OPtimising Treatment with Tumour necrosis factor (TNF) Inhibitors in Rheumatoid Arthritis: is dose tapering practical in good responders?

Not Applicable

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN28955701
• Lead Sponsor: King's College London (KCL) (UK)

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28968858 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29862047

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-25
• Study Completion: 2013-08-31
• Last Update Posted: 2 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

1. RA by American College of Rheumatology and EULAR criteria
2. Etanercept or adalimumab treatment for at least 6 months (a break of up to 4 consecutive weeks is permitted)
3. Taking at least one DMARD
4. Stable clinical response for at least 3 months (one DAS28 score of 3.2 or less; no increase in DAS28 greater than 0.6)
5. Patient considers he or she has achieved a suitable response to TNF inhibitors
6. Supervising rheumatologist considers further improvements are unlikely on the patients current treatment regimen
7. At least 18 years of age, either sex
8. Willing and able to give informed consent

Exclusion Criteria

1. Serious concurrent illness (e.g. terminal cancer)
2. Prednisolone at more than 10mg daily (for doses > 10mg daily, a 4 week washout period is required)
3. Recently received intramuscular (IM)/intra-areterial (IA) steroids (12 weeks washout required)
4. Pregnancy, breast-feeding or women of child-bearing potential not using adequate contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The development of flares, defined as an increase in DAS28 scores at least 0.6. To ensure such changes in DAS28 represent a genuine flare in RA and are not due to unrelated events (e.g. an inter-current illness like influenza) additional criteria required for a flare are:<br>1. It must include an increase in the swollen joint count<br>2. It must be present on two occasions at least one week apart<br>3. It results in DAS28 scores greater than 3.2<br><br>Large increases in DAS28 scores (1.2 or more) which result in DAS28 greater than 3.2 will not require any additional criteria. DAS28 measurements at baseline, 3, 6, 9 and 12 monthly assessments. The participants will also be telephoned every month to check whether their RA symptoms have increased. If it is suspected a patient is experiencing a flare, they should come in for a flare assessment within 2 weeks.

Secondary Outcome Measures

Name	Time	Method
1. DAS28 [tender and swollen joint counts, patient global Visual Analogue Scale (VAS), erythrocyte sedimentation rate (ESR)] and Extended Joint Count 68/66, monitored at baseline, 3, 6, 9 and 12 months<br>2. Simple disease activity score (SDAI) and clinical disease activity score (CDAI), at baseline, 3, 6, 9 and 12 months<br>3. Health Assessment Questionnaire (HAQ) scores, at baseline, 3, 6, and 12 months <br>4. Adverse events, at baseline, 3, 6, 9 and 12 months<br>5. EuroQol scores, at baseline, 3, 6, and 12 months <br>6. SF-36, at baseline, 3, 6, and 12 months<br>7. Plain x-rays of the hands and feet scored by Larsens and Van Der Heijdi Sharpe Modified Scores (to provide preliminary data), at baseline, 6, and 12 months<br>8. Analysis of serum, immunological and gene expression profiles; biomarker blood taken at baseline for the experimental groups and at 6 months for the control group