| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN77249875 |
| Date ISRCTN assigned | 30/04/2007 |
| Local reference number(s) | N/A |
| Public title | Objective assessment of the remission state and Predictors of sustained Remission in Rheumatoid Arthritis: leading to development of new management guidelines |
| Scientific title |
|
| Acronym | OPRRA |
| Disease/condition/study domain | Rheumatoid arthritis |
| Study hypothesis | The presence of sustained clinical remission is dependant on objective imaging and immunological characteristics of remission. |
| Design/methodology | Prospective observational study of two cohorts: early rheumatoid arthritis patients, and established rheumatoid arthritis patients |
| Research ethics review | Approval received from the Harrogate Local Research Ethics Committee on th 21st September 2005 (ref: 05/Q1107/57). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | 1. Patients who are unwilling or unable to give consent
2. Patients who are pregnant |
| Patient information material |
|
| Anticipated start date | 01/12/2005 |
| Anticipated end date | 01/06/2008 |
| Status of trial | Ongoing |
| Target number of participants | 100 |
| 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 |
| Primary outcome measure(s) | 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 outcome measure(s) | 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 |
| Sources of funding | Abbott Laboratories Ltd (UK) |
| Sponsor name | University of Leeds (UK) |
| Sponsor details | c/o Clare Skinner
Research Grants Manager
School of Medicine
Leeds
United Kingdom
LS2 9JT |
| Sponsor telephone | +44 (0)113 3434897 |
| Sponsor email | c.e.skinner@leeds.ac.uk |
| Sponsor website | http://www.leeds.ac.uk/ |
| Contact name | Prof Paul Emery |
| Contact details | c/o Dr Benazir Saleem
Academic Unit of Musculoskeletal Disease
2nd Floor, Chapel Allerton Hospital
Chapeltown Road
Leeds
United Kingdom
LS7 4SA |
| Contact telephone | +44 (0)113 392 4883 |
| Contact email | benazir_saleem@yahoo.co.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN77249875 |
| Date last extracted from ISRCTN register | 17/04/2008 |
