Treatment in the Rotterdam Early Arthritis CoHort

Not Applicable

Completed

• Conditions: Recent onset arthritis, rheumatoid arthritis; Musculoskeletal Diseases; Other rheumatoid arthritis

• Registration Number: ISRCTN26791028
• Lead Sponsor: Erasmus Medical Centre (Netherlands)

Brief Summary

2009 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/19538718 protocol 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22673898 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24788619 1-year results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27283332 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31242943 results on association between DNA methylation and methotrexate response (added 28/06/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29760159 results (added 12/08/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33484138/ results on correlation between risk factors and clinical course (added 25/01/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33725091/ results on cost utility (added 17/03/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34352094/ results on DMARD-free remission (added 06/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-23
• Study Completion: 2011-07-01
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 568

Inclusion Criteria

1. Participant of the REACH cohort (patients with inflammatory joint complaints less then one year)
2. All patients must at least have one (out of 66) swollen joint

Added 23/04/2009:
3. Aged 18 years or older, either sex

Exclusion Criteria

1. Definite diagnosis of crystal arthropathy, (post) infective arthritis or autoimmune rheumatic disorder
2. Previous therapy with disease modifying anti-rheumatic drugs (DMARDs) or corticosteroids
3. Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception
4. Concomitant treatment with an other experimental drug
5. History or presence of malignancy within the last five years
6. Elevated hepatic enzyme levels (aspartate aminotransferase [ASAT], alanine aminotransferase [ALAT] greater than two times normal value)
7. Thrombopoenia less than 150 x 10^9/l
8. Leucopoenia less than 3.0 x 10^9/l
9. Serum creatinine level greater than 150 umol/l

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Functional ability as measured by HAQ and DAS over time (area under the curve), assessed every 3 months<br> 2. Progression of radiological joint damage as measured by Sharp/van der Heijde score, assessed every 6 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. American College of Rheumatology (ACR) arthritis core-set, assessed every 3 months<br> 2. Quality of Life, as measured with 36-item Short Form (SF-36), European Quality of Life scale (EuroQoL), assessed every 3 months<br> 3. Costs<br>