Last updated on February 2020

The Norwegian Drug Monitoring Study


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Rheumatoid Arthritis (Pediatric) | Rheumatoid Arthritis | Ulcerative Colitis | Ulcerative Colitis (Pediatric) | Crohn's Disease | Ankylosing spondylitis | Spondylarthritis | Psoriasis | Crohn's Disease (Pediatric) | Psoriasis and Psoriatic Disorders | PSORIATIC ARTHRITIS
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

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

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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