Objective assessment of the remission state and Predictors of sustained Remission in Rheumatoid Arthritis: leading to development of new management guidelines

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Paul Emery
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
Email	benazir_saleem@yahoo.co.uk

Primary study design	Observational
Study design	Prospective observational study of two cohorts: early rheumatoid arthritis patients, and established rheumatoid arthritis patients
Secondary study design	Cohort study
Study type	Participant 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(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).
Key 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
Completion date	01/06/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

c/o Dr Benazir Saleem

Leeds
LS7 4SA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes