Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000284066
Ethics application status
Approved
Date submitted
3/04/2010
Date registered
8/04/2010
Date last updated
26/08/2024
Date data sharing statement initially provided
26/08/2024
Date results information initially provided
26/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A longitudinal study of patients with rheumatoid arthritis starting biological therapy; Assessment of joint inflammation by use of ultrasonography
Scientific title
ULRABIT: ULtrasonography of Rheumatoid Arthritis (RA) patients starting BIological Treatment: A longitudinal study assessing joint inflammation
Secondary ID [1] 1572 0
None
Universal Trial Number (UTN)
Trial acronym
ULRABIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis in patients with rheumatoid arthritis 257090 0
Synovitis and vascularization by use of ultrasonography including power Doppler 257091 0
Condition category
Condition code
Inflammatory and Immune System 257244 257244 0 0
Rheumatoid arthritis
Musculoskeletal 257245 257245 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 256258 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258143 0
To assess whether ultrasonographic examination of 36 joints and 4 tendons will be able to indicate responders to biological medication earlier than regular assessments (clinical and laboratory)
Timepoint [1] 258143 0
Assessments at baseline and after 1, 2, 3, 6 and 12 months.
Secondary outcome [1] 263798 0
Degree of power Doppler activity at baseline and radiographic detorioration (hands and feet) after 12 months.
Timepoint [1] 263798 0
Baseline power Doppler
12 months radiography
Secondary outcome [2] 263799 0
Associations between ultrasonographic findings and clinical as well as laboratory assessments.
Timepoint [2] 263799 0
Baseline and at 1, 2, 3, 6 and 12 months

Eligibility
Key inclusion criteria
Patients with rheumatoid arthritis
Clinical indication for starting biological treatment
Minimum age
18 Years
Maximum age
85 Years
Sex
Both 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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2010
Actual
11/01/2010
Date of last participant enrolment
Anticipated
Actual
1/07/2014
Date of last data collection
Anticipated
Actual
1/08/2015
Sample size
Target
200
Accrual to date
Final
296
Recruitment outside Australia
Country [1] 2567 0
Norway
State/province [1] 2567 0

Funding & Sponsors
Funding source category [1] 256768 0
Commercial sector/Industry
Name [1] 256768 0
Abbott Norge AS
Country [1] 256768 0
Norway
Funding source category [2] 256769 0
Commercial sector/Industry
Name [2] 256769 0
Roche Norge AS
Country [2] 256769 0
Norway
Funding source category [3] 256770 0
Commercial sector/Industry
Name [3] 256770 0
Pfizer
Country [3] 256770 0
Norway
Primary sponsor type
Commercial sector/Industry
Name
Abbott Norge AS
Address
Martin Lingesv. 25, Box 1, N-1330 Fornebu
Country
Norway
Secondary sponsor category [1] 256035 0
Commercial sector/Industry
Name [1] 256035 0
Roche Norge AS
Address [1] 256035 0
Kristoffer Robinsv. 13, Box 41 Haugenstua, N-0915 Oslo
Country [1] 256035 0
Norway
Secondary sponsor category [2] 256038 0
Commercial sector/Industry
Name [2] 256038 0
Pfizer
Address [2] 256038 0
Lilleakerv. 2B, Box 3, N-1324 Lysaker
Country [2] 256038 0
Norway

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258769 0
Helse Sor-Ost, Regional Ethical Committee
Ethics committee address [1] 258769 0
Oslo universitetssykehus, Ullev?l, Kirkeveien 166, N- 0450 Oslo
Ethics committee country [1] 258769 0
Norway
Date submitted for ethics approval [1] 258769 0
Approval date [1] 258769 0
07/10/2009
Ethics approval number [1] 258769 0
2009/ 1254

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31015 0
Prof Hilde Berner Hammer
Address 31015 0
Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319 Oslo
Country 31015 0
Norway
Phone 31015 0
+4797723158
Fax 31015 0
Email 31015 0
[email protected]
Contact person for public queries
Name 14262 0
Hilde Berner Hammer
Address 14262 0
Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319 Oslo
Country 14262 0
Norway
Phone 14262 0
+47 22451748
Fax 14262 0
Email 14262 0
[email protected]
Contact person for scientific queries
Name 5190 0
Hilde Berner Hammer
Address 5190 0
Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319 Oslo
Country 5190 0
Norway
Phone 5190 0
+47 22451748
Fax 5190 0
Email 5190 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Clinical, laboratory and ultrasound data may be shared
When will data be available (start and end dates)?
From now to 1.1.2025
Available to whom?
Scientists
Available for what types of analyses?
Clinical, laboratory and ultrasound
How or where can data be obtained?
By the PI of the study


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCalprotectin (S100A8/A9) has the strongest association with ultrasound-detected synovitis and predicts response to biologic treatment: Results from a longitudinal study of patients with established rheumatoid arthritis.2017https://dx.doi.org/10.1186/s13075-016-1201-0
EmbaseUltrasound of the hand is sufficient to detect subclinical inflammation in rheumatoid arthritis remission: A post hoc longitudinal study.2017https://dx.doi.org/10.1186/s13075-017-1428-4
EmbaseAssessing synovitis in the hands in patients with rheumatoid arthritis by ultrasound: An agreement study exploring the most inflammatory active side from two Norwegian trials.2019https://dx.doi.org/10.1186/s13075-019-1930-y
EmbaseSynovial hypertrophy without Doppler in the feet changes during treatment: Results from a longitudinal study of rheumatoid arthritis patients initiating biological treatment.2020https://dx.doi.org/10.1093/rheumatology/kez607
EmbaseTrajectories of fatigue in actively treated patients with established rheumatoid arthritis starting biologic DMARD therapy.2020https://dx.doi.org/10.1136/rmdopen-2020-001372
EmbaseFatigue is cross-sectionally not associated with objective assessments of inflammation, but changes in fatigue are associated with changes of disease activity assessments during biologic treatment of patients with established rheumatoid arthritis.2021https://dx.doi.org/10.1007/s10067-020-05402-y
N.B. These documents automatically identified may not have been verified by the study sponsor.