After 2 years of treatment with a combination of antirheumatic drugs including adalimumab with the aim of achieving and maintaining remission in patients with mild arthritis, there is less radiographic progression than in patients treated with…
ID
Bron
Verkorte titel
Aandoening
rheumatoid arthritis, undifferentiated oligo- or polyarthritis
Ondersteuning
VUmc
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Progression of radiographic damage score after 2 years.
Achtergrond van het onderzoek
There are indications that patients with mild early arthritis are undertreated with joint damage as a consequence. Therefore, we have designed a trial to test the hypothesis that a treatment strategy aimed at achieving and maintaining remission with (a combination of) disease modifying antirheumatic drugs including adalimumab leads to less joint damage than the usual care in patients with early, mild arthritis. In the active group, treatment is switched on the basis of a disease activity score (DAS44), which should become and remain under 1.6. The study duration is 2 years per patient.
Doel van het onderzoek
After 2 years of treatment with a combination of antirheumatic drugs including adalimumab with the aim of achieving and maintaining remission in patients with mild arthritis, there is less radiographic progression than in patients treated with ususal care.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Methotrexate, in case of insufficient response followed by adalimumab, and then by a combination of methotrexate, sulfasalazine, hydroxychloroquin and prednisone versus usual care according to preference physician.
Publiek
Dr. Jan van Breemenstraat 2
D. Schaardenburg, van
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
The Netherlands
+31 (0)20 5896589
d.v.schaardenburg@janvanbreemen.nl
Wetenschappelijk
Dr. Jan van Breemenstraat 2
D. Schaardenburg, van
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
The Netherlands
+31 (0)20 5896589
d.v.schaardenburg@janvanbreemen.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age 18+;
2. Symptom duration less than 3 years;
3. Swelling 2-5 joints.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Earlier treatment with disease modifying antirheumatic drugs except hydrxychloroquine;
2. Prednisone use within 3 months;
3. Bacterial arthritis, crystal induced arthritis, reactive arthritis, sarcoidosis, osteoarthritis or systemic autoimmune disease other than RA;
4. Pregnancy;
5. Erosive disease.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL113 |
NTR-old | NTR144 |
Ander register | : N/A |
ISRCTN | ISRCTN56637846 |