Table 1.

Eligibility criteria

Inclusion criteria

NOR-DRUM A

All of the following conditions must apply to the prospective patient at screening;  1. A clinical diagnosis of one of the following: RA, SpA, PsAa, UC, CD or Ps  2. Male or non-pregnant female  3. Age ≥ 18 and < 75 years at screening  4. A clinical indication to start INX  5. Patient not in remission according to diagnosis-specific disease activity scores  6. Patient capable of understanding and signing an informed consent form

NOR-DRUM B

All of the following conditions must apply to the prospective patient at screening;  1. A clinical diagnosis of one of the following: RA, SpA, PsAa, UC, CD or Ps  2. Male or non-pregnant female  3. Age ≥ 18 and < 75 years at screening  4. On maintenance therapy with INX for a minimum of 30 weeks and a maximum of three years  5. A clinical indication for further INX treatment  6. Patient capable of understanding and signing an informed consent form

Exclusion criteria

NOR-DRUM A

A patient will be excluded from the study if they meet any of the following criteria:  1. Major co-morbidities, such as previous malignancies within the last five years, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease, severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, laboratory abnormalities/significant renal or hepatic disease and/or other diseases or conditions where treatment with INX is either found contra-indicated by the clinician or which make adherence to the protocol difficult  2. A positive screening for tuberculosis or viral hepatitis  3. Inadequate birth control, pregnancy or patient considering becoming pregnant during the study period  4. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult  5. Prior use of INX within the last six months  6. For patients with UC and CD: functional colostomy or ileostomy or extensive colonic resection with < 25 cm of the colon left in situ

NOR-DRUM B

A patient will be excluded from the study if they meet any of the following criteria:  1. Major co-morbidities, such as previous malignancies within the last five years, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease, severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, laboratory abnormalities/significant renal or hepatic disease and/or other diseases or conditions where treatment with INX is either found contra-indicated by the clinician or which make adherence to the protocol difficult  2. Inadequate birth control, pregnancy or patient considering becoming pregnant during the study period  3. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult  4. For patients with UC and CD: functional colostomy or ileostomy. Extensive colonic resection with < 25 cm of the colon left in situ.

^aPsA with predominantly axial manifestations should be included and assessed as SpA

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