Clinical Research Unit

Project supervisor: Signe Rifbjerg-Madsen1,2, MD, PhD Student

Clinically responsible physician: Kirstine Amris1,2, Consultant, MD

Senior Biostatistician: Robin Christensen1, BSc, MSc, PhD

Other collaborators: Bente Danneskiold-Samsøe1, Professor, MD, DMSc Henning Bliddal1, Professor, MD, DMSc Anton T. Christensen1,2 , MD, PhD Student Christian Cato Holm1, MSc,

Database manager DANBIO collaborators: Merete Lund Hetland3 Professor, MD, PhD, DMSc Niels Steen Krogh4, MSc, Database manager Affiliations:

Association between surrogate markers of inflammation as detected by ultrasound and results of an intensive weight loss program obese patients with knee osteoarthritis: a prospective cohort study based on the CAROT Trial v. 2.0 (january 17, 2017)

Factors associated with fatigue in patients with psoriasis arthritis: A nationwide DANBIO study


The objective of this study is to investigate whether PsA comorbidities, assessed by use of the CCI, are associated with disease activity, treatment response and treatment adherence in patients with PsA treated with their first TNFi. Furthermore, we will assess whether depression and/or anxiety have an influence on the treatment effect and adherence.

The aim of the study is to assess Work Disability, i.e. the extent of sick leave and receipt of a disability pension before and after having been diagnosed with pSS according to the American-European Classification Group criteria.
The severity and duration of flair-up symptoms (temporarily increase in symptoms after treatment) after local steroid injection therapy are unknown. Whether the region treated, severity of inflammation or distribution of medicine plays a role are unclear. The aim of this study is to register flair-up symptoms after steroid injection and relate any symptoms to region, present of inflammation and distribution of medicine seen on ultrasound examination. The results of this study will enable more sufficient information on flair-up symptoms to patients treated with steroid injection therapy

Persistent pain is a common symptom in patients with psoriatic arthritis (PsA) and may be caused by ongoing inflammation in joints, entheses and tendons. In some cases, ongoing pain may be due to “sensitization” of nerve cells involved in pain processing, which leads to increased pain perception even in the absence of disease activity. We aim to study pain mechanisms in relation to disease activity measured by clinical examination and ultrasound (US) of several musculoskeletal structures, in patients with PsA. Further, we intend to clarify if assessment of pain mechanisms and US are valuable tools to predict response to anti-inflammatory treatment in PsA.

Time plan

The study is enrolling PsA patients until February 2017

The Goback trial is a Randomised controlled trial enrolling 300 participants with difficulty in maintaining physically demanding jobs due to low back pain. The participants will be randomised and stratified according to their age and gender before being allocated in a 1:1 ratio to either control or additional occupational medicine intervention. Both groups will receive conventional treatment for their low back pain during the study. All participants will be thoroughly assessed for causes of low back pain and potential prognostic factors by questionnaires, clinical specialist assessments and magnetic resonance imaging (MRI) scans of the lumbar spine. Primary outcome is the accumulated duration of self-assessed sick leave (in days) due to low back pain during 6 months from baseline. Secondary outcomes include general self-rated back pain, disability and screening for potential prognostic factors: fear avoidance behaviour, disability, health status and degenerative MRI findings. For tertiary purposes selected outcomes will also be assessed after 1 and 2 years from baseline.


Henrik Rindel Gudbergsen, Henning Bliddal, Marie Skougaard Nielsen, Lars Erik Kristensen


Knowledgecentre for telemedicin and The European Commissions Research and Innovation Framework Programme


The ELECTOR project aims to develop a web-based platform for home-based monitoring of self-reliant patients with rheumatoid arthritis. The solution will encompass point-of-care devices for the measurement of biochemistry at home and a web-based user interface for capturing patient reported outcomes.

The proposed eHealth platform will encompass point-of-care devices used for measuring biochemistry at home and a web-based graphical user interface for communication, knowledge transfer and for the reporting of questionnaires as well as joint assessments. This solution will constitute a reliable, safe and straightforward method for obtaining self-assessments and facilitate easy, rapid and customizable access to health care assistance at times of need.

The end result is a platform that will provide an integrated and direct collection of data into patient notes in the set-up of an e-Health outpatient clinic for citizens with rheumatoid arthritis. This solution will constitute a reliable, safe and straightforward method for obtaining self-assessments and facilitate easy and rapid access to health care assistance at times of need for the individual patient.




Henning Bliddal (principal investigator), Signe Rifbjerg-Madsen, Anton W Christensen, Bjarke B Hansen, Mikael Boesen




Joints with osteoarthritis are characterized by inflammation in many instances. The inflammation may cause tissue damage, while also be a major contributor to the clinical problems with the joint, especially pain. Over the years, joints with inflammation have been treated with injection of glucocorticosteroids to deal with this problem. This treatment, however, is not a lasting solution to the inflammation and there is a demand for other medications with anti-inflammatory properties. In this project, subjects with defined signs of inflammation in the osteoarthritic knee joint will be enrolled in a RCT. Test drug is acting on Il-1 and the effect will be followed both clinically and by imaging, in this case dynamic contrast enhanced MRI. The randomization has 4 arms with one placebo and three active, with a distribution 1:2:2:2. The test medication is given as injection every 2 weeks for a year.

Principal investigator: Eva Ejlersen Wæhrens(EEW), OT, PhD; Study manager/ Facility coordinator: Alice Røpke (AR), OT; Co-Investigator: Karen Ellegaard(KE), PT, PhD; Biostatistician: Robin ChristensenRC), M.Sc., PhD; Co-Investigator: Marius Henriksen(MH), PT, PhD; Co-Investigator/ Medically responsible: Signe Rifbjerg-Madsen (SRM), MD; Co-Investigator: Henning Bliddal(HB), MD, D.M.Sc. Co-Investigator/: Bente Danneskiold-Samsøe(BDS), MD, D.M.Sc


Female patients with rheumatoid arthritis will be randomized to hand exercise therapy as an add on to a compensatory intervention program focused on joint protection, assistive devices and alternative methods of doing. Hand exercise effects on self-reported and observed ADL ability, disease activity and grip strength will be assessed. Furthermore, the perfusion of the synovial tissue as indicator of inflammation in the wrist and finger joints will be determined by means of US Doppler.