Randomised controlled trial of tumour necrosis factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis

Phase 4

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases; Arthropathies

• Registration Number: ISRCTN37438295
• Lead Sponsor: King's College London (UK)

Brief Summary

2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25351370 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25769495 results 2016 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/27651924 secondary analysis 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/30629813/ cost-effectiveness results (added 13/07/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36148396/ Characterization of missing data patterns and mechanisms (added 29/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-12
• Study Completion: 2010-03-31
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

1. Males and females aged over 18 years
2. Established RA by the criteria of the American College of Rheumatology
3. Disease duration of at least 12 months
4. Meet NICE criteria for being prescribed TNF inhibitors:
4.1. Disease Activity Score (DAS) over 5.1
4.2. Failure to respond to two DMARDs including methotrexate
4.3. No contra-indications to TNF inhibitors (including possibility of pregnancy)

Exclusion Criteria

1. Unable or unwilling to give informed consent
2. Failure of, or contra-indications to, all proposed DMARD combinations (including possibility of pregnancy)
3. Serious inter-current illness
4. Patients on high dose steroids (in excess of 10 mg prednisolone or equivalent per day at trial entry)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Heath Assessment Questionnaire (HAQ).<br> Primary and secondary outcomes will be measured at baseline (month 0), 6 months and 12 months.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Joint damage<br> 2. Quality of life<br> 3. Disease activity<br> 4. Withdrawal rates<br> 5. Adverse effects<br> 6. Economic evaluation:<br> 6.1. Societal costs<br> 6.2. Cost-effectiveness<br> 6.3. Cost-utility<br><br> Primary and secondary outcomes will be measured at baseline (month 0), 6 months and 12 months. Patients will be asked to attend monthly for blood monitoring and will be asked a short questionnaire regarding concomitant medication, any tests outside routine monitoring and adverse events within the last month.<br>