Arthralgia of hands or feet of patients that are suspect to progress to reumatoid arthritis according to the treating rheumatologist and because of subclinical inflammation on MRI of hands and feet (Clinical Suspect Artralgia CSA)
Conditions
Interventions
Trade Name: Methotrexaat
Product Name: Methotrexaat
Product Code: L04AX03
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Pharmaceutical form of the
Sponsors
Leiden University medical Centre
Eligibility
Sex/Gender
All
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 (=65 years) no F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Main Objective: 1.This study will determine the efficacy of intervention with antirheumatic treatment in the preclinical phase of RA in preventing the progression from subclinical joint inflammation in patient with clinically suspect arthralgia to clinically apparent persistent arthritis. ;Secondary Objective: 2.To characterise the efficacy of DMARD treatment on the regression of MRI features of inflammation (synovitis, bone marrow edema, tenosynovitis) and on symptoms of arthralgia 3.To characterise immune and inflammatory responses in patients with subclinical MRI inflammation without clinical arthritis before, during and after therapy. ;Primary end point(s): Primary endpoint The primary end point is the frequency of clinically detectable arthritis fulfilling the 2010 criteria for RA or of unclassified arthritis with a SJC of =2 joints, both persisting for at least 4 weeks, obtained after 2 years. ;Timepoint(s) of evaluation of this end point: evaluation of endpoints every 4 months during 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: •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 (more than 2 points on 5 point Likert scale) •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 Exploratory endpoints •Reduction in MRI inflammation compared to the baseline MRI •Signatures of immune responses (such as characteristics of the ACPA response and other post-translational modifications such as anti-carbamylated protein antibodies) and inflammatory responses as defined through the analysis of serum and peripheral blood cell subsets (RNA expression profiling) and proteomics. ;Timepoint(s) of evaluation of this end point: evaluation of endpoints every 4 months during 2 years | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
LUMC
Outcome results
None listed