Primary: to compare improvement on the Health Assessment Questionnaire (HAQ) between HandScan guided tight control and treat-to-target treatment and the conventional ACR/EULAR remission guided tight control and treat-to-target treatment of RA after…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the Health Assessment Questionnaire (HAQ)
Secondary outcome
Cost-effectiveness
Radiological damage
Time until remission
Background summary
The treatment of rheumatoid arthritis (RA) has significantly been improved over
the past years due to earlier and more intensive treatment including the use of
biologicals. Due to the demanding approach of tight control and treat-to-target
treatment in an early stage, these principles have not yet been adequately
implemented in general hospitals. Recently, the HandScan has been developed, to
objectively assess disease activity in RA patients in only 1.5 minutes. Our
hypothesis is that clinical efficacy of HandScan remission guided treatment is
at least as good as and more cost-effective than the conventional ACR/EULAR
remission guided treatment. This makes this novel imaging technology more
cost-effective allowing implementation in standard rheumatology care.
Study objective
Primary: to compare improvement on the Health Assessment Questionnaire (HAQ)
between HandScan guided tight control and treat-to-target treatment and the
conventional ACR/EULAR remission guided tight control and treat-to-target
treatment of RA after 1 * years. Secondary: to compare cost effectiveness of
both arms, based on customized cost questionnaires. Tertiary: to evaluate
radiographic joint damage based on a fully automated radiographic scoring of
the hand joints as well as the Sharp van der Heijde score in both study arms.
Study design
Randomized double-blind controlled trial comparing the ACR/EULAR remission
criteria guided treatment with the HandScan remission guided treatment in
rheumatoid arthritis.
Intervention
HandScan guided treatment strategy
Study burden and risks
All included patients visit the outpatient clinic every month to assess disease
activity as needed for the tight control strategy in clinical practice. At
baseline, 3 months, 6, 12, and 18 months, patients are asked to fill in the
Health Assessment Questionnaire (HAQ; 1st outcome), the health survey SF36,
EQ5D and the questionnaire on direct and indirect costs. Radiographs of hand
and feet are taken at baseline and at 18 months according to clinical practice.
Since the HandScan guided treatment is novel, treatment strategy decision may
in theory deviate too much from proven standard tight control care leading to
undesired over- or under treatment. This will be monitored extensively during
the study and the treatment strategy will be adjusted if needed (see paragraphs
3.16 en 5.5).
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Male or non-pregnant, non-nursing female
>= 18 years of age
Early RA patients, fulfilling 2010 ACR/EULAR criteria: Evidence of clinically apparent arthritis < 1y as assessed by a rheumatologist
Patients able and willing to give written informed consent and comply with the requirements of the study protocol
Exclusion criteria
Significant visual deformations of hands or fingers
Rheumatic autoimmune disease other than RA
Current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
Known porphyria (HandScan risk analysis).
Contraindication for methotrexate or prednisolone
Glucocorticoids used for RA < 6 weeks prior to baseline (NB: inhaled glucocorticoids are allowed)
Previous treatment with any DMARD that is used in the treatment of RA
Previous treatment with any biological drug that is used in the treatment of RA
• Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening.
Patients using photodynamic therapy medication (HandScan risk analysis).
History of alcohol, drug, or chemical abuse within the 6 months prior to screening
Neuropathies or other painful conditions that might interfere with pain evaluation
Psychological or intellectual disorders that impede to participate in the study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL50026.041.14 |
| OMON | NL-OMON29197 |