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van CCT (UK)

van CCT (UK)

Strategies in early arthritis management.

- candidate number1235
- NTR NumberNTR144
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR24-aug-2005
- Secondary IDsN/A 
- Public TitleStrategies in early arthritis management.
- Scientific TitleStrategies in early arthritis management.
- hypothesisAfter 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.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis, Arthritis, Polyarthritis
- Inclusion criteria1. Age 18+;
2. Symptom duration less than 3 years;
3. Swelling 2-5 joints.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2004
- planned closingdate1-jul-2007
- Target number of participants80
- InterventionsMethotrexate, 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.
- Primary outcomeProgression of radiographic damage score after 2 years.
- Secondary outcome1. Functional capacity;
2. Quality of life;
3. Disease activity.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDhr. D. Schaardenburg, van
- CONTACT for SCIENTIFIC QUERIESDhr. D. Schaardenburg, van
- Sponsor/Initiator Jan van Breemen Instituut
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryThere 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.
- Main changes (audit trail)
- RECORD19-aug-2005 - 9-dec-2009

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