The Norwegian Drug Monitoring Study

Summary

Infliximab and other TNF-inhibitors have revolutionised the treatment of several immunological inflammatory diseases. Still, more than half of the patients either do not respond sufficiently to infliximab therapy or loose efficacy over time. The large individual variation in the serum drug concentrations on standard doses and the development of anti-drug antibodies are thought to be main reasons for these treatment failures. An individualised treatment strategy based on systematic assessments of serum drug concentrations, therapeutic drug monitoring, has been proposed as a clinical tool to optimise efficacy of infliximab treatment. Therapeutic drug monitoring seems reasonable both from a clinical and an economical point of view, but the effectiveness of this treatment strategy still remain to be shown. The NOR-DRUM study is planned as a national, randomised controlled multicentre trial in two parts aiming to assess the effectiveness of therapeutic drug monitoring in order to achieve remission in patients with immunological inflammatory diseases starting infliximab treatment (part A) and in order to maintain disease control in patients on maintenance infliximab treatment (part B). The results of the NOR-DRUM study will hopefully contribute to an implementation of a personalised medicine approach to treatment with infliximab and other biological drugs.

Conditions

• Rheumatoid Arthritis
• Spondyloarthritis
• Ankylosing Spondylitis
• Crohn Disease
• Ulcerative Colitis
• Psoriasis
• Psoriatic Arthritis

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

Sponsors & Collaborators

• Oslo University Hospital

  collaborator OTHER

• University Hospital, Akershus

  collaborator OTHER

• Diakonhjemmet Hospital

  lead OTHER

Principal Investigators

• Espen A Haavardsholm, MD, PhD · Diakonhjemmet Hospital

• Tore K Kvien, MD, PhD · Diakonhjemmet Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-01

Primary Completion

2020-12-14

Completion

2020-12-14

Countries

• Norway

Study Locations