Therapeutic drug monitoring of infliximab compared to standard clinical treatment with infliximab: study protocol for a randomised, controlled, open, parallel-group, phase IV study (the NOR-DRUM study)

Table 2 Definition of primary outcomes

Disease	Disease activity scoring tool	Value defining remission	Values defining disease worsening
RA	Disease Activity Score using 28 joint (DAS 28)	< 2.6	Increase ≥ 1.2 from inclusion and a minimum score of 3.2
PsA	Disease Activity Score using 28 joint (DAS 28)	< 2.6	Increase ≥ 1.2 from inclusion and a minimum score of 3.2
SpA	Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP)	< 1.3	Increase of ≥ 1.1 from inclusion and a minimum of 2.1
CD	Harvey-Bradshaw Index (HBI) score	≤ 4	Increase of ≥ 3 points from inclusion and a minimum partial score of 5 points
UC	Partial Mayo score	≤ 2 with no sub scores > 1	Increase of ≥ 3 points from inclusion and a minimum partial score of 5 points
Ps	Psoriasis Area and Severity Index (PASI)	≤ 4	Increase ≥ 4 points from inclusion and a minimum score of 7 points

CD Crohn’s disease, Ps psoriasis, PsA psoriatic arthritis, RA rheumatoid arthritis, SpA spondyloarthritis, UC ulcerative colitis

ISSN: 1745-6215