Rheumatoid Arthritis - Clincally Suspect Artralgia
Conditions
Interventions
At the study start all patients will be randomized to treatment with one IM glucocorticoid injection (120 mg methylprednisolone) followed by 12 months of methotrexate or placebo (injection and tablets
Sponsors
Leiden University Medical Centre
Eligibility
Inclusion criteria
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) 3.Extremity MRI positive for subclinical inflammation. 4.Ability and willingness to give written informed consent and to comply with the requirements of the study protocol
Exclusion criteria
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) 3.Previous or current treatment with DMARDs or corticosteroids (this precludes CSA) 4.Contra indications for MRI: certain metal implants, pacemakers, GFR3 times normal value) 8.Serum creatinine level >150 umol/l or estimated clearance of <60% 9.Serious infections such as hepatitis, pyelonefritis in the past three months or chronic infectious disease such as chronic chest infections with bronchiectasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| •Percentage of patients in DMARD-free sustained remission after 2 years (DMARD-free sustained remission is the persistent absence of clinically detectable synovitis) •Percentage of patients with symptom reduction •Functional ability measured using health assessment questionnaires (HAQ) •Change in quality of life •Work loss (absenteeism), presenteeism, work related financial loss •Changes in Sharp van der Heijde scores on hand and foot radiographs •Adverse events •Cost-efficacy | — |
Contacts
Public ContactA. Helm, van der
LUMC
Outcome results
None listed