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


- candidate number20741
- NTR NumberNTR4853
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-okt-2014
- Secondary IDsP14.296 METC LUMC Leiden 
- Public TitleTreat early arthralgia to reverse or limit impending exacerbation to rheumatoid arthritis
- Scientific TitleA randomized clinical trial in recent-onset arthralgia patients that are suspect to progress to rheumatoid arthritis evaluating the efficacy of intervention with a single dose of IM corticosteroids and methotrexate
- ACRONYMTREAT EARLIER
- hypothesisThis 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.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteria1.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 criteria1.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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2015
- planned closingdate1-jan-2019
- Target number of participants200
- InterventionsAt 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).
- Primary outcomeThe 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 4 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 (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
- TimepointsEvery 4 months during 2 years follow-up
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES A. Helm, van der
- CONTACT for SCIENTIFIC QUERIES A. Helm, van der
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryProof-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.
- Main changes (audit trail)
- RECORD20-okt-2014 - 13-mrt-2015


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