Treat early arthralgia to reverse or limit impending exacerbation to rheumatoid arthritis

Conditions: Rheumatoid Arthritis - Clincally Suspect Artralgia

Registration Number: NL-OMON20145

Lead Sponsor: eiden University Medical Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 230

Inclusion Criteria

1.Age >=18 years

2.Patients without clinically detectable arthritis but with arthralgia of small hand or feet joints of recent-onset (<1 year) that according to the rheumatologist is suspect to be an early presentation of RA (this symptom complex is called Clinically Suspect Arthralgia, CSA)

Exclusion Criteria

1.Symptoms or signs making diagnoses other than RA more likely. These are amongst others >6 tender points or Heberden or Bouchard nodules (the presence of such characteristics preclude CSA)

2.Presence of, or history of, clinically apparent arthritis (this precludes CSA)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency of clinically detectable arthritis fulfilling the 2010 criteria for RA or of unclassified arthritis with a SJC of more than 2 joints, both persisting for at least 2 weeks, obtained after 2 years.

Secondary Outcome Measures

Name	Time	Method
•Percentage of patients in DMARD-free sustained remission after 2 years (DMARD-free sustained remission is the persistent absence of clinically detectable synovitis)<br /><br>•Percentage of patients with symptom reduction <br /><br>•Functional ability measured using health assessment questionnaires (HAQ)<br /><br>•Change in quality of life<br /><br>•Work loss (absenteeism), presenteeism, work related financial loss<br /><br>•Changes in Sharp van der Heijde scores on hand and foot radiographs <br /><br>•Adverse events<br /><br>•Cost-efficacy <br>