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9RT",{"type":57,"coordinates":666},[659,660],{"lat":660,"lon":659},{"facility":669,"status":43,"city":670,"state":43,"zip":671,"country":655,"countryCode":656,"cosmosGeoPoint":672,"geoPoint":676,"contacts":43},"Mid Essex Hospitals NHS Trust \u002FID# 151636","Chelmsford","CM1 7ET",{"type":57,"coordinates":673},[674,675],0.46958,51.73575,{"lat":675,"lon":674},{"facility":678,"status":43,"city":679,"state":43,"zip":680,"country":655,"countryCode":656,"cosmosGeoPoint":681,"geoPoint":685,"contacts":43},"Western General Hospital \u002FID# 132966","Edinburgh","EH4 2XU",{"type":57,"coordinates":682},[683,684],-3.19648,55.95206,{"lat":684,"lon":683},{"facility":687,"status":43,"city":688,"state":43,"zip":689,"country":655,"countryCode":656,"cosmosGeoPoint":690,"geoPoint":694,"contacts":43},"Chapel Allerton Hospital \u002FID# 129208","Leeds","LS7 4SA",{"type":57,"coordinates":691},[692,693],-1.54785,53.79648,{"lat":693,"lon":692},{"facility":696,"status":43,"city":697,"state":43,"zip":698,"country":655,"countryCode":656,"cosmosGeoPoint":699,"geoPoint":703,"contacts":43},"University Hospital Aintree \u002FID# 132980","Liverpool","L9 7AL",{"type":57,"coordinates":700},[701,702],-2.97794,53.41058,{"lat":702,"lon":701},{"facility":705,"status":43,"city":706,"state":43,"zip":707,"country":655,"countryCode":656,"cosmosGeoPoint":708,"geoPoint":712,"contacts":43},"Queen Alexandra Hospital \u002FID# 132982","Portsmouth","PO6 3LY",{"type":57,"coordinates":709},[710,711],-1.09125,50.79899,{"lat":711,"lon":710},{"type":714,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100224389","phase-4-a-phase-4-trial-assessing-the-impact-of-residual-inflammation-detected-via-imaging-techniques-drug-levels-and-patient-characteristics-on-the-outcome-of-dose-tapering-of-adalimumab-in-clinical-remission-rheumatoid-arthritis-ra-subjects-100224389",true,"NCT02198651","A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects","A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA)","PREDICTRA","Inclusion Criteria:\n\n1. Participant had a diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and\u002For the ACR \u002FEuropean League Against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis).\n2. Participant must have met the following criteria:\n\n   * Must have been treated with adalimumab 40 mg subcutaneously every other week (sc eow) for at least 12 months prior to Week 0 Visit\n   * Must have been treated with concomitant methotrexate (MTX) at a stable dose (oral, sc or intramuscular (im) at any dose) for at least 12 weeks prior to Week 0 Visit or if not on MTX, must have been treated with other allowed conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) at a stable dose for at least 12 weeks prior to Week 0 Visit or if not treated with csDMARDs must maintain this regimen for at least 12 weeks prior to Week 0 Visit.\n3. Participant must be in sustained clinical remission based on the following:\n\n   * At least one documented 4 or 3 (if Patient's Global Assessment ; PGA is not available) variables Disease Activity Score 28 Erythrocyte sedimentation rate (DAS28 ESR) or DAS28 C-reactive protein (CRP) \\\u003C 2.6 (or calculated based on documented components of the DAS28) in the participant's chart 6 months or longer prior to the Screening Visit;\n   * 4 variables DAS28 (ESR) assessed at Screening \\\u003C 2.6, with all components including ESR assessed at Screening.\n4. If participant was receiving concomitant allowed csDMARDs (in addition or not to MTX) the dose must have been stable for at least 12 weeks prior to the Week 0 Visit (e.g., chloroquine, hydroxychloroquine, sulfasalazine, gold formulations \\[including auranofin, gold sodium thiomalate, and aurothioglucose\\] and\u002For leflunomide).\n5. If participant was receiving concomitant oral corticosteroids, prednisone or equivalent must have been \\\u003C 10 mg\u002Fday and the dose must have been stable for at least 4 weeks prior to the Week 0 Visit.\n6. If participant was receiving concomitant non-steroidal anti-inflammatory drugs (NSAIDs), tramadol or other equivalent opioids and\u002For non-opioid analgesics, the dose and\u002For therapeutic scheme must have been stable for at least 4 weeks prior to the Week 0 Visit.\n7. Participant must have been able and willing to provide written informed consent and comply with the requirements of this study protocol.\n\nExclusion Criteria:\n\n1. Any 4 or 3 (if PGA is not available) variables DAS28 (ESR) or DAS28 (CRP) (or calculated based on documented components of the DAS28) assessed within 6 months prior to the Screening Visit ≥ 2.6.\n2. Participant was on an additional concomitant biological disease-modifying anti-rheumatic drug (bDMARD) (including but not limited to abatacept, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab or tocilizumab).\n3. Participant had been treated with intra-articular or parenteral corticosteroids within the last four weeks before Screening.\n4. Participant had undergone joint surgery within 12 weeks of Screening (at joints to be assessed by magnetic resonance imaging (MRI) and\u002For ultrasound).\n5. Participant had a medical condition precluding an MRI (e.g. magnetic activated implanted devices - cardiac pace-maker, insulin pump, neuro stimulators, etc. and metallic devices or fragments or clips in the eye, brain or spinal canal and in the hand\u002Fwrist undergoing MRI)\n6. Participant had a medical condition precluding a contrast MRI with gadolinium \\[e.g. nephrogenic systemic fibrosis, previous anaphylactic\u002Fanaphylactoid reaction to gadolinium containing contrast agent, pregnancy or breast feeding, severe renal insufficiency with an estimated Glomerular Filtration Rate (eGFR) below 30 mL\u002Fmin\u002F1.73m\\^2 at Screening, hepato-renal syndrome, severe chronic liver function impairment\\]\n7. Participant had been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Screening Visit.",false,"ALL","18 Years",{"count":727,"type":728},149,"ACTUAL","INTERVENTIONAL",[731],"PHASE4","The primary objective of the study was to investigate the association between residual disease activity at Baseline as detected by Magnetic Resonance Imaging (MRI) and the occurrence of flares in participants with rheumatoid arthritis (RA) randomized to an adalimumab dose tapering regimen controlled by adalimumab withdrawal.",[734,735],"Rheumatoid Arthritis","Musculoskeletal and Connective Tissue Diseases",[734,32,737,738,739,740,741,742,743,744,745,746],"Taper","Flare","Arthritis","Anti-rheumatic drugs","Remission","Magnetic Resonance Imaging","Ultrasound","Biomarker","Drug Level","Reduced dose","COMPLETED","2019-06-06",{"date":750,"type":728},"2019-06-25",{"date":752,"type":728},"2015-01-05",{"date":754,"type":728},"2018-08-08",{"name":5,"class":6},70]