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.
ID
Bron
Verkorte titel
Aandoening
Rheumatoid Arthritis - Clincally Suspect Artralgia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Every 4 months during 2 years follow-up
Onderzoeksproduct en/of interventie
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).
Algemeen / deelnemers
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
Wetenschappers
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4599 |
| NTR-old | NTR4853 |
| Ander register | METC Leiden Den Haag Delft (LDD) : P14.296 METC LDD |