No registrations found.
Source
Brief title
Health condition
Rheumatoid Arthritis - Clincally Suspect Artralgia
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
•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
Background summary
Proof-of-concept study to determine whether intervention with methylprednisolon/MTX vs Placebo in the preclinical phase in symptomatic patients at risk for RA is effective in progression from subclinical inflammation to clinically apparent persistent arthritis.
Study objective
This proof-of-concept study aims to determine whether intervention in the preclinical phase in symptomatic patients at risk for RA is effective in progression from subclinical inflammation to clinically apparent persistent arthritis.
Study design
Every 4 months during 2 years follow-up
Intervention
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).
A. Helm, van der
LUMC Dept. Rheumatology
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
+31 71 526 3598
A.H.M.van_der_Helm@lumc.nl
A. Helm, van der
LUMC Dept. Rheumatology
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
+31 71 526 3598
A.H.M.van_der_Helm@lumc.nl
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
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, GFR<30 ml/min.
5.Pregnancy or the wish to become pregnant, breast feeding
6.Bone marrow hypoplasia
7.Elevated hepatic enzyme levels (ASAT, ALAT >3 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4599 |
NTR-old | NTR4853 |
Other | METC Leiden Den Haag Delft (LDD) : P14.296 METC LDD |