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

ULRABIT: ULtrasonography of Rheumatoid Arthritis (RA) patients starting BIological Treatment: A longitudinal study assessing joint inflammation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12610000284066
Acronym
ULRABIT
Enrollment
296
Registered
2010-04-08
Start date
2010-01-11
Completion date
2014-07-01
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

Patients with active rheumatoid arthritis (RA) in spite of traditional disease modifying medication like methotrexate, with high clinical and laboratory disease activiy as well as increased symptoms of RA, will, according to national guidelines, be requested for treatment with biological medication (if there are no contraindications). All the biological treatments are high-cost medications and includes anti-Tumor Necrosis Treatment (anti-TNF): infliximab (Remicade), etanercept (Enbrel), adalimum

Patients with active rheumatoid arthritis (RA) in spite of traditional disease modifying medication like methotrexate, with high clinical and laboratory disease activiy as well as increased symptoms of RA, will, according to national guidelines, be requested for treatment with biological medication (if there are no contraindications). All the biological treatments are high-cost medications and includes anti-Tumor Necrosis Treatment (anti-TNF): infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira), golimumab (Simponi), anti-B-cell therapy; rituximab (MabThera), anti-T-cell therapy; abatacept (Orencia) and anti-Interleukin 6 (IL-6)(tocilizumab). The patient's rheumatologist will decide the indication for starting biological medication. Up till now clinical examination and assessment of inflammatory varibles (C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR)) are used to examine the response to this expensive treatment. However, ultrasonography (US) is found to be a valid and reliable method for detecting arthritis (synovitis, effusion and vascularization) with sensitivity almost like Magnetic Resonance Imaging (MRI), and highly more sensitive than clinical assessments. All the patients at dept. of rheumatology, Diakonhjemmet hospital, Oslo, Norway, starting one of the biological medications will be asked to participate in the present study. They will all be assessed by use of US of 36 joints (bilateral wrists; radiocarpal, intercarpal, radioulnar joints, MCP 1-5, PIP 2-3, elbow, knee, ankle; talocrural, MTP 1-5, extensor carpi ulnaris and tibialis posterior tendons) with scoring (semiquantitative 0-3) of the degree of synovitis and vascularization (power Doppler). In addition, the patients will be assessed traditionally (clinical, joint count, questionnaires, laboratory markers). All patients will be examined at baseline and after 1, 2, 3, 6 and 12 months. Patients will be recruited consecutively during one year.

Sponsors

Abbott Norge AS
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Patients with rheumatoid arthritis Clinical indication for starting biological treatment

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 17, 2026