Clinical Trial Finder

Inclusion Criteria:

NOR-DRUM A 1. A clinical diagnosis of one of the following; rheumatoid arthritis, spondyloarthritis (including ankylosing spondylitis), psoriatic arthritis*, ulcerative colitis, Crohn's disease or chronic plaque psoriasis 2. Male or non-pregnant female 3. ≥18 and < 75 years of age at screening 4. A clinical indication to start INX 5. Subject not in remission according to diagnosis-specific disease activity scores 6. Subject capable of understanding and signing an informed consent form

• - Patients with psoriatic arthritis with predominantly axial manifestations should be included and assessed as spondyloarthritis NOR-DRUM B 1.

A clinical diagnosis of one of the following; rheumatoid arthritis, spondyloarthritis (including ankylosing spondylitis), psoriatic arthritis*, ulcerative colitis, Crohn's disease or chronic plaque psoriasis 2. Male or non-pregnant female 3. ≥18 and < 75 years of age at screening 4. On maintenance therapy with infliximab for a minimum of 30 weeks and a maximum of 3 years 5. A clinical indication for further infliximab treatment 6. Subject capable of understanding and signing an informed consent form

• - Patients with psoriatic arthritis and predominantly axial manifestations should be included and assessed as spondyloarthritis

  Exclusion Criteria:

  NOR-DRUM A 1.

Major co-morbidities, such as previous malignancies within the last 5 years, severe diabetes mellitus, severe infections (including HIV), uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, laboratory abnormalities or significant renal or hepatic disease and/or other diseases or conditions where treatment with infliximab is either found contra-indicated by the clinician or which make adherence to the protocol difficult 2. A positive screening for TB and hepatitis 3. Inadequate birth control, pregnancy or subject 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 infliximab within the last 6 months NOR-DRUM B 1. Major co-morbidities, such as previous malignancies within the last 5 years, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, laboratory abnormalities or significant renal or hepatic disease and/or other diseases or conditions where treatment with infliximab is either found contra-indicated by the clinician or which make adherence to the protocol difficult 2. Inadequate birth control, pregnancy or subject 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

Arms

Experimental: Therapeutic drug monitoring

Administration of infliximab according to a treatment strategy based on therapeutic drug monitoring and assessments of anti-drug antibodies

Active Comparator: Standard care

Administration of infliximab according to standard clinical care, without knowledge of drug levels or status of anti-drug antibodies

Interventions

Other: - Therapeutic drug monitoring

Treatment algorithm based on assessments of serum drug levels and anti-drug antibodies

Other: - Standard care

Treatment algorithm based on standard clinical assessments, without knowledge of serum drug levels and anti-drug antibodies