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arthritis, trial, patients, study, participants, data, article, mri, clinical, pubmed, google, scholar, rheumatoid, van, csa, mtx, inflammation, endpoint, rheumatology, arthralgia, primary, disease, protocol, treatment, rheum, subclinical, clinically, joints, ann, dis, department, lumc, phase, joint, netherlands, months, time, rheumatologists, results, participant, followup, early, development, risk, years, medical, cas, symptoms, mil, intervention,

Topics {✒️}

nl/richtlijnen/nvr-richtlijnen-standpunten-en-zorgpaden/ org/standaarden/volledig/nhg-standaard-artritis disease-modifying anti-rheumatic drugs van der horst-bruinsma steroidal anti-inflammatory drugs anti-citrullinated peptide antibody placebo-controlled trials aiming age-matched symptom-free persons anti-carbamylated protein antibodies van steenbergen hw article download pdf van nies ja joint/bone/tendon sheath level van der kooij placebo-controlled intervention study multiple joints/bones/tendon sheaths open-label dmard therapy participant open-ended questions randomized placebo-controlled mri-detected subclinical inflammation acute bone stress symptomatic pre-arthritis phase maturing auto-antibody response imaging-detected subclinical inflammation rheumatism eq-5d-5l acute-phase reactants achieve secondary prevention age-matched general population van de laar placebo-controlled trial received concomitant medication disease-modifying drugs bmc musculoskelet disord c-reactive protein van baarsen lg van dijk bt van gaalen fa gillet-van dongen ra-specific inflammation starts shared decision-making healthcare central committee achieved dmard-free status privacy choices/manage cookies ten brinck rm cyclic citrullinated peptide longitudinal leiden-csa cohort checking medical forms informed written consent—randomization clinically apparent arthritis open access reported

Questions {❓}

• Costs for hospital care, drugs and lost work days in incident and prevalent rheumatoid arthritis: how large, and how are they distributed?
• Is anti-citrullinated protein antibody-positive rheumatoid arthritis still a more severe disease than anti-citrullinated protein antibody-negative rheumatoid arthritis?
• Rheumatoid arthritis prevention in arthralgia: fantasy or reality?
• The earlier, the better or the worse?
• What is the prevalence of MRI-detected inflammation and erosions in small joints in the general population?
• Which patients presenting with arthralgia eventually develop rheumatoid arthritis?
• Who will take informed consent?

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WebPage:
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         headline:TREAT Early Arthralgia to Reverse or Limit Impending Exacerbation to Rheumatoid arthritis (TREAT EARLIER): a randomized, double-blind, placebo-controlled clinical trial protocol
         description:We present a study protocol for a randomized, double-blind, placebo-controlled trial that investigates the hypothesis if intervention in the symptomatic phase preceding clinical arthritis (clinically suspect arthralgia (CSA)) is effective in preventing progression from subclinical inflammation to clinically apparent persistent arthritis. Currently, rheumatoid arthritis (RA) can be recognized and diagnosed when arthritis (joint swelling) has become detectable at physical examination. Importantly, at this time, the immune processes have already matured, chronicity is established, and patients require long-standing treatment with disease-modifying anti-rheumatic drugs. The TREAT EARLIER trial studies the hypothesis that intervention in the symptomatic phase preceding clinical arthritis is more often successful in permanent disease modification because of less matured underlying disease processes. A two-level definition to identify patients that are prone to develop RA is used. First, patients should have CSA and recent-onset arthralgia (< 1 year) that is suspect to progress to RA according to the expertise of the treating rheumatologist. Second, patients need to have subclinical inflammation of the hand or foot joints at 1.5 T MRI. The trial aims to recruit 230 participants from secondary care hospital settings across the south-west region of The Netherlands. Intervention will be randomly assigned and includes a single-dose of intramuscular 120 mg methylprednisolon followed by methotrexate (increasing dose to 25 mg/week orally) or placebo (both; injection and tablets) over the course of 1 year. Thereafter, participants are followed for another year. The primary endpoint is the development of clinically detectable arthritis, either fulfilling the 2010 criteria for RA or unclassified clinical arthritis of ≥ 2 joints, which persists for at least 2 weeks. DMARD-free status is a co-primary endpoint. The patient-reported outcomes functioning, along with workability and symptoms, are key secondary endpoints. Participants, caregivers (including those assessing the endpoints), and scientific staff are all blinded to the group assignment. This proof-of-concept study is the logical consequence of pre-work on the identification of patients with CSA with MRI-detected subclinical joint inflammation. It will test the hypothesis whether intervention in patients in this early phase with the cornerstone treatment of classified RA (methotrexate) hampers the development of persistent RA and reduce the disease burden of RA. Dutch Trial Register NL4599 (NTR4853). Registered on 20 October 2014
         datePublished:2020-10-16T00:00:00Z
         dateModified:2020-10-16T00:00:00Z
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            Methotrexate
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      headline:TREAT Early Arthralgia to Reverse or Limit Impending Exacerbation to Rheumatoid arthritis (TREAT EARLIER): a randomized, double-blind, placebo-controlled clinical trial protocol
      description:We present a study protocol for a randomized, double-blind, placebo-controlled trial that investigates the hypothesis if intervention in the symptomatic phase preceding clinical arthritis (clinically suspect arthralgia (CSA)) is effective in preventing progression from subclinical inflammation to clinically apparent persistent arthritis. Currently, rheumatoid arthritis (RA) can be recognized and diagnosed when arthritis (joint swelling) has become detectable at physical examination. Importantly, at this time, the immune processes have already matured, chronicity is established, and patients require long-standing treatment with disease-modifying anti-rheumatic drugs. The TREAT EARLIER trial studies the hypothesis that intervention in the symptomatic phase preceding clinical arthritis is more often successful in permanent disease modification because of less matured underlying disease processes. A two-level definition to identify patients that are prone to develop RA is used. First, patients should have CSA and recent-onset arthralgia (< 1 year) that is suspect to progress to RA according to the expertise of the treating rheumatologist. Second, patients need to have subclinical inflammation of the hand or foot joints at 1.5 T MRI. The trial aims to recruit 230 participants from secondary care hospital settings across the south-west region of The Netherlands. Intervention will be randomly assigned and includes a single-dose of intramuscular 120 mg methylprednisolon followed by methotrexate (increasing dose to 25 mg/week orally) or placebo (both; injection and tablets) over the course of 1 year. Thereafter, participants are followed for another year. The primary endpoint is the development of clinically detectable arthritis, either fulfilling the 2010 criteria for RA or unclassified clinical arthritis of ≥ 2 joints, which persists for at least 2 weeks. DMARD-free status is a co-primary endpoint. The patient-reported outcomes functioning, along with workability and symptoms, are key secondary endpoints. Participants, caregivers (including those assessing the endpoints), and scientific staff are all blinded to the group assignment. This proof-of-concept study is the logical consequence of pre-work on the identification of patients with CSA with MRI-detected subclinical joint inflammation. It will test the hypothesis whether intervention in patients in this early phase with the cornerstone treatment of classified RA (methotrexate) hampers the development of persistent RA and reduce the disease burden of RA. Dutch Trial Register NL4599 (NTR4853). Registered on 20 October 2014
      datePublished:2020-10-16T00:00:00Z
      dateModified:2020-10-16T00:00:00Z
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         Clinically suspect arthralgia
         Subclinical inflammation
         MRI
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         Prevention
         Methotrexate
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         Medicine/Public Health
         general
         Biomedicine
         Statistics for Life Sciences
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         Health Sciences
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      name:Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
      name:Department of Rheumatology, Erasmus Medical Center, Rotterdam, The Netherlands

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