No registrations found.
ID
Source
Brief title
Health condition
rheumatoid arthritis, undifferentiated oligo- or polyarthritis
Sponsors and support
VUmc
Intervention
Outcome measures
Primary outcome
Progression of radiographic damage score after 2 years.
Secondary outcome
1. Functional capacity;
2. Quality of life;
3. Disease activity.
Background summary
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.
Study objective
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.
Study design
N/A
Intervention
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.
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
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
Inclusion criteria
1. Age 18+;
2. Symptom duration less than 3 years;
3. Swelling 2-5 joints.
Exclusion criteria
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.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL113 |
| NTR-old | NTR144 |
| Other | : N/A |
| ISRCTN | ISRCTN56637846 |