Improving outcomes for patients with rheumatoid arthritis with intermediate disease - is intensive management more effective than standard care?

Not Applicable

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN70160382
• Lead Sponsor: King's College London

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-16
• Study Completion: 2018-07-14
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 335

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
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 swollen joints and three tender joints on 66/68 joint count
4. Willing and able to follow an intensive management programme
5. Able and willing to give informed consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease remission at 12 months (final assessment) measured by the Disease Activity Score-28 (DAS28) criterion (DAS28-ESR<2.6)