Contact information
Type
Scientific
Primary contact
Prof Paul Emery
ORCID ID
Contact details
c/o Dr Benazir Saleem
Academic Unit of Musculoskeletal Disease
2nd Floor
Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
+44 (0)113 392 4883
benazir_saleem@yahoo.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
OPRRA
Study hypothesis
The presence of sustained clinical remission is dependant on objective imaging and immunological characteristics of remission.
Ethics approval
Approval received from the Harrogate Local Research Ethics Committee on th 21st September 2005 (ref: 05/Q1107/57).
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
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/12/2005
Overall trial end date
01/06/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Patients who are unwilling or unable to give consent
2. Patients who are pregnant
Recruitment start date
01/12/2005
Recruitment end date
01/06/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
c/o Dr Benazir Saleem
Leeds
LS7 4SA
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
c/o Clare Skinner
Research Grants Manager
School of Medicine
Leeds
LS2 9JT
United Kingdom
+44 (0)113 3434897
c.e.skinner@leeds.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Abbott Laboratories Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19565512
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20421345
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21242236
Publication citations
-
Results
Saleem B, Brown AK, Keen H, Nizam S, Freeston J, Karim Z, Quinn M, Wakefield R, Hensor E, Conaghan PG, Emery P, Disease remission state in patients treated with the combination of tumor necrosis factor blockade and methotrexate or with disease-modifying antirheumatic drugs: A clinical and imaging comparative study., Arthritis Rheum., 2009, 60, 7, 1915-1922, doi: 10.1002/art.24596.
-
Results
Saleem B, Keen H, Goeb V, Parmar R, Nizam S, Hensor EM, Churchman SM, Quinn M, Wakefield R, Conaghan PG, Ponchel F, Emery P, Patients with RA in remission on TNF blockers: when and in whom can TNF blocker therapy be stopped?, Ann. Rheum. Dis., 2010, 69, 9, 1636-1642, doi: 10.1136/ard.2009.117341.
-
Results
Saleem B, Brown AK, Keen H, Nizam S, Freeston J, Wakefield R, Karim Z, Quinn M, Hensor E, Conaghan PG, Emery P, Should imaging be a component of rheumatoid arthritis remission criteria? A comparison between traditional and modified composite remission scores and imaging assessments., Ann. Rheum. Dis., 2011, 70, 5, 792-798, doi: 10.1136/ard.2010.134445.