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Danish Multicenter Study of Adalimumab in Spondyloarthritis

NCT00477893 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2012-03-28

No results posted yet for this study

Summary

Spondyloarthropathies (SpA) are often diagnosed with a considerable delay (often 8-10 years from symptom onset), because the available clinical, biochemical and radiological methods are not sufficiently sensitive. TNF-a antagonists have recently been introduced for treatment of SpA, and current data indicate a higher efficacy than previously available therapies. The improved treatment options have increased the need for improved methods for diagnosis, monitoring and prognostication of these diseases, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.

Conditions

  • Spondyloarthritis

Interventions

DRUG

Adalimumab

sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study

DRUG

Placebo

sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Glostrup University Hospital, Copenhagen

    lead OTHER

Principal Investigators

  • Inge Juul Sørensen, Dr. · Department of Rheumatology, Glostrup University Hospital

  • Susanne Juhl Pedersen, Dr. · Department of Rheumatology, Glostrup University Hospital

  • Mikkel Ostergaard, Professor · Department of Rheumatology, Glostrup University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-01-31
Completion
2013-01-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00477893 on ClinicalTrials.gov