate step in patient with methotrexate intolerance11
  • *Prednisolone dose 0 mg/day.

  • †Prednisolone dose 0 and 5 mg/day.

  • ‡Prednisolone dose 10mg/day.

  • §Prednisolone dose 15 mg/day.

  • DMARD, disease-modifying antirheumatic drug; TNF, tumour necrosis factor.