5. Study objective(s) and hypothesis:The aim of this study is to assess the value of early, intensive and efficient treatment of patients with recent acquired arthritis, in preventing progression into destructive RA
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
•Primary endpoints: Disease activity:
Disease activity:
Area under the curve (AUC) DAS
Functionality:
AUC HAQ during 1 year of therapy
Joint damage:
Radiologic progression
Secondary outcome
•Secondary endpoints:
Absence of arthritis
WHO/ILAR Core-set
Self-assessed disease activity (RADAI)
Cost (medical direct/indirect)
Mediation reduction in time
Background summary
5. Study objective(s) and hypothesis:
The aim of this study is to assess the value of early, intensive and efficient
treatment of patients with recent acquired arthritis, in preventing progression
into destructive RA
6. Study background/rationale:
Recognition of rheumatoid arthritis (RA) early in the disease course is
becoming increasingly important since early and intensive treatment has shown
to prevent joint damage, achieves higher remission rates, and preserves
function and work participation. However, the obstacle of RA is early
recognition since the early phase of RA, the disease has a atypical
presentation. Furthermore, 60% of the patients with recent acquired arthritis
are self-limiting. The most effective therapies of RA are also the ones with
the highest risk of toxicity and/or infections. Consequently, for efficient
treatment it is important to pick only those patients who will develop RA.
In this trial the value of early, intensive and efficient treatment of patients
with recent acquired arthritis will be assessed, in preventing the progress to
destructive RA.
Early treatment will be derived by recruiting patients directly from the
general practitioner via the *Rotterdam Early Arthritis Cohort* (REACH). This
cohort includes patients who are 16 years and older with signs of inflammatory
joints existing less than one year.
The assessment of Intensive treatment will be accomplished by randomizing
patients in three treatment strategies of DMARD combination therapy which has
been shown to be effective in patients with established RA. The treatment is
aimed to achieve *no arthritis* in all subgroups. Patients will be monitored
every 3 months. If initial therapy fails ( DAS > 2.4) the next step in the
treatment strategy will be HUMIRA. If patients have a low disease activity (DAS
< 2.4) at two visits in row ( > 6 months) medication will be tapered. (see
attachment organization chart)
Efficient treatment will be accomplished by treating patients stratified by
their chance to develop RA. This chance will be calculated by using a
prediction rule which was developed based on probability of RA.[1] Patients
with a chance of more than 70% to develop a RA will be treated more intensively
than patients with a 50% chance or less. The attached abstract shows that this
efficient manner of treatment guided by a prediction rule, will keep the over-
and under treatment of patients to a minimum.[see attached abstract]
Study objective
5. Study objective(s) and hypothesis:
The aim of this study is to assess the value of early, intensive and efficient
treatment of patients with recent acquired arthritis, in preventing progression
into destructive RA
Study design
7. Study design:
• prospective
• parallel
• multi-center
If study is multicenter, attach list of all participating sites and names of
local investigators:
Erasmus MC
SFG
Maasstad
AsZ
Vlietland
Zorgsaam
Ziekenhuis walcheren
Oosterschelde ziekenhuis
• Single-blind
• Randomized
Intervention
17. Dose/regimen:
Per subgroup patients will be randomized in three treatment strategies of DMARD
combination therapy. Treatment strategies are aimed to achieve *no arthritis*
in all subgroups. Patients will be monitored every 3 months. If initial therapy
succeeds, medication will be reduced, if initial therapy fails ( DAS > 2.4) the
next step in the treatment strategy will be initiated. If patient has a good
response to the administered medication, an attempt is made to reduce the dose
of the drug(s).
Subgroup 1 (high probability (> 70%; RA group)
a. Methotrexate in combination with a cumulative high dose corticosteroids
b. Combination of MTX, SSZ, HCQ and single bridging i.m. corticosteroids
c. Combination of MTX, SSZ, HCQ and a cumulative high dose corticosteroids
Subgroup 2 (intermediate probability > 34% and < 70%)
a. Methotrexate
b. Plaquenil
b. Corticosteroids
Initial dose:
MTX 25 mg/ week
SSZ 2 dd 1 gr
HCQ 2 dd 200 mg
Prednison 1 dd 10 mg
Enbrel
Study burden and risks
Patients are threated confirm existing medication protocols. The extra Burden
consist of time necessairy for filling out questionaires
Patients tapering down methotrexate and anti-TNF will be asked permission to
undergo max 6 ultrasonographic examinations of the joints (30 min/examination)
dr. Molewaterplein 50
Rotterdam 3015 GE
NL
dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Listed location countries
Age
Inclusion criteria
To be able te sign informed consent
-Patients must meet the inclusion criteria for the REACH. That is: object arthritis, pain and or limitation of motion in 2 or more joints in combination with 2 of the following criteria: morningstiffness, tangential pain in MTP/MCP, pos fam anamneses, symm presentation, unexplained fatigue.
Exclusion criteria
Complaints> 1 year by trauma or overload, no possibility to communicate, definitive diagn of gout, infectious arthritis or systematic disease, use of antirheumatic preparates before start study, contra indication for medication.
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-005771-18-NL |
| CCMO | NL14580.078.06 |