Clinical Trial Details

A longitudinal study of patients with rheumatoid arthritis starting biological therapy; Assessment of joint inflammation by use of ultrasonography

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Trial Information

Broad Health Condition Inflammatory and Immune System
Musculoskeletal

Specific Health ConditionRheumatoid arthritis
Other muscular and skeletal disorders

Trial Focus

Recruitment statusRecruiting


Trial location outside Australia
Norway

Anticipated date of first participant enrolment1/01/2010

Anticipated date of last participant enrolment1/01/2010

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

Patients with active rheumatoid arthritis in spite of disease modifying anti-rheumatic drugs (DMARD) treatment should after international guidelines be treated with biological medication. The patients are followed regularly by use of clinical and laboratory examination to assess the response to treatment. Ultrasonography has been shown to be a valid and reliable method for assessing the degree of inflammation (grey scale) and vascularization (power Doppler). The present study will explore ultrasonography as a method to differentiate between responders and non-responders early in the treatment period. In addition, the ultrasonographic findings will be compared to radiographic, laboratory and clinical responses to therapy.
Eligibility

Key inclusion criteria

Patients with rheumatoid arthritis
Clinical indication for starting biological treatment

Minimum age18 Years

Maximum age85 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Not prosthesis in more than 5 of the joints examined by ultrasonography.
Not enough knowledge of the Norwegian language to answer questionnaires.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Abbott Norge AS
Primary Sponsor Address: Martin Lingesv. 25, Box 1, N-1330 Fornebu
Primary Sponsor Country: Norway

Trial IDACTRN12610000284066

Contact person for information and recruitment
Hilde Berner Hammer
Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319 Oslo
+47 22451748

Further information iconhbham@online.no
Norway