Skip to main content
Clinical Trials/ISRCTN70160382
ISRCTN70160382
Completed
未知

A pragmatic randomised controlled open trial of the effect of intensive management (IM) compared with standard care (SC) on remission rates at 12 months in rheumatoid arthritis patients with intermediate disease activity

King's College London0 sites335 target enrollmentJanuary 16, 2014

Overview

Phase
未知
Intervention
Not specified
Conditions
Musculoskeletal Diseases
Sponsor
King's College London
Enrollment
335
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32931984/ results (added 06/10/2020) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37749588/ Secondary analysis (added 26/09/2023)

Registry
who.int
Start Date
January 16, 2014
End Date
July 14, 2018
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Current inclusion criteria as of 11/06/2015:
  • 1\. Diagnosis of Rheumatoid Arthritis (by ACR, 2010 criteria)
  • 2\. Have received at least one DMARD for at least six months, and currently receiving at least one DMARD
  • 3\. Have intermediate disease activity, defined by:
  • 3\.1\. DAS28\-ESR 3\.2\-5\.1\.
  • 3\.2\. At least three active joints (defined as swollen and/or tender) on 66/68 joint count, to include at least one swollen joint
  • 4\. Willing and able to follow an intensive management programme
  • 5\. Able and willing to give informed consent
  • Previous inclusion criteria:
  • 1\. Diagnosis of Rheumatoid Arthritis (by ACR, 2010 criteria); duration six months to 10 years

Exclusion Criteria

  • 1\. Major co\-morbidities making intensive treatment inadvisable (e.g. heart failure)
  • 2\. Previously failed multiple DMARDs (more than or equal to 5 treatments) or having received biologics
  • 3\. Irreversible disability from extensive joint damage (for example, replacement of three or more major joints)
  • 4\. Women who are pregnant, breastfeeding or planning to conceive
  • 5\. Currently in early RA pathway
  • 6\. Current or recent (within the previous 12 weeks) participation in another interventional trial

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
Is a mobile phone app delivering cognitive behavioural therapy effective at helping people quit smoking?Tobacco useMental and Behavioural Disorders
ISRCTN65853476Digital Therapeutics Inc.531
Completed
Not Applicable
Pilot randomized-controlled trial on the efficacy of acupuncture in people with an increased stress levelAdults with high self-reported stress levelsMental and Behavioural Disorders
ISRCTN15259166niversity Hospital Heidelberg70
Completed
Not Applicable
Trial comparing the effectiveness and cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of Standard And New Antiepileptic DrugsTopic: Medicines for Children Research Network, NeurologicalSubtopic: All Diagnoses, Neurological (all Subtopics)Disease: Nervous system disordersNervous System DiseasesEpilepsy
ISRCTN30294119niversity of Liverpool (UK)1,510
Completed
Not Applicable
A comparison of Orve+ Wrap and forced air warming blankets in managing patients’ temperature following surgerySpecialty: Anaesthesia, perioperative medicine and pain management, Primary sub-specialty: Anaesthesia, Perioperative Medicine and Pain ManagementUKCRC code/ Disease: Injuries and Accidents/ Complications of surgical and medical care, not elsewhere classifiedSigns and SymptomsHypothermia post-surgery
ISRCTN11563874Hull and East Yorkshire Hospitals NHS Trust129
Completed
Not Applicable
REACT Trial: Supporting relatives of people with psychosis or bipolar disorderTopic: Mental Health, Primary CareSubtopic: Bipolar affective disorder, Psychosis, Primary careDisease: Bipolar affective disorder, Psychosis, All DiseasesMental and Behavioural Disorders1. Psychosis 2. Bipolar Disorder
ISRCTN72019945ancaster University800