Rheumatoid arthritis Musculoskeletal Diseases Arthropathies
Conditions
Interventions
1. Withdrawal of anti-TNF therapy
2. Ultrasound of hands of dominant hand
3. Metacarpophalangeal joints two to five and wrist
4. X-ray of hands and feet
5. Blood tests for immunological assessment
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years 2. Male or female 3. American College of Rheumatology (ACR) diagnosis of rheumatoid arthritis 4. Stable Tumor Necrotising Factor (TNF) antagonist and concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs) (e.g. methotrexate treatment for six months) 5. Clinical remission for six months (at time of screening) as defined by Disease Activity Score (DAS28) less than 2.6 6. No clinical indication to change current treatment
Exclusion criteria
Exclusion criteria: 1. Patients who are unwilling or unable to give consent 2. Patients who are pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients experiencing flare of disease at six months (defined as an increase in DAS28 more than 1.2 or to a total DAS more than 2.6). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in damage at six months when compared to baseline as measured by X-ray of both hands and feet (modified Sharpe Van de Heijde score) and ultrasound 2. Change in clinical and laboratory markers of disease activity, function and quality of life 3. Assessment of regulatory T cell levels in remission patients 4. Flare of disease by 12 months | — |
Countries
United Kingdom
Outcome results
None listed