Objective assessment of the remission state and Predictors of sustained Remission in Rheumatoid Arthritis: leading to development of new management guidelines
| ISRCTN | ISRCTN77249875 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77249875 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/12/2006
- Registration date
- 30/04/2007
- Last edited
- 24/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Paul Emery
Scientific
Scientific
c/o Dr Benazir Saleem
Academic Unit of Musculoskeletal Disease
2nd Floor, Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
| Phone | +44 (0)113 392 4883 |
|---|---|
| benazir_saleem@yahoo.co.uk |
Study information
| Study design | Prospective observational study of two cohorts: early rheumatoid arthritis patients, and established rheumatoid arthritis patients |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | OPRRA |
| Study objectives | The presence of sustained clinical remission is dependant on objective imaging and immunological characteristics of remission. |
| Ethics approval(s) | Approval received from the Harrogate Local Research Ethics Committee on th 21st September 2005 (ref: 05/Q1107/57). |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/12/2005 |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key exclusion criteria | 1. Patients who are unwilling or unable to give consent 2. Patients who are pregnant |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 01/06/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
c/o Dr Benazir Saleem
Leeds
LS7 4SA
United Kingdom
LS7 4SA
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
c/o Clare Skinner
Research Grants Manager
School of Medicine
Leeds
LS2 9JT
England
United Kingdom
| Phone | +44 (0)113 3434897 |
|---|---|
| c.e.skinner@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Industry
Abbott Laboratories Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2009 | Yes | No | |
| Results article | results | 01/09/2010 | Yes | No | |
| Results article | results | 01/05/2011 | Yes | No |
